A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Phase: PHASE3
Conditions: Colitis, Ulcerative
Sponsor: Janssen Research & Development, LLC

CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
1
Status: Approved: 11 November 2023
Janssen Research & Development *
Clinical Protocol
A Phase 3 Randomized, Open-label Study to Assess the Efficacy, Safety, and
Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody,
Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active
Ulcerative Colitis
PURSUIT 2
Short Title
A Study of the Efficacy and Safety of Golimumab in Pediatric Participants
with Moderately to Severely Active Ulcerative Colitis
Protocol CNTO148UCO3003; Phase 3
AMENDMENT 6
SIMPONI (golimumab)
*Janssen Research & Development is a global organization that operates through different legal entities in
various countries. Therefore, the legal entity acting as the sponsor for Janssen Research & Development
studies may vary, such as, but not limited to Janssen Biotech, Inc.; Janssen Products, LP; Janssen Biologics,
BV; Janssen-Cilag International NV; Janssen, Inc; Janssen Pharmaceutica NV; Janssen Sciences Ireland
UC; or Janssen Research & Development, LLC. The term “sponsor” is used throughout the protocol to
represent these various legal entities; the sponsor is identified on the Contact Information page that
accompanies the protocol.
US sites of this study will be conducted under US Food & Drug Administration IND regulations
(21 CFR Part 312).
EudraCT NUMBER: 2017-004496-31
EU TRIAL NUMBER: 2023-507142-83
Status: 
Approved
Date: 
11 November 2023
Prepared by: Janssen Research & Development, LLC
EDMS number: 
EDMS-ERI-151778403; 12.0
GCP Compliance: This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory
requirements.
Confidentiality Statement
The information provided herein contains Company trade secrets, commercial or financial information that the Company
customarily holds close and treats as confidential.  The information is being provided under the assurance that the recipient
will maintain the confidentiality of the information under applicable statutes, regulations, rules, protective orders or
otherwise.
NCT03596645

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
2
Approved, Date: 11 November 2023
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE
DOCUMENT HISTORY
Document 
Date
Amendment 6 
11 November 2023
Amendment 5 
14 October 2022
Amendment 4 
16March 2021
Amendment 3 
8 Jul 2019
Amendment 2 
13 May 2019
Amendment 1 
27 Jun 2018
Original Protocol 
17 May 2018
Amendment 6 (11 November 2023)
Overall Rationale for the Amendment: Upon implementation of this amendment, laboratory assessments
will be streamlined and PUCAI will be eliminated after Week 90 to reduce subjectburden while maintaining
collection of meaningful safety data during the study extension.
The changes made to the clinical protocol CNTO148UCO3003 as part of Protocol Amendment 6 are listed
below, including the rationale of each change and a list of all applicable sections. Changes made in previous
protocol amendments are listed in Section 10.20 Appendix 20: Protocol Amendment History.
Section Number 
and Name
Description of Change 
Brief Rationale
Section 1.1. 
Synopsys 
Statistical Methods 
Statistical 
Hypothesis 
Section 9.1. 
Statistical 
Hypothesis 
Primary hypothesis was revised as follows: 
The primary hypothesis is that golimumab is an effective 
therapy in pediatric UC relative to a historical placebo
control as assessed by clinical remission at Week 6 based
on the Mayo score. The historical placebo clinical
remission rate control is based on meta-analysis of 7
adult UC studies including infliximab Phase 3
(C0168T37 and C0168T46), golimumab Phase 2/3
(C0524T16 and C0524T17), adalimumab Phase 3
(ULTRA 1 and ULTRA 2), and vedolizumab Phase 3
(GEMINI 1).
Specified the timing when
clinical remission is assessed.
1.1 Synopsis 
Statistical Methods 
Sample size
calculations
“Mayo clinical” added throughout the text. 
Added to clarify planned
analyses.
Section 1.1. 
Synopsis 
Endpoints 
Section 3.1.
Endpoints
Major Secondary
Endpoints
Section 9.4.1.2.
Major Secondary
Endpoints
Section 9.4.1.3.
Sentence moved or added: 
For endpoints beyond Week 6, analyses will be performed 
on participants who are in clinical response at Week 6 as
assessed by the Mayo score.
Clarified definition of several
secondary endpoints.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
3
Approved, Date: 11 November 2023
Section Number
and Name
Description of Change 
Brief Rationale
Other Endpoints
Section 1.3.
Schedule of
Activities
Table 2
Title of column 3 was revised: Every 6 months starting
Week 66through and including Week 90 for all
participants.
Addition of new column 4: Every year after Week 90
(starting at Week 114) for all participants with Xs
added for Clinical Laboratory Assessments and
PK/Immunogenicity.
Footnote o was revised: Samples should be collected
every 6 months during Year 1 of the study extension and,
starting at Week 108 114, annually thereafter.
New footnote p was added: PUCAI will be collected
until each participant completes a Week 90 visit.
Sufficient information will
be collected up to and
including Week 90 to assess
safety and efficacy.
After Week 90, safety
laboratory assessments will
be collected annually to
reduce participant burden.
PUCAI was removed after
each participant completes
Week 90 since sufficient
information for this endpoint
will have been collected in
the study prior to this point.
Section 4.1.
Overall Design
Study extension
(Week 54 to end of
study)
Text for Group 1 was revised:
Group 1 (Golimumab): After the Week 54 evaluations,
at the discretion of the investigator, if participants
receiving golimumab are able to benefit from continued
SC golimumab, the participants will continue to receive
SC golimumab q4w starting at Week 54 under this
protocol’s study extension until marketing authorization
is obtained for golimumab for the treatment of pediatric
participants with UC, the participant turns 18 and has
access to commercially available golimumab or until a
decision is made not to pursue an indication in this
pediatric UC population, whichever occurs first.
Participants who continue golimumab treatment as part of
the study extension will be intermittently evaluated per
the protocol for efficacy, PK, and safety.
Group 1 (Golimumab): Following the Week  54
evaluations (end of the main pivotal study), participants
who are receiving benefit from golimumab, at the
discretion of the investigator, may continue to receive SC
golimumab q4w in an extension period until one of the
following conditions below is met, whichever occurs first:
1. marketing authorization is obtained for golimumab for
the treatment of pediatric participants with UC and
golimumab is either commercially available or 2 years
have lapsed since marketing authorization, or
2. the participant turns 18 years of age and has access to
commercially available golimumab, or
3. until a decision is made by the sponsor not to pursue
an indication in this pediatric UC population.
Further defined end of study
language.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
4
Approved, Date: 11 November 2023
Section Number 
and Name
Description of Change 
Brief Rationale
Section 4.4.1. 
Study Completion 
Study extension 
The text for the section was revised as follows: 
At Week 54, participants who may benefit will continue
to receive SC golimumab q4w under this protocol until
marketing authorization is obtained for golimumab for
the treatment of pediatric participants with UC, the
participant turns 18 and has access to commercially
available golimumab, or until a decision is made not to
pursue an indication in this pediatric UC population,
whichever occurs first. Participants who prematurely
discontinue study interventions for any reason before this
time point will not be considered to have completed the
study extension phase.
Following the Week 54 evaluations (end of the main
pivotal study), participants who are receiving benefit from
golimumab, at the discretion of the investigator, may
continue to receive SC golimumab q4w in an extension
period until one of the following conditions below is met,
whichever occurs first:
1. marketing authorization is obtained for golimumab for
the treatment of pediatric participants with UC and
golimumab is either commercially available or 2 years
have lapsed since marketing authorization, or
2. the participant turns 18 years of age and has access to
commercially available golimumab, or
3. until a decision is made by the sponsor not to pursue
an indication in this pediatric UC population.
Further defined end of study
language.
Section 6.4. 
Study Intervention 
Compliance 
The text for the section was revised as follows: 
Visit window: From Week 0 through Week 54, it is 
expected that all visits will occur within a range of ±7 
days of the scheduled visit. Any visits outside of these 
ranges should be discussed with the sponsor. If a study 
visit occurs outside the specified visit window, the 
participant should then resume his or her normal dose
schedule relative to the baseline visit (Week 0) as soon as
possible. After Week 54 the follow-up study visits should
occur within ±14 days of the scheduled study visit. Any
out-of-range visits after Week 54 should be documented
in the participant’s source notes. Dosing window: From
Week 0 through the end of the trial, any doses that are
planned to occur outside of ±7 day dosing window
should be discussed with the sponsor.
Golimumab should be administered as close as
possible to the q4w dosing schedule.
Doses outside of ±7 days
range requires discussion
with the sponsor to
determinate appropriate dose
schedule to ensure adequate
time between doses.
Throughout the 
protocol 
Minor grammatical, formatting, or spelling changes were 
made.
Minor errors were noted.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
5
Approved, Date: 11 November 2023
TABLE OF CONTENTS
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ............................................................... 2
TABLE OF CONTENTS ............................................................................................................................... 5
LIST OF IN-TEXT TABLES AND FIGURES................................................................................................ 8
1. 
PROTOCOL SUMMARY..................................................................................................................... 9
1.1. 
Synopsis........................................................................................................................................... 9
1.2. 
Schema.......................................................................................................................................... 17
1.3. 
Schedule of Activities (SoA)........................................................................................................... 18
2. 
INTRODUCTION................................................................................................................................ 26
2.1. 
Study Rationale.............................................................................................................................. 26
2.2. 
Background.................................................................................................................................... 29
2.3. 
Benefit/Risk Assessment ............................................................................................................... 30
2.3.1. 
Known and Potential Benefits..................................................................................................... 30
2.3.1.1. 
Known Benefits........................................................................................................................ 30
2.3.1.2. 
Potential Benefits..................................................................................................................... 31
2.3.2. 
Known and Potential Risks......................................................................................................... 31
2.3.2.1. 
Known Risks............................................................................................................................ 31
2.3.2.2. 
Potential Risks......................................................................................................................... 31
2.3.3. 
Overall Benefit: Risk Assessment .............................................................................................. 31
3. 
OBJECTIVES AND ENDPOINTS ..................................................................................................... 35
3.1. 
ENDPOINTS .................................................................................................................................. 35
4. 
STUDY DESIGN ................................................................................................................................ 36
4.1. 
Overall Design................................................................................................................................ 36
4.2. 
Scientific Rationale for Study Design............................................................................................. 42
4.2.1. 
Historical Placebo....................................................................................................................... 42
4.2.2. 
Infliximab..................................................................................................................................... 43
4.2.3. 
Biomarker Collection................................................................................................................... 44
4.2.4. 
Study-Specific Ethical Design Considerations ........................................................................... 44
4.3. 
Justification for Dose...................................................................................................................... 45
4.3.1. 
Randomization............................................................................................................................ 48
4.4. 
End of Study Definition................................................................................................................... 48
4.4.1. 
Study Completion ....................................................................................................................... 48
4.4.2. 
End of study................................................................................................................................ 49
5. 
STUDY POPULATION ...................................................................................................................... 49
5.1. 
Inclusion Criteria............................................................................................................................ 49
5.2. 
Exclusion Criteria........................................................................................................................... 54
5.3. 
Lifestyle Considerations................................................................................................................. 62
5.4. 
Screen Failures.............................................................................................................................. 62
6. 
STUDY INTERVENTION................................................................................................................... 63
6.1. 
Study Interventions Administered .................................................................................................. 63
6.1.1. 
Dosing Devices........................................................................................................................... 66
6.2. 
Preparation/Handling/Storage/Accountability ................................................................................ 67
6.3. 
Measures to Minimize Bias: Randomization and Blinding............................................................. 68
6.4. 
Study Intervention Compliance...................................................................................................... 68
6.5. 
Concomitant Therapy..................................................................................................................... 69
6.5.1. 
Ulcerative Colitis-Specific Allowed Concomitant Therapies....................................................... 69
6.5.2. 
Ulcerative Colitis-Specific Prohibited Concomitant Medications ................................................ 70
6.5.3. 
Rescue Medication ..................................................................................................................... 71
6.6. 
Dose Modification........................................................................................................................... 72
6.7. 
Intervention After the End of the Study.......................................................................................... 72

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
6
Approved, Date: 11 November 2023
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL............................................................................................... 73
7.1. 
Discontinuation of Study Intervention ............................................................................................ 73
7.2. 
Participant Discontinuation/Withdrawal from the Study................................................................. 76
7.2.1. 
Withdrawal from the Main Study and the Use of Biomarker Samples ....................................... 76
7.3. 
Lost to Follow-up............................................................................................................................ 77
8. 
STUDY ASSESSMENTS AND PROCEDURES ............................................................................... 77
8.1. 
Efficacy Assessments .................................................................................................................... 79
8.1.1. 
Mayo Score................................................................................................................................. 79
8.1.2. 
Partial Mayo Score ..................................................................................................................... 80
8.1.3. 
Pediatric Ulcerative Colitis Activity Index Score ......................................................................... 80
8.1.4. 
C-reactive Protein....................................................................................................................... 80
8.1.5. 
Fecal Calprotectin....................................................................................................................... 80
8.1.6. 
IMPACT III .................................................................................................................................. 81
8.1.7. 
Exploratory Evaluations.............................................................................................................. 81
8.1.7.1. 
TUMMY-UC and Observer TUMMY-UC ................................................................................. 81
8.2. 
Safety Assessments....................................................................................................................... 81
8.2.1. 
Physical Examination.................................................................................................................. 81
8.2.2. 
Vital Signs................................................................................................................................... 81
8.2.3. 
Clinical Safety Laboratory Assessments .................................................................................... 81
8.2.4. 
Concomitant Medication Review ................................................................................................ 83
8.2.5. 
Injection-site Reactions............................................................................................................... 83
8.2.6. 
Infections .................................................................................................................................... 84
8.3. 
Adverse Events and Serious Adverse Events ............................................................................... 85
8.3.1. 
Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event
Information.................................................................................................................................. 85
8.3.2. 
Method of Detecting Adverse Events and Serious Adverse Events .......................................... 86
8.3.3. 
Follow-up of Adverse Events and Serious Adverse Events ....................................................... 86
8.3.4. 
Regulatory Reporting Requirements for Serious Adverse Events ............................................. 86
8.3.5. 
Pregnancy................................................................................................................................... 86
8.3.6. 
Tuberculosis Evaluation.............................................................................................................. 87
8.3.6.1. 
Initial Tuberculosis Evaluation................................................................................................. 87
8.3.6.2. 
Ongoing Tuberculosis Evaluation............................................................................................ 87
8.4. 
Treatment of Overdose .................................................................................................................. 88
8.5. 
Pharmacokinetics........................................................................................................................... 89
8.5.1. 
Immunogenicity (Antibodies to Golimumab and Infliximab) ....................................................... 89
8.6. 
Biomarkers..................................................................................................................................... 90
9. 
STATISTICAL CONSIDERATIONS.................................................................................................. 91
9.1. 
Statistical Hypotheses.................................................................................................................... 91
9.2. 
Criteria for Success........................................................................................................................ 91
9.3. 
Sample Size Determination ........................................................................................................... 91
9.4. 
Statistical Analyses ........................................................................................................................ 92
9.4.1. 
Efficacy Analyses........................................................................................................................ 93
9.4.1.1. 
Primary Endpoint..................................................................................................................... 93
9.4.1.2. 
Major Secondary Endpoints .................................................................................................... 94
9.4.1.3. 
Other Endpoints....................................................................................................................... 94
9.4.1.4. 
Analyses of Study Extension................................................................................................... 97
9.4.2. 
Safety Analyses.......................................................................................................................... 97
9.4.3. 
Other Analyses ........................................................................................................................... 98
9.4.3.1. 
Pharmacokinetic Analyses ...................................................................................................... 98
9.4.3.2. 
Immunogenicity Analyses........................................................................................................ 98
9.4.3.3. 
Biomarkers Analyses............................................................................................................... 99
9.4.3.4. 
Pharmacodynamic Analyses ................................................................................................... 99
9.5. 
Data Monitoring Committee ........................................................................................................... 99
10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .......................... 100

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
7
Approved, Date: 11 November 2023
10.1. 
Appendix 1: Abbreviations ........................................................................................................... 100
10.2. 
Appendix 2: Definitions of Inadequate Response to or Intolerance of Corticosteroids,
MTX, or AZA/6-MP and Corticosteroid Dependence................................................................... 102
10.3. 
Appendix 3: Tuberculin Skin Testing ........................................................................................... 103
10.4. 
Appendix 4: Mayo Score.............................................................................................................. 105
10.5. 
Appendix 5: Pediatric Ulcerative Colitis Activity Index (PUCAI) .................................................. 106
10.6. 
Appendix 6: Attribution Definitions and Severity Criteria............................................................. 107
10.7. 
Appendix 7: IMPACT III Questionnaire........................................................................................ 108
10.8. 
Appendix 8: Examples of the TUMMY-UC and the Observer TUMMY-UC Questionnaires ....... 117
10.9. 
Appendix 9: PFS-U and PFP-V Actual Use Data Collection........................................................ 124
10.10. Appendix 10: Injection Device Observer Injection Checklist........................................................ 125
10.11. Appendix 11:  Injection Device Assessment Questionnaire ........................................................ 126
10.12. Appendix 12: Regulatory, Ethical, and Study Oversight Considerations..................................... 127
REGULATORY AND ETHICAL CONSIDERATIONS ........................................................................ 127
FINANCIAL DISCLOSURE ................................................................................................................ 130
INFORMED CONSENT PROCESS ................................................................................................... 130
DATA PROTECTION ......................................................................................................................... 132
LONG-TERM RETENTION OF SAMPLES FOR ADDITIONAL FUTURE RESEARCH.................... 132
COMMITTEES STRUCTURE ............................................................................................................ 133
PUBLICATION POLICY/DISSEMINATION OF CLINICAL STUDY DATA......................................... 133
DATA QUALITY ASSURANCE .......................................................................................................... 134
DATA COLLECTION.......................................................................................................................... 135
SOURCE DOCUMENTS .................................................................................................................... 135
MONITORING .................................................................................................................................... 136
ON-SITE AUDITS............................................................................................................................... 137
RECORD RETENTION ...................................................................................................................... 137
STUDY AND SITE CLOSURE ........................................................................................................... 138
10.13. Appendix 13: Liver Safety: Suggested Actions and Follow-up Assessments.............................. 139
10.14. Appendix 14: Contraceptive and Barrier Guidance and Collection of Pregnancy
Information ................................................................................................................................... 140
10.15. Appendix 15: Hepatitis B Virus (HBV) Screening with HBV DNA Testing................................... 143
10.16. Appendix 16: Adverse Events: Definitions and Procedures for Recording, Evaluating,
Follow-up, and Reporting............................................................................................................. 144
ADVERSE EVENT DEFINITIONS AND CLASSIFICATIONS............................................................ 144
ATTRIBUTION DEFINITIONS............................................................................................................ 145
SEVERITY CRITERIA........................................................................................................................ 145
SPECIAL REPORTING SITUATIONS ............................................................................................... 146
PROCEDURES .................................................................................................................................. 146
CONTACTING SPONSOR REGARDING SAFETY........................................................................... 147
PRODUCT QUALITY COMPLAINT HANDLING................................................................................ 147
10.17. Appendix 17: Anticipated Events ................................................................................................. 149
10.18. Appendix 18: Usability Assessment Substudy............................................................................. 150
10.19. Appendix 19: Guidance on Study Conduct during the COVID-19 Pandemic.............................. 153
10.20. Appendix 20: Protocol Amendment History................................................................................. 155
11. REFERENCES................................................................................................................................. 205
INVESTIGATOR AGREEMENT............................................................................................................... 208

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
8
Approved, Date: 11 November 2023
LIST OF IN-TEXT TABLES AND FIGURES
TABLES
Table 1: 
Study Schedule of Activities from Screening Through Week 54.............................................. 18
Table 2: 
Study Schedule of Activities for the Study Extension for Participants Who May Benefit
from Continued Treatment: Golimumab Arm............................................................................ 23
Table 3: 
Schedule of Activities for AHA and the Usability Assessment Substudy ................................. 25
Table 4: 
Summary of Selected Safety Findings Through Week 14; Treated Subjects
(Study CNTO148UCO1001)..................................................................................................... 28
Table 5: 
SC Golimumab Dosage by Body Weight.................................................................................. 64
Table 6: 
Probability of Observing a Clinical Remission Rate of ≥18.3% With Differing
Assumptions for the True Remission Rate ............................................................................... 92
FIGURES
Figure 1: Study Schema for CNTO148UCO3003 (Modified in Amendment 5) ....................................... 17
Figure 2: Descriptive Exposure-response Analysis of Key Efficacy Endpoints by Median Serum
Golimumab Concentrations at Week 6..................................................................................... 28

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
9
Approved, Date: 11 November 2023
1. 
PROTOCOL SUMMARY
1.1. 
Synopsis
A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of
Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody, Administered Subcutaneously in
Pediatric Participants with Moderately to Severely Active Ulcerative Colitis
Protocol number: CNTO148UCO3003
EudraCT Number: 2017-004496-31
STUDY INTERVENTION
SIMPONI (golimumab) is a fully human monoclonal antibody with an immunoglobulin G1 heavy chain
isotype (G1m[z] allotype) and a kappa light chain isotype. The molecular weight of golimumab ranges from
149,802 to 151,064 daltons. Golimumab binds to human tumor necrosis factor alpha (TNFα) with high
affinity and specificity and neutralizes TNFα bioactivity.
OBJECTIVES
Primary Objectives
To evaluate the efficacy of golimumab in inducing clinical remission as assessed by the Mayo score,
in pediatric participants with moderately to severely active ulcerative colitis (UC).
To evaluate the safety profile of golimumab, in pediatric participants with moderately to severely
active UC.
Secondary Objectives
To evaluate the efficacy of golimumab in inducing clinical response as assessed by the Mayo Score
and clinical remission as measured by the Pediatric Ulcerative Colitis Activity Index Score (PUCAI)
Score.
To evaluate the efficacy of golimumab on endoscopic healing.
To evaluate the efficacy of golimumab during the long-term phase.
To evaluate the effect of golimumab on additional efficacy and quality of life measures.
To evaluate the pharmacokinetic (PK) and exposure-response of golimumab during short- and long-
term phases.
Additional Objective (Usability Assessment Substudy)
To evaluate the potential for at home use of golimumab in the participant population during the
Usability Assessment Substudy.
OVERALL DESIGN
This is a multicenter, randomized, open-label golimumab study in pediatric participants aged 2 to 17 years
with moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with
an endoscopy subscore of ≥2. Prior to Amendment 4, central randomization was implemented in this study.
Participants ≥30 kg were randomized in a 3:1 ratio across intervention groups, golimumab and infliximab,
respectively. Upon implementation of Amendment 4, no additional participants will be randomized to
infliximab; all newly enrolled participants will receive golimumab.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
10
Approved, Date: 11 November 2023
In this study, the remission rate of golimumab in pediatric participants will be formally compared with a
historical placebo remission rate derived from a meta-analysis of 2 adult Phase 2/3 studies of golimumab
for UC and 5 adult Phase 3 studies of other products approved in this indication utilizing similar populations
and endpoints.
This study will also include an infliximab arm. No formal comparisons between golimumab and infliximab
will be performed.
Endoscopies performed for this study are to be performed using study software and submitted for central
review. Scoring for disease activity based on endoscopic appearance is to be performed both by the local
endoscopist and the central reviewer. All decisions to initiate (Week 0) or continue therapy (Week 6) will
be based on local reads. Analyses of the primary and major secondary endpoints will be based on locally
read endoscopy measures. Analyses of these endpoints will also be performed using the centrally read
endoscopy measures.
This 54-week study will consist of a 6-week short-term phase and a 48-week long-term phase followed by
a study extension (for eligible golimumab-treated participants).
Beginning at Week 58, participants who are eligible to continue receiving golimumab in the study extension
will be offered the option for self-administration (at least 12 years old) or caregiver administration (any
age). At home administration (AHA) is optional; if a pediatric participant or caregiver elects against self- or
caregiver administration, the health care professional will continue to administer injections in this study.
At select sites, participants entering the study extension who elect to administer the study intervention at
home will have the option to be enrolled in a Usability Assessment Substudy. An attempt will be made to
enroll approximately 10-20 participants in the Usability Assessment Substudy at Week 58. The objective
of the Substudyis to provide supportive data that the Prefilled Syringe with UltraSafe (PFS-U) and Prefilled
Pen-Varioject (PFP-V) as designed, together with the appropriate training and written Instructions for Use,
are suitable for AHA by pediatric participants or their caregivers.
An internal Data Monitoring Committee (consisting of Sponsor members [a gastroenterologist, a clinician
and a statistician at a minimum] outside of the study team), will be established to monitor safety data (for
both golimumab and infliximab treatments arms) on an ongoing basis until all participants reach the Week
54 visit or terminate the study prior to the Week 54 visit.
STUDY POPULATION
The study population will include pediatric participants aged 2 to 17 years with moderately to severely
active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with an endoscopy subscore of ≥2.
All study participants must have:
Demonstrated an inadequate response to, have failed to tolerate, or have a medical contraindication to
conventional therapies (ie, intravenous or oral corticosteroids or the immunomodulators methotrexate,
azathioprine or 6-mercaptopurine);
OR
Demonstrated corticosteroid dependence;
OR
Require repeated (>3 per year) courses of corticosteroids.
Participants with prior exposure to biologic anti-TNFα agents will be ineligible for participation.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
11
Approved, Date: 11 November 2023
NUMBER OF PARTICIPANTS
Prior to Amendment 4, approximately 125 participants who satisfy inclusion/exclusion criteria were to be
included in the study at sites located globally, including in North and South America, Asia, and Europe. At
least 24 golimumab participants with body weight <45 kg, and at least 5 golimumab participants with body
weight <30 kg will be included.
In order to ensure at least 5 participants with body weight <30 kg receive golimumab, participants who
weigh <30 kg were to only be allocated to the golimumab treatment arm. The remaining 120 participants
were to be randomized in a 3:1 ratio to golimumab or infliximab, respectively.
Upon implementation of Amendment 4, no additional participants will be randomized to infliximab; all
newly enrolled participants will receive golimumab.
Upon implementation of Amendment 5, no new participants will be enrolled. Approximately 70 participants
will participate in this study (at least 60 participants will receive golimumab, at least 10 participants will
receive infliximab). Of the 60 golimumab participants, at least 15 will have a body weight <45 kg and at
least 5 will have a body weight <30 kg.
INTERVENTION GROUPS AND DURATION
Golimumab
During the short-term phase, pediatric participants will receive dose regimens of subcutaneous (SC)
golimumab at Week 0 and Week 2 based on body weight as shown in Table I below. Participants must
weigh ≥10 kg and be >70 cm tall. This is the lower range of weight and height that the prefilled pen has
been validated for to deliver SC golimumab. This limit accommodates >97% of all 2-year old girls based
on published growth charts (www.cdc.gov/growthcharts). Participants' golimumab doses for all
administrations through Week 10 (inclusive) will be based on the participants' weight and height at Week 0
or, if not available, the most recent height and weight from screening. The same weight and height should
be used through Week 10. Golimumab doses from Week 14 through Week 54 will be based on the
participants' weight and height obtained with that week’s visit or the height and weight measured at the
previous site visit. In the study extension, golimumab doses will be based on the participants' most current
weight and height or the last recorded height and weight.
Table I: 
Dosage by body weight
Pediatric participants with ulcerative
colitis (2 to 17 years of age)
Short-term phase 
Long-term phase†
With body weight <45 kg
120 mg/m2 at Week 0*
60 mg/m2 at Week 2*
60 mg/m2 every 4 weeks from Week 6*
With body weight ≥45 kg
200 mg at Week 0
100 mg at Week 2
100 mg every 4 weeks from Week 6
† Participants in clinical response to golimumab at Week 6.
*BSA doses are capped at 200 mg and 100 mg for the 120 mg/m2 and 60 mg/m2 doses, respectively.
At Week 6, all participants will be evaluated for clinical response; participants in clinical response will
continue receiving open-label golimumab during the long-term phase.
Participants not in clinical response (as evaluated by the Mayo score) at Week 6 may have study
intervention discontinued (and complete a safety follow-up at least 16 weeks after the last administration
of golimumab) OR may continue receiving golimumab for up to 2 additional doses at Weeks 6 and 10 as
specified in Table I at the discretion of the investigator. At Week 14, these participants who received the 2
additional doses will need to demonstrate a partial Mayo response to continue on in the study; participants
in partial Mayo response will continue receiving open-label golimumab once every 4 weeks (q4w) during

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
12
Approved, Date: 11 November 2023
the long-term phase (Table I). Participants who received the 2 additional doses and are not partial Mayo
responders at Week 14 will have study intervention discontinued and should complete a final safety
follow-up at least 16 weeks following the last administration of study intervention.
Infliximab
All participants in the infliximab treatment arm will be administered infliximab 5 mg/kg at Weeks 0 and 2.
Starting at Week 6, infliximab administrations of 5 mg/kg will continue q8w through Week 46 for those
participants in clinical response at Week 6. Infliximab doses for all administrations through Week 8
(inclusive) will be based on the participants' weight at Week 0 or, if not available, the most recent weight
from screening. The same weight should be used through Week 8. Infliximab doses from Week 14 through
Week 46 will be based on the participants' weight obtained with that week’s visit or the weight measured
at the previous site visit.
For those participants not in clinical response at Week 6 (as defined by the Mayo score), or participants
who were in response at Week 6 but have a clinical flare in their UC (defined in Section 6.5.3) an additional
step-wise dose escalation approach may be taken at the investigator’s discretion. The first step is a dose
increase at Week 6 to 10 mg/kg [capped at 1 gm] q8w or 5 mg/kg at Weeks 6 and 8, and 10 mg/kg (capped
at 1 gm) at Week 14 and q8w thereafter, respectively). At Week 14, if the participant has demonstrated a
partial Mayo response, they will continue to receive infliximab 10mg/kg q8w. Additionally, if the
participant has not achieved a partial Mayo response by Week 14, starting at the Week 14 visit, the
investigators can also shorten the interval between doses to q4w.
At Week 22, those participants who had received an escalation in their infliximab dosing to 10 mg/kg q4w
will need to demonstrate a partial Mayo response to continue in the study. Participants in partial Mayo
response will continue receiving open-label infliximab 10 mg/kg q4w through Week 46. Participants who
have not achieved a partial Mayo response at Week 22 will have study intervention discontinued and should
complete a final safety follow-up at least 8 weeks following the last administration of infliximab.
Participants who dose-escalate in response to a UC flare after Week 6 will be reassessed after 2
administrations at the new higher dose. Participants in partial Mayo response will continue receiving
open-label infliximab through Week 46 at the new higher dose. Participants who have not achieved a partial
Mayo response will have study intervention discontinued and should complete a final safety visit at least 8
weeks following the last administration of infliximab.
After the Week 8 visit and before the Week 54 visit, participants in the infliximab arm will only require
study visits on treatment days. All other nontreatment visits during this time period will be optional. All
participants must have the Week 54 or Early Termination visit.
Finally, while dose escalation should be based on clinical criteria as described above, investigators at their
discretion may utilize infliximab serum levels to assist their decision making. This approach was chosen as
it most closely mimics clinical practice in treatment of pediatric UC, allowing investigators some flexibility
in dosing to treat their patients. Also, if an investigator wants to dose-escalate using a different regimen
than listed above, discuss the plan with the medical monitor. After the Week 54 evaluations, participants
receiving infliximab will be transitioned off the study to standard medical care.
EFFICACY EVALUATIONS
Efficacy evaluations will include the following:
Mayo score
Partial Mayo score
PUCAI score
C-reactive protein

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
13
Approved, Date: 11 November 2023
Fecal calprotectin
IMPACT III
TUMMY-UC and Observer TUMMY-UC
Endpoints
Primary Endpoint
The primary endpoint is clinical remission at Week 6 as assessed by the Mayo score.
Clinical remission as measured by the Mayo score is defined as a Mayo score ≤2 points, with no individual
subscore >1 (based on Mayo endoscopy subscore assigned by the local endoscopist).
Major Secondary Endpoints
For endpoints beyond Week 6, analyses will be performed on participants who are in clinical response at
Week 6 as assessed by the Mayo score.
Symptomatic remission at Week 54.
Clinical remission at Week 54 as assessed by the Mayo score (based on Mayo endoscopy subscore
assigned by the local endoscopist).
Clinical remission at Week 54 as assessed by the PUCAI score.
Clinical remission at Week 6 as assessed by the PUCAI score.
Clinical response at Week 6 as assessed by the Mayo score (based on Mayo endoscopy subscore
assigned by the local endoscopist).
Endoscopic healing at Week 6 (based on Mayo endoscopy subscore assigned by the local endoscopist).
Endoscopic healing at Week 54 (based on Mayo endoscopy subscore assigned by the local
endoscopist).
Clinical remission at Week 54, as assessed by the Mayo score, for participants who are in clinical
remission at Week 6 (based on Mayo endoscopy subscore assigned by the local endoscopist).
Participants who were not receiving corticosteroids for at least 12 Weeks prior to Week 54 and in
clinical remission at Week 54, as assessed by the Mayo score (based on Mayo endoscopy subscore
assigned by the local endoscopist).
The definitions of the major secondary endpoints are provided below:
Symptomatic remission: Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of0.
Clinical response: a decrease from baseline in the Mayo score of ≥30% and ≥3 points, with either a
decrease from baseline in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1.
Clinical remission as measured by the PUCAI score: a PUCAI score <10.
Endoscopic healing: an endoscopy subscore of the Mayo score of 0 or 1.
PHARMACOKINETIC EVALUATIONS
Serum samples will be used to evaluate the pharmacokinetics of golimumab and infliximab. Samples
collected for the analyses of serum concentrations of golimumab or infliximab may additionally be used to
evaluate safety or efficacy aspects that address concerns arising during or after the study period, or for the

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
14
Approved, Date: 11 November 2023
evaluation of relevant biomarkers. Genetic analyses will not be performed on these serum samples.
Participant confidentiality will be maintained.
IMMUNOGENICITY EVALUATIONS
Serum samples will be screened for antibodies binding to golimumab or infliximab and the titer of
confirmed positive samples will be reported as applicable. Other analyses may be performed to further
characterize the immunogenicity of golimumab or infliximab.
PHARMACODYNAMIC AND BIOMARKER EVALUATIONS
Inflammatory pharmacodynamics (PD) markers (C-reactive protein  and fecal calprotectin) will be
evaluated. Exploratory biomarker assessments will be performed to identify ribonucleic acid (RNA; mRNA
or microRNA) expression patterns and microbial activities that are relevant to golimumab and/or infliximab
treatment and/or pediatric UC, to correlate histologic and immunohistochemical assessments of disease and
healing, and to evaluate whether biomarkers can be developed to predict a golimumab response and/or UC
disease activity.
SAFETY EVALUATIONS
Safety evaluations conducted at each study visit will include the assessment of adverse events (AEs; at the
visit and those occurring between evaluation visits), a tuberculosis evaluation and other infection
assessment, clinical laboratory blood tests (complete blood count and serum chemistries), vital signs,
concomitant medication review, and observations for injection-site reactions, reactions temporally
associated with an infusion, and/or allergic reactions.
STATISTICAL METHODS
Statistical Hypothesis
The primary hypothesis is that golimumab is an effective therapy in pediatric UC relative to a historical
placebo control as assessed by clinical remission at Week 6based on the Mayo score. The historical placebo
clinical remission rate is based on a meta-analysis of 7 adult UC studies including infliximab Phase 3
(C0168T37 and C0168T46), golimumab Phase 2/3 (C0524T16 and C0524T17), adalimumab Phase 3
(ULTRA 1 and ULTRA 2), and vedolizumab Phase 3 (GEMINI 1).
Criteria for Success
The success of the study will ultimately be based on the totality of evidence. The primary analysis will be
based on the proportion of golimumab pediatric participants in clinical remission at Week 6 based on the
Mayo score and its associated 90% confidence interval (CI). The criteria for the primary analysis will have
been met if the lower limit of the two-sided 90% CI for the proportion of golimumab participants in clinical
remission at Week 6 is >10.0% (ie, the upper limit of the 95% CI for the proportion of placebo participants
in clinical remission at Week 6 derived from a meta-analysis of 7 adult UC studies including 2 adult
Phase 2/3 studies of golimumab and 5 adult Phase 3 studies of other products approved in this indication
utilizing similar populations and endpoints).
Sample Size Calculation
Sample size calculations were based on the need to have a sufficient number of participants assigned to the
golimumab treatment arm to achieve the criteria defined in the Criteria for Success. In addition, collecting
sufficient PK data to adequately characterize the PK of golimumab in participants with UC is also
considered.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
15
Approved, Date: 11 November 2023
A sample size of 60 participants in the golimumab arm will ensure that the lower bound of the 90% CI for
the pediatric golimumab Mayo clinical remission rate is above 10.0% (ie, the upper bound of the 95% CI
for the historical placebo control) as long as the observed remission rate is at least 18.3%. The probability
of observing a Mayo clinical remission rate of ≥18.3%, given different assumptions for the true rate of
Mayo clinical remission is shown in Table II below.
With 60 golimumab-treated participants, the probability of observing a Mayo clinical remission rate of
≥18.3% ranges from 50% (if the golimumab adult UC remission rate of 17.8% is assumed) to greater than
99% (if the remission rate of 42.9% from the first golimumab study in pediatric UC is assumed). It is
reasonable to assume that the true Mayo clinical remission rate in pediatric UC participants is greater than
the remission rate observed in the adult UC study, as the remission rate in the first golimumab pediatric UC
study was at least twice that observed in the adult UC study. Therefore, if we assume the remission rate to
be 22.5%, then the probability of observing a remission rate of ≥18.3% is at least 80% (Table II).
Table II: 
Probability of Observing a Clinical Remission Rate of ≥18.3% With Differing Assumptions
for the True Remission Rate
Clinical Remission as Assessed by the Mayo Score 
Probability of Observing ≥18.3%
N=60
17.8% (observed adult remission rate; C0524T17) 
50%
20.0%  
68%
22.5% 
82%
25.0% 
91%
42.9% (observed pediatric remission rate; CNTO148UCO1001) 
>99.9%
The precision (ie, half width of the CI) based on this sample size of60 golimumab participants is 8.1%
(assuming a Mayo clinical remission rate of 17.8% at Week 6) and 10.5% (assuming a clinical remission
rate at Week 6 of 42.9%).
Furthermore, the Fisher Information Matrix-based optimal design analysis indicates that PK data from a
total of 60 participants (including 45 participants in the ≥45 kg subgroup and 15 participants in the <45 kg
subgroup) would be sufficient to adequately characterize the PK of golimumab in pediatric participants
with UC.
Primary Efficacy Analysis
The primary analysis population includes all participants (including the youngest weight cohort [<30 kg])
who were treated with golimumab. The primary analysis will be based on the proportion of pediatric
participants who received golimumab and who were in clinical remission at Week 6 based on the Mayo
score (endoscopy subscore assigned by local endoscopist) and its associated 90% CI. The criteria for the
primary analysis will have been met if the lower limit of the two-sided 90% CI for the proportion of
pediatric golimumab participants in clinical remission at Week 6 is greater than the upper limit of the 95%
CI for the proportion of placebo participants in clinical remission at Week 6 (ie, >10.0%) derived from a
meta-analysis of 7 adult UC studies including 2 Phase 2/3 studies of golimumab and 5 Phase 3 studies of
other products approved in this indication utilizing similar populations and endpoints.
Treatment failure rules will override the clinical remission status based on the Mayo score. Participants
who meet any of the following criteria for treatment failure through Week 6 will be considered to not have
achieved clinical remission at Week 6:
Had a colectomy (partial or full) or ostomy,
OR
Discontinued study intervention due to lack of efficacy or an AE of worsening of UC,

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
16
Approved, Date: 11 November 2023
OR
Had a protocol prohibited medication change (to be detailed in the Statistical Analysis Plan).
In addition, participants who do not return for evaluation or have insufficient data to calculate their Mayo
Score at Week 6 (ie, all 4 Mayo subscores are missing) will be considered to not have achieved clinical
remission (based on the Mayo Score) at Week 6.
Major Secondary Efficacy Analyses
Summary statistics will be provided for all efficacy endpoints. In particular, counts and percentages will be
used to summarize major secondary endpoints. Unless otherwise specified, all endpoints that involve the
Mayo endoscopy subscore will be based on the subscore assigned by the local endoscopist. For endpoints
beyond Week 6, analyses will be performed on participants who are in clinical response at Week 6 as
assessed by the Mayo score.
Pharmacokinetic Analyses
Serum golimumab and infliximab concentrations will be summarized for each golimumab/infliximab
treatment group over time using descriptive statistics for all participants who receive at least 1
administration of golimumab/infliximab and had at least 1 postdose sample.
Immunogenicity Analyses
The incidence of anti-golimumab and anti-infliximab antibodies will be summarized for all participants
who receive at least 1 dose of golimumab or infliximab and have appropriate samples for detection of
antibodies to golimumab or infliximab (ie, participants with at least 1 sample obtained after their first dose
of golimumab or infliximab).
Other immunogenicity
Other immunogenicity analyses may be performed to further characterize the immune responses that are
generated.
Biomarker Analyses
Changes in serum/RNA or other biomarkers over time will be summarized by intervention group.
Associations between baseline levels and changes from baseline in select markers and clinical response at
screening and Weeks 0, 2, 6, and 54 will be explored.
Pharmacodynamic Analyses
Planned biomarker analyses may be deferred if emerging study data show no likelihood of providing useful
scientific information. Any pharmacodynamic (PD) samples received by the contract vendor or Sponsor
after the cut-off date will not be analyzed, and therefore, excluded from the PD analysis.
Safety Analyses
The following analyses will be used to assess the safety of participants in the study:  frequency and type of
AEs, frequency and type of serious adverse events, frequency and type of reasonably related AEs as
assessed by the investigator, frequency and type of AEs leading to discontinuation of study intervention,
frequency and type of infections (including serious infections, and infections requiring oral or parenteral
antimicrobial treatment), frequency and type of AEs temporally associated with infusion, and frequency
and type of injection-site reactions.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
17
Approved, Date: 11 November 2023
Laboratory parameters and change from baseline in selected laboratory parameters (hematology and
chemistry), and maximum Common Terminology Criteria for Adverse Events (CTCAE) toxicity grade for
postbaseline laboratory parameters will be summarized by treatment group. In addition, a listing of
participants with any abnormal postbaseline laboratory values of CTCAE Grade ≥2 will also be provided.
All safety analyses will be based on the population of participants who received at least 1 administration of
study intervention. Participants will be summarized by the treatment they actually received (golimumab
versus infliximab).
1.2. 
Schema
Figure 1: 
Study Schema for CNTO148UCO3003 (Modified in Amendment 5)

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
21
Approved, Date: 11 November 2023
a. 
Screening for eligible participants will be performed within 6 weeks before administration of the study intervention.
b. 
All participants should return for a final visit, 16 weeks after the last administration of golimumab or 8 weeks after last infliximab administration.
c. 
All assessments are to be completed prior to study intervention administration, unless otherwise specified. Visit window should be ±7 days for each visit up to and including the
Week 54 visit.
d. 
If there is an early discontinuation of study intervention (before Week 54) these study assessments should be collected. In the case of study termination refer to Section 7.
e. 
Participants who discontinue study intervention prior to Week 14 but do not terminate study participation should return for protocol specified procedures and evaluations up to
and including the Week 14 visit. These participants should also return for the final safety visit 16 weeks after the last administration of golimumab or 8 weeks after the last
administration of infliximab.
f. 
Prior to withdrawal of consent, participants who terminate study participation prior to Week 14 should complete assessments indicated at Week 14.
g. 
Should be performed within 2 weeks prior to the administration of study intervention at Week 0, within 2 weeks prior to Week 54, and within 7 days prior to study intervention
for Week 6. All study endoscopies (sigmoidoscopy preferred unless colonoscopy clinically indicated) must be performed with study software to permit central reads and
scoring in addition to local site study scoring. A colonoscopy will replace a sigmoidoscopy if screening for dysplasia is required. The Sponsor suggests that at least 48 hours
must elapse between a colonoscopy with polypectomy or multiple biopsies and the study intervention administration (Week 0) visit.
h. 
Previous assessment must be consistent with a diagnosis of UC (eg, crypt distortion, crypt abscess, goblet cell depletion, and continuous distribution).
i. 
A tuberculin skin test is required if the QuantiFERON TB or T Spot test is not approved/registered in that country, OR the tuberculin skin test is mandated by local health
authorities.
j. 
Chest radiograph should be obtained during the screening period unless one was obtained within 6 months before screening and the findings recorded in the study source
documents. Chest radiographs should be reviewed to assess for potential undiagnosed pulmonary pathologies that may include manifestations of IBD, malignancies, and prior
or current infection (eg, latent TB). Chest radiographs must be obtained in all cases when the QuantiFERON TB or T Spot test and/or the tuberculin skin test for TB is positive
or repeatedly indeterminate.
k. 
Stool studies for enteric pathogens, including a stool culture and Clostridium difficile toxin assay, that have been performed at a local laboratory during the current episode of
disease exacerbation and within 4 months prior to Week 0 may be used for screening. Additional testing such as ova and parasite or E. coli 0157:H7 assessments may be
performed at the investigator’s clinical discretion by the central laboratory. If previous results are unavailable, the central laboratory should be used to perform the tests at
screening.
l. 
Refer to local immunization guidelines for immunosuppressed participants prior to Week 0.
m. For additional details, refer to Appendix 15 (Section 10.15).
n. 
HIV testing in study participants who are less than 6 years of age is not universally required. It is required in those study participants who are less than 6 years of age and the
birth history is unknown (ie, adopted) or has exposure risks (parents with HIV or with risk factors) or at the discretion of the study investigator. In subjects who are less than 6
years of age where testing would be required, if there is a record of a negative HIV test at birth this is acceptable at the discretion of the study physician as long as it is entered
into the study record.
o. 
Participants’ golimumab or infliximab doses for Weeks 0 through 10, inclusive, will be based on the participants’ height and weight at Week 0 or, if not available, the most
recent height and weight from screening. The same height and weight should be used through Week 10 for golimumab administrations, and the same weight should be used
through Week 8 for infliximab administrations. For all dose administrations after Week 10, weight and height at the current visit or the last recorded data will be used to
determine study intervention dosage. For AHA of golimumab administrations after Week 54, dosages will be based on the most recent recorded height and weight obtained by
the investigator during scheduled office visits.
p. 
Golimumab is to be administered only if the participant is eligible and will be participating in the study extension (see Table 2).
q. 
Participants should be evaluated for vital signs (including temperature, pulse/heart rate, respiratory rate, and blood pressure) before and approximately 30 minutes after every
SC golimumab administration. Vital signs will be obtained before, approximately every 30 minutes during, and twice (at approximately 30 minute intervals) after completion of
the IV infusion(s) of infliximab.
r. 
Only if decision is made to escalate the dose of infliximab to 10 mg/kg q8w, and only if participant was given 5 mg/kg Week 6, may the participant receive a dose at Week 8 of
infliximab at 5 mg/kg, with subsequent doses of 10 mg/kg starting at Week 14. Infliximab infusions are capped at 1 gm maximum per administration. Additional details are
available in Section 4, Study Design. If participant receives infliximab infusion at Week 8, they will need a urine pregnancy test in addition to the other assessments collected
from all study participants.
s. 
Temperature, pulse/heart rate, respiratory rate, and blood pressure.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
22
Approved, Date: 11 November 2023
t. 
All girls of childbearing potential must have a negative urine pregnancy test prior to all study site administration of study intervention. If the visit does not include study
intervention administration, a urine pregnancy test is not required unless it is the Week 54 or early discontinuation visit.
u. 
Concomitant medications administered up to 30 days before first dose of study intervention must be recorded at screening.
v. 
Mayo Patient Diary is completed for 7 continuous days within the 14 days prior to the screening visit. For the screening visit, the Mayo diary will be provided at screening and
collected at the Week 0 visit.
w. Required only if participant is ≥10 years of age at Week 0.
x. 
Participants will record TUMMY UC questionnaire data daily for 5 days before the study site visit in a participant diary. For participants less than 8 years old, their caregiver
will complete the Observer TUMMY UC questionnaire. The version used at the Week 0 assessment will be used at all subsequent assessments regardless of participant age.
y. 
At drug administration visits, blood samples should be collected prior to study intervention administration (for both golimumab and infliximab) and 1 hour postinfusion (only
for infliximab at Weeks 0, 2, 6, and 46). The same blood draw can be used to collect serum samples for measuring study intervention concentration and antibodies to study
intervention. Blood sampling in participants with a body weight of 10 kg to 24 kg must be divided between visits during the screening period. Contact Sponsor for details of
recommended sampling sequence.
z. 
Should be performed within 2 weeks prior to the administration of study intervention at Week 0 and Week 54, and within 7 days for Week 6.
aa. The RNA blood sample should not be collected at any time point for any participant who at screening has a body weight of 10 kg to <12.3 kg, even if the weight increases to
above 12.3 kg during the study. For participants who weighed more at screening but whose body weight falls to between 10 kg to <12.3 kg, the RNA blood sample should not
be collected, and blood draws are not to exceed 8.0 mL at any one visit for this weight group.
bb. At visits during which the participant does not receive an administration ofinfliximab, the following evaluations do not need to be performed: urine pregnancy and injection
site evaluation.
cc. For infliximab patients only: Visits at Week 10, 18, 26, 34, 36, 42, 50 and associated study procedures are optional, and only required if investigator implements flexible dosing
and is administering infliximab at these time points.
dd. Infliximab participants who do not have a dosing visit at Week 26 should have hematology, chemistry, ANA, and anti dsDNA antibodies performed at Week 22 visit.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
25
Approved, Date: 11 November 2023
Table 3: 
Schedule of Activities for AHA and the Usability Assessment Substudy
Events 
AHA and Usability Assessment Substudy Activities
First 
Training/self or 
caregiver 
administration 
visitb 
Second 
self or 
caregiver 
administration 
visitb 
Third  
self or 
caregiver 
administration
visitb
Subsequent study
interventions to end of
study
Informed consent/assent for Substudya 
X
Inclusion/exclusion criteria 
X
Training session conducted by site personnel 
X
Observation of self or caregiver training/administration by site personnel and
completion ofobserver checklist (Appendix 10 [Section 10.10])
X
Administration of golimumab by selfor caregiver; or continued administration at
the site, if desired
X 
X 
X 
X
Completion of the Injection Device Assessment Questionnaire after completion of
the second and third self- or caregiver administration visits by Substudy 
participants (Appendix 11 [Section 10.11])
X 
X
AHA diary  
X 
X 
X 
X
Device complaints/device-related AEs captured/investigated 
X 
X 
X 
X
a. 
Approximately 10 20 participants entering the study extension who elect to administer the study intervention at home will have the option to be enrolled in an Usability
Assessment Substudy at Week 58.
b. 
The training and self or caregiver administration visits will occur at Weeks 58, 62, and 66 visits for those participating in the Usability Assessment Substudy

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
26
Approved, Date: 11 November 2023
2. 
INTRODUCTION
SIMPONI (golimumab) is a fully human monoclonal antibody (mAb) with an immunoglobulin
G1 heavy chain isotype (G1m[z] allotype) and a kappa light chain isotype. The molecular weight
of golimumab ranges from 149,802 to 151,064 daltons. Golimumab binds to human tumor necrosis
factor alpha (TNFα) with high affinity and specificity and neutralizes TNFα bioactivity.
Golimumab (subcutaneous [SC]) has been approved for both induction and maintenance therapy
in adults with moderately to severely active ulcerative colitis (UC) disease in 88 countries globally
including the United States (US) (15 May 2013), European Union (EU) (19September 2013), and
Canada (19 September 2013). Additionally, golimumab is approved for the treatment of
rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (AS), and non-radiographic axial
spondyloarthritis. The first of these approvals in rheumatologic indications was in 2009.
Golimumab for SC administration is also approved for use in children with polyarticular juvenile
idiopathic arthritis (pJIA) in 46 countries, including the EU. Golimumab for intravenous (IV)
administration is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, and AS in
several countries, with additional marketing authorizations pending for these indications
worldwide.
This Phase 3 study (CNTO148UCO3003) will be a multicenter, randomized, open-label
golimumab study in pediatric participants aged 2 to 17 years with moderately to severely active
UC. This study will assess the efficacy, safety, and pharmacokinetics (PK) of SC golimumab in
pediatric participants. The remission rate of golimumab in these pediatric participants will be
formally compared with a historical placebo remission rate derived from a meta-analysis of 2 adult
Phase 2/3 studies of golimumab for UC and 5 adult Phase 3 studies of other products approved for
this indication utilizing similar populations and endpoints. Additionally, the study will include an
infliximab arm. Upon implementation of Amendment 4, no additional participants will be
randomized to the infliximab arm; all newly enrolled participants will receive golimumab.
For the most comprehensive nonclinical and clinical information regarding the efficacy and safety
of golimumab and infliximab, refer to the latest versions of the Investigator's Brochure (IB) for
golimumab and infliximab, respectively.
The term "Sponsor" used throughout this document refers to the entities listed in the Contact
Information page(s), which will be provided as a separate document.
2.1. 
Study Rationale
Golimumab was studied in a Phase 3 program of adults with moderately to severely active UC.
This program demonstrated that golimumab is an effective anti-TNFα therapy in adults and was
generally well tolerated, with a safety profile consistent with that observed for golimumab in other
indications. Studies C0524T17 and C0524T18 were the basis for the approval of golimumab in
adults with moderately to severely active UC in both the US (15 May 2013) and the European
Union (EU [19September 2013]).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
27
Approved, Date: 11 November 2023
Golimumab has the potential to offer pediatric participants with moderately to severely active UC
a safe and effective therapy with a convenient SC injection option given every 4 weeks (q4w).
Accordingly, golimumab is being studied in pediatric participants from the ages of 2 to 17 years
with moderately to severely active UC.
The clinical development program for golimumab in pediatric UC includes 2 studies.
The first study is:
CNTO148UCO1001 (ongoing): A multicenter, open-label study to assess the PK and safety
of golimumab treatment in pediatric participants from 2 to 17 years of age with moderately to
severely active UC. This study was divided into 2 parts: the main part of the study was the PK
portion through Week 14, and the second part was the study extension. At Week 6, participants
in clinical response were eligible to continue receiving open-label maintenance therapy with
golimumab and to enter the study extension at Week 14. The study extension through the
Week 126 database lock (DBL) is complete. The study extension after Week 126 is still
ongoing.
During the PK portion of the study, at Week 6, Mayo clinical response was induced in 21 of35
(60.0%) participants, Mayo clinical remission in 15 of 35 (43%) participants, Pediatric
Ulcerative Colitis Activity Index Score (PUCAI) clinical remission in 12 of 35 (34%)
participants, and mucosal healing (Mayo subscore 0/1) in 19of 35 (54%) participants.
Results at Week 14 also demonstrated similarity of PK and a similar exposure-response (E-R)
relationship between pediatric UC and adult UC. Figure 2 shows the descriptive E-R analysis
of key efficacy endpoints by median serum golimumab concentrations at Week 6 from
evaluable participants. Both the pediatric UC and the adult UC studies were each categorized
into 2 groups based on the median serum concentration observed in the pediatric UC study:
<2.64 μg/mL and ≥2.64 μg/mL.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
28
Approved, Date: 11 November 2023
Figure 2: 
Descriptive Exposure-response Analysis of Key Efficacy Endpoints by Median Serum
Golimumab Concentrations at Week 6
Adapted from: [TEFEP06GAH.rtf] [CNTO148\CNTO148UCO1001\DBR W14\RE W14\tefep06gah.sas] 15JUL2015, 09:33.
Table 4 provides the safety data during the PK portion of the study. The safety profile did not differ
from that observed in adults with moderately to severely active UC.
Table 4: 
Summary of Selected Safety Findings Through Week 14; Treated Subjects
(Study CNTO148UCO1001)
Golimumab
Treated Subjects 
35
Average duration of follow up (weeks) 
13.1
Average exposure (number of administrations) 
3.2
Subjects who died 
0
Subjects who discontinued study intervention because of 1 or more adverse events 
3 (8.6%)
Subjects with 1 or more:
Adverse events 
33 (94.3%)
Serious adverse events 
11 (31.4%)
Infections a 
13 (37.1%)
Serious infections a 
0
Neoplasms (malignant) 
0
Injection site reactions 
6 (17.1%)
a Infection as assessed by the investigator.
Adapted from: [TSFAE23.rtf] [CNTO148\CNTO148UCO1001\DBR_W14\RE_W14\tsfae23.sas] 29APR2015, 19:38

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
29
Approved, Date: 11 November 2023
Key findings through the Week 126 DBL are summarized as follows:
Overall, 11 of 20 participants starting the study extension at Week 14 completed the Week 126
visit. Ten of 20 participants (50%) starting the study extension at Week 14 were in clinical
remission (PUCAI<10) at Week 110.21 Safety data from this study extension appear to be
consistent with other studies conducted in UC with golimumab.
The second study is:
CNTO148UCO3003 (this study): A multicenter, randomized, open-label study to assess the
efficacy, safety, and PK of golimumab treatment in pediatric participants from 2 to 17 years
of age with moderately to severely active UC. In this study, the remission rate on golimumab
in these pediatric participants will be formally compared with a historical placebo remission
rate derived from a meta-analysis of 2 adult Phase 2/3 studies of golimumab for UC and 5
adult Phase 3 studies of other products approved in this indication utilizing similar populations
and endpoints. A study extension is included for eligible golimumab-treated participants. In
this study extension, participants will be eligible for at home administration (AHA).
Participants entering the study extension who elect to administer the study intervention at
home will have the option to be enrolled in a Usability Assessment Substudy (Appendix 18
[Section 10.18]).
2.2. 
Background
Ulcerative colitis is a chronic gastrointestinal inflammatory disorder which involves the surface
mucosa, the crypt epithelium, and submucosa of the colon.43 Clinically, participants with UC suffer
from diarrhea, rectal bleeding, weight loss, abdominal pain, fever, and may also display prominent
extraintestinal manifestations, commonly colitic arthritis and AS.20,43 Ulcerative colitis is
characterized by a life-long chronic course of remissions and exacerbations, with most participants
having an acute attack requiring hospitalization at some time during their illness.
Approximately 20% of participants with UC present before the age of 20 years, with disease being
extensive in approximately 50% to 80% of these participants.2,52 While the peak occurrence of
pediatric UC is in late adolescence, all ages can be affected, and 4% of pediatric inflammatory
bowel disease (IBD) participants are diagnosed in early (age <5 years) childhood.25 Children aged
2 to 6 years account for approximately 10% of pediatric UC.16,28 The disease affects equal
proportions of males and females.
The overall clinical features, clinical course of the disease, and response to treatment are generally
comparable in pediatric and adult populations with UC. However, pediatric-onset UC is often more
extensive and severe with a greater prevalence of pancolitis (ie, up to 80% to 90% in pediatric
participants compared with approximately 25% in adult participants).19,39,52

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
30
Approved, Date: 11 November 2023
Overall, the cumulative frequency of colectomy is similar in pediatric- and adult-onset participants
with UC.52 However, the time from diagnosis to first surgery in UC has been reported to be
significantly shorter in children compared with adults with UC. Within 10 years of diagnosis,
40.9% of children and 19.9% of adults with UC had undergone colectomy.52 Colorectal carcinoma
rarely occurs during childhood or adolescence.24 However, the cumulative probability of
developing colorectal cancer among adult participants with pediatric-onset UC is slightly higher
than that observed among participants with adult-onset UC.11 Pediatric participants with UC may
also experience growth failure and delayed sexual development.2,20,22
Although there are multiple therapies in several distinct drug classes approved to treat adult UC,
approved pharmacologic treatment options are limited for pediatric participants with UC,
especially for those children who have failed to respond to or tolerate conventional therapy
(5-aminosalicylate [5-ASA], corticosteroids, or immunomodulators [ie, 6-mercaptopurine (6-MP),
azathioprine (AZA), and methotrexate (MTX)]).  REMICADE® (infliximab) has been shown to be
a safe and effective treatment for pediatric UC.18 With the approval of infliximab for UC
participants 6 years of age and older, pediatric participants with moderately to severely active UC
have the treatment option of IV infusions of infliximab administered at Weeks 0, 2, and 6 and
every 8 weeks thereafter.
When pharmacologic treatment is no longer effective in managing UC, the only alternative is
colectomy. However, colectomy is associated with notable morbidity, particularly in children,
along with detrimental impacts on their quality of life (QoL), their probability of conception later
in life, and their physical and emotional development at a critical age of personality
development.49,50 As such, there is a need for additional safe and efficacious treatment options for
pediatric participants with moderately to severely active UC.
2.3. 
Benefit/Risk Assessment
Detailed information about the known and expected benefits and risks of golimumab and
infliximab may be found in their respective IB.
2.3.1. 
Known and Potential Benefits
2.3.1.1. 
Known Benefits
The clinical benefit of golimumab, an anti-TNFα agent approved for the treatment of UC in adults,
has not yet been established in moderately to severely active UC in pediatric participants as the
clinical development program is ongoing.
While it is possible that the participants in this study may not benefit from the study treatment, a
Phase 1 study with golimumab that enrolled children between 2 to 17 years of age with moderate
to severely active UC showed that continued clinical benefit was observed in children with UC
who received golimumab q4w maintenance therapy through Week 110 as assessed by PUCAI
scores.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
31
Approved, Date: 11 November 2023
The clinical benefit of infliximab is known, as infliximab has been demonstrated to be safe and
efficacious for the treatment of moderately to severely active UC in pediatric patients (aged
6to 17 years) and has been approved for this indication in multiple jurisdictions globally.
2.3.1.2. 
Potential Benefits
Participants in this study will be children 2 to 17 years of age with moderately to severely active
UC. As golimumab has already been established as safe and efficacious for adults with moderately
to severely active UC, the Sponsor anticipates that pediatric participants with UC are likely to
benefit from treatment with golimumab as well, at least commensurate with that demonstrated in
the adult studies of golimumab in UC. This is supported by our observations in
CNTO148UCO1001, a Phase 1b multicenter, open-label study ofgolimumab in pediatric
participants with moderately to severely active UC. This study, though of limited size,
demonstrates that pediatric and adult golimumab pharmacokinetics are similar. Moreover, clinical
benefit was suggested in these biologically naive pediatric participants with UC.21 Participants
may also have some benefit from the participation in a clinical trial irrespective of receiving study
treatment, due to regular visits and assessments monitoring their overall health. Lastly, while not
directly benefitting the participant, results from this clinical study will support a new indication
for golimumab in treating moderately to severely active UC in pediatric participants aged 2 to
17 years, which would benefit other pediatric UC participants.
2.3.2. 
Known and Potential Risks
2.3.2.1. 
Known Risks
All therapies have the potential to cause adverse experiences. The anti-TNFα class of agents has
been extensively studied in adults and pediatric participants and has a well-defined safety profile.
Known risks for anti-TNFα agents such as golimumab and infliximab include infections, serious
infections, tuberculosis (TB), and opportunistic infections. Other known risks include but are not
limited to lymphoma, leukemia, lupus-like syndrome, and demyelinating disorders.
2.3.2.2. 
Potential Risks
A potential risk for the development of other malignancies and exposure during pregnancy are
common to both golimumab and infliximab. In addition, for participants treated with golimumab,
serious depression (including suicidality), and serum sickness are additional potential risks which
cannot be excluded.
Detailed information about the safety profile and risks for golimumab, including a table of adverse
drug reactions, may be found in the golimumab IB.
Detailed information about the safety profile and risks for infliximab, including a table of adverse
drug reactions, may be found in the infliximab IB.
2.3.3. 
Overall Benefit: Risk Assessment
Based on the available data and proposed safety measures, the overall benefit: risk assessment for
using golimumab in this clinical study is deemed acceptable based on the following considerations.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
32
Approved, Date: 11 November 2023
Disease morbidity: Pediatric UC is a debilitating disease that inflicts significant morbidity in
participants and for which available treatments still impose a substantial burden on both
participants and caregivers. Approved pharmacologic treatment options are limited for pediatric
UC participants, especially for those children who have failed to respond to conventional therapy
(5-ASAs, immunomodulators [6-MP, AZA, or MTX], or corticosteroids). Often, when medical
therapies fail, the only alternative is colectomy, which is itself associated with notable morbidity,
particularly in children. Colectomy can impact the child’s QoL, can contribute to fertility issues
later in life, and can be detrimental to the child’s physical and emotional development.
UC Disease Similarity in Adults and Children: The basic pathogenesis and etiology of UC is
likely the same in the pediatric and adult populations. Adult and pediatric genome-wide association
scans have yet to identify risk variants that are specific to pediatric or adult UC,34 although several
risk variants have recently been identified in  UC.31 Ulcerative colitis is characterized by an
abnormal and exacerbated immune response against mucosal constituents and components of the
luminal flora in individuals with a genetic predisposition. Early preclinical and clinical data
suggested that TNFα plays an important role in the pathogenesis of UC. In rodent models of
chronic colitis, anti-TNFα antibodies downregulate production or activity of inflammatory
cytokines and reduce the severity of intestinal inflammation.27,29 In participants with UC, serum
concentrations of TNFα and interleukin -6 have been shown to be elevated during active disease
and to decrease during disease remission.24,26,35 Braegger et al6 demonstrated that elevated TNFα
in the stool of participants with UC was a marker of disease activity.
These data led to the initiation of clinical studies to assess the efficacy and safety of the anti-TNFα
agent infliximab. Subsequently, the positive outcomes of the randomized, placebo controlled
clinical trials of the anti-TNFα infliximab, in the treatment of adults with moderate to severely
active UC (ACT 1 and ACT 210,30,33) provided further support for the role of TNFα in the
pathogenesis of UC.
Benefit: Risk of Golimumab
Golimumab is the third anti-TNFα agent approved for the treatment of UC in adults, and its
efficacy and safety have been demonstrated in adequate and well-controlled studies in adults with
UC. Currently, the only approved anti-TNFα treatment option for pediatric participants with
moderately to severely active UC is infliximab. Although infliximab is an effective treatment, it is
administered IV by healthcare professionals in a clinic or hospital setting and may be inconvenient
for pediatric participants and their caregivers. Moreover, infliximab is approved only for
participants 6 years and above, which means pediatric UC participants between 2 and 6 have no
approved anti-TNFα biologic therapies available to them.
Based upon their overall positive benefit: risk profile, TNFα-blockers such as etanercept,
infliximab, adalimumab, and golimumab, have been studied in a number of pediatric autoimmune
conditions such as pJIA, psoriasis, Crohn’s disease, and UC and have been registered for pediatric
indications globally. Golimumab was studied for pJIA in 173 children 2 years old and above.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
33
Approved, Date: 11 November 2023
For pediatric UC, there have been several supportive studies as well. Infliximab was approved in
children 6 years old and above with Crohn’s disease and UC. Moreover, as described in
Section 2.1, the efficacy and safety of golimumab in pediatric UC has been tested in a small study
of 35 children, ages 6 to 17 years (CNTO148UCO1001), which is presently in its study extension.
Median serum golimumab concentrations in this group were comparable with a historical reference
adult UC population at Weeks 2, 4, and 6. At Week 6, 60%, 34%, and 54%, of participants
achieved Mayo clinical response, PUCAI clinical remission, and mucosal healing (Mayo
subscore 0/1). A planned DBL of the study extension was conducted at Week 126. Overall, 11 of
20 participants starting the study extension at Week 14 completed the Week 126 visit. Ten of
20 participants (50%) starting the study extension at Week 14 were in clinical remission
(PUCAI<10) at Week 110.21
Thus far, pediatric use of golimumab has been well tolerated in studies (CNTO148DML2001 [to
arrest β-cell loss in Type 1 Diabetes], CNTO148JIA3003 [treatment of pJIA],
CNTO148UCO1001 [treatment of UC], and CNTO148JIA3001 [treatment of pJIA]) with
pediatric participants of 2 to 17 years of age. In general, the safety profile of golimumab in the
pJIA and pediatric UC studies, including the type and frequency of the adverse reactions seen, is
consistent with the known safety profile for the adult populations studied and consistent with other
TNFα inhibitors. No new safety signals have been observed in pediatric populations using
golimumab.
Benefit: Risk of Infliximab
The efficacy and safety of infliximab has been evaluated in adult subjects with moderately to
severely active UC in 3 completed clinical studies: C0168T12, C0168T37 (ACT 1), and C0168T46
(ACT 2). Both ACT 1 and ACT 2 achieved the primary endpoint of clinical response at Week 8
(ACT 1: infliximab 5 mg/kg and 10 mg/kg [69.4% and 61.5%, respectively, versus placebo 37.2%;
both p <0.001]; ACT 2: infliximab 5 mg/kg and 10 mg/kg [64.5% and 69.2%, respectively, versus
placebo; 29.3%; both p <0.001]).
Approximately 500 adult subjects with UC have been treated with infliximab during clinical
studies. The percentage of subjects who died or experienced malignancies during the clinical
studies was <1%. Although serious infections did occur in ACT 1 and ACT 2, the overall
occurrence was low: 3.9% in the combined infliximab group versus 2.5% in the placebo group.
The C0168T72 study was a Phase 3, randomized, open-label, parallel-group, multicenter study to
assess the safety and efficacy of induction and maintenance infliximab treatment in pediatric
subjects aged 6through 17 years who had moderately to severely active UC (defined as a Mayo
score of 6 to 12, inclusive, at baseline, including an endoscopic subscore ≥2). The study showed
that infliximab 5 mg/kg administered at Weeks 0, 2, and 6 was efficacious in pediatric subjects
with UC, with efficacy consistent with that seen in adults with UC in the infliximab 5 mg/kg group
from the pooled ACT studies (73.3% and 66.9%, respectively, for the proportion of subjects in
clinical response).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
34
Approved, Date: 11 November 2023
Infliximab was generally well tolerated in the pediatric UC population, with a safety profile
consistent with that reported in other studies. There were no reports of deaths, malignancies,
opportunistic infections, serious neurologic events, or TB and the safety profiles observed in the
every 8 weeks (q8w) and every 12 weeks (q12w) maintenance treatment groups were similar. No
new safety signals have been observed in pediatric populations using infliximab.
The conventional posology, however, is thought to be inadequate for certain groups of patients.
In order to better mimic current clinical practice, this protocol permits step-wise dose escalation
of infliximab (to a maximum of 10 mg/kg [capped at 1gm] q4w). This approach has been discussed
and deemed appropriate by US Food and Drug Administration (FDA) and Pediatric Committee of
the European Medicines Association, as well as experts in pediatric IBD in the US and EU. Real
world experience has demonstrated that there is a need for more intensive dosing in patients in the
setting of acute severe colitis or in patients with a flare in their UC due to a secondary loss of
response.
Trough levels of infliximab tend to be lower in patients with acute severe colitis.37,51 Higher rates
of remission and lower rates of colectomy have been reported in UC patients treated with escalated
dosing of infliximab in adults13 and pediatric patients,1,17 and these observations and clinical
practice are being reflected in new guidelines for the management of acute severe colitis in
pediatric patients.48 Similarly, secondary loss of response (LOR) to infliximab after an initial
response occurs in 20-40% of all IBD patients after 1 year of therapy.4,5 Several studies in IBD
broadly14 and UC more specifically41,38 have found significant clinical benefit in escalating
infliximab dosing, with response rates generally between 25-45% and avoidance of the need for
colectomy.44Small retrospective studies in psoriasis45 and IBD8,15 have found that dose escalation
is generally well tolerated and not associated with new safety signals. These benefits in clinical
response and avoidance of colectomy have offset concerns about the risks of infection and other
side effects from the escalated infliximab dosing.
Additional Measures for Study Safety: Use of golimumab and other TNFα-blockers for both
adults and children includes routine evaluation of safety. Participants in this study will be
extensively evaluated during screening and excluded from participation if they have any relevant
risk factors for TNFα-blockers or golimumab use, to limit the chance of untoward and adverse
effects in this study.
Study sites are selected based on proven experience and qualification to run pediatric UC studies.
An internal Data Monitoring Committee (DMC) comprised of experienced medical personnel not
involved in the conduct of this study, will be in place prior to the start of the study and will perform
unblinded review of individual participant and cumulative safety data. The DMC will monitor data
until all participants reach the Week 54 visit or terminate the study prior to the Week 54 visit (for
additional details, see Section 9.5).
Criteria are established for discontinuation of treatment in individual participants, and study
termination (Section 7).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
35
Approved, Date: 11 November 2023
More detailed information about the known and expected benefits and risks of golimumab and
infliximab may be found in the respective IBs.
3. 
OBJECTIVES AND ENDPOINTS
Primary Objectives
To evaluate the efficacy of golimumab in inducing clinical remission as assessed by the Mayo
score, in pediatric participants with moderately to severely active UC.
To evaluate the safety profile of golimumab, in pediatric participants with moderately to
severely active UC.
Secondary Objectives
To evaluate the efficacy of golimumab in inducing clinical response as assessed by the Mayo
Score and clinical remission as measured by the PUCAI Score.
To evaluate the efficacy of golimumab on endoscopic healing.
To evaluate the efficacy of golimumab during the long-term phase.
To evaluate the effect of golimumab on additional efficacy and QoL measures.
To evaluate the PK and exposure-response of golimumab during short- and long-term phases.
Additional Objective (Usability Assessment Substudy)
To evaluate the potential for at home use of golimumab in the participant population during
the Usability Assessment Substudy.
3.1. 
ENDPOINTS
Primary Endpoint
The primary endpoint is clinical remission at Week 6 as assessed by the Mayo score.
Clinical remission as measured by the Mayo score is defined as a Mayo score ≤2 points, with no
individual subscore >1 (based on Mayo endoscopy subscore assigned by the local endoscopist).
Major Secondary Endpoints
For endpoints beyond Week 6, analyses will be performed on participants who are in clinical
response at Week 6 as assessed by the Mayo score.
1. Symptomatic remission at Week 54.
2. Clinical remission at Week 54 as assessed by the Mayo score (based on Mayo endoscopy
subscore assigned by the local endoscopist).
3. Clinical remission at Week 54 as assessed by the PUCAI score.
4. Clinical remission at Week 6 as assessed by the PUCAI score.
5. Clinical response at Week 6 as assessed by the Mayo score (based on Mayo endoscopy
subscore assigned by the local endoscopist).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
36
Approved, Date: 11 November 2023
6. Endoscopic healing at Week 6 (based on Mayo endoscopy subscore assigned by the local
endoscopist).
7. Endoscopic healing at Week 54 (based on Mayo endoscopy subscore assigned by the local
endoscopist).
8. Clinical remission at Week 54, as assessed by the Mayo score, for participants who are in
clinical remission at Week 6 (based on Mayo endoscopy subscore assigned by the local
endoscopist).
9. Participants who were not receiving corticosteroids for at least 12 Weeks prior to Week 54 and
in clinical remission at Week 54, as assessed by the Mayo score (based on Mayo endoscopy
subscore assigned by the local endoscopist).
The efficacy endpoint definitions are as follows:
Symptomatic remission: Mayo stool frequency subscore of 0 or 1 and a rectal bleeding
subscore of 0.
Clinical response: a decrease from baseline in the Mayo score of ≥30% and ≥3 points, with
either a decrease from baseline in the rectal bleeding subscore of ≥1 or a rectal bleeding
subscore of 0 or 1.
Clinical remission as measured by the PUCAI score: a PUCAI score <10.
Endoscopic healing: an endoscopy subscore of the Mayo score of 0 or 1.
HYPOTHESIS
Golimumab is an  effective therapy in pediatric UC participants relative to historical placebo
outcomes for clinical remission in adults based on the Mayo score.
4. 
STUDY DESIGN
4.1. 
Overall Design
This is a multicenter, randomized, open-label golimumab study in pediatric participants aged 2 to
17 years with moderately to severely active UC, defined as a baseline Mayo score of 6 through 12,
inclusive, with an endoscopy subscore of ≥2. Additionally, all study participants must have
demonstrated an inadequate response to, have failed to tolerate, or have a medical contraindication
to conventional therapies (ie, IV or oral corticosteroids or the immunomodulators MTX, AZA, or
6-MP); or, demonstrated corticosteroid dependence; or, require repeated (>3 per year) courses of
corticosteroids. Participants with prior exposure to biologic anti-TNFα agents will be ineligible for
participation.
In this study, the remission rate on golimumab in pediatric participants will be formally compared
with a historical placebo remission rate derived from a meta-analysis of 2 adult Phase 2/3 UC
studies of golimumab and 5 adult Phase 3 studies of other biologic products approved in this
indication utilizing similar populations and endpoints. For additional details see Sections 4.2.1,
9.1, and 9.2.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
37
Approved, Date: 11 November 2023
This study also includes an infliximab arm. Upon implementation of Amendment 4, no additional
participants will be randomized to the infliximab arm; all newly enrolled participants will receive
golimumab. No formal comparisons between golimumab and infliximab will be performed.
Prior to Amendment 4, approximately 125 participants who satisfy inclusion/exclusion criteria
were to be included in the study at sites located globally, including in North and South America,
Asia, and Europe. At least 24 golimumab participants with body weight <45 kg, and at least 5
golimumab participants with body weight <30 kg will be included.
In order to ensure that at least 5 participants <30 kg receive golimumab, participants who weigh
<30 kg were to only be allocated to the golimumab treatment arm. The remaining 120 participants
were to be randomized in a 3:1 ratio to golimumab or infliximab, respectively.
Upon implementation of Amendment 4, no additional participants will be randomized to
infliximab; all newly enrolled participants will receive golimumab.
Upon implementation of Amendment 5, no new participants will be enrolled. Approximately 70
participants will participate in this study (at least 60 participants will receive golimumab, at least
10 participants will receive infliximab). Of the 60 golimumab participants, at least 15 will have a
body weight <45 kg and at least 5 will have a body weight <30 kg.
Participants must weigh ≥10 kg and be >70 cm tall. This is the lower range of weight and height
that the Prefilled Pen-Varioject (PFP-V) has been validated for to deliver SC golimumab. This
limit accommodates >97% of all 2-year old girls based on published growth charts.54 If a study
participant’s weight falls below 10 kg after Week 10, the study intervention must be withheld until
their body weight is ≥10 kg. If they miss 2 consecutive doses of golimumab because of body
weight below this 10 kg limit, the study intervention should be discontinued.
The following concomitant medications for UC are allowed in this study: 5-ASAs, corticosteroids,
and immunomodulators (ie, 6-MP, AZA, MTX). Dosages of these concomitant medications must
be stable for 2 weeks prior to first administration of study intervention at Week 0.  For participants
receiving 5-ASAs at Week 0, the dose must remain stable through Week 54 (except for
weight-based adjustments, as treatment for a documented UC flare after Week 6, or if investigator
judgment requires dose reduction or cessation  because of toxicity or medical necessity
(Section 6.5.3)). For participants receiving immunomodulators at Week 0, the dose should not be
increased (except for weight-based adjustments) through Week 6. Although immunomodulators
may be discontinued or the dose reduced at any time during the study, it is preferred, at the
discretion of the investigator, that they be continued at least through Week 14. For participants
receiving corticosteroids, the steroids may be tapered beginning at Week 0, although it would be
preferable to delay the stopping of steroids until after the Week 6 evaluation if clinically
reasonable. UC-specific medical therapies (ie, oral/rectal corticosteroids, oral/rectal
5-aminosalicylate (5-ASA) compounds, or the immunomodulators 6-MP, AZA, or methotrexate
[MTX]) may not be initiated or their dose increased at any time after Week 6to Week 54 except
for weight-based dose adjustments or unless there is a documented UC flare and loss of response

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
38
Approved, Date: 11 November 2023
that makes the subject eligible for rescue medication (Section  6.5.3). For additional details
regarding UC-specific allowed concomitant therapies, see Section 6.5.1.
This 54-week study will consist of a 6-week short-term phase and a 48-week long-term phase
followed by a study extension (for eligible golimumab-treated participants) as presented in
Figure 1.
Short-term Phase (Weeks 0 to 6)
Prior to Protocol Amendment 4, the randomization scheme below was followed.
At Week 0, participants ≥30 kg were randomized 3:1 to either Group 1 or Group 2. All participants
<30 kg were placed in Group 1.
Group 1 - golimumab SC at Weeks 0 and 2
Participants with body weight ≥45 kg will receive fixed induction doses of 200 mg at Week 0
and 100 mg at Week 2.
Participants with body weight <45 kg will receive body-surface area (BSA)-adjusted
induction doses of 120 mg/m2 (up to a maximum of 200 mg) at Week 0 and 60 mg/m2 (up to
a maximum of 100 mg) at Week 2.
Group 2 - Infliximab 5 mg/kg IV at Weeks 0 and 2 (participants ≥30 kg only)
Upon implementation of Amendment 4, no additional participants will be randomized to
infliximab; all newly enrolled participants will receive golimumab.
At Week 6, golimumab and infliximab participants will undergo sigmoidoscopy (or colonoscopy
at the investigator’s discretion) and will be evaluated for efficacy, PK, and safety.
Exposure-response analysis for golimumab participants will be based on the PK and efficacy
assessments conducted at Week 6.
Long-term Phase (Week 6 through Week 54)
Group 1 (Golimumab): At Week 6, participants in clinical response to golimumab (as evaluated
by the Mayo score using the local read for the sigmoidoscopy subscore) will continue to receive
SC golimumab 100 mg or 60 mg/m2 q4w through Week 50. Participants not in clinical response
at Week 6, may (at the discretion of the investigator) receive 2 additional doses of golimumab (ie,
at Week 6 and Week 10). Of these participants, those who are partial Mayo responders at Week 14
(defined as a decrease from the Week 0 partial Mayo score of≥3 points) will continue to receive
SC golimumab 100 mg or 60 mg/m2 q4w through Week 50. Participants who are not in partial
Mayo response at Week 14 will be withdrawn from further study intervention administrations and
complete a final safety follow-up period of 16 weeks (more than 5.5 half-lives for SC golimumab)
following the last administration of study intervention.
Group 2 (Infliximab): At Week 6, participants in clinical response to infliximab (as evaluated by
the Mayo score using the local read for the sigmoidoscopy subscore) will continue to receive IV
infliximab 5 mg/kg administered q8w through Week 46. The infliximab arm permits flexible dose

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
39
Approved, Date: 11 November 2023
escalation based on clinical response. Participants not in clinical response at Week 6 (as evaluated
by the Mayo score) may be considered for an increased dose of infliximab (to 10 mg/kg [capped
at 1 gm] at Week 6 and q8w thereafter or 5 mg/kg at Weeks 6 and 8, and 10 mg/kg (capped at
1 gm) at Week 14 and q8w thereafter, respectively). Participants who have achieved a partial Mayo
response at Week 14 (defined as a decrease from the Week 0 partial Mayo score of ≥3 points)
should continue receiving infliximab at 10 mg/kg q8w through Week 46. For participants not in
partial Mayo response, they may also be considered for a change of the dosage interval to q4w. At
Week 22, those participants who received an escalation in their infliximab dosing to 10 mg/kg q4w
will need to demonstrate a partial Mayo response (defined as a decrease from the Week 0 partial
Mayo score of ≥3 points) to continue in the study. Participants in partial Mayo response will
continue receiving open-label infliximab 10 mg/kg (capped at 1 gm) q4w through Week 46.
Participants who are not in partial Mayo response at Week 22 will have study intervention
discontinued and should complete a final safety follow-up at least 8 weeks following the last
administration of infliximab.
A clinical flare in UC is defined as an increase from the start of the long-term phase ([Week 6] in
the partial Mayo score of at least 2 points and an absolute partial Mayo score ≥4; or an absolute
partial Mayo score ≥7 points. Participants who experience a flare in their UC disease (defined in
Section 6.5.3) from Week 6 onward may initiate this step-wise dose escalation at any time to the
maximum of10 mg/kg (capped at 1gm) q4w. Participants who dose-escalate in response to a UC
flare will be reassessed after 2 administrations at the final escalated dose. Participants in partial
Mayo response (ie, a decrease from flare baseline of ≥2 in the partial Mayo score) will continue
receiving open-label infliximab through Week 46 at the escalated dose. Participants who have not
achieved a partial Mayo response will be discontinued from study intervention administration and
should return for a final safety visit at least 8 weeks after their last infliximab administration.
After the Week 8 visit and before the Week 54 visit, participants in the infliximab arm will only
require study visits on treatment days.  All other nontreatment visits during this time period will
be optional. All participants must have the Week 54 or Early Termination visit.
Lastly, while escalation should be based on clinical criteria as described above, investigators at
their discretion, may utilize infliximab serum levels to assist their decision making in this flexible
dosing approach.
Assessments during the long-term phase for both groups include efficacy, PK, and safety.
At Week 54, all participants remaining in the study will undergo a sigmoidoscopy (or colonoscopy
at the investigator’s discretion) to permit a full Mayo score efficacy determination.
Study extension (Week 54 to end of study)
Group 1 (Golimumab): Following the Week 54 evaluations (end of the main pivotal study),
participants who are receiving benefit from golimumab, at the discretion of the investigator, may
continue to receive SC golimumab q4w in an extension period until one of the following conditions
below is met, whichever occurs first:

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
40
Approved, Date: 11 November 2023
1. marketing authorization is obtained for golimumab for the treatment of pediatric participants
with UC and golimumab is either commercially available or 2 years have lapsed since
marketing authorization, or
2. the participant turns 18 years of age and has access to commercially available golimumab, or
3. until a decision is made by the sponsor not to pursue an indication in this pediatric UC
population.
Beginning with the Week 54 evaluations, participants in those regions where the adult maintenance
posology is weight-based (eg, 50 mg for those weighing ≤80 kg and 100 mg for those weighing
>80 kg) may make a one-time reduction in their golimumab dose to 50 mg q4w. Participants may
return to the golimumab 100 mg q4w dosing at the discretion of the investigator, but then no
additional changes in dosing can be made for the duration of the study extension.
Beginning with Week 58, eligible participants or their caregivers will have the option to administer
golimumab at home after being properly trained (see below; At Home Administration).
Group 2 (Infliximab): After the Week 54 evaluations, participants receiving infliximab will be
withdrawn from study participation and transition to local standard of care which may include
continued commercially available infliximab at the discretion of their physician.
At Home Administration
At any time after Week 54 (Week 58 at the earliest), participants who are eligible to continue
receiving golimumab in the study extension will be offered the option for self-administration (at
least 12 years old) or caregiver administration (any age; Appendix 18 [Section 10.18]). This is
optional; if a pediatric participant or caregiver elects against self- or caregiver administration, the
health care professional (HCP) will continue to administer injections in this study.
All participants who elect AHA of the study intervention will receive a face-to-face training from
study site staff on the use of the Prefilled Syringe with UltraSafe (PFS-U) or the Prefilled Pen-
Varioject (PFP-V). Training for AHA will occur over 3 q4w administration visits beginning as
early as Week 58. Participants will complete a training administration at the first visit, using the
PFS-U or PFP-V device at the clinic under the observation/supervision of site staff. Site staff will
complete an observer checklist (Appendix 10 [Section 10.10]). An HCP will determine whether a
participant (≥12 years of age) or their caregiver (participant may be any age) can perform the
injections. The 2 remaining self- or caregiver-dose administrations will be performed in the clinic
by the participants or their caregivers, with site staff available for any questions, and should be
performed by the person who received the appropriate training. Participants may elect at any time
during the study extension to have golimumab administered by an HCP or return entirely to HCP
administration of study intervention.
Participants will be observed for at least 30 minutes after the administration of study intervention
for symptoms of an injection-site reaction at the investigative site.
In addition to recording the details of the study intervention, dosing day, time, anatomic site and
if there were any complications of the injection, participants and/or caregivers should be instructed

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
41
Approved, Date: 11 November 2023
to monitor the injection-site for any reactions, including, but not limited to swelling,
redness/erythema, pain, tenderness, warmth, bruising, or bleeding. All dosing and adverse event
(AE) (including injection-site reaction) information, as well as concomitant medications and TB
exposure will be documented in an AHA diary, that is to be returned to the site at the upcoming
visit and entered by site staff into the electronic case report form (eCRF). For any severe injection-
site reactions, or changes at the injection-site, or any mild to moderate to severe golimumab
reaction which occur hours to days following injection, the participant/caregiver should contact
the study site for consultation. Acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs),
and/or diphenhydramine or locally available alternative may be administered at the investigators’
direction. In case of a severe allergic reaction (eg, anaphylaxis, difficulty breathing, light-
headedness, hives, or widely spread body rash), participants or their caregivers should call for
emergency medical assistance (paramedic or ambulance) first before contacting the study site.
All product quality device complaints (PQC) and device-related AEs will be collected and
investigated. For additional details on PQC procedures, see Appendix 16(Section 10.16).
Usability Assessment Substudy
Participants at certain study sites entering the study extension who elect to administer the study
intervention at home will have the option to be enrolled in an Usability Assessment Substudy
(Appendix 18 [Section 10.18]). An attempt will be made to enroll approximately 10-20 participants
in the Usability Assessment Substudy at Week 58. Participants administering study intervention
at home will receive detailed instructions on how to monitor and report potential injection-site
reactions.
For all AHAs of golimumab beginning at Week 58, the details of the study intervention, dosing
day, time, anatomic site and if there were any complications of the injection, as well as AE
(including injection-site reaction), concomitant medications and TB exposure information will be
documented in an AHA diary, that is to be returned to the site at the upcoming visit, and entered
by site staff into the eCRF.
Details of the Substudy  are provided in Appendix 9 (Section 10.9) and Appendix 18
(Section 10.18).
Database Locks (DBL)
There are 2 planned DBLs in this study:
The first DBL will occur when all participants have either completed the Week 54 visit or
terminated the study prior to Week 54. This DBL may also include data from the Usability
Assessment Substudy questionnaire.
A final DBL will occur when all participants who entered the study extension have either
completed the final visit or have terminated study participation.
Additional DBLs other than the 2 specified above may be performed.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
42
Approved, Date: 11 November 2023
Data Monitoring Committee (DMC)
An internal DMC (consisting of Sponsor members [a gastroenterologist, a clinician, and a
statistician at a minimum] outside of the study team), will be established to monitor safety data
(for both golimumab and infliximab treatments arms) on an ongoing basis until all participants
reach the Week 54 visit or terminate the study prior to the Week 54 visit (Section 9.5).
4.2. 
Scientific Rationale for Study Design
4.2.1. 
Historical Placebo
The primary analysis will involve a formal statistical comparison to a historical adult placebo
remission rate derived from a meta-analysis of 2 Phase 2/3 UC studies of golimumab and 5 Phase 3
studies of other products approved in this indication (for additional details see Sections 9.1 and
9.2) utilizing similar endpoints (clinical remission as assessed by the Mayo Score), populations,
and methodologies for endpoint determination (clinical remission as determined by the local
endoscopy). This approach of comparing to a historical adult placebo control has been discussed
with health authorities (both US and EU) and is similar to the approach employed for infliximab
approval in pediatric UC.
To ensure a robust estimate of the placebo remission rate, the Sponsor has derived a historical
adult placebo remission rate from a meta-analysis of placebo-controlled studies that met the
following criteria:
Supported successful biologic product registration in UC
Had similar study design and endpoints (ie, Mayo score remission)
Utilized local (versus central) endoscopic reading
Enrolled similar participant populations (eg, participants with moderately to severely active
UC)
Enrolled TNFα-naïve populations or had publicly available information on the subgroup of
enrolled participants who were TNFα-naïve
Based on the above criteria, a total of 7 adult UC studies including infliximab Phase 3 (C0168T37
and C0168T46), golimumab Phase 2/3 (C0524T16 and C0524T17), adalimumab Phase 3
(ULTRA 1 and ULTRA 2), and vedolizumab Phase 3 (GEMINI 1) are included in the meta-
analysis of the historical adult UC placebo remission rate. Combined, these studies have a total of
988 placebo participants.
The meta-analysis was conducted by taking the weighted average of the point estimate for clinical
remission from the various studies, where the study weight is the inverse of the standard error. The
studies with smaller standard error and larger sample sizes provide more weight. The estimate of
the historical adult UC placebo remission rate based on the meta-analysis is 8.3% (95% confidence
interval (CI): 6.6%, 10.0%).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
43
Approved, Date: 11 November 2023
4.2.2. 
Infliximab
Infliximab, a mouse-human chimeric anti-TNFα mAb, was the first anti-TNFα therapy approved
for the treatment of adult and pediatric participants with moderately to severely active UC who
had an inadequate response to conventional therapies.
In response to a request from health authorities, an infliximab reference arm was included in this
proposed study to assess assay sensitivity (primarily relying on PUCAI and partial Mayo scores)
in comparison to historical data from the infliximab C0168T72 pediatric UC study. Upon
implementation of Amendment 4, no additional participants will be randomized to infliximab; all
newly enrolled participants will receive golimumab, and assay sensitivity will not be assessed.
This amendment to the infliximab arm was discussed with health authorities and it was accepted
that enrollment into the infliximab arm could be stopped.
Participants who weigh <30 kg will not be eligible for infliximab, as this rare subpopulation will
only be allocated to the golimumab treatment arm.
Participants in the infliximab arm will receive initial treatment of 5 mg/kg Weeks 0, 2, and 6then
q8w through Week 46 if in clinical response. For participants not in clinical response or who have
lost clinical response and experience a flare in their UC, a step-wise flexible dosing approach will
be permitted in the infliximab arm only. This approach was chosen as it most closely mimics
clinical practice in treatment of pediatric UC, allowing investigators some flexibility in dosing to
treat their participants.
Specifically, participants in the infliximab arm will receive IV infliximab 5 mg/kg at Weeks 0
and 2. At Week 6, participants in clinical response to infliximab (as evaluated by the Mayo score)
will continue to receive IV infliximab 5 mg/kg administered q8w through Week 46. After the
Week 54 evaluations, participants receiving infliximab will be transitioned off the study to
standard medical care.
Participants not in clinical response at Week 6, will be considered for an increased dose of
infliximab (10 mg/kg [capped at 1 gm] at Week 6 and q8w thereafter or 5 mg/kg at Weeks 6 and
8 and 10 mg/kg [capped at 1 gm] starting at Week 14 and q8w thereafter, respectively) at the
discretion of the investigator. Participants who demonstrate a partial Mayo response (defined as a
decrease from the Week 0 partial Mayo score of ≥3 points) at Week 14 will continue to receive
infliximab 10 mg/kg [capped at 1 gm] q8w through Week 46. Participants not in partial Mayo
response may also be considered for a change of the dosage interval to q4w. At Week 22,
participants who demonstrate a partial Mayo response (defined as a decrease from the Week 0
partial Mayo score of ≥3 points) will be able to continue in the study and receive infliximab
10 mg/kg (capped at 1 gm) q4w through Week 46. Participants who are not partial Mayo
responders at Week 22 will have study intervention discontinued and should complete a final
safety follow-up at least 8 weeks following the last of infliximab administration.
Participants who experience a flare in their UC disease (defined in Section 6.5.3) after Week 6
may initiate this step-wise dose escalation at any time to the maximum of 10 mg/kg (capped at
1 gm) q4w. Participants who dose-escalate in response to a UC flare will be reassessed after 2

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
44
Approved, Date: 11 November 2023
administrations at the final new higher dose. Participants in partial Mayo response (ie, a decrease
from flare baseline of ≥2 in the partial Mayo score) will continue receiving open-label infliximab
through Week 46 at the escalated dosage. Participants who have not achieved a partial Mayo
response will be discontinued from study intervention administration and should return for a final
safety visit at least 8 weeks after their last infliximab administration. After the Week 8 visit and
before the Week 54 visit, participants in the infliximab arm will only require study visits on
treatment days.  All other nontreatment visits during this time period will be optional.  All
participants must have Week 54 or Early Termination visit. Importantly, while escalation should
be based on clinical criteria as described above, investigators, may utilize infliximab serum levels
to assist their decision making in this flexible dosing approach.
Lastly, after the Week 54 evaluations, participants receiving infliximab will be withdrawn from
study participation and transition to local standard of care which may include continued
commercially available infliximab at the discretion of their physician.
4.2.3. 
Biomarker Collection
Biomarker samples will be collected to explain interindividual variability in clinical outcomes or
may help to identify population subgroups that respond differently to an intervention. The goal of
the biomarker analyses is to evaluate the PD of golimumab and aid in evaluating the
intervention-clinical response relationship.
Biomarker samples may be used to help address emerging issues and to enable the development
of safer, more effective, and ultimately individualized therapies. The RNA blood sample should
not be collected at any time point for any participant who at Screening has a body weight of 10 kg
to <12.3 kg, even if the weight increases to above 12.3 kg during the study. For participants who
weighed more at Screening but whose body weight falls to between 10 kg to <12.3 kg, the RNA
blood sample should not be collected.
4.2.4. 
Study-Specific Ethical Design Considerations
Potential participants will be fully informed of the risks and requirements of the study and, during
the study, participants will be given any new information that may affect their decision to continue
participation. They will be told that their consent to participate in the study is voluntary and may
be withdrawn at any time with no reason given and without penalty or loss of benefits to which
they would otherwise be entitled. Only participants who are fully able to understand the risks,
benefits, and potential adverse events of the study, and provide their consent voluntarily will be
enrolled.
When referring to the signing of the Informed Consent Form (ICF), the terms legal guardian and
legally acceptable representative refer to the legally appointed guardian of the child with authority
to authorize participation in research. For each participant, his or her parent(s) (preferably both
parents, if available) or legally acceptable representative(s), as required by local regulations, must
give written consent (permission) according to local requirements after the nature of the study has
been fully explained and before the performance of any study-related assessments. Assent must be
obtained from children (minors) capable of understanding the nature of the study, typically

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
45
Approved, Date: 11 November 2023
participants 7 years of age and older, depending on the institutional policies and national/local
guidelines. For the purposes of this study, all references to participants who have provided consent
(and assent as applicable) refers to the participants and his or her parent(s) or the participant's legal
guardian(s) or legally acceptable representative(s) who have provided consent according to this
process. Minors who assent to a study and later withdraw that assent should not be maintained in
the study against their will, even if their parent(s) still want them to participate.
The total blood volume to be collected is considered to be an acceptable amount of blood to be
collected over this time period from the population in this study. Total blood volume to be collected
in this study is in line with the allowable blood sample volumes described in the EU guideline on
clinical trials conducted with minors (EU Guideline: Ethical considerations for clinical trials on
medicinal products conducted with minors [Rev 1; 18 Sep 2017]).12
4.3. 
Justification for Dose
Golimumab: As the pediatric UC development program for golimumab is a global program, the
choice of the 100 mg or its BSA equivalent (60 mg/m2) where applicable, will facilitate evaluation
of the efficacy and safety with a dose that is equivalent to the adult UC maintenance dose of
golimumab which is relevant across all regions and is consistent with the approach to dosing that
was used in study CNTO148UCO1001. After the evaluation of the key maintenance endpoints at
Week 54, investigators will have the option to decrease the maintenance dose to mimic local
labeling posology as applicable.
The following golimumab doses will be evaluated in this Phase 3 pediatric study:
Participants ≥45kg: Short-term phase  200 mg at Week 0 and 100 mg at Week 2;
Long-term phase 100 mg q4w from Week 6
Participants <45kg: Short-term phase - 120 mg/m2 at Week 0 and 60 mg/m2 at Week 2;
Long-term phase 60 mg/m2 q4w from Week 6
The golimumab dosages planned for this Phase 3 study were determined based on data from the
adult golimumab UC studies and the Phase 1 pediatric UC study (CNTO148UCO1001). Based on
the assumption of similarity in disease and response to treatment between pediatric and adult
participants with UC, the golimumab dosage in this pediatric study aims to attain systemic
exposures in children similar to those established to be safe and effective in adult participants with
UC.
A BSA-based dose adjustment was conservatively adopted for pediatric participants with lower
body weight in order to minimize the variability of golimumab exposure across the pediatric age
continuum. The expectation of consistent exposure following BSA-adjusted posology has been
confirmed in a clinical trial of golimumab in pediatric participants with pJIA), where similar
golimumab exposure was achieved across the pediatric age (2 to 17 years) and body weight (11 to
110 kg) ranges compared with exposures in adults, using a BSA-based adjusted dosing regimen.
Unlike the pJIA study which employed BSA-dose adjustment across the entire pediatric weight
range, BSA-dose adjustment is limited to those with body weight <45 kg in this pediatric UC

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
46
Approved, Date: 11 November 2023
study. This dosing approach in pediatric UC is supported by PK simulations which demonstrated
that using a 45-kg body weight cut-off to transition from a BSA-adjusted dose to the corresponding
fixed adult dose would achieve golimumab systemic exposures in pediatric participants that are
comparable with exposures achieved in adults with UC.
With respect to the short-term phase (induction) in this study, the golimumab dosage is expected
to provide exposure similar to that observed for the approved adult dosage of 200 mg →100 mg
at Week 0 and Week 2, respectively. In the Phase 1 pediatric UC study (CNTO148UCO1001),
pediatric participants with UC with body weight <45 kg who received golimumab 90 mg/m2 →
45 mg/m2 BSA-adjusted dose regimen (at Week 0 and Week 2, respectively) achieved lower
relative mean golimumab concentrations when compared with the reference adult UC population
who received golimumab 200 mg → 100 mg. Accordingly, in the present Phase 3 study, higher
BSA-adjusted doses of 120 mg/m2 → 60 mg/m2 will be employed to more closely match the
exposure in the reference adult UC population. These higher golimumab BSA-adjusted doses are
supported by PK modeling and simulation analyses.
With respect to the long-term phase (maintenance), the reference adult dose of 100 mg (or its BSA
equivalent of 60 mg/m2) q4w will be employed. While the approved induction dose regimen for
golimumab in adult participants with UC is the same worldwide, the maintenance posology is not
identical across all markets as the 100 mg dose is approved across all body weights in some
countries; whereas a body weight tiered dose regimen (50 mg for those with body weight <80 kg
and 100 mg in those ≥80 kg) is approved in other markets. In the pivotal adult UC study
(C0524T18), both the 100 mg and 50 mg dose regimens met the primary endpoint of maintaining
clinical response through Week 54; however, only the 100 mg dosage met the major secondary
endpoints of achieving remission and mucosal healing at both Week 30 and Week 54. In addition,
the safety of the golimumab 100 mg maintenance dosage in UC was similar to that seen in other
indications in which golimumab has been studied.
Infliximab: The conventional weight-based regimen for infliximab in the treatment of pediatric
UC is 5 mg/kg. This posology is based on studies in both adult and pediatric subjects with
moderately to severely active ulcerative colitis. In 3 completed clinical trials in adult subjects with
moderately to severely active UC (C0168T12, C0168T37 [ACT 1], and C0168T46 [ACT 2]),
infliximab safety and efficacy has been evaluated. Both ACT 1 and ACT 2 achieved the primary
endpoint of clinical response at Week 8 (ACT 1: infliximab 5 mg/kg and 10 mg/kg [69.4% and
61.5%, respectively, versus placebo 37.2%; both p < 0.001]; ACT 2: infliximab 5 mg/kg and
10 mg/kg [64.5% and 69.2%, respectively, versus placebo; 29.3%; both p < 0.001]). Further, at
Week 54 of ACT 1, a significantly greater proportion of subjects in the combined infliximab
treatment group were in clinical response (44.9%), in clinical remission (34.6%), and achieved
mucosal healing (46.1%) compared with subjects in the placebo treatment group (19.8%, 16.5%,
and 18.2% for clinical response, clinical remission, and mucosal healing, respectively). Similar
results were observed at Week 30 of ACT 2.
In addition to efficacy, these clinical trials established the safety of infliximab. Of the
approximately 500 adult subjects with UC treated with infliximab during these clinical studies,
less than 1% died or experienced malignancies. Serious infections did occur in ACT 1 and ACT 2,

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
47
Approved, Date: 11 November 2023
with the overall occurrence rate of 3.9% in the combined infliximab group versus 2.5% in the
placebo group.
This conventional weight-based posology (5 mg/kg) was evaluated in pediatric UC patients in the
C0168T72 clinical study. This was a Phase 3, randomized, open-label, parallel-group, multicenter
study to assess the safety and efficacy of induction and maintenance infliximab treatment in
pediatric subjects aged 6through 17 years with moderately to severely active UC (defined as a
Mayo score of 6 to 12, inclusive, at baseline, including an endoscopic subscore ≥2), despite current
adequate treatment or who had previously failed to respond to or tolerate treatment with 6-MP,
AZA, corticosteroids, and/or 5-ASA compounds. A total of 60 pediatric subjects were enrolled at
27 investigational sites in North America and Europe and followed for safety and efficacy through
Week 54.
The C0168T72 study showed that infliximab at 5 mg/kg administered at Weeks 0, 2, and 6 was
efficacious in these pediatric subjects with UC, with efficacy consistent with that seen in adults
with UC in the infliximab 5 mg/kg group (73.3% and 66.9%, respectively, for the proportion of
subjects in clinical response). Further, in this 54-week study of pediatric subjects with UC, a
notably greater proportion of subjects was in remission at Week 54 in the q8w maintenance group
(38.1%) compared with the q12w maintenance group (18.2% p
0.146).
Infliximab was generally well tolerated in the pediatric UC population, with a safety profile
consistent with that reported in other studies. There were no reports of deaths, malignancies,
opportunistic infections, serious neurologic events, or TB and the safety profiles observed in the
q8w and q12w maintenance treatment groups were similar. No new safety signals have been
observed in pediatric populations using infliximab.
With respect to the step-wise dose escalation of infliximab (to a maximum of 10 mg/kg [capped at
1gm] q4w) which is available if the participant fails to achieve a clinical response at Week 6 or,
after responding, has a flare in their UC disease after Week 6, this dose escalation posology is
consistent with current clinical practice. This approach has been discussed and deemed appropriate
by US FDA and Pediatric Committee of the European Medicines Association, as well as experts
in pediatric IBD in the US and EU. Real world experience has demonstrated that there is a need
for more intensive dosing in some patients, particularly in the setting of acute severe colitis or in
patients with a UC flare and a secondary loss of response.
The conventional posology is thought to be inadequate for those patients with acute severe colitis.
Either because the inflammatory burden is so high, or due to altered pharmacokinetics, trough
levels of infliximab tend to be lower in patients with acute severe colitis.37,51 Higher rates of
remission and lower rates of colectomy have been reported in UC patients with the escalated
dosing of infliximab in adults10 and pediatric patients.1,17 New guidelines developed in a
collaboration between the European Society of Paediatric Hepatology, Gastroenterology, and
Nutrition (ESPHGAN) and the European Crohn’s Colitis Organization (ECCO) support  intensive
infliximab dosing in this setting.48

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
48
Approved, Date: 11 November 2023
For the purposes of this study, a flare in UC symptoms (defined Section 6.5.3) is an increase in the
partial Mayo score and is consistent with a secondary loss of response (LOR) to infliximab.
Secondary LOR to infliximab after an initial response occurs in 20-40% of all IBD patients after
1 year of therapy.4,5 Several studies in IBD broadly14 and UC more specifically38,41 have found
significant clinical benefit in escalating infliximab dosing in the setting of secondary LOR, with
response rates generally between 25-45% and avoidance of the need for colectomy.44 Small
retrospective studies in psoriasis45 and IBD8,15 have found that dose escalation is generally well
tolerated and not associated with new safety signals.  In one retrospective study in 86 adult patients
with Crohn’s disease receiving up to 22.5 mg/kg of infliximab q4w, the rate of serious infections
was reported to be 7.4 per 100 patient years. These benefits in clinical response and avoidance of
colectomy have offset concerns about the risks of infection and other side effects from the
enhanced infliximab dosing.
4.3.1. 
Randomization
Prior to Amendment 4, central randomization was to be implemented in this study. Participants
≥30 kg were randomized in a 3:1 ratio across intervention groups, golimumab and infliximab,
respectively. Randomization was to be used to minimize bias in the assignment of participants to
intervention groups and to increase the likelihood that known and unknown participant attributes
(eg, demographic and baseline characteristics) are evenly balanced across intervention groups.
Participants <30 kg were not to be randomized and offered only golimumab. This was
implemented to ensure that the Sponsor enrolled at least 5 participants who weigh <30 kg and
received golimumab as this is a rare subpopulation.
Upon  implementation of Amendment 4, no additional participants will be randomized to
infliximab; all newly enrolled participants will receive golimumab.
4.4. 
End of Study Definition
4.4.1. 
Study Completion
Short-term and long-term phase through Week 54
A participant will be considered to have completed the short-term and long-term phase of the study
if he or she has completed study assessments through Week 54 of the study. Participants who
prematurely discontinue study interventions for any reason before completion of the Week 54
assessments of the study will not be considered to have completed the study through Week 54.
Study extension
Following the Week 54 evaluations (end of the main pivotal study), participants who are receiving
benefit from golimumab, at the discretion of the investigator, may continue to receive SC
golimumab q4w in an extension period until one of the following conditions below is met,
whichever occurs first:

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
49
Approved, Date: 11 November 2023
1. marketing authorization is obtained for golimumab for the treatment of pediatrics participants
with UC and golimumab is either commercially available or 2 years have lapsed since
marketing authorization, or
2. the participant turns 18 years of age and has access to commercially available golimumab, or
3. until a decision is made by the sponsor not to pursue an indication in this pediatric UC
population
4.4.2. 
End of study
The end of study is considered as the last scheduled study assessment for the last participant in the
study extension as shown in the Schedule of Activities. The final data from the study site will be
sent to the sponsor (or designee) after completion of the final participant assessment at that study
site, in the time frame specified in the Clinical Trial Agreement.
5. 
STUDY POPULATION
The study population will include pediatric participants aged 2 to 17 years (at the time of the first
administration of study intervention at Week 0) with moderately to severely active UC, defined as
a baseline Mayo score of 6 through 12, inclusive, with an endoscopy subscore of ≥2. Additionally,
participants must have demonstrated an inadequate response to, have failed to tolerate, or have a
medical contraindication to conventional therapies (ie, IV or oral corticosteroids or the
immunomodulators MTX, AZA, or 6-MP); or, demonstrated corticosteroid dependence; or,
require repeated (>3 per year) courses of corticosteroids. Participants with prior exposure to
biologic anti-TNFα agents will be ineligible for participation in this study.
Screening for eligible participants should be performed within 6 weeks before administration of
the study intervention. Refer to Section 5.4 Screen Failures for conditions under which the repeat
of any screening procedures is allowed. On a case-by-case basis, and after consultation with the
medical monitor, procedures may exceed the 6-week window and will not be considered protocol
deviations.
The inclusion and exclusion criteria for enrolling participants in this study are described below. If
there is a question about these criteria, the investigator must consult with the appropriate sponsor
representative and resolve any issues before enrolling a participant in the study. Waivers are not
allowed.
5.1. 
Inclusion Criteria
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1. 
Must be 2 to 17 years of age (at the time of the first administration of study intervention
at Week 0) of either gender with a body weight ≥10 kg and >70 cm height.
2. 
Must have had UC diagnosed for at least 1 month prior to screening.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
50
Approved, Date: 11 November 2023
3. 
Must have the diagnosis of UC confirmed by a prior endoscopic biopsy that is consistent
with a diagnosis of UC (eg, crypt distortion, crypt abscess, goblet cell depletion, and
continuous distribution).
4. Must have moderately to severely active UC (as defined by baseline Mayo score of 6
through 12 [endoscopy {sigmoidoscopy or colonoscopy} subscore assigned by local
endoscopist], inclusive).
5. 
Must have a Mayo endoscopy (sigmoidoscopy or colonoscopy) subscore ≥2 (subscore
assigned by local endoscopist) at baseline endoscopy (indicative of moderately to
severely active UC). Baseline endoscopy (sigmoidoscopy or colonoscopy) must be
performed with study software and occur no more than 2 weeks before first study
intervention administration.
6. Criterion modified per Amendment 3.
6.1. Prior or current medication for UC must include at least 1 of the following
(Appendix 2 [Section 10.2]):
a. Current treatment with at least 1 of the following therapies: oral corticosteroids,
or the immunomodulators 6-MP, MTX, or AZA;
OR
b. Have a history of failure to respond to or tolerate, or have a medical
contraindication to, at least 1 of the following therapies: oral or intravenous
corticosteroids or the immunomodulators 6-MP, MTX, or AZA  as defined in
Appendix 2 (Section 10.2);
OR
c. Currently have or have had a history of corticosteroid dependency (ie, an inability
to successfully taper corticosteroids without a return of the symptoms of UC) as
defined in Appendix 2 (Section 10.2);
OR
d. Have required more than 3 courses of oral or intravenous corticosteroids in the
past year.
7. 
Criterion modified per Amendment 3.
7.1. Must meet concomitant medication dose stability prior to the first administration of
study intervention:
a. Corticosteroids:
1) If receiving oral, the dose (in prednisone equivalents) must have
been stable for at least 2 weeks prior to Week 0.
2) If receiving rectal corticosteroids, the dose must have been stable
for at least 2 weeks prior to Week 0.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
51
Approved, Date: 11 November 2023
3) If oral, IV, or rectal corticosteroids have recently been
discontinued, they must have been stopped for at least 2 weeks
prior to Week 0.
b. 5-ASA, MTX, 6-MP, and AZA compounds:
1) If receiving oral or rectal 5-ASA compounds, the dose must have
been stable for at least 2 weeks prior to Week 0.
2) If oral or rectal 5-ASA compounds have been recently
discontinued, they must have been stopped for at least 2 weeks
prior to Week 0.
3) If receiving MTX, 6-MP, or AZA compounds, the participant must
have been taking them for ≥12 weeks and on a stable dose for 2
weeks prior to Week 0. If the MTX, 6-MP, or AZA have been
recently discontinued, they must have been stopped for at least 2
weeks prior to Week 0.
8. 
Criterion modified per Amendment 3.
8.1. If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks
prior to the first administration of study intervention at Week 0. Participants who
receive parenteral nutrition are not permitted to enroll in the trial.
9. Must have discontinued the use of antibiotics for the treatment of UC (eg, ciprofloxacin,
metronidazole, or rifaximin) for at least 1 week prior to screening.
10. Must have discontinued the use of 6-thioguanine (6-TG) for at least 4 weeks prior to
screening.
11. If at increased risk for colon cancer, must either have had a colonoscopy to assess the
presence of dysplasia within 1 year prior to the first administration of study intervention
at Week 0 or a colonoscopy to assess the presence of malignancy as the baseline
endoscopy. Baseline endoscopy (sigmoidoscopy or colonoscopy) must be performed with
study software and occur no more than 2 weeks before first study intervention
administration.
Note: All participants who have had extensive colitis for ≥8 years, or disease limited to
the left side of the colon for ≥10 years, are considered at increased risk. For participants
with a pathology finding of “indefinite dysplasia with reactive atypia” on colonoscopy,
the investigator should discuss the case with the medical monitor to determine eligibility.
12. Criterion modified per Amendment 4.
12.1. Before enrollment, a girl must be either:
a. Not of childbearing potential defined as:
1) Premenarchal
a) A premenarchal state is one in which menarche has not yet occurred.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
52
Approved, Date: 11 November 2023
2) Permanently sterile
a) Permanent sterilization methods include hysterectomy, bilateral
salpingectomy, bilateral tubal occlusion/ligation procedures, and
bilateral oophorectomy.
b. Of childbearing potential and
1) Practicing a highly effective method of contraception (failure rate of <1%
per year when used consistently and correctly) during the study and for 6
months after receiving the last dose of study intervention. Both user-
independent and user-dependent methods of contraception are allowed.
Examples of highly effective contraceptives include:
a) User-independent methods:
Implantable progestogen-only hormone contraception associated with
inhibition of ovulation; intrauterine device; intrauterine hormone-
releasing system; vasectomized partner.
b) User-dependent methods:
Combined 
(estrogen- 
and 
progestogen-containing) 
hormonal
contraception associated with inhibition of ovulation: oral, intravaginal,
and transdermal; progestogen-only hormone contraception associated
with inhibition of ovulation: oral and injectable. Sexual abstinence
(sexual abstinence is considered a highly effective method only if
defined as refraining from heterosexual intercourse during the entire
period of risk associated with the study intervention. The reliability of
sexual abstinence needs to be evaluated in relation to the duration of the
study and the preferred and usual lifestyle of the participant).
Typical use failure rates may differ from those when used consistently and correctly.
Moreover, user-dependent methods of contraception (eg, oral contraceptives) may have
higher failure rates than non-user-dependent methods. Participants who employ user-
dependent methods are therefore urged to include an additional contraception method,
such as a barrier method (eg, condom or diaphragm). Use should be consistent with local
regulations regarding the use of contraceptive methods for participants participating in
clinical studies.
Note: If the childbearing potential changes after start of the study (eg, girl who is not
heterosexually active becomes active, premenarchal girl experiences menarche) a girl
must agree to begin using a highly effective method of birth control, as described above.
13. Criterion modified per Amendment 3.
13.1. Boys must agree not to donate sperm for the purpose of reproduction during the
study and for a minimum 6 months after receiving the last dose of study
intervention. During the study and for a minimum of 6 months after receiving the

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
53
Approved, Date: 11 November 2023
last dose of study intervention, in addition to the highly effective method of
contraception, a boy:
a. Who is sexually active with a girl of childbearing potential must agree to use
a barrier method of contraception (eg, condom with spermicidal foam / gel /
film / cream / suppository).
b. Who is sexually active with a girl who is pregnant must use a condom.
14. All girls of childbearing potential must have a negative serum pregnancy test at screening.
15. A girl of childbearing potential must have a negative urine pregnancy test prior to study
intervention administration at Week 0.
16. Girls of childbearing age must agree not to donate eggs (ova, oocytes) for the purposes of
assisted reproduction during the study and for a minimum 6 months after receiving the
last dose of study intervention.
17. Criterion modified per Amendment 4.
17.1. Are considered eligible according to the following TB screening criteria:
Have no history of latent or active TB prior to screening.
Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.
Have had no recent close contact with a person with active TB.
During the screening period have a negative QuantiFERON®-TB test or T-Spot® test
result. Within 1 month, prior to the first study intervention administration, a negative
tuberculin skin test is additionally required if the QuantiFERON-TB test or T-Spot
test is not approved/registered in that country or the tuberculin skin test (Appendix 3
[Section 10.3]) is mandated by local health authorities. The results of the T-Spot test
will be acceptable in place of the QuantiFERON-TB test. If the QuantiFERON-TB
or T-Spot test cannot be obtained, the tuberculin skin test can be performed instead
after discussion with the medical monitor.
Indeterminate results should be handled as outlined in Section 8.3.6.
18. Have screening laboratory test result as follows:
a. Hemoglobin  
≥7.5 g/dL
b. White blood cells 
≥2.5 x 103 cells/µL (SI:  ≥2.5 x109 cells/L)
c. Neutrophils 
≥1.5 x 103 cells/µL (SI:  ≥1.5 x109 cells/L)
d. Platelets 
            ≥100 x 103 cells/µL (SI:  ≥100 x109 cells/L)

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
54
Approved, Date: 11 November 2023
e. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
levels not exceeding 2.0 times the upper limit of normal (ULN) for the central
laboratory
f. Serum creatinine not to exceed:
1) 0.5 mg/dL (SI: 44 µmol/L) for ages 2 to 5 years
2) 0.7 mg/dL (SI: 62 µmol/L) for ages 6 to 10 years
3) 1.0 mg/dL (SI: 88 µmol/L) for ages 11 to 12 years
4) 1.2 mg/dL (SI: 106 µmol/L) for ages ≥13 years
19. Criterion modified per Amendment 4.
19.1. Participants must be up to date with all immunizations (ie, measles, mumps, rubella,
and varicella) in agreement with current local immunization guidelines for
immunosuppressed participants before Week 0.
20. Criterion modified per Amendment 4.
20.1. For participants who have not completed the recommended vaccination schedule
for varicella, measles, mumps, and rubella, and the subsequent vaccination falls
within the next 4 years, an accelerated vaccination schedule must be completed
prior to study enrollment, per local or professional guidelines. If live, attenuated
viral vaccine is utilized, it is necessary for at least 4 weeks (or longer as indicated
on the package insert of the relevant vaccine) to elapse between the vaccination and
receipt of study intervention. Once study intervention has been initiated, at least a
16-week period must elapse after last dose before a live vaccine is utilized. For
additional restrictions regarding Bacille Calmette-Guerin (BCG) vaccination, see
Exclusion Criterion 41 in Section 5.2.
21. For each participant, his or her parent(s) (preferably both parents, if available) or legally
acceptable representative(s), as required by local regulations, must sign an ICF indicating
that he or she understands the purpose of, and procedures required for, the study and is
willing to allow the child to participate in the study.
22. Assent is also required of children capable of understanding the study (typically
participants 7 years of age and older, depending on the institutional policies), as described
in Informed Consent Process in Appendix 12 [Section 10.12], Regulatory, Ethical, and
Study Oversight Considerations].
23. Must be willing and able to adhere to the lifestyle considerations specified in this protocol.
5.2. 
Exclusion Criteria
Any potential participant who meets any of the following criteria will be excluded from
participating in the study:

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
55
Approved, Date: 11 November 2023
1. Have severe, extensive colitis as evidenced by:
a. Investigator judgment that the participant is likely to require a colectomy within
12 weeks of Week 0;
OR
b. Symptom complex at screening or Week 0 visit that includes at least 4 of the
following:
1) 
Diarrhea with ≥6 bowel movements/day with macroscopic blood in stool
2) 
Focal severe or rebound abdominal tenderness
3) 
Persistent fever (≥37.5°C) for more than 5 days
4) 
Persistent tachycardia for more than 5 days
5) 
Anemia (hemoglobin <8.5 g/dL)
2. Participants with very severe active UC disease who are currently hospitalized for UC
disease exacerbation when initiating study screening and who have a Mayo score of 12
should be excluded from the study.
3. History of liver or renal insufficiency; significant cardiac, vascular, pulmonary,
gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric
(including suicidality), or metabolic disturbances.
4. History of malignancy or macrophage activation syndrome or hemophagocytic
lymphohistiocytosis.
5. Aserious allergic reaction to latex.
6. Contraindications to the use of golimumab or infliximab or anti-TNFα therapy per local
prescribing information.
7. Taken any disallowed therapies as noted in Section 6.5, Concomitant Therapy before
the planned first dose of study intervention.
8. Criterion modified per Amendment 4.
8.1. Received an investigational vaccine or used an invasive investigational medical
device within 3 months before the planned first dose of study intervention or is
currently enrolled in an investigational study. Receipt of an investigational vaccine
for Coronavirus Disease 2019 (COVID-19) is not an automatic exclusion criterion,
discuss with the medical monitor.
9. Pregnant, or breast feeding, or planning to become pregnant while enrolled in this study
or within 6 months after the last dose of study intervention.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
56
Approved, Date: 11 November 2023
10. Plans to father a child while enrolled in this study or within 6 months after the last dose
of study intervention.
11. Any condition for which, in the opinion of the investigator, participation would not be
in the best interest of the participant (eg, compromise the well-being) or that could
prevent, limit, or confound the protocol-specified assessments.
12. Had major surgery, (eg, requiring general anesthesia) within 3 months before screening,
or will not have fully recovered from surgery, or has surgery planned during the time
the participant is expected to participate in the study or within 3 months after the last
dose of study intervention administration.
Note: Participants with planned surgical procedures to be conducted under local
anesthesia may participate if the surgery is to be performed after the Week 14 visit.
13. Have UC limited to the rectum only or to <20% of the colon.
14. Presence of a stoma.
15. Presence or history of a fistula.
16. Have severe, fixed symptomatic stenosis of the large or small intestine.
17. Require, or required within the 2 months prior to screening, surgery for active
gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or
pancreatic abscess requiring surgical drainage, or other conditions possibly
confounding the evaluation of benefit from study intervention treatment.
18. Presence or history of colonic or small bowel obstruction within 6 months prior to
screening, confirmed by objective radiographic or endoscopic evidence of a stricture
with resulting obstruction (dilation of the colon or small bowel proximal to the stricture
on barium radiograph or an inability to traverse the stricture at endoscopy).
19. History of extensive colonic resection (eg, less than 30 cm of colon remaining) that
would prevent adequate evaluation of the effect of study intervention on clinical disease
activity.
20. Presence on screening endoscopy of adenomatous colonic polyps, if not removed prior
to study entry, or history of adenomatous colonic polyps that were not removed.
21. Have evidence of Crohn’s disease:
a. Small intestinal or ileal disease by upper gastrointestinal small bowel
follow-through, ileocolonoscopy with histology, videocapsule
endoscopy, or Magnetic Resonance Enterography

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
57
Approved, Date: 11 November 2023
b. Noncaseating and non-mucin granulomas that are suggestive of a
diagnosis of Crohn’s disease on colonoscopy
c. Skip lesions on colonoscopy including absolute rectal sparing, with a
normal rectum both endoscopically and histologically
d. Perianal disease
Concomitant or previous medical therapies received
22. Have received any anti-TNFα biologic agents (eg, monoclonal antibody therapies).
23. Has received other agents intended to suppress or eliminate TNFα <8 weeks prior to
first administration of study intervention.
24. Have received natalizumab within 12 months of first study intervention administration.
25. Have received vedolizumab within 12 weeks of the first study intervention.
26. Have received agents that deplete B or T cells (eg, rituximab, alemtuzumab, or
visilizumab) within 12 months of first study intervention administration or continue to
manifest depletion of B or T cells more than 12 months after completion of therapy with
lymphocyte depleting agents.
27. Are receiving oral corticosteroids at a dose >50 mg of prednisone or its equivalent per
day.
28. Require routine use (≥2 times per week) of antimotility agents for control of diarrhea
(ie, diphenoxylate hydrochloride with atropine sulfate, loperamide, or other opioids).
29. Have used laxatives, except preparations for endoscopy or other procedures, within
1 week prior to Mayo screening procedures.
30. Other oral immunomodulatory agents (eg, 6-TG, cyclosporine, tacrolimus, sirolimus,
or mycophenolate mofetil) within 8 weeks prior to first administration of study
intervention.
31. Have used any investigational drug within 4 weeks prior to first administration of study
intervention or within 5 half-lives of the investigational agent, whichever is longer, or
is currently enrolled in an investigational study.
32. Received thalidomide or related agent within 8 weeks of screening.
33. Have used apheresis (ie, Adacolumn apheresis, Cellsorba apheresis) within 4 weeks
prior to first administration of study intervention.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
58
Approved, Date: 11 November 2023
Infections or predisposition to infections
34. Criterion modified per Amendment 4.
34.1. Has a stool culture or other examination positive for an enteric pathogen, including
Clostridium difficile toxin in the previous 4 months, unless a repeat examination
is negative and there are no signs of ongoing infection with that pathogen.
Note: For participants who have a positive C. difficile test during the screening
period, participant may be treated and retested during the screening period
(extensions of the screening period can be discussed with the medical monitor). If
repeat test is negative and there are no signs of ongoing infection, participant can
be considered for enrollment. If repeat C. difficile test remains positive during the
screening period, the participant must be a screen failure and may be treated and
rescreened.
35. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not
limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusitis,
recurrent urinary tract infection (eg, recurrent pyelonephritis, chronic cystitis), an open,
draining, or infected skin wound, or an ulcer.
36. Have immune deficiency syndrome (eg, severe combined immunodeficiency syndrome,
T-cell deficiency syndromes, B-cell deficiency syndromes, or chronic granulomatous
disease).
37. Have a known history of infection with HIV.
38. Have a known history of hepatitis C infection.
39. Participants must undergo screening for hepatitis B virus (HBV). At a minimum, this
includes testing for HBV surface antigen (HBsAg), HBV surface antibody (anti-HBs),
and HBV core antibody (anti-HBc total) (Appendix 15 [Section 10.15]):
a. Participants who test positive for surface antigen (HBsAg+) are not eligible for
this study, regardless of the results of other hepatitis B tests.
b. Participants who test negative for surface antigen (HBsAg-) and test positive
for core antibody (anti-HBc+) and surface antibody (anti-HBs+) are eligible for
this study.
c. Participants who test positive only  for surface antibody  (anti-HBs+) are
eligible for this study.
d. Participants who test positive only for core antibody (anti-HBc+) must undergo
further testing for hepatitis B deoxyribonucleic acid (HBV DNA test). If the
HBV DNA test is positive, the participant is not eligible for this study. If the

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
59
Approved, Date: 11 November 2023
HBV DNA test is negative, the participant is eligible for this study. In the event
the HBV DNA test cannot be performed, the participant is not eligible for this
study.
Note:  For participants who are not eligible for this study due to HBV test results,
consultation with a physician with expertise in the treatment of HBV  infection is
recommended.
40. Have a history of latent or active granulomatous infection, including histoplasmosis or
coccidioidomycosis, prior to screening.
41. Have had a BCG vaccination within 12 months of screening.
42. Criterion modified per Amendment 3.
42.1. Have a chest radiograph during screening or 6 months prior to screening that
shows an abnormality suggestive of an undiagnosed pulmonary pathology that
may include manifestations of IBD, malignancy, prior or current active infection,
including TB.
43. Have had a nontuberculous mycobacterial infection or opportunistic infection (eg,
cytomegalovirus, pneumocystosis, aspergillosis).
44. Criterion modified per Amendment 4.
44.1. Have persistently indeterminate (indeterminate on repeat sampling)
QuantiFERON-TB or T-Spottest results. Indeterminate results should be handled
as outlined in Section 8.3.6.
45. Have had a serious infection (eg, hepatitis, pneumonia, or pyelonephritis), have been
hospitalized for an infection, or have been treated with parenteral antibiotics for an
infection within 2 months prior to first administration of study intervention.
46. Criterion modified per Amendment 4.
46.1. Have had 2 or more serious infections requiring hospitalization or treatment with
parenteral antibiotics within the past year.  Less serious infections (eg, acute
upper respiratory tract infection, simple urinary tract infection) need not be
considered exclusionary at the discretion of the investigator. Prior parenteral
antibiotics administered for the indication of UC are acceptable and not a reason
for exclusion.
47. Criterion modified per Amendment 4.
47.1. Must not have received, or are expected to receive, any live vaccination within 8
weeks (or longer as indicated in the package insert of the relevant vaccine) prior
to the first administration of study intervention, during the study, or within 16
weeks (more than 5.5 half-lives of SC golimumab) after the last administration

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
60
Approved, Date: 11 November 2023
of study intervention. Receipt of a live SARS-CoV-2 vaccine (against the virus
that causes COVID-19) is not automatically an exclusion criterion and must be
discussed with the medical monitor.
Malignancy or increased potential for malignancy
48. Presence or history of any malignancy.
49. Presence or history of lymphoproliferative disease including lymphoma, or signs and
symptoms 
suggestive 
of possible 
lymphoproliferative 
disease, 
such 
as
lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the
neck, infraclavicular, epitrochlear, or periaortic areas) and monoclonal gammopathy of
undetermined significance, or clinically significant hepatomegaly or splenomegaly.
Coexisting medical conditions or past medical history
50. Have known allergies, a known hypersensitivity to human immunoglobulin proteins or
other components of golimumab, or intolerance to golimumab or its excipients (refer to
golimumab IB).
51. Have known allergies, a known hypersensitivity to human immunoglobulin proteins or
other components of infliximab, or intolerance to infliximab or its excipients (refer to
infliximab IB).
52. Is currently undergoing or has previously undergone allergy immunotherapy for a
history of anaphylactic reactions.
53. Fever of greater than 3 weeks duration of unknown origin within 3 months prior to
screening.
54. Concomitant diagnosis or history of congestive heart failure.
55. Concomitant diagnosis or history of systemic lupus erythematosus.
56. Have a transplanted organ (with the exception of a corneal transplant performed
>3 months prior to first administration of study intervention).
57. Concomitant diagnosis or history of demyelinating disease, such as multiple sclerosis
or optic neuritis.
58. Have or have had a history of substance abuse (drug or alcohol).
Other
59. Have poor tolerability of venipuncture or lack of adequate venous access for required
blood sampling.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
61
Approved, Date: 11 November 2023
60. Employee of the investigator or study site, with direct involvement in the proposed
study or other studies under the direction of that investigator or study site, as well as
family members of the employees or the investigator.
Infections or predisposition to infections
61. During the 6 weeks prior to baseline, have had ANY of:
a. Confirmed SARS-CoV-2 (COVID-19) infection (test positive);
OR
b. Suspected SARS-CoV-2 infection (clinical features without documented test
results);
OR
c. Close contact with a person with known or suspected SARS-CoV-2 infection.
Exception: may be included with a documented negative result for a
validated SARS-CoV-2 test:
1) obtained at least 2 weeks after conditions (a), (b), (c) above (timed from
resolution of key clinical features if present, eg, fever, cough, dyspnea);
AND
2) with absence of ALL conditions (a), (b) (c) above during the period
between the negative test result and the baseline study visit.
NOTES on COVID-19-related exclusion:
The field of COVID-19-related testing (for presence of, and immunity to, the
SARS-CoV-2 virus) is rapidly evolving. Additional testing may be performed as
part of screening and/or during the study if deemed necessary by the investigator
and in accordance with current regulations/guidance from authorities/standards of
care.
Precaution: for those who may carry a higher risk for severe COVID-19 illness,
follow guidance from local health authorities when weighing the potential benefits
and risks of enrolling in the study, and during participation in the study.
NOTE: Investigators should ensure that all available study enrollment criteria have been met at
screening. If a participant's clinical status changes (including any available laboratory results or
receipt of additional medical records) after screening but before the first dose of study intervention
is given such that he or she no longer meets all eligibility criteria, then the participant must be
excluded from participation in the study. The required source documentation to support meeting
the enrollment criteria are noted in Appendix 12 (Section 10.12), Regulatory, Ethical, and Study
Oversight Considerations.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
62
Approved, Date: 11 November 2023
5.3. 
Lifestyle Considerations
Potential participants must be willing and able to adhere to the following lifestyle restrictions
during the course of the study to be eligible for participation:
1. Refer to Section 6.5, Concomitant Therapy for details regarding prohibited and
restricted therapy during the study.
2. Agree to follow all requirements that must be met during the study as noted in the
Inclusion and Exclusion Criteria (eg, contraceptive requirements).
3. If sexually active, all participants must agree to follow the contraceptive requirements
as noted in Inclusion Criterion #12.
5.4. 
Screen Failures
Participant Identification, Enrollment, and Screening Logs
The investigator agrees to complete a participant identification and enrollment log, which reports
on all participants who were seen to determine eligibility for inclusion in the study, to permit easy
identification of each participant during and after the study. This document will be reviewed by
the sponsor study site contact for completeness.
The participant identification and enrollment log will be treated as confidential and will be filed
by the investigator in the study file. To ensure participant confidentiality, no copy will be made.
All reports and communications relating to the study will identify participants by participant
identification number and age at initial informed consent. In cases where the participant is not
randomized into the study the date seen and age at initial informed consent will be used.
If, during the screening phase, a participant has not met all inclusion criteria or has met any
exclusion criteria or is unable or unwilling to adhere to the lifestyle considerations of the study,
the participant is considered to be a screen failure and is not eligible to be enrolled in the study.
In general, if a participant is a screen failure, but at some-point in the future meets all of the
participant eligibility criteria, the participant may be rescreened after a new informed
consent/assent has been obtained. Participants who are rescreened should be assigned a new
participant number and will restart a new screening phase.
Screening and enrollment procedures should typically be completed within the specified screening
window of within 6 weeks; extensions can be discussed with the medical monitor.
If any delay leads to the expiration of time-specific assessments (eg, TB, chest radiograph, stool
analysis, sigmoidoscopy) further discussion with the Sponsor should occur before the participant
is considered for rescreen, the participant will be considered a screen failure because he/she will
not meet eligibility criteria, and the expired assessments (along with the non-time-specific
laboratory tests) will have to be repeated on rescreening.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
63
Approved, Date: 11 November 2023
Additional criteria for retesting and rescreening are outlined below and in the Retesting and
Rescreening Plan.
Retesting
Retesting of abnormal laboratory values that may lead to exclusion will be allowed once. Retesting
can occur at an unscheduled visit during the screening phase, as long as this is done within the
specified screening window of within 6weeks (6 weeks may be exceeded on a case-by-case basis).
Rescreening
Participants who do not meet the criteria for participation in this study (screen failure) may be
rescreened 1 time. In rare cases, a participant may be screened a third time after discussion with
the medical monitor. Participants who are rescreened will be assigned a new participant number,
undergo the informed consent/assent process, and then start a new screening phase. On a
case-by-case basis, after consultation with the medical monitor, rescreening procedures may
exceed the 6-week window and will not be considered protocol deviations.
6. 
STUDY INTERVENTION
Study intervention administrations must be captured in the source documents and the electronic
case report form (eCRF). Study site personnel will instruct eligible participants on how to store
study intervention for AHA in the study extension as indicated for this protocol.
Golimumab and infliximab will be manufactured and provided under the responsibility of the
sponsor. Refer to the IB for a list of excipients.
6.1. 
Study Interventions Administered
Golimumab
During the short-term phase, pediatric participants will receive dose regimens of SC golimumab
at Week 0 and Week 2 based on body weight as shown in Table 5. Participants must weigh ≥10 kg
and be >70 cm tall. This is the lower range of weight and height that the PFP-V has been validated
for to deliver SC golimumab. This limit accommodates >97% of all 2-year-old girls based on
published growth charts (www.cdc.gov/growthcharts). Participants' golimumab doses for all
administrations through Week 10 (inclusive) will be based on the participants' weight and height
at Week 0 or, if not available, the most recent height and weight from screening. The same weight
and height should be used through Week 10. Golimumab doses from Week 14 through Week 54
will be based on the participants' weight and height obtained with that week’s visit or the
last recorded height and weight. In the study extension, golimumab doses will be based on the
participants' most current weight and height or the last recorded height and weight.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
64
Approved, Date: 11 November 2023
Table 5: 
SC Golimumab Dosage by Body Weight
Pediatric participants with ulcerative 
colitis (2 to 17 years of age)
Short-term phase 
Long-term phase†
With body weight <45 kg
120 mg/m2 at Week 0* 
60 mg/m2 at Week 2* 
60 mg/m2 every 4 weeks from
Week 6*†
With body weight ≥45 kg
200 mg at Week 0
100 mg at Week 2
100 mg every 4 weeks from Week 6†
† Participants in clinical response to golimumab at Week 6or partial Mayo response at Week 14
*BSA doses are capped at 200 mg and 100 mg for the 120 mg/m2 and 60 mg/m2 doses, respectively.
At Week 6, all participants will be evaluated for clinical response; participants in clinical response
will continue receiving open-label golimumab during the long-term phase (Table 5).
Participants not in clinical response (defined as decrease from baseline in the Mayo score of ≥30%
and ≥3 points, with either a decrease from baseline in the rectal bleeding subscore of ≥1 or a rectal
bleeding subscore of0 or 1; Section 3.1 and Section 8.1.1) at Week 6 may have study intervention
discontinued (and complete a safety follow-up at least 16 weeks after the last administration of
golimumab) or may continue receiving golimumab for up to 2 additional doses at Weeks 6 and 10
at the discretion of the investigator, as specified in Table 5. At Week 14, these participants will be
evaluated for partial Mayo response (defined as a decrease from the Week 0 partial Mayo score of
≥3 points); participants in partial Mayo response will continue receiving open-label golimumab
(q4w) during the long-term phase (Table 5). Participants who are not partial Mayo responders at
Week 14 will have study intervention discontinued and should complete a final safety follow-up
at least 16 weeks following the last administration of study intervention.
After the Week 54 evaluations, at the discretion of the investigator, if participants receiving
golimumab are able to benefit from continued SC golimumab, the participants will enter the study
extension. Participants will continue to receive SC golimumab q4w under the study extension at
the doses specified in Table 5 until marketing authorization is obtained for golimumab for the
treatment of pediatric participants with UC, the participant turns 18 and has access to commercially
available golimumab, or until a decision is made not to pursue an indication in this pediatric UC
population, whichever occurs first.
At entry into the study extension (Week 54) or any time thereafter during the study extension,
participants will have the option to decrease their dose one-time, at the discretion of the
investigator, to mimic the approved local product label for adult UC. After this decrease in dose,
participants can, at the discretion of the investigator, resume their original study intervention
dosage, but no further dose adjustments are permitted while the participant is enrolled in the study.
In the study extension  beginning at Week 58 participants will have the option of AHA  of
golimumab by participants and/or their caregivers after being properly trained.
Infliximab
All participants in the infliximab treatment arm will be administered infliximab 5 mg/kg at
Weeks 0 and 2. Starting at Week 6, infliximab administrations of 5 mg/kg will continue q8w

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
65
Approved, Date: 11 November 2023
through Week 46 for those participants in clinical response at the Week 6 assessments. Infliximab
doses for all administrations through Week 8 (inclusive) will be based on the participants' weight
at Week 0 or, if not available, the most recent weight from screening. The same weight should be
used through Week 8. Infliximab doses from Week 14 through Week 46 will be based on the
participants' weight obtained with that week’s visit or the last recorded weight.
Additionally, a step-wise flexible dose escalation approach (to a maximum dose of 10 mg/kg
[capped at 1 gm] at an interval of q4w) will be permitted in the infliximab arm, at the investigator’s
discretion, for those participants not in clinical response at Week 6 (defined by the Mayo score),
or participants who were in response at Week 6 but have a worsening of their UC signs and
symptoms during the study period. This approach was chosen as it most closely mimics clinical
practice in treatment of pediatric UC, allowing investigators some flexibility in dosing to treat their
patients. Also, if an investigator wants to dose-escalate using a different regimen than listed above,
discuss the plan with the medical monitor.
After the Week 54 efficacy and safety evaluations, participants receiving infliximab will be
transitioned to standard medical care. At the investigator’s discretion a separate blood sample may
be obtained and submitted to the central laboratory to evaluate infliximab dose levels and anti-
infliximab antibodies (at a maximum of 2 timepoints at Week 6 or later) to inform dose escalations.
Infliximab will be supplied in a 20 mL disposable glass vial. Infliximab will be administered as an
IV infusion by qualified studysite personnel and the details of each administration will be recorded
in the source notes and in the eCRF (including date, start and stop times of the IV infusion, and
volume infused).
After the Week 8 visit and before the Week 54 visit, participants in the infliximab arm will only
require study visits on treatment days.  All other nontreatment visits during this time period will
be optional.  All participants must have Week 54 or Early Termination visit.
At Home Administration
Beginning at Week 58, for eligible participants in the golimumab treatment arm,
participants/caregivers will have the option to receive training to administer golimumab at home;
the training must be documented. Training of the participants/caregivers will occur at the
investigative site under the supervision of a health care professional.
Participants/caregivers who are unable or unwilling to administer golimumab at home will return
to the investigative site for each administration of golimumab.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
66
Approved, Date: 11 November 2023
Participants will be trained in the recognition and documentation of adverse events (AE) including
injection-site reactions (eg, swelling, redness/erythema, pain, tenderness, warmth, bruising, or
bleeding). Participants (and caregivers) will be given instructions and encouraged to contact the
investigator promptly if an AE occurs. Investigative site personnel will instruct participants (and
caregivers) on how to store medication for at home use and how to dispose of used syringes.
For all AHAs of golimumab beginning at Week 58, the details of the study intervention, dosing
day, time, anatomic site and if there were any complications of the injection, as well as Adverse
Event (including injection-site reaction), Concomitant Medications and TB exposure information
will be documented in an AHA diary, that is to be returned to the site at the upcoming visit, and
entered by site staff into the eCRF.
Usability Assessment Substudy
At Sponsor identified sites, the participant and/or caregiver will have the option to be enrolled in
a Usability Assessment Substudy at Week 58. At Weeks 62 and 66, after self-dosing, the sponsor
will collect data on their experience using PFS-U for administrations of golimumab. For additional
details see Appendix 18 (Section 10.18).
6.1.1. 
Dosing Devices
Golimumab will be supplied as a sterile liquid for SC injection in single use prefilled syringes or
prefilled pen. Each prefilled syringe contains either 100 mg (1 mL of liquid) or 50 mg (0.5 mL of
liquid) of golimumab, with each 0.1 mL of liquid containing 10 mg of golimumab. The prefilled
pen for pediatric use can deliver a dose between 10 and 45 mg in 5 mg increments.
Prefilled Syringe with UltraSafe (PFS-U): The UltraSafe Passive Delivery System (UltraSafe)
is a manually-operated, single use, disposable needle guard system that is an accessory to the PFS.
Each 50 mg or 100 mg-single dose prefilled glass syringe (27-gauge ½ inch needle) contains 50 mg
or 100 mg of golimumab per 0.5 or 1.0 mL of solution, respectively.
Prefilled Pen for Pediatric Use (PFP-V): The PFP-V is a variable single dose injection for
pediatric use to deliver doses less than 50 mg. It includes an integrated needle guard. Each product
can deliver a variable dose between 10 and 45 mg in 5 mg increments. Each PFP-V is assembled
with a SIMPONI glass prefilled syringe (27-gauge ½ inch needle) contains 50 mg of golimumab
per 0.5 mL of solution.
Dosing device incidents, including those resulting from malfunctions of the device, must be
detected, documented, and reported by the investigator throughout the study.
The needle-cover on the PFS assembled with the UltraSafe and PFP-V are manufactured from dry
natural rubber containing latex and may cause allergic reactions in individuals who are sensitive
to latex.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
67
Approved, Date: 11 November 2023
6.2. 
Preparation/Handling/Storage/Accountability
All study intervention must be stored at controlled temperatures ranging from 36°F to 46°F (2°C to
8°C).
Refer to the Instructions for Use and Site Investigational Product Procedures Manual for additional
guidance on study intervention preparation, handling, and storage.
The investigator is responsible for ensuring that all study intervention received at the site is
inventoried and accounted for throughout the study.
For the short- and long-term phases of the study the study intervention will be administered at the
study site. The study intervention administered to the participant must be documented on the
accountability form. All study intervention will be stored and disposed of according to the
sponsor's instructions. Study site personnel must not combine contents of the study intervention
containers.
During the study extension, study intervention may be provided to participants for AHA. The
dispensing of study intervention to the participant, and the return of study intervention from the
participant (if applicable), must be documented on the accountability form. Participants or their
legally acceptable representatives where applicable, must be instructed to return all original
containers, whether empty or containing study intervention.
Study intervention must be handled in strict accordance with the protocol and the container label
and must be stored at the study site in a limited access area or in a locked cabinet under appropriate
environmental conditions. Unused study intervention, and study intervention returned by the
participant, must be available for verification by the sponsor's study site monitor during on-site
monitoring visits. The return to the sponsor of unused study intervention, or used returned study
intervention for destruction, will be documented on the intervention return form. When the study
site is an authorized destruction unit and study intervention supplies are destroyed on-site, this
must also be documented on the intervention return form.
For at site study intervention administrations, potentially hazardous materials such as used
ampules, needles, syringes and vials containing hazardous liquids, should be disposed of
immediately in a safe manner and therefore will not be retained for accountability purposes. For
AHA of study intervention, appropriate hazardous waste disposal containers will be provided to
participants. These containers will be collected by the study site for safe disposal of their contents.
Study intervention should be dispensed under the supervision of the investigator or a qualified
member of the study site personnel, or by a hospital/clinic pharmacist when administered at the
site. Study intervention will be supplied only to participants participating in the study. Returned
study intervention must not be dispensed again, even to the same participant. Study intervention
may not be relabeled or reassigned for use by other participants. The investigator agrees neither to
dispense the study intervention from, nor store it at, any site other than the study sites agreed upon
with the sponsor.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
68
Approved, Date: 11 November 2023
6.3. 
Measures to Minimize Bias: Randomization and Blinding
Intervention Allocation
Procedures for Randomization and Stratification
Prior to implementation of Amendment 4, participants weighing ≥30 kg were to be randomly
assigned to 1 of 2 intervention groups based on a computer-generated randomization schedule
prepared before the study by or under the supervision of the sponsor. Participants were to be
randomized in a 3:1 ratio to golimumab or infliximab. Based on this randomization code, study
intervention was assigned and administered to each participant.
Permuted block randomization was used. The interactive web response system (IWRS) assigned a
unique treatment code, which dictated the treatment assignment and matching study intervention
kit for the participant. The requestor used his or her own user identification and personal
identification number when contacting the IWRS and gave the relevant participant details to
uniquely identify the participant.
Participants <30 kg were not to be randomized and offered only golimumab. This ensured that at
least 5 participants who weighed <30 kg received golimumab treatment.
Upon  implementation of Amendment 4, no additional participants will be randomized to
infliximab; all newly enrolled participants will receive golimumab.
Blinding
This is an open-label study, and therefore blinding procedures are not applicable.
6.4. 
Study Intervention Compliance
Because golimumab and infliximab will be administered at the investigational site by trained study
site staff or golimumab will be self-administered by the participant or their caregiver, treatment
compliance for these study interventions will be controlled by site personnel.
Visit window: From Week 0 through Week 54, it is expected that all visits will occur within a
range of ±7 days of the scheduled visit. Any visits outside of these ranges should be discussed with
the sponsor. After Week 54 the follow-up study visits should occur within ±14 days of the
scheduled study visit. Any out-of-range visits after Week 54 should be documented in the
participant’s source notes.
Dosing window: From Week 0 through the end of the trial, any doses that are planned to occur
outside of ±7 day dosing window should be discussed with the sponsor. Golimumab should be
administered as close as possible to the q4w dosing schedule.
Study site personnel will maintain a log of all study intervention administered. Study intervention
supplies for each participant will be inventoried and accounted for. Information regarding study
intervention administrations that are administered outside of the scheduled windows or missed will
be recorded. Participant charts and worksheets may be reviewed and compared with the data

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
69
Approved, Date: 11 November 2023
entries on the eCRFs to ensure accuracy. Although it is understood that treatment may be
interrupted for many reasons, compliance with the treatment schedule is strongly encouraged.
When golimumab is administered by the participant or caregiver away from the site, the amount
of study intervention dispensed will be recorded and compared with number of injection devices
returned and the and the participant or caregiver will be asked to record administration information
on the AHA diary. Participants (and parent/caregiver) will receive instructions on compliance with
study treatment when they begin self-administration of golimumab at home. During the course of
the study, the investigator or designated study research personnel will be responsible for providing
additional instruction to reeducate any participant who is not compliant with taking the study
intervention.
6.5. 
Concomitant Therapy
Prestudy therapies, including prescription or over-the-counter medications, vaccines, vitamins,
herbal supplements; non-pharmacologic therapies such as electrical stimulation, acupuncture,
special diets, exercise regimens administered up to 30 days before first dose of study intervention
must be recorded at screening.
The following are permitted medications; their use at any time during study must be recorded in
the eCRF.  The recorded information will include a description of the type of therapy, duration of
use, dosing regimen, route of administration, and indication.
Over-the-counter medications, vitamins, herbal supplements
Prescription therapies, including antibiotics, special diets or dietary supplements
Concomitant therapies must be recorded throughout the study beginning with the screening
process and through the final safety visit after the last dose of study intervention. This includes
medications given for endoscopies and sedation that occur during the study.
All concomitant medications will be recorded in the eCRF through Week 54. After Week 54, only
concomitant medications associated with AEs and SAEs (ie, used to treat event or suspected in
causing event) and/or with the treatment of UC will be recorded in the eCRF.
Modification of an effective preexisting therapy should not be made for the explicit purpose of
entering a participant into the study.
6.5.1. 
Ulcerative Colitis-Specific Allowed Concomitant Therapies
The following concomitant medications for UC are allowed in this study: 5-ASAs, corticosteroids,
and immunomodulators (ie, 6-MP, AZA, MTX). For participants receiving concomitant therapy
with 5-ASAs, immunomodulators and/or corticosteroids for UC, the dosage of these medications
must be stable for 2 weeks before the first administration of study intervention at Week 0
(Section 5.1). For participants receiving 5-ASAs at Week 0, the dose must remain stable through
Week 54 (except for weight-based adjustments, as treatment of a documented UC flare after
Week 6, or if investigator judgment requires dose reduction or cessation because of toxicity or
medical necessity).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
70
Approved, Date: 11 November 2023
Immunomodulators (ie, 6-MP, AZA, or MTX) should not be initiated between Week 0 and
Week 6. For participants receiving immunomodulators at Week 0, the dose should not be increased
(except for weight-based adjustments) through Week 6. Although immunomodulators may be
discontinued at any time during the study, it is preferred, at the discretion of the investigator, that
they be continued at least through Week 14.
For participants receiving corticosteroids (including budesonide), the steroids may be tapered
beginning at Week 0, although it would be preferable to delay the stopping of steroids until after
the Week 6 evaluation if clinically reasonable. Corticosteroids cannot be started to treat UC disease
flare until after Week 6 study assessments (Section 6.5.3).
UC-specific medical therapies (ie, oral/rectal corticosteroids, oral/rectal 5-aminosalicylate
(5-ASA) compounds, or the immunomodulators 6-MP, AZA, or methotrexate [MTX]) may not be
initiated or their dose increased at any time from Week 6to Week 54 except for weight-based dose
adjustments or unless there is a documented UC flare and loss of response that makes the subject
eligible for rescue medication (Section 6.5.3).
Rare postmarketing cases of hepatosplenic T-cell lymphoma have been reported in participants
treated with other TNFα-blocking agents. This rare type of T-cell lymphoma has a very aggressive
disease course and is usually fatal. Nearly all of these cases have occurred in participants with UC
or Crohn’s disease. The majority were in adolescent and young adult males. Almost all these
participants had received treatment with AZA or 6-MP concomitantly with a TNFα blocker at or
prior to diagnosis. The potential risk with the combination of AZA or 6-MP and golimumab should
be carefully considered. A risk for the development for hepatosplenic T-cell lymphoma in
participants treated with TNFα blockers cannot be excluded.
6.5.2. 
Ulcerative Colitis-Specific Prohibited Concomitant Medications
The following are prohibited medications; participants who initiate any of these treatments at any
time during study participation will have their study intervention discontinued:
Immunomodulatory agents other than 6-MP, AZA, or MTX (including, but not limited to,
6-TG, cyclosporine, mycophenolate mofetil, tacrolimus, and sirolimus)
Immunomodulatory biologic agents (including, but not limited to, TNFα antagonists
(eg, etanercept, adalimumab), ustekinumab, abatacept, anakinra, rituximab, alemtuzumab,
vedolizumab, natalizumab, and visilizumab)
Thalidomide or related agents
Investigational drugs
The sponsor must be notified in advance (or as soon as possible thereafter) of any instances in
which prohibited therapies are administered.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
71
Approved, Date: 11 November 2023
6.5.3. 
Rescue Medication
The sponsor will not supply rescue medication.
During the long-term phase of the study, participants who meet the following criteria will be
considered to be in clinical flare:
For study subjects who responded at Week 6 - an increase of the partial Mayo score from
Week 6 of at least 2 points and an absolute partial Mayo score ≥4; or an absolute partial
Mayo score ≥7 points, or
For study subjects who did not have a Week 6 response but achieved a response at Weeks 14
or 22 (after additional discretionary doses of golimumab or infliximab [Section 4.1]) - an
increase in the partial Mayo score from Weeks 14 or 22 of at least 2 points and an absolute
partial Mayo score ≥4; or an absolute partial Mayo score ≥7 points.
In the study extension, the determination that a subject is in clinical flare will be at the discretion
of the investigator. However, the basis for this determination should be consistent with the criteria
used in the long-term phase, namely an increase in the partial Mayo score by 2 points and an
absolute partial Mayo score ≥4; or an absolute partial Mayo score of ≥7 and based on the study
participant(or caregiver)-reported stool frequencyand degree ofrectal bleeding, as well as a global
assessment of UC disease activity made by a study primary- or sub-investigator. These findings
supporting a determination of UC disease flare in the study extension should be recorded in the
study source documents.
UC-specific medical therapies (ie, oral/rectal corticosteroids, oral/rectal 5-aminosalicylate (5ASA)
compounds, or the immunomodulators 6-MP, AZA, or methotrexate [MTX]) may not be initiated
or their dose increased at any time from Week 6 to Week 54  except for weight-based dose
adjustments or unless there is a documented UC flare and loss of response that makes the subject
eligible for rescue medication (Section 6.5.1).
Participants who flare while enrolled in the study will be eligible to receive rescue medication (ie,
corticosteroids, 6-MP, AZA, MTX, and/or 5-ASAs) while continuing to receive study intervention
administration as scheduled. Participants who flare between Weeks 6 and 54 (at the discretion of
the investigator) can receive rescue treatment with 2 limited courses (prednisolone/prednisone at
1 mg/kg/d [max 40 mg] once daily for up to 3 weeks followed by a tapering period of up to 8 to
10 weeks) of corticosteroids for UC as clinically indicated. Second-generation oral steroids with
lower systemic effect such as beclomethasone and budesonide may be used to treat a UC disease
flare in place of systemic steroids. Their use counts towards the 2 steroid courses. After Week 54,
participants may receive 2 additional steroid courses at the discretion of the investigator to treat a
UC disease flare. The date and time of rescue corticosteroid administration as well as the name
and dosage regimen of the rescue medication must be recorded.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
72
Approved, Date: 11 November 2023
Participants who are receiving infliximab and experience a flare in their UC disease after Week 6
may initiate the step-wise dose escalation to the maximum of 10 mg/kg (capped at 1 gm) q4w as
defined in Section 4, Study Design.
Other UC-specific rescue therapies (ie, rectal corticosteroids, oral/rectal 5-aminosalicylate
[5-ASA] compounds, or the immunomodulators 6-MP, AZA, or methotrexate [MTX]) may be
initiated or their dose increased at the discretion of the investigator to manage symptoms in the
setting of a documented UC flare. The use of rectal steroids does not count toward the permitted
steroid courses.
However, any participant who uses UC-prohibited medications (Section 6.5.2) or requires more
than 2 courses of corticosteroids (including budesonide) or requires parenteral (IV) steroids for
UC during the 54-week study will be discontinued from further administration of study
intervention.
6.6. 
Dose Modification
During the early and late-phases of the study, 2 types of dose adjustments are permissible.
Weight-based dosing adjustments are required for all participants receiving infliximab, and for
those participants receiving golimumab who weigh <45 kg. In addition, for participants receiving
infliximab, dose escalation (to 10 mg/kg to a maximum of 1 gm, q4w) is permitted using the
protocol as defined in Section 4, Study Design. In the study extension, participants in certain
jurisdictions who weigh between 45 kg and 80 kg can, at the discretion of the investigator, reduce
their 100 mg q4w golimumab dose to 50 mg SC  q4w. This reflects permitted posologies and
clinical practice in these specific jurisdictions and is not applicable to all study participants. After
this dose de-escalation, participants are permitted to return to the 100 mg q4w dosing, but no
additional dose adjustments for golimumab are permitted. Any dose/dosage adjustment should be
overseen by medically-qualified study site personnel.
The decision to proceed to the next dose level of golimumab or infliximab (either an increase or a
decrease) will be made by the investigator based on safety, tolerability, and clinical judgment.
Infliximab dosing will not exceed 10 mg/kg (capped at 1 gm) at an interval more frequent than
q4w.
6.7. 
Intervention After the End of the Study
The study extension is described in Section 4.1, Overall Design.
After the Week 54 evaluations, at the discretion of the investigator, if participants receiving
golimumab are able to benefit from continued SC golimumab, the participants will continue to
receive SC golimumab q4w starting at Week 54 under this protocol’s study extension until
marketing authorization is obtained for golimumab for the treatment of pediatric participants with
UC, the participant turns 18 and has access to commercially available golimumab, or until a
decision is made not to pursue an indication in this pediatric UC population, whichever occurs
first. Participants who continue golimumab treatment as part of the study extension will be
intermittently evaluated per the protocol for efficacy, PK, and safety.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
73
Approved, Date: 11 November 2023
After the Week 54 evaluations, participants receiving infliximab will be withdrawn from study
participation and transition to local standard of care which may include continued infliximab at
the discretion of their physician.
Participants who discontinue the study and are not transitioning to commercially available
golimumab must complete a final safety visit at the study site about 8 weeks (infliximab) or 16
weeks (golimumab) after the last dose of study intervention, unless the participant has died, is lost
to follow-up, is continuing golimumab after exiting the study, or has withdrawn consent.
Participants who are planning to continue golimumab treatment after exiting the study should have
all final safety visit assessments done during the last study visit while on study golimumab. Ifthe
participant has died, the date and cause of death will be collected and documented on the eCRF.
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT
DISCONTINUATION/WITHDRAWAL
7.1. 
Discontinuation of Study Intervention
A participant's study intervention must be discontinued if:
1. The investigator believes that for safety reasons or tolerability reasons (eg, AE) it is in the
best interest of the participant to discontinue study intervention.
2. The participant initiates treatment with prohibited therapies for UC (Section 6.5.2).
3. The participant requires the addition of parenteral (IV) steroids or more than 2 courses of
corticosteroids (including budesonide) for UC flares during the 54-week study.
4. The participant fails to meet Week 6, Week 14, or Week 22 criteria to continue study
intervention.
5. The participant has a disease-related surgery that represents a lack of efficacy of study
intervention (ie, colectomy) or that will preclude the future ability to assess efficacy using the
Mayo score or other instruments required for demonstration of efficacy endpoints.
6. The participant becomes pregnant or plans a pregnancy within the study period. Refer to
Appendix 14 (Section 10.14, Contraceptive and Barrier Guidance and Collection of
Pregnancy Information).
7. The participant develops a clinically significant cardiovascular event, including but not
limited to congestive heart failure, at any time during the study.
8. The participant (or the participant’s representative) withdraws consent for administration of
study intervention.
9. The participant develops a systemic opportunistic infection.
10. The participant misses 2 consecutive doses of golimumab after Week 10 because of body
weight below the 10 kg limit.
11. The participant is deemed ineligible according to the following TB screening criteria:
A diagnosis of active TB is made.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
74
Approved, Date: 11 November 2023
A participant has symptoms suggestive of active TB based on follow-up assessment
questions and/or physical examination or has had recent close contact with a person with
active TB and cannot or will not continue to undergo additional evaluation.
A participant undergoing evaluation has a chest radiograph with evidence of current
active TB and/or a positive QuantiFERON-TB or T-Spot test result (and/or a positive
tuberculin skin test result in countries in which the QuantiFERON-TB or T-Spot test is
not approved/registered or the tuberculin skin test is mandated by local health authorities),
unless active TB can be ruled out and appropriate treatment for latent TB can be initiated
prior to the next study intervention administration and continued to completion (see also
Section 8.3.6, and Appendix 3 [Section 10.3]). Indeterminate QuantiFERON-TB test or
T-Spot test results should be handled as in Section 8.3.6.
A participant whose first QuantiFERON-TB test result or T-Spot test result is
indeterminate should have the test repeated. In the event that the second
QuantiFERON-TB or T-Spot test result is also indeterminate, the participant should be
excluded from the study.
12. The participant has a serious adverse reaction that is related to an injection or an infusion,
including an injection-site or infusion reaction, resulting in bronchospasm with wheezing
and/or dyspnea that requires ventilatory support OR that results in symptomatic hypotension
with a decrease in systolic blood pressure >40 mm Hg or blood pressure <90/60 mm Hg.
13. The participant has a reaction resulting in myalgia and/or arthralgia with fever and/or rash
(suggestive of serum sickness and not representative of signs and symptoms of other
recognized clinical syndromes) occurring 1 to 14 days after an injection of study intervention.
These may be accompanied by other events including pruritus, facial, hand, or lip edema,
dysphagia, urticaria, sore throat, and/or headache.
14. The participant has severe hepatic function abnormalities, as described in Section 8.2.3 and
Appendix 13 (Section 10.13).
15. The participant has a malignancy including squamous cell skin cancer. Consideration may be
given to allowing participants who develop ≤2 basal cell skin cancers that are adequately
treated with no evidence of residual disease to continue to receive study intervention.
Participants will not be automatically withdrawn from the study if they discontinue study
intervention before the end of the treatment regimen.
Discontinuation of a participant’s study intervention must be strongly considered under
the following conditions:
1. 
Persistent inadequate response or worsening of UC:
a. Participants in the long-term or study extension phases of the study who meet the criteria
as defined Section 6.5.3 will be considered to be in clinical flare. A sigmoidoscopy (or
colonoscopy) can be considered to aid clinical judgment and should be performed using
study software and submitted for central review.
b. Participants in clinical flare will be eligible to receive rescue medication (ie,
corticosteroids, 5-ASA, 6-MP, AZA, MTX, Section 6.5.3 or infliximab dose escalation
Section 6.6) while continuing to receive study intervention administration as scheduled.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
75
Approved, Date: 11 November 2023
c. Participants will be reassessed after 2 administrations of study intervention after the visit
at which the loss of clinical response criteria was met or, for infliximab receiving
participants, after 2 administrations at the escalated dose using the protocol as defined in
Section 4, Study Design. During this interval, clinical flare criteria will not be applied.
Participants in the long-term phase who have not achieved a partial Mayo response (ie, a
decrease from the flare baseline of ≥2 in the partial Mayo score) at this visit despite rescue
medications will be discontinued from study intervention administration and should return
for a final safety visit approximately 8 (infliximab) or 16 (golimumab) weeks after their
last study intervention administration.
For participants in the study extension, a clinical response to rescue therapy will be at the
discretion of the study investigator but should be consistent with a partial Mayo score of≤4
based on participant (or caregiver)-reported stool frequency and degree of rectal bleeding,
as well as a global assessment of UC disease activity determined by a study primary- or
sub-investigator. These findings demonstrating a clinical response should be recorded in
the study source documents. Participants in the study extension who do not achieve a
clinical response despite rescue medications will be discontinued from the study
interventions and should return for a final safety visit 16 weeks after the last administration
of study intervention.
Participants who are assessed as having responded to rescue therapy will continue in the
study.
d. After the clinical flare, participants who remain in the study will continue to be assessed
for clinical flare. Participants who subsequently meet the criteria for clinical flare again
may receive rescue medication a second time and be assessed for an adequate response and
managed as described above.
e. If a third clinical flare occurs or the participant experiences AEs consistent with clinically
significant worsening of UC at any time during the study, discontinuation of study
intervention should be strongly considered.
These events should be evaluated by the investigator and the Sponsor to decide on
discontinuation of study intervention. Discontinuation of study intervention should be
considered in participants with clinically significant worsening of UC disease where
continuation of the study intervention is not in the best interest of the participant.
2. 
The participant develops a serious infection, including but not limited to sepsis or pneumonia.
If a participant discontinues study intervention for any reason before Week 14, they should return
for all scheduled visits through Week 14 (including endoscopy at Week 6) and a final safety visit,
16 weeks after the last dose of golimumab or 8 weeks after the last dose of infliximab. During the
long-term phase of the study, if a participant discontinues study intervention for any reason before
the Week 54 assessments, the early discontinuation assessments should be obtained if possible as
specified in the Schedule of Activities (Table 1), and a final safety visit completed 16weeks after
the last dose of golimumab or 8 weeks after the last dose of infliximab. If a participant discontinues
study intervention during the study extension, a final safety visit, 16weeks after the last dose of
golimumab should be completed as specified in the Schedule of Activities (Table 2). If the reason
for discontinuation of study intervention is withdrawal of consent, every effort should be made to
conduct the efficacy and safety visit assessments, as indicated in the Schedule of Activities, prior

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
76
Approved, Date: 11 November 2023
to terminating study participation. After termination of consent, no additional protocol assessments
are allowed.
7.2. 
Participant Discontinuation/Withdrawal from the Study
Participant discontinuation/withdrawal from the study is defined as no longer following up for
study visits. It is different from discontinuation from study intervention, as described in
Section 7.1.
A participant will be withdrawn from the study for any of the following reasons:
Lost to follow-up
Withdrawal of consent
Sponsor decision  (eg, participating in any other clinical study with an investigational
intervention)
Death
Noncompliance with scheduled study activities as deemed appropriate by the sponsor
When a participant withdraws before completing the study, the reason for withdrawal is to be
documented in the eCRF and in the source document. Study intervention assigned to the withdrawn
participant may not be assigned to another participant. Additional participants will not be entered.
If a participant discontinues study intervention and withdraws from the study, end-of-intervention
efficacy and safety assessments should be obtained. If the reason for withdrawal from the study is
withdrawal ofconsent, then no additional assessments are allowed.
7.2.1. 
Withdrawal from the Main Study and the Use of Biomarker Samples
A participant who withdraws from the study will have the following options regarding the
biomarker sample:
The collected samples will be retained and used in accordance with the participant's original
informed consent/assent.
The participant may withdraw consent for biomarker sample, in which case the sample will
be destroyed, and no further testing will take place. To initiate the sample destruction process,
the investigator must notify the sponsor study site contact of withdrawal of consent for the
biomarker samples and to request sample destruction. The sponsor study site contact will, in
turn, contact the biomarker representative to execute sample destruction. If requested, the
investigator will receive written confirmation from the sponsor that the samples have been
destroyed.
Withdrawal from the Biomarker Samples While Remaining in the Main Study
The participant may withdraw consent for biomarker samples while remaining in the study. The
participant may refuse the collection of biomarker samples or may withdraw consent after samples
have been obtained. In such a case, the biomarker samples will be destroyed. The sample
destruction process will proceed as described above.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
77
Approved, Date: 11 November 2023
Withdrawal from the Use of Samples in Future Research
The participant may withdraw consent for use of samples for research (refer to Appendix 12
[Section 10.12, Regulatory, Ethical, and Study Oversight Considerations]). In such a case, samples
will be destroyed after they are no longer needed for the clinical study. Details of the sample
retention for research are presented in the main ICF.
7.3. 
Lost to Follow-up
If a participant is lost to follow-up, every reasonable effort must be made by the study site
personnel to contact the participant and determine the reason for discontinuation/withdrawal. Such
efforts should include repeated telephone calls, certified letters, and email requests. The measures
taken 
to 
follow-up 
must 
be 
documented. 
Refer 
to 
Section 
7.2, 
Participant
Discontinuation/Withdrawal from the Study.
8. 
STUDY ASSESSMENTS AND PROCEDURES
Overview
The Schedule of Activities (Table 1 and Table 2) summarizes the frequency and timing of efficacy,
PK, immunogenicity, PD, biomarker, and safety measurements applicable to this study.
All visit-specific patient-reported outcomes (PRO) assessments should be conducted/completed
after the PUCAI is administered but before any other tests, procedures, or other consultations for
that visit to prevent influencing participant perceptions. All other efficacy evaluations should be
completed before study intervention administrations.
Actual dates of visit-specific assessments will be recorded in the source documentation and eCRF
as required.
The following efficacy outcomes (PUCAI and IMPACT III) will be captured electronically in a
tablet device at the appropriate visits, as outlined in the Schedule of Activities (Section 1.3 [Table 1
and Table 2]).
Information about how and when data are filed, stored, and transmitted to or from the study site is
provided in the electronic patient-reported outcome (ePRO) electronic tablet device and User
Manual.
Additional serum or urine pregnancy tests may be performed, as determined necessary by the
investigator or required by local regulation, to establish the absence of pregnancy at any time
during the participation in the study.
The total blood volume to be collected from each participant will be approximately 105 mL blood
over 54 weeks and an additional approximately 5 to 10 mL (depending upon the visit) during study
extension. Participants with body weight of 10 kg to <12.3 kg will not have the RNA blood sample
collected and will have lesser total volume.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
78
Approved, Date: 11 November 2023
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the
samples.
Sample Collection and Handling
The actual dates and times of sample collection must be recorded in the eCRF or laboratory
requisition form.
Refer to the Schedule of Activities (Section 1.3 [Table 1 and Table 2]) for the timing and frequency
of all sample collections.
Instructions for the collection, handling, storage, and shipment of samples are found in the
laboratory manual. Collection, handling, storage, and shipment of samples must be under the
specified, and where applicable, controlled temperature conditions as indicated in the laboratory
manual.
Study-Specific Materials
The investigator will be provided with the following:
Golimumab IB
Infliximab IB
Instructions for Use
Site Investigational Product Procedures Manual
Laboratory manual
Retesting and rescreening plan
NCI-CTCAE
PRO questionnaires and PRO completion guidelines
IWRS Manual
eCRF guidelines
Sample ICF/assent forms
Participant diaries
Imaging kit (laptop) and manual
ePRO electronic tablet device and User Manual
iPad® and site user guide, if the study site is participating in electronic informed
consent/assent.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
79
Approved, Date: 11 November 2023
8.1. 
Efficacy Assessments
Efficacy evaluations will include the following:
Mayo score
Partial Mayo score
PUCAI score
C-reactive protein (CRP)
Fecal calprotectin
IMPACT III
TUMMY-UC and Observer TUMMY-UC
The Schedule of Activities summarizes the frequency and timing of efficacy measurements
applicable to this study (Section 1.3 [Table 1 and Table 2]).
8.1.1. 
Mayo Score
The Mayo score40 was developed from the criteria of Truelove and Witts46 for mild, moderate, and
severe UC; and from the criteria of Baron et al3 for grading the mucosal appearance. The Mayo
score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician’s
global assessment), each of which is rated on a scale from 0 to 3, indicating normal to severe
activity. The Mayo score is calculated as the sum of the 4 subscores and values range from 0 to
12. The Mayo scoring system is provided in Appendix 4 (Section 10.4).
A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately
active disease; and a score of 11 to 12 indicates severe disease.
Mayo scores are calculated using the following:
1. The stool frequency and rectal bleeding data collected in a study diary over 7 consecutive
days within the 14 days prior to the visit. Stool frequency and rectal bleeding subscores
will be calculated using the average of the 3-consecutive day period in the diary closest
to the study visit. Refer to the study reference study binder on how to proceed when a
consecutive 3-day period is not available. Days on which the following conditions are
met should be excluded from the calculation:
a. The day medications for constipation, diarrhea, or irregularity were taken  (For
participants maintained on a stable dose of bulking or stool softening agents
throughout the study, the days on which these agents are taken should not be
excluded from consideration in calculating the Mayo score).
b. The day(s) of a procedure or preparation for a procedure (eg, enemas, other laxatives,
a clear liquid diet) that would affect bowel frequency and/or blood content of the
stool.
c. The 48 hours after the use of antimotility agents (ie, diphenoxylate hydrochloride
with atropine sulfate, loperamide, or other opioids).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
80
Approved, Date: 11 November 2023
d. The 48 hours immediately following a colonoscopy.
2. The Physician's Global Assessment.
3. The results of a sigmoidoscopy or colonoscopy. Endoscopies are to be performed using
study software and submitted for central review. Scoring for disease activity based on
endoscopic appearance is to be performed both by the local endoscopist and the central
reviewer. All decisions to initiate (Week 0) or continue therapy (Weeks 6 and 54) based
on mucosal disease activity will be based on local reads.
Approaches to calculating Mayo and partial Mayo scores in participants who have missing
subscores will be detailed in the Statistical Analysis Plan (SAP).
8.1.2. 
Partial Mayo Score
The partial Mayo score is the Mayo score without the endoscopy subscore and values range from
0 to 9. Partial Mayo scores are calculated using data from items 1 and 2 of the Mayo score
calculation (Section 8.1.1).
8.1.3. 
Pediatric Ulcerative Colitis Activity Index Score
The PUCAI, a noninvasive measure of UC disease activity, is calculated using variables listed in
Appendix 5 (Section 10.5). It comprises 6 scales and ranges between 0 and 85 points. The scales
are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel
movement, and activity level.47
The PUCAI score is calculated as the sum of the 6 subscores. The PUCAI score will be calculated
if at least 3 of the 6 subscores are available from the visit at which the PUCAI score is measured.
For missing PUCAI subscores, the last available subscore value will be carried forward to calculate
the score. If the PUCAI score cannot be calculated, it will be considered missing (insufficient data)
for that visit.
A PUCAI score of <10 indicates remission, and a decrease of 20 points is considered a minimally
clinically important change.46,47
8.1.4. 
C-reactive Protein
C-reactive protein has been demonstrated to be useful as a marker of inflammation in participants
with IBD. In UC, elevated CRP has been associated with severe clinical activity, an elevated
sedimentation rate, and active disease as detected by colonoscopy.42,53 C-reactive protein will be
assayed using a validated, high sensitivity CRP assay.
8.1.5. 
Fecal Calprotectin
Fecal calprotectin has been demonstrated to be sensitive and specific marker of intestinal
inflammation and response to treatment in participants with IBD.7,9,23 Assays for fecal calprotectin
concentration will be performed using a validated method.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
81
Approved, Date: 11 November 2023
8.1.6. 
IMPACT III
Quality of life measures will be assessed in participants who are 10 to 17 years of age at Week 0
using the IMPACT-III questionnaire (Appendix 7 [Section 10.7]). The questionnaire comprises 35
questions on a variety of topics, from mood, self-image, and school absences to self-perceptions
of weight and height. It has been validated in many studies and is applicable for children 10 to 17
years of age with UC or Crohn’s disease. The score ranges from 35 to 175.36
8.1.7. 
Exploratory Evaluations
8.1.7.1. 
TUMMY-UC and Observer TUMMY-UC
The TUMMY-UC is an exploratorynoninvasive PRO for the measurement of signs and symptoms
for pediatric UC which is undergoing validation.32 It is calculated using variables listed in
Appendix 8 (Section 10.8). It includes 6 components similar to the PUCAI index and ranges from
0 to 114. The Observer TUMMY-UC  is for participants under age 8 and is completed by
caregivers. The version used at the Week 0 assessment will be used at all subsequent assessments
regardless of if participant age changes.
8.2. 
Safety Assessments
Adverse events will be reported and followed by the investigator as specified in Section 8.3,
Adverse Events and Serious Adverse Events and Appendix 16 (Section 10.16), Adverse Events:
Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting.
Any clinically significant abnormalities persisting at the end of the study/early withdrawal will be
followed by the investigator until resolution or until a clinically stable endpoint is reached.
The study will include the following evaluations of safety and tolerability according to the time
points provided in the Schedule of Activities (Section 1.3 [Table 1] and [Table 2]).
8.2.1. 
Physical Examination
Physical examinations (including skin examinations) will be performed as specified in the
Schedule of Activities. Height and weight will be recorded at screening; height, weight and other
vital signs will also be recorded at timepoints specified in the Schedule of Activities (Section 1.3
[Table 1] and [Table 2]).
8.2.2. 
Vital Signs
Vital signs (including temperature, pulse/heart rate, respiratory rate, and blood pressure) should be
obtained before and approximately 30 minutes after every SC golimumab administration when
administered by a healthcare provider. Vital signs will be obtained before, approximately every
30 minutes during, and twice (at approximately 30-minute intervals) after completion of the IV
infusion(s) of infliximab.
8.2.3. 
Clinical Safety Laboratory Assessments
Blood samples will be collected for routine hematology and blood chemistry laboratory analyses
at timepoints specified in the Schedule of Activities (Section 1.3. [Table 1] and [Table 2]).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
82
Approved, Date: 11 November 2023
The investigator must review the laboratory report in a timely manner, document this review, and
record any clinically relevant changes occurring during the studies in the adverse event section of
the eCRF. The laboratory reports must be filed with the source documents.
The following tests will be performed by the central laboratory:
Hematology panel
Hemoglobin
Hematocrit
White blood cell count with differential
Platelet count
Serum chemistry panel
sodium
potassium
chloride
blood urea nitrogen
creatinine
aspartate aminotransferase (AST)
alanine aminotransferase (ALT)
gamma glutamyl transferase (GGT)
total and direct bilirubin
alkaline phosphatase
calcium
phosphate
albumin
total protein
Abnormal liver function tests: If laboratory testing for a participant who is enrolled in the
study and receiving study intervention reveals an increase of serum aminotransferases (ALT
or AST) to >3 x upper limit of normal (ULN) and an increase of bilirubin to >2 x ULN, study
intervention should be suspended immediately. In addition, laboratory tests for ALT, AST,
alkaline phosphatase, and total bilirubin should be confirmed by a retest within 24 hours if
possible, but no later than 72 hours following notification of test results. See Appendix 13
(Section 10.13; Liver Safety: Suggested Actions and Follow-up Assessments) for additional
information on monitoring and assessment of abnormal liver function tests.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
83
Approved, Date: 11 November 2023
Pregnancy testing: Girls of childbearing potential will undergo a serum β-human chorionic
gonadotropin pregnancy test at screening, and a urine pregnancy test before all study
intervention administration visits.
Serology for HBV: HBsAg, anti-HBs, and anti-HBc total at screening.
HBV DNA detection will only be performed for participants who test positive for core
antibody and negative for surface antibody.
Serology for hepatitis C virus (HCV) at screening.
Serology for HIV at screening: HIV testing in study participants who are less than 6 years of
age is not universally required. It is required in those study participants who are less than 6
years of age and the birth history is unknown (ie, adopted) or has exposure risks (parents with
HIV or with risk factors) or at the discretion of the study investigator. In subjects who are less
than 6 years of age where testing would be required, if there is a record of a negative HIV test
at birth this is acceptable at the discretion of the study physician as long as it is entered into
the study record.
Serology for antinuclear antibodies (ANA) and anti-dsDNA.
8.2.4. 
Concomitant Medication Review
Concomitant medications will be reviewed at each visit.
All concomitant medications will be recorded in the eCRF through Week 54. After Week 54, only
concomitant medications associated with AEs and SAEs (ie, used to treat event or suspected in
causing event) and/or with the treatment of UC will be recorded in the eCRF.
8.2.5. 
Injection-site Reactions
A study intervention injection-site reaction is any adverse reaction at a SC study intervention
injection-site. Through Week 54, the injection sites will be evaluated by site staff for reactions and
any injection-site reactions will be recorded as an AE in the eCRF and source data. In addition,
the duration of injection-site reactions, including injection-site pain, will be captured with the
standard AE information which includes information on the start and end date, as well as the start
and end time of the AE. Discontinuations due to injection-site reactions, including injection-site
pain, will also be recorded. Participants will be observed for at least 30 minutes after the
administration of study intervention for symptoms of an injection-site reaction at the investigative
site.
Beginning at Week 58, participants administering study intervention at home will receive detailed
instructions on how to monitor and report potential injection-site reactions. Any adverse reaction
(eg, swelling, redness/erythema, pain, tenderness, warmth, bruising, or bleeding) should be noted
in the AHA diary and in the AE page of the eCRF.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
84
Approved, Date: 11 November 2023
Reactions temporarily associated with an infusion
An infusion reaction is defined as an AE that occurs during or within 1 hour after the infusion of
study intervention, with the exception of laboratory abnormalities. Minor infusion reactions may
be managed by slowing the rate of the IV infusion and/or treating with antihistamines and/or
acetaminophen (paracetamol) as clinically indicated. If an IV infusion of study intervention is
stopped because of an infusion reaction and the reaction, in the opinion of the investigator, is not
severe or does not result in a serious adverse event (SAE; Section 8.3) the infusion may be restarted
with caution.
Allergic Reactions
Before any on-site SC injection or IV infusion, appropriately trained personnel and medications
must be available to treat allergic reactions, including anaphylaxis. Appropriate medical personnel
must be in attendance at the time of the injection and for at least 30 minutes after the SC injection.
Appropriate medical personnel must remain in close proximity  to the infusion center for the
remaining duration of the infusion, and for 1 hour after the end of the infusion in the event that
emergency resuscitation is required. All participants must be observed carefully for symptoms of
an allergic reaction (eg, urticaria, itching, hives).
If a mildor moderate allergic reaction is observed, paracetamol, NSAIDs, and/or diphenhydramine
or locally available alternative may be administered. In the case of a severe allergic reaction (eg,
anaphylaxis), SC aqueous epinephrine, corticosteroids, respiratory assistance, and other proper
resuscitative measures are essential and must be available at the study site where the injections or
infusions are being given.
Participants who experience severe adverse reactions related to an injection or infusion must be
discontinued from further study intervention administrations.
For moderate or lesser adverse reactions related to an injection or infusion, the participant may be
permanently discontinued from further study interventions at the discretion of the investigator.
Participants who experience serious adverse reactions after an injection or infusion that
result in bronchospasm with wheezing and/or dyspnea that requires ventilatory support OR
that result in symptomatic hypotension with a decrease in systolic blood pressure >40 mm Hg
or blood pressure <90/60 mm Hg will not be permitted to receive additional study
intervention.
8.2.6. 
Infections
Study intervention should not be administered to a participant with a clinically important, active
infection. Investigators are required to evaluate participants for any signs or symptoms of infection
at scheduled visits as specified in the Schedule of Activities. If a participant develops a serious
infection, including but not limited to sepsis or pneumonia, discontinuation of study intervention
administration must be considered. For an active varicella-zoster infection or a significant
exposure to varicella-zoster infection in a participant without a history of chickenpox, study

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
85
Approved, Date: 11 November 2023
intervention administration should be interrupted until the symptoms have resolved and no active
infection is present.
8.3. 
Adverse Events and Serious Adverse Events
Timely, accurate, and complete reporting and analysis of safety information from clinical studies
are crucial for the protection of participants, investigators, and the sponsor, and are mandated by
regulatory agencies worldwide. The sponsor has established Standard Operating Procedures in
conformity with regulatory requirements worldwide to ensure appropriate reporting of safety
information; all clinical studies conducted by the sponsor or its affiliates will be conducted in
accordance with those procedures.
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate,
or the participant’s legally acceptable representative) for the duration of the study. At each visit,
participants (or, when appropriate, a caregiver, surrogate, or the participant’s legally acceptable
representative) will be questioned about any AEs (eg, “side effects”) occurring since the previous
visit and the outcomes for any AEs reported at previous visits.
Anticipated events will be recorded and reported as described in Appendix 6(Section 10.6).
For further details on AEs and SAEs (Definitions and Classifications; Attribution Definitions;
Severity Criteria; Special Reporting Situations; Procedures) as well as product quality complaints,
refer to Appendix 16 (Section 10.16Adverse Events: Definitions and Procedures for Recording,
Evaluating, Follow-Up, and Reporting).
8.3.1. 
Time Period and Frequency for Collecting Adverse Event and Serious
Adverse Event Information
All Adverse Events
All AEs and special reporting situations, whether serious or non-serious, will be reported from the
time a signed and dated ICF is obtained until completion of the participant's last study-related
procedure, which may include contact for follow-up of safety. Serious adverse events, including
those spontaneously reported to the investigator within 8 (infliximab) or 16 (golimumab) weeks
after the last dose of study intervention, must be reported using the Serious Adverse Event Form.
The sponsor will evaluate any safety information that is spontaneously reported by an investigator
beyond the time frame specified in the protocol.
Serious Adverse Events
All SAEs occurring during the study must be reported to the appropriate sponsor contact person
by study site personnel within 24 hours of their knowledge of the event.
Information regarding SAEs will be transmitted to the sponsor using the Serious Adverse Event
Form and Safety Report Form of the eCRF, which must be completed and reviewed by a physician
from the study site and transmitted to the sponsor within 24 hours. The initial and follow-up reports
of a SAE should be transmitted electronically or by facsimile (fax).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
86
Approved, Date: 11 November 2023
8.3.2. 
Method of Detecting Adverse Events and Serious Adverse Events
Care will be taken not to introduce bias when detecting AEs or SAEs. Open-ended and nonleading
verbal questioning of the participant and the participant’s caregiver is the preferred method to
inquire about adverse event occurrence.
Solicited Adverse Events
Solicited AEs are predefined local events occurring at the injection-site and systemic events for
which the participant is specifically questioned and which are noted by participants in their diary
(see Section 8; Study Assessments and Procedures).
Unsolicited Adverse Events
Unsolicited AEs are all adverse events for which the participant is not specifically questioned.
8.3.3. 
Follow-up of Adverse Events and Serious Adverse Events
Adverse events, including pregnancy, will be followed by the investigator as specified in
Appendix 16 (Section 10.16, Adverse Events: Definitions and Procedures for Recording,
Evaluating, Follow-up, and Reporting).
8.3.4. 
Regulatory Reporting Requirements for Serious Adverse Events
The sponsor assumes responsibility for appropriate reporting of AEs to the regulatory authorities.
The sponsor will also report to the investigator (and the head of the investigational institute where
required) all suspected unexpected serious adverse reactions (SUSARs). For anticipated events
reported as individual SAEs the sponsor will make a determination of relatedness in addition to
and independent of the investigator’s assessment Appendix 17 (Section 10.17). The sponsor will
periodically evaluate the accumulating data and, when there is sufficient evidence and the sponsor
has determined there is a reasonable possibility that the intervention caused a serious anticipated
event, they will submit a safety report in narrative format to the investigators (and the head of the
institute where required). The sponsor assumes responsibility for appropriate reporting of
anticipated events to the regulatory authorities according to requirements of the countries in which
the studies are conducted. The investigator (or sponsor where required) must report SUSARs to
the appropriate Independent Ethics Committee/Institutional Review Board (IEC/IRB) that
approved the protocol unless otherwise required and documented by the IEC/IRB.
8.3.5. 
Pregnancy
All initial reports of pregnancy in girls or partners of boys must be reported to the sponsor by the
study  site personnel within  24 hours of their knowledge of the event using the appropriate
pregnancy notification form. Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal
death, stillbirth, congenital anomalies, ectopic pregnancy) are considered SAEs and must be
reported using the Serious Adverse Event Form. Any participant who becomes pregnant during the
study must discontinue further study treatment.
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the
infant will be required.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
87
Approved, Date: 11 November 2023
8.3.6. 
Tuberculosis Evaluation
8.3.6.1. 
Initial Tuberculosis Evaluation
During the screening period, participants must undergo testing for TB and their medical history
assessment must include specific questions about a history of TB or known occupational or other
personal exposure to individuals with active TB. The participant should be asked about past testing
for TB, including chest radiograph results and responses to tuberculin skin or other TB testing.
Participants with a negative QuantiFERON-TB or T-Spot test result (and/or a negative tuberculin
skin test result in countries in which the QuantiFERON-TB test is not approved/registered or the
tuberculin skin test is mandated by local health authorities) are eligible to continue with
prerandomization procedures. Participants with a newly identified positive QuantiFERON-TB or
T-Spot or tuberculin skin test result must be excluded from the study  (see Appendix 3
[Section 10.3]).
If the QuantiFERON-TB or T-Spot cannot be obtained, the tuberculin skin test can be performed
instead after discussion with the medical monitor. The tuberculin skin test will be required in
addition to the QuantiFERON-TB or T-Spot in countries where QuantiFERON-TB or T-Spot is
not registered/approved or if the tuberculin skin test is mandated by local health authorities.
Investigators have the option to use 2 TB screening tests (selecting from the QuantiFERON-TB
test, the T-Spot test, and the tuberculin skin test) to screen for latent TB if they believe, based on
their judgment, that the use of 2 tests is clinically indicated in order to evaluate a participant who
has high risk of having latent TB. If a single test is positive, the participant is considered to have
latent TB infection for the purposes of eligibility for this study and must be excluded from the
study.
A participant whose first QuantiFERON-TB or T-Spot or tuberculin skin test result is
indeterminate should have the test repeated. In the event that the second QuantiFERON-TB or
T-Spot or tuberculin skin test result is also indeterminate, the participant should be excluded from
the study.
In select circumstances as approved by the Sponsor, a local laboratory may be used to perform the
QuantiFERON-TB or T-Spot test.
8.3.6.2. 
Ongoing Tuberculosis Evaluation
Early Detection of Active Tuberculosis
To aid in the early detection of TB reactivation or new TB infection during study participation,
participants must be evaluated for signs and symptoms of active TB at scheduled visits (refer to
the Schedule of Activities). The following series of questions is suggested for use during the
evaluation:

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
88
Approved, Date: 11 November 2023
“Has your child had a new cough of >14 days duration or a change in a chronic cough?”
Has your child had any of the following symptoms:
Persistent fever?
Unintentional weight loss?
Night sweats?”
Has your child had close contact with an individual with active TB?”  (If there is uncertainty
as to whether a contact should be considered “close,” a physician specializing in TB should
be consulted).
If the evaluation raises suspicion that a participant may have TB reactivation or new TB infection,
an immediate and thorough investigation should be undertaken, including, where possible,
consultation with a physician specializing in TB.
Investigators should be aware that TB reactivation in immunocompromised participants may
present as disseminated disease or with extrapulmonary features. Participants with evidence of
active TB should be referred for appropriate treatment.
Participants who experience close contact with an individual with active TB during the conduct of
the study must have a chest radiograph, a repeat QuantiFERON-TB or T-Spot test, a repeat
tuberculin skin test in countries in which the QuantiFERON-TB or T-Spot test is not
approved/registered or the tuberculin skin test is mandated by local health authorities, and if
possible, referral to a physician specializing in TB to determine the participant’s risk of developing
active TB and whether treatment for latent TB is warranted. If the QuantiFERON-TB or T-Spot
test result is indeterminate, the test should be repeated. In the event that the second
QuantiFERON-TB or T-Spot test result is also indeterminate, the participant must immediately
discontinue further administration of study intervention and be encouraged to return for all
subsequent scheduled study visits according to the protocol.
Adverse Event Reporting
Any newly identified case of active TB occurring after the first study intervention administration(s)
in participants participating in this clinical study must be reported by the investigator according to
the procedures in (Section 7). Investigators are also advised that active TB is considered a
reportable disease in most countries. These events are to be considered serious only if they meet
the definition of a serious adverse event.
8.4. 
Treatment of Overdose
For this study, any dose of golimumab or infliximab greater than 15% higher than planned or
indicated based on the participants weight will be considered an overdose. If this happens during
the AHA portion of the study, parents/caregivers should immediately contact study site personnel.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
89
Approved, Date: 11 November 2023
In the event of an overdose, the investigator or treating physician should:
Contact the medical monitor immediately.
Closely monitor the participant for AE/SAE and laboratory abnormalities.
Document the quantity of the excess dose as well as the duration of the overdosing in the CRF.
Decisions regarding dose interruptions or modifications will be made by the investigator in
consultation with the medical monitor based on the clinical evaluation of the participant.
8.5. 
Pharmacokinetics
Serum samples will be used to evaluate the PK of golimumab and infliximab. Samples collected
for the analyses of serum concentrations of golimumab or infliximab may additionally be used to
evaluate safety or efficacy aspects that address concerns arising during or after the study period,
or for the evaluation of relevant biomarkers. Genetic analyses will not be performed on these serum
samples. Participant confidentiality will be maintained.
Evaluations
Venous blood samples of approximately 55 mL will be collected for measurement of serum
concentrations of golimumab or infliximab and anti-golimumab or anti-infliximab antibodies over
54 weeks and final safety visits. An additional approximately 50 mL will be collected for other
study measurements including CRP, complete blood count, chemistries, and biomarker studies
through study Week 54. An additional approximately 5 mL per visit will be collected during study
extension when laboratory assessments are indicated in the Schedule of Assessments.
Pharmacokinetic Analytical Procedures
Serum samples will be analyzed to determine concentrations of golimumab or infliximab using
respective validated, specific, and sensitive assay methods by or under the supervision of the
sponsor.
Pharmacokinetic Parameters
Serum samples will be used to evaluate various golimumab PK parameters based on blood drawn
from participants receiving golimumab according to the Schedule of Activities (Section 1.3
[Table 1] and [Table 2]).
8.5.1. 
Immunogenicity (Antibodies to Golimumab and Infliximab)
Antibodies to golimumab or infliximab will be evaluated on blood drawn from all participants
according to the Schedule of Activities. Additionally, samples should also be collected at the final
visit for participants who are discontinued from intervention or withdrawn from the study.
Serum samples will be screened for antibodies binding to golimumab or infliximab and the titer of
confirmed positive samples will be reported as applicable. Other analyses may be performed to
further characterize the immunogenicity of golimumab or infliximab.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
90
Approved, Date: 11 November 2023
Immunogenicity Analytical Procedures
The detection and characterization of antibodies to golimumab or infliximab will be performed
using validated assay methods by or under the supervision of the sponsor.
All samples collected for detection of anti-drug antibodies will also be evaluated for the respective
serum drug concentration to enable interpretation of the antibody data.
8.6. 
Biomarkers
Exploratory biomarker assessments will be performed to identify RNA (mRNA or microRNA)
expression patterns and microbial activities that are relevant to golimumab and/or infliximab
treatment and/or pediatric UC, to correlate histologic and immunohistochemical assessments of
disease and healing, and to evaluate whether biomarkers can be developed to predict a golimumab
response and/or UC disease activity. Biomarker assessments (described below) will include the
evaluation of relevant markers in tissue biopsies, blood, and feces for all participants as specified
in the Schedule of Activities.
Instructions for the collection and shipment of biomarker samples will be provided in the
laboratory manual.
Mucosal Biopsy Histology and RNA
Mucosal biopsy samples will be collected from all participants during endoscopy according to the
Schedule of Activities. Total RNA will be isolated and used for differential gene expression
analyses to identify mRNA expression patterns that are relevant to golimumab or infliximab
treatment and/or pediatric UC, and to evaluate markers that can predict clinical response and/or
monitor UC disease activity. The biopsy samples collected will also be used for the histologic and
immunohistochemical assessment of disease and healing. Genetic (DNA) analyses will not be
performed on these biopsy samples.
Whole Blood RNA
Whole blood samples will be collected from all participants according to the Schedule of
Activities. Total RNA will be isolated and used for differential gene expression analyses to identify
mRNA or microRNA expression patterns that are relevant to golimumab or infliximab treatment
and/or pediatric UC, and to identify markers that can predict clinical response and/or monitor
disease activity. Genetic (DNA) analyses will not be performed on these blood samples.
Fecal Biomarkers
Fecal samples will be collected from all participants as specified in the Schedule of Activities.
Microbiome and associated products analysis will be conducted to evaluate the association
between microbial activities and golimumab and/or pediatric UC. The relationships between
microbiome, metabolites, and biomarkers in other tissue samples will also be assessed.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
91
Approved, Date: 11 November 2023
Stopping Analysis
Biomarker analyses are dependent upon clinical response rates. Biomarker analysis may be
deferred or not performed, if there are not enough samples or responders to allow for adequate
biomarker evaluation. In the event the study is terminated early or shows poor clinical efficacy,
completion of biomarker assessments is based on justification and intended utility of the data.
9. 
STATISTICAL CONSIDERATIONS
Statistical analysis will be done by the sponsor or under the authority of the sponsor. A general
description of the statistical methods to be used to analyze the efficacy and safety data is outlined
below. Specific details will be provided in the SAP.
9.1. 
Statistical Hypotheses
The primary hypothesis is that golimumab is an effective therapy in pediatric UC relative to a
historical placebo control as assessed by clinical remission at Week 6based on the Mayo score.
The historical placebo clinical remission rate is based on a meta-analysis of 7 adult UC studies
including infliximab Phase 3 (C0168T37 and C0168T46), golimumab Phase 2/3 (C0524T16 and
C0524T17), adalimumab Phase 3 (ULTRA 1 and ULTRA 2), and vedolizumab Phase 3 (GEMINI
1).
9.2. 
Criteria for Success
The success of the study will ultimately be based on the totality of evidence. The primary analysis
will be based on the proportion of golimumab pediatric participants in clinical remission at Week 6
based on the Mayo score and its associated 90% CI. The criteria for the primary analysis will have
been met if the lower limit of the two-sided 90% CI for the proportion of golimumab participants
in clinical remission at Week 6 is >10.0% (ie, the upper limit of the 95% CI for the proportion of
placebo participants in clinical remission at Week 6 derived from a meta-analysis of 7 adult UC
studies including 2 adult Phase 2/3 studies of golimumab for UC and 5 adult Phase 3 studies of
other products approved in this indication utilizing similar populations and endpoints).
9.3. 
Sample Size Determination
Sample size calculations were based on the need to have a sufficient number of participants
assigned to the golimumab treatment arm to achieve the criteria defined in Section 9.2. In addition,
collecting sufficient PK data to adequately characterize the PK of golimumab in participants with
UC is also considered.
A sample size of 60 participants in the golimumab arm will ensure that the lower bound of the
90% CI for the pediatric golimumab remission rate is above 10.0% (ie, the upper bound of the
95% CI for the historical placebo control) as long as the observed remission rate is at least 18.3%.
The probability of observing a remission rate of ≥18.3%, given different assumptions for the true
rate of clinical remission is shown in Table 6.
With 60 golimumab-treated participants, the probability of observing a remission rate of ≥18.3%
ranges from 50% (if the golimumab adult UC remission rate of 17.8% is assumed) to greater than

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
92
Approved, Date: 11 November 2023
99% (if the remission rate of 42.9% from the first golimumab study in pediatric UC is assumed).
It is reasonable to assume that the true remission rate in pediatric UC participants is greater than
the remission rate observed in the adult UC study, as the remission rate in the first golimumab
pediatric UC study was at least twice that observed in the adult UC study. Therefore, if we assume
the remission rate to be 22.5%, then the probability of observing a remission rate of ≥18.3% is at
least 80% (Table 6).
Table 6: 
Probability of Observing a Clinical Remission Rate of ≥18.3% With Differing Assumptions for
the True Remission Rate
Clinical Remission as Assessed by the Mayo Score 
Probability of Observing ≥18.3%
N=60
17.8% (observed adult remission rate; C0524T17) 
50%
20.0%  
68%
22.5% 
82%
25.0% 
91%
42.9% (observed pediatric remission rate; CNTO148UCO1001) 
>99.9%
The precision (ie, half width of the CI) based on this sample size of60 golimumab participants is
8.1% (assuming a clinical remission rate of 17.8% at Week 6) and 10.5% (assuming a clinical
remission rate at Week 6 of 42.9%).
Furthermore, the Fisher Information Matrix-based optimal design analysis indicates that PK data
from a total of 60 participants (including 45 participants in the ≥45 kg subgroup and 15 participants
in the <45 kg subgroup) would be sufficient to adequately characterize the PK of golimumab in
pediatric participants with UC.
Upon implementation of Amendment 4, no additional participants will be randomized to
infliximab; all newly enrolled participants will receive golimumab.
9.4. 
Statistical Analyses
Descriptive statistics (eg, mean, median, standard deviation, interquartile range, minimum, and
maximum) will be used to summarize continuous variables. Counts and percentages will be used
to summarize categorical variables. Graphical data displays may also be used to summarize the
data. Listings may also be utilized to present data at participant level. Specific details will be
provided in the SAP.
In general, efficacy and participant information analyses will be based on all participants
(including the youngest weight cohort [<30 kg]) who received at least 1 dose (complete or partial)
of study treatment.
Safety analyses will include all participants who received at least 1 dose (complete or partial) of
study treatment and participants will be analyzed based on the treatment they actually received,
regardless of the treatment group they were assigned to.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
93
Approved, Date: 11 November 2023
Pharmacokinetics analysis for golimumab and infliximab will include participants who received
at least one complete dose of golimumab (or infliximab) and have at least one postdose sample
collection. Antibodies to golimumab or infliximab will be analyzed for participants who received
at least one dose of study intervention and have at least one postdose sample collection.
9.4.1. 
Efficacy Analyses
A formal comparison is planned for the primary endpoint. Summary statistics will be provided for
all efficacy endpoints for golimumab and infliximab. Unless otherwise specified, all endpoints that
involve the Mayo endoscopy subscore will be based on the subscore assigned by the local
endoscopists.
No comparisons of infliximab to golimumab will be performed.
Upon implementation of Amendment 4, participants will not be randomized to the infliximab arm.
However, summary statistics will still be provided for the infliximab group.
9.4.1.1. 
Primary Endpoint
The primary endpoint is clinical remission at Week 6.
Treatment failure rules will override the clinical remission status based on the Mayo score.
Participants who meet any of the following criteria for treatment failure through Week 6 will be
considered to not have achieved clinical remission at Week 6:
Had a colectomy (partial or full) or ostomy,
OR
Discontinued study intervention due to lack of efficacy or an AE of worsening of UC,
OR
Had protocol prohibited medication changes including increase above the baseline
corticosteroid dose due to worsening UC (detailed in the SAP).
In addition, participants who do not return for evaluation or have insufficient data to calculate their
Mayo score at Week 6 (ie, all 4 Mayo subscores are missing) will be considered to not have
achieved clinical remission (based on the Mayo score) at Week 6.
The primary analysis population includes all participants (including the youngest weight cohort
[<30 kg]) who were treated with golimumab. The success of the study will ultimately be based on
the totality of evidence. The primary analysis will be based on the proportion of pediatric
participants who received golimumab and who were in clinical remission at Week 6 based on the
Mayo score (endoscopy subscore assigned by local endoscopist) and its associated 90% CI. The
criteria for the primary analysis will have been met if the lower limit of the two-sided 90% CI for
the proportion of pediatric golimumab participants in clinical remission at Week 6 is greater than
the upper limit of the 95% CI for the proportion of placebo participants in clinical remission at
Week 6 (ie, >10.0%) derived from a meta-analysis of 7 adult UC studies (2 adult Phase 2/3 UC

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
94
Approved, Date: 11 November 2023
studies of golimumab and 5 adult Phase 3 studies of other products approved in this indication
utilizing similar populations and endpoints).
9.4.1.2. 
Major Secondary Endpoints
For endpoints beyond Week 6, analyses will be performed on participants who are in clinical
response at Week 6 as assessed by the Mayo score.
1. Symptomatic remission at Week 54.
2. Clinical remission at Week 54, as assessed by the Mayo score (based on the Mayo endoscopy
subscore assigned by the local endoscopist).
3. Clinical remission at Week 54 as assessed by the PUCAI score.
4. Clinical remission at Week 6 as assessed by the PUCAI score.
5. Clinical response at Week 6 as assessed by the Mayo score (based on the Mayo endoscopy
subscore assigned by the local endoscopist).
6. Endoscopic healing at Week 6 (based on the Mayo endoscopy subscore assigned by the local
endoscopist).
7. Endoscopic healing at Week 54 (based on the Mayo endoscopy subscore assigned by the local
endoscopist).
8. Clinical remission at Week 54, as assessed by the Mayo score, for participants who are in
clinical remission at Week 6 (based on Mayo endoscopy subscore assigned by the local
endoscopist).
9. Participants who were not receiving corticosteroids for at least 12 Weeks prior to Week 54 and
in clinical remission at Week 54, as assessed by the Mayo score (based on Mayo endoscopy
subscore assigned by the local endoscopist).
Treatment failure rules will be applied as specified in the primary efficacy analysis. In addition,
participants who use rescue medication for a clinical flare after Week 6 will be considered a
treatment failure for endpoints after Week 6 (detailed in the SAP). Participants who have any
treatment failure events prior to the timepoint of interest will be considered to not have achieved
the endpoints at that timepoint. These rules will override the response status based on the Mayo,
PUCAI, and endoscopy score.
Participants who do not return for evaluation or have insufficient data to calculate their Mayo score
or PUCAI Score at Week 6 or Week 54 will be considered not to be in clinical response or clinical
remission, and not to have endoscopic healing at these timepoints. Participants who do not have
sufficient data to calculate their stool frequency and rectal bleeding subscores at Week 54 will be
considered to not have achieved symptomatic remission at these timepoints. Approaches to
participants with missing subscores, including those missing an endoscopy subscore at Week 6 or
Week 54, will be detailed in the SAP.
9.4.1.3. 
Other Endpoints
For endpoints beyond Week 6, analyses will be performed on participants who are in clinical
response at Week 6 as assessed by the Mayo score.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
95
Approved, Date: 11 November 2023
Remission
1. Symptomatic remission at Week 6.
2. Clinical remission at Week 30, as assessed by the PUCAI score, for participants who are in
clinical remission at Week 6.
3. Clinical remission at Week 54, as assessed by the PUCAI score, for participants who are in
clinical remission at Week 6.
4. Symptomatic remission at Week 54 for participants who are in symptomatic remission at
Week 6.
5. Corticosteroid-free clinical remission at Week 54, as assessed by the PUCAI score.
6. Corticosteroid-free clinical remission at Week 54, as assessed by the Mayo score (based on
Mayo endoscopy subscore assigned by the local endoscopist).
7. Corticosteroid-free symptomatic remission at Week 54.
8. Remission at Week 6 based on a Mayo score less than or equal to 2, with no individual
subscore greater than 1, a stool frequency subscore of 0, and a rectal bleeding subscore of 0.
9. Partial Mayo remission at Week 6.
10. Partial Mayo remission at Week 54.
11. Participants who were not receiving corticosteroids for at least 12 weeks prior to Week 54 and
in symptomatic remission at Week 54.
12. Participants who were not receiving corticosteroids for at least 12 weeks prior to Week 54 and
in clinical remission at Week 54, as assessed by the PUCAI score.
Partial Mayo remission is defined as a partial Mayo score ≤2.
Other Clinical Efficacy endpoints
1. Clinical response at Week 54, as assessed by the Mayo score (based on Mayo endoscopy
subscore assigned by the local endoscopist).
2. Baseline and postbaseline values and the change from baseline in the Mayo score at Week 6
and at Week 54 (based on Mayo endoscopy subscore assigned by the local endoscopist).
3. Baseline and postbaseline values in the Mayo subscores at Week 6 and at Week 54 (based on
Mayo endoscopy subscore assigned by the local endoscopist).
4. Baseline and postbaseline values and the change from baseline in the PUCAI score through
Week 6 and during the long-term phase through Week 54.
5. Baseline and postbaseline values and the change from baseline in the Partial Mayo score
through Week 6 and during the long-term phase through Week 54.
6. Clinically important change at Week 6 as assessed by the PUCAI score.
7. Clinically important change at Week 30 as assessed by the PUCAI score.
8. Clinically important change at Week 54 as assessed by the PUCAI score.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
96
Approved, Date: 11 November 2023
Clinically important change is defined as a decrease of ≥20 from Week 0 in the PUCAI score.
CRP and Fecal Marker Endpoints
1. Baseline and postbaseline values and the change from baseline in CRP through Week 6 and
during the long-term phase through Week 54.
2. Baseline and postbaseline values and the change from baseline in fecal calprotectin
concentrations through Week 6 and during the long-term phase through Week 54.
3. Normalization of CRP concentration (≤3 mg/L) through Week 6 and during the long-term
phase through Week 54 among participants with abnormal CRP concentration (>3 mg/L) at
baseline.
4. Normalization of fecal calprotectin concentration (≤250 mg/kg) through Week 6 and during
the long-term phase through Week 54  among participants with abnormal fecal calprotectin
concentration (>250 mg/kg) at baseline.
Quality of Life
1. Baseline and postbaseline values and the change from baseline in IMPACT III over time
through Week 54 for participants ≥10 years at Week 0.
Analyses of the primary and major secondary endpoints will also be conducted utilizing the
centrally read endoscopy measures. Additional sensitivity analyses in which subjects with
friability present on endoscopy are considered nonresponders in the analysis are detailed in the
SAP.
Alternate definitions of clinical remission will be explored. Details will be provided in the SAP.
Exploratory analyses of the TUMMY-UC and the Observer TUMMY-UC scores and analyses
based on different approaches to handling missing endoscopies at Week 54 will also be performed.
Details will be provided in the SAP.
Treatment failure rules will be applied as specified in the primary efficacy analysis. Participants
who use rescue medication for a clinical flare after Week 6 will be considered a treatment failure
for endpoints after Week 6 (detailed in the SAP). For continuous endpoints (ie, PUCAI score,
Mayo score, partial Mayo score, fecal markers and CRP), the same treatment failure rules that will
be applied for the dichotomous efficacy endpoints will also be applied to these endpoints. The
baseline value will be carried forward from the time the treatment failure occurs onward.
Missing data rules for these endpoints will be specified in the SAP.
For endpoints beyond Week 6, analyses will also be conducted on all golimumab participants
including partial Mayo responders at Week 14 and separately for all infliximab participants
including partial Mayo responders at Week 14 or Week 22. Details will be provided in the SAP.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
97
Approved, Date: 11 November 2023
9.4.1.4. 
Analyses of Study Extension
The proportion of participants in clinical remission based on the PUCAI score will be summarized
over time. The change from study extension baseline in the PUCAI score will be summarized over
time. Treatment failure and missing data rules will be detailed in the SAP.
For the Usability Assessment Substudy, data from the questionnaire will be descriptively
summarized. Details will be provided in the SAP.
9.4.2. 
Safety Analyses
Adverse Events
The verbatim terms used in the eCRF by investigators to identify AEs will be coded using the
Medical Dictionary for Regulatory Activities (MedDRA). Intervention-emergent AEs are adverse
events with onset during the intervention phase or that are a consequence of a preexisting condition
that has worsened since baseline. All reported intervention-emergent AEs will be included in the
analysis. For each AE, the percentage of participants who experience at least 1 occurrence of the
given event will be summarized by intervention group.
The following analyses of AEs will be used to assess the safety of participants:
Frequency and type of AEs.
Frequency and type of SAEs.
Frequency and type of reasonably related AEs as assessed by the investigator.
Frequency and type of AEs leading to discontinuation of study intervention.
Frequency and type of infections, serious infections, and infections requiring oral or parenteral
antimicrobial treatment.
Frequency and type of AEs temporally associated with an infusion.
Frequency and type of injection-site reactions.
In addition, the following targeted events will also be assessed:
Malignancy, study participant death, pregnancy in a girl or the partner of a boy, TB diagnosis
or treatment.
Summaries, listings, datasets, or participant narratives may be provided, as appropriate, for those
participants who die, who discontinue intervention due to an AE, or who experience a SAE.
Clinical Laboratory Tests
Laboratory data will be summarized by type of laboratory test. Reference ranges and Common
Terminology Criteria for Adverse Events (CTCAE) grade results (specified in the SAP) will be
used in the summary of laboratory data. Descriptive statistics will be calculated for selected
laboratory analytes at baseline and for observed values and changes from baseline at scheduled
time points. Frequency tabulations of abnormalities will be made.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
98
Approved, Date: 11 November 2023
The following summaries of clinical laboratory tests will be used to assess participant safety:
Laboratory parameters and change from baseline in laboratory parameters (hematology and
chemistry)
Summary of maximum CTCAE toxicity grade for postbaseline laboratory values (hematology
and chemistry)
Listings of participants with any abnormal postbaseline laboratory values of CTCAE Grade ≥2
will also be provided.
9.4.3. 
Other Analyses
9.4.3.1. 
Pharmacokinetic Analyses
Descriptive statistics of the serum golimumab or infliximab concentrations will be calculated at
each sampling time point. These concentrations will be summarized over time.
All concentrations below the lowest quantifiable concentration or missing data will be labeled as
such in the concentration database or data presentations. Concentrations below the lowest
quantifiable concentration will be treated as zero in the summary statistics.
A population PK analysis approach for golimumab using nonlinear mixed effects modeling
(NONMEM) will be used to evaluate PK parameters. The influence of important covariates on the
population PK parameter estimates may be evaluated. The results of the population PK analysis
will be presented in a separate technical report.
Participants will be excluded from the PK analysis if their data do not allow for accurate
assessment of the PK (eg, incomplete administration of the study intervention; missing time of
study intervention administration). Detailed rules for the analysis will be specified in the SAP.
Exposure-response analyses will be performed to evaluate the relationship between serum
golimumab concentrations and clinical efficacy endpoints using summary statistics and a modeling
approach.
9.4.3.2. 
Immunogenicity Analyses
Golimumab
The incidence of anti-golimumab antibodies will be summarized for all participants who receive
at least 1 dose of golimumab and have appropriate samples for detection of antibodies to
golimumab (ie, participants with at least 1 sample obtained after their first dose of golimumab).
A listing of participants who are positive for antibodies to golimumab will be provided. The
maximum titers of antibodies to golimumab will be summarized for participants who are positive
for antibodies to golimumab.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
99
Approved, Date: 11 November 2023
Infliximab
The incidence of anti-infliximab antibodies will be summarized for all participants who receive at
least 1 dose of infliximab and have appropriate samples for detection of antibodies to infliximab
(ie, participants with at least 1 sample obtained after their first dose of infliximab).
A listing of participants who are positive for antibodies to infliximab will be provided. The
maximum titers of antibodies to infliximab will be summarized for participants who are positive
for antibodies to infliximab.
Other immunogenicity
Other immunogenicity analyses may be performed to further characterize the immune responses
that are generated.
9.4.3.3. 
Biomarkers Analyses
Changes in serum/RNA or other biomarkers over time will be summarized by intervention group.
Associations between baseline levels and changes from baseline in select biomarkers and clinical
response at screening and Weeks 0, 2, 6, and 54 will be explored.
Biomarker analyses are considered exploratory and results will be presented in a separate report.
9.4.3.4. 
Pharmacodynamic Analyses
Planned biomarker analyses may be deferred if emerging study data show no likelihood of
providing useful scientific information. Any pharmacodynamics (PD) samples received by the
contract vendor or sponsor after the cut-off date will not be analyzed, and therefore, excluded from
the PD analysis.
9.5. 
Data Monitoring Committee
An internal DMC (consisting of Sponsor members [a gastroenterologist, a clinician and a
statistician at a minimum] outside of the study team), will be established to monitor safety data
(for both golimumab and infliximab treatments arms) on an ongoing basis until all participants
reach the Week 54 visit or terminate the study prior to the Week 54 visit.
The major function of the DMC is to monitor the safety of the study intervention by reviewing the
SAEs each month and by reviewing the interim study safety data every 3-months.
The content of the safety summaries, the DMC role and responsibilities and the general procedures
(including communications) and their recommendations on the study conduct are defined and
documented in the DMC charter, which will be finalized prior to the first DMC review.  The first
DMC meeting will occur approximately 4 months after the first participant is dosed with study
intervention.
In addition, during the study, the sponsor's study responsible physician (or designee) will regularly
review safety data from the sites and notify the DMC and appropriate Sponsor personnel of any
issues.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
100
Approved, Date: 11 November 2023
10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Abbreviations
5-ASA  
5-aminosalicylate
6-MP  
6-mercaptopurine
6-TG 
6-thioguanine
AE 
adverse event
AHA  
at home administration
ALT  
alanine aminotransferase
ANA  
antinuclear antibodies
anti-HBc 
HBV core antibody total
anti-HBs 
HBV surface antibody
ARC  
anticipated event review committee
AS  
ankylosing spondylitis
AST  
aspartate aminotransferase
AZA  
azathioprine
BCG 
Bacille Calmette-Guerin
BSA 
body-surface area
CI 
confidence interval
COVID-19 
Coronavirus Disease 2019
CRP  
C-reactive protein
CSR  
clinical study report
CTCAE  
Common Terminology Criteria for Adverse Events
DBL  
database lock
DCS  
data collection system
DMC  
Data Monitoring Committee
DNA  
deoxyribonucleic acid
eCRF  
electronic case report form
ePRO  
electronic patient-reported outcome
E-R 
exposure-response
EU  
European Union
FDA  
Food and Drug Administration
FSH  
follicle stimulating hormone
HBsAg 
HBV surface antigen
HBV  
hepatitis B virus
HCP  
health care professional
HCV  
hepatitis C virus
HRT  
hormone replacement therapy
IB  
Investigator's Brochure
IBD  
inflammatory bowel disease
ICF  
informed consent form
ICH  
International Council on Harmonisation
ICMJE  
International Committee of Medical Journal Editors
IRB  
Institutional Review Board
IV  
intravenous
IWRS  
interactive web response system
LOR  
loss of response
mAb 
monoclonal antibody
MTX  
methotrexate
NSAIDs 
nonsteroidal anti-inflammatory drugs
PD 
pharmacodynamics
PFP-V 
prefilled pen Varioject
PFS  
prefilled syringe
PFS-U 
prefilled syringe with UltraSafe
pJIA  
polyarticular juvenile idiopathic arthritis
PK 
pharmacokinetics
PPD 
purified protein derivative

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
101
Approved, Date: 11 November 2023
PQC  
product quality complaint
PRO  
participant-reported outcomes
PUCAI 
Pediatric Ulcerative Colitis Activity Index Score
q4w  
every 4 weeks
q8w  
every 8 weeks
q12w  
every 12 weeks
QoL 
quality of life
RNA  
ribonucleic acid
SAE 
serious adverse event
SAP  
Statistical Analysis Plan
SC 
subcutaneous
SUSAR  
suspected unexpected serious adverse reactions
TB  
tuberculosis
TNFα 
tumor necrosis factor alpha
TU 
tuberculin units
UC  
ulcerative colitis
ULN  
upper limit of normal
US  
United States

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
102
Approved, Date: 11 November 2023
10.2. Appendix 2: Definitions of Inadequate Response to or Intolerance of
Corticosteroids, MTX, or AZA/6-MP and Corticosteroid Dependence
CORTICOSTEROIDS
Participants have failed to respond to corticosteroids if they have had evidence of an initial inadequate
response, recurrent disease, or a relapse despite receiving at least 1.0 mg/kg/day or a maximum of
40 mg/day of prednisone (or corticosteroid equivalent, given orally or intravenously) for 2 weeks; or
≥9mg/day of budesonide or ≥5 mg/day of beclomethasone dipropionate given orally for at least 4 weeks.
Participants are intolerant of corticosteroids if:
They have developed clinically significant adverse events (eg, osteonecrosis or osteoporosis,
psychosis, uncontrolled diabetes) unresponsive to dose reduction that, in the judgment of the
investigator, precluded the use of corticosteroids to treat UC.
OR
They have a medical condition that precludes the use of corticosteroids as a treatment for UC.
Participants are corticosteroid dependent ifthey have failed to successfully taper their corticosteroid (ie,
had a flare of disease) within 3 months of starting therapy, or if a relapse occurs within 3 months after
stopping corticosteroids or if they are unable to discontinue these agents without flare within 3 months after
starting them.
METHOTREXATE, 6-MERCAPTOPURINE (6-MP) OR AZATHIOPRINE (AZA)
Participants have failed to respond to MTX, 6-MP or AZA if they have had evidence of an initial
inadequate response, recurrent disease, or a relapse despite receiving:
At least 3 months of therapy before screening on MTX or at least 3 months of therapy before screening
with 1 mg/kg/day of 6-MP or 2 mg/kg/day of AZA.
OR
At least 3 months before screening at lower dosage of 6-MP or AZA when country or local guidelines
specify a different treatment regimen. (In such an event, the country or local guidelines needs to be
included in the source document).
OR
At least 3 months before screening at a dosage of 6-MP or AZA confirmed to be therapeutic for the
participant with whole blood thioguanine nucleotide levels >200 pmol/8 x 108 red blood cells.
OR
At least 3 months before screening at the highest tolerated dosage due to leukopenia, elevated liver
enzymes, or nausea.
Participants are intolerant of MTX, 6-MP or AZA if:
They have developed clinically significant adverse events (eg, pancreatitis, arthritis accompanied by
high fever and/or rash, leukopenia, or persistently elevated liver enzymes) unresponsive to dose
reduction that, in the judgment of the investigator, precluded the use of MTX, 6-MP or AZA to treat
UC within the past 5 years.
OR
They have a medical condition that precludes the use of MTX, 6-MP or AZA.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
103
Approved, Date: 11 November 2023
10.3. Appendix 3: Tuberculin Skin Testing
Administering the Mantoux Tuberculin Skin Test
The Mantoux tuberculin skin test (CDC, 2000) is the standard method of identifying persons
infected with Mycobacterium tuberculosis.  Multiple puncture tests (Tine and Heaf) should not be
used to determine whether a person is infected because the amount of tuberculin injected
intradermally cannot be precisely controlled. Tuberculin skin testing is both safe and reliable
throughout the course of pregnancy. The Mantoux tuberculin test is performed by placing an
intradermal injection of 0.1 mL of tuberculin into the inner surface of the forearm. The test must
be performed with tuberculin that has at least the same strength as either 5 tuberculin units (TU)
of standard purified protein derivative (PPD)-S or 2 TU of PPD-RT 23, Statens Seruminstitut, as
recommended by the World Health Organization. PPD strengths of 1 TU or 250 TU are not
acceptable (Menzies, 2000). Using a disposable tuberculin syringe with the needle bevel facing
upward, the injection should be made just beneath the surface of the skin. This should produce a
discrete, pale elevation of the skin (a wheal) 6mm to 10 mm in diameter. To prevent needle-stick
injuries, needles should not be recapped, purposely bent or broken, removed from disposable
syringes, or otherwise manipulated by hand. After they are used, disposable needles and syringes
should be placed in puncture-resistant containers for disposal. Institutional guidelines regarding
universal precautions for infection control (eg, the use of gloves) should be followed. A trained
health care worker, preferably the investigator, should read the reaction to the Mantoux test 48 to
72 hours after the injection. Participants should never be allowed to read their own tuberculin skin
test results. If a participant fails to show up for the scheduled reading, a positive reaction may still
be measurable up to 1 week after testing. However, if a participant who fails to return within 72
hours has a negative test, tuberculin testing should be repeated. The area of induration (palpable
raised hardened area) around the site of injection is the reaction to tuberculin. For standardization,
the diameter of the induration should be measured transversely (perpendicular) to the long axis of
the forearm. Erythema (redness) should not be measured. All reactions should be recorded in
millimeters, even those classified as negative.
Interpreting the Tuberculin Skin Test Results
In the US and many other countries, the most conservative definition of positivity for the tuberculin
skin test is reserved for immunocompromised participants, and this definition is to be applied in
this study to maximize the likelihood of detecting latent TB, even though the participants may not
be immunocompromised at baseline.
In the US, an induration of 5 mm or greater in response to the intradermal tuberculin skin test is
considered to be a positive result and evidence for either latent or active TB.
In countries outside the US, country-specific guidelines for immunocompromised participants
should be consulted for the interpretation of tuberculin skin test results. If no local country
guidelines for immunocompromised participants exist, US guidelines must be followed.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
104
Approved, Date: 11 November 2023
Treatment of Latent Tuberculosis
Local country guidelines for immunocompromised participants should be consulted for acceptable
anti-tuberculous treatment regimens for latent TB. If no local country guidelines for
immunocompromised participants exist, US guidelines must be followed.
References
Centers for Disease Control and Prevention.  Core curriculum on tuberculosis:  What the clinician should know (Fourth
Edition).  Atlanta, GA:  Department of Health and Human Services; Centers for Disease Control and Prevention;
National Center for HIV, STD, and TB Prevention; Division of Tuberculosis Elimination; 2000:25-86.
Menzies RI.  Tuberculin skin testing.  In:  Reichman LB, Hershfield ES (eds). Tuberculosis, a comprehensive
international approach.  2nd ed.  New York, NY:  Marcel Dekker, Inc; 2000:279-322.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
105
Approved, Date: 11 November 2023
10.4. Appendix 4: Mayo Score
Mayo scoring system for assessment of ulcerative colitis activity
Stool frequencya
0  Normal number of stools for this participant
1  1-2 stools more than normal
2  3-4 stools more than normal
3  5 or more stools more than normal
Rectal bleedingb
0  No blood seen
1  Streaks of blood with stool less than half the time
2  Obvious blood with stool most of the time
3  Blood alone passed
Findings of endoscopy
0  Normal or inactive disease
1  Mild disease (erythema, decreased vascular pattern, mild friability)
2  Moderate disease (marked erythema, absent vascular pattern, friability, erosions)
3  Severe disease (spontaneous bleeding, ulceration)
Physician’s global assessmentc
0  Normal
1  Mild disease
2  Moderate disease
3  Severe disease
a Each participant serves as his or her own control to establish the degree of abnormality of
the stool frequency.
b The daily bleeding score represents the most severe bleeding of the day.
c The physician’s global assessment acknowledges the 3 other criteria, the participant’s
recall of abdominal discomfort and general sense of well-being, and other observations,
such as physical findings and the participant’s performance status.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
106
Approved, Date: 11 November 2023
10.5. Appendix 5: Pediatric Ulcerative Colitis Activity Index (PUCAI)
ITEM  
POINTS
1.  Abdominal pain
No pain  
0
Pain can be ignored 
5
Pain cannot be ignored 
10
2.  Rectal bleeding
None 
0
Small amount only, in less than 50% of stools 
10
Small amount with most stools 
20
Large amount (>50% of the stool content) 
30
3.  Stool consistency of most stools
Formed 
0
Partially formed 
5
Completely unformed 
10
4. Number of stools per 24 hours
0-2 
0
3-5 
5
6-8 
10
>8 
15
5. Nocturnal bowel movement (any diarrhea episode causing wakening)
No 
0
Yes 
10
6. Activity level
No limitation of activity  
0
Occasional limitation of activity  
5
Severe restricted activity  
10
SUM OF PUCAI (0-85)

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
107
Approved, Date: 11 November 2023
10.6. Appendix 6: Attribution Definitions and Severity Criteria
Attribution Definitions
Not Related
An AE that is not related to the use of the drug.
Doubtful
An AE for which an alternative explanation is more likely, eg, concomitant drug(s), concomitant
disease(s), or the relationship in time suggests that a causal relationship is unlikely.
Possible
An AE that might be due to the use of the drug. An alternative explanation, eg, concomitant
drug(s), concomitant disease(s), is inconclusive. The relationship in time is reasonable; therefore,
the causal relationship cannot be excluded.
Probable
An AE that might be due to the use of the drug. The relationship in time is suggestive
(eg, confirmed by dechallenge). An alternative explanation is less likely, eg, concomitant drug(s),
concomitant disease(s).
Very Likely
An AE that is listed as a possible adverse reaction and cannot be reasonably explained by an
alternative explanation, eg, concomitant drug(s), concomitant disease(s). The relationship in time
is very suggestive (eg, it is confirmed by dechallenge and rechallenge).
Severity Criteria
An assessment of severity grade will be made using the following general categorical descriptors:
Mild: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not
interfering with everyday activities.
Moderate: Sufficient discomfort is present to cause interference with normal activity.
Severe:Extreme distress, causing significant impairment of functioning or incapacitation. Prevents
normal everyday activities.
The investigator should use clinical judgment in assessing the severity of events not directly
experienced by the participant (eg, laboratory abnormalities).
Note that seriousness and severity should not be confused. A participant could experience a severe
headache that would not qualify as an SAE, while another might experience a mild stroke that,
while not severe, would be considered serious.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
108
Approved, Date: 11 November 2023
10.7. Appendix 7: IMPACT III Questionnaire

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
109
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
110
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
111
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
112
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
113
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
114
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
115
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
116
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
117
Approved, Date: 11 November 2023
10.8. Appendix 8: Examples of the TUMMY-UC and the Observer TUMMY-UC
Questionnaires

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
118
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
119
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
120
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
121
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
122
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
123
Approved, Date: 11 November 2023

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
124
Approved, Date: 11 November 2023
10.9. Appendix 9: PFS-U and PFP-V Actual Use Data Collection
Introduction
The PFS-U and PFP-V Actual Use Data Collection is designed to capture and document real-life
handling and use experience data from injections administered by pediatric participants or
caregivers in a home-like setting, including complaints and failures in use. The actual use data to
be collected is intended as additional support of the human factors and labeling comprehension
data obtained during Summative Human Factors Studies but is not itself considered a human
factors study. Following the second independent self- or caregiver- administration by appropriately
trained pediatric participants capable of self-administration or their caregivers, all study
participants performing the injection will be asked to complete a questionnaire (provided below)
regarding their experience using either the PFS-U or the PFP-V. Evaluation of the user experience
after the second independent administration is considered adequate to evaluate how well
participants can understand and recall the dosage instructions, and to assess for any common
difficulties with injections.
The Schedule of Activities (Table 2) summarizes the setup of data collection. Pediatric participants
aged 12 and older, or caregivers of participants of any age will be offered the option for self- or
caregiver administration after the Week 54 study evaluations. This is optional; if a pediatric
participant or caregiver elects against self- or caregiver administration, the HCP will administer
injections in this study. If a pediatric participant or caregiver does elect self- or caregiver
administration, the pediatric participant or caregiver will perform a training administration no
earlier than Week 58. Pediatric participants or caregivers will receive face-to-face training by study
site staff on the use of the injection device. The training will include a review of the IFU with site
staff, a demonstration with a device Trainer (when available) performed by the site staff, and
‘hands-on’ practice injections performed by the pediatric participants and/or their caregivers using
the device Trainer. An Observer Checklist will be completed by the trainer in order to determine
that the user is able to correctly administer the injection. Based on this information, the HCP will
determine whether the pediatric participant, or their caregiver, is able to administer the injection
in a home-like setting at the site.
If caregiver injection is selected, then injections should be continued at subsequent weeks by the
caregiver and not be switched to the pediatric participant. Similarly, if pediatric participant self-
injection is selected, then injections should be continued at subsequent weeks by the pediatric
participant and not be switched to the caregiver. At any time, pediatric participants or caregivers
can opt to continue on with self- or caregiver-injections performed at the study site or can return
to HCP administration in the clinic after they start self- or caregiver administration, ifdesired.
Self- or caregiver training injections will occur in 2 subsequent study intervention administrations,
the second and third self- or caregiver administration visits. Injections will be performed
independently in a home-like setting in the clinic, with the IFU available for reference.
Approximately 10-20 participants from Sponsor identified sites who choose AHA will enter the
Usability Assessment Substudy  at Week 58 and complete an injection device Usability
Questionnaire at Weeks 62 and 66 after completion of the second and third self- or caregiver
administration visits (Sections 4.1 and 6.1).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
125
Approved, Date: 11 November 2023
10.10. Appendix 10: Injection Device Observer Injection Checklist
This form is intended to be completed to determine if the first AHA training dose was delivered
successfully by the caregiver or participant and should be completed by the study staff observing
the injections.
Injection Device Observer Injection Checklist
Participant Number: 
Type of Injection Device: 
 PFS-U 
PFP-V
By my signature below, I hereby certify that:
 Participant Passed Training OR 
 Caregiver Passed Training
Circle level of training aptitude:
Below Average
(must justify passing)
Average 
Above Average
I have trained and/or observed the participant/caregiver whose participant number is listed above to
properly comply with each and every one of the methods and procedures for administering the drug via an
injection.
I observed the participant/caregiver perform a successful and simulated injection.
I observed the participant/caregiver demonstrate adequate learning of the tasks and information relevant for
first-time use of this device;
I observed the participant/caregiver perform the injection without undue effort or frustration;
I have concluded that the participant/caregiver can safely use the device on their own;
The participant/caregiver is competent and capable of such use and does not require my further presence or
assistance when using the device.
 Participant Failed Training OR 
 Caregiver Failed Training
During training, the participant/caregiver failed for the following reason(s): (Check all that apply)
Participant/caregiver showed an inability to learn how to use the device and did not successfully
demonstrate correct use the device, after being trained.
Participant/caregiver showed high levels of frustration, stress or workload that may prevent them from
using the device correctly or safely.
Participant/caregiver was not willing to interact with the device per the trainer’s instructions.
Participant’s/caregiver’s behaviors, attitudes and/or abilities were not representative of their typical
user group and falls outside of the norm.
Use This Space To Note Additional Information:
Trainer Signature: 
    Date: 

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
126
Approved, Date: 11 November 2023
10.11. Appendix 11:  Injection Device Assessment Questionnaire
Thank you for completing this questionnaire by yourself or with the assistance of a parent or
caregiver if necessary, preferably in a quiet environment. Take as much time as you need to
complete it. There are no right or wrong answers. Your answers will remain strictly confidential
and anonymous.
TYPE OF INJECTION DEVICE
Prefilled Syringe (PFS-U) 
Prefilled Pen-
Varioject (PFP-V)
Which type of injection device did you use for
this injection?
CONFIRMATION OF SUCCESSFUL INJECTION
Yes 
No
Were you able to successfully inject using the
injection device (PFS-U or PFP-V)?
EASE OF USE OF THE INJECTION DEVICE
The following questions ask about the ease of use of the injection device (PFS-U or PFP-V).
Please answer each question below by checking the box that best represents your opinion (Check
only one box per question).
How difficult or easy was
it to:
Very
difficult
Difficult 
Somewhat
difficult
Somewhat
easy
Easy  
Very
easy
position the injection
device at the injection-
site?
press the plunger on the
injection device to inject
the liquid?
hold the injection device
during the injection?
withdraw the needle into
the safety guard after
completion of the
injection?

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
127
Approved, Date: 11 November 2023
THANK YOU FOR COMPLETING THIS QUESTIONNAIRE
10.12. Appendix 12: Regulatory, Ethical, and Study Oversight Considerations
REGULATORY AND ETHICAL CONSIDERATIONS
Investigator Responsibilities
The investigator is responsible for ensuring that the study is performed in accordance with the
protocol, current International Council on Harmonisation (ICH) guidelines on Good Clinical
Practice (GCP), and applicable regulatory and country-specific requirements.
Good Clinical Practice is an international ethical and scientific quality standard for designing,
conducting, recording, and reporting studies that involve the participation of human participants.
Compliance with this standard provides public assurance that the rights, safety, and well-being of
study participants are protected, consistent with the principles that originated in the Declaration of
Helsinki, and that the study data are credible.
Protocol Amendments
Neither the investigator nor the sponsor will modify this protocol without a formal amendment by
the sponsor. All protocol amendments must be issued by the sponsor and signed and dated by the
investigator. Protocol amendments must not be implemented without prior IEC/IRB approval, or
when the relevant competent authority has raised any grounds for non-acceptance, except when
necessary to eliminate immediate hazards to the participants, in which case the amendment must
be promptly submitted to the IEC/IRB and relevant competent authority. Documentation of
amendment approval by the investigator and IEC/IRB must be provided to the sponsor or designee.
When the change(s) involve only logistic or administrative aspects of the study, the IEC/IRB
(where required) only needs to be notified.
During the course of the study, in situations where a departure from the protocol is unavoidable,
the investigator or other physician in attendance will contact the appropriate sponsor designee.
Except in emergency situations, this contact should be made before implementing any departure
from the protocol. In all cases, contact with the sponsor or designee must be made as soon as
possible to discuss the situation and agree on an appropriate course of action. The data recorded in
the Data Collection System (DCS) and source documents will reflect any departure from the
protocol, and the source documents will describe this departure and the circumstances requiring it.
Regulatory Approval/Notification
This protocol and any amendment(s) must be submitted to the appropriate regulatory authorities
in each respective country, if applicable. A study may not be initiated until all local regulatory
requirements are met.
Required Prestudy Documentation
The following documents must be provided to the sponsor or designee before shipment of study
intervention to the study site:

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
128
Approved, Date: 11 November 2023
Protocol and amendment(s), if any, signed and dated by the principal investigator
A copy of the dated and signed (or sealed, where appropriate per local regulations), written
IEC/IRB approval of the protocol, amendments, ICF, any recruiting materials, and if
applicable, participant compensation programs. This approval must clearly identify the
specific protocol by title and number and must be signed (or sealed, where appropriate per
local regulations) by the chairman or authorized designee.
Name and address of the IEC/IRB, including a current list of the IEC/IRB members and their
function, with a statement that it is organized and operates according to GCP and the
applicable laws and regulations. If accompanied by a letter of explanation, or equivalent, from
the IEC/IRB, a general statement may  be substituted for this list. If an investigator or a
member of the study site personnel is a member of the IEC/IRB, documentation must be
obtained to state that this person did not participate in the deliberations or in the vote/opinion
of the study.
Regulatory authority approval or notification, if applicable
Signed and dated statement of investigator (eg, Form FDA 1572), if applicable
Documentation of investigator qualifications (eg, curriculum vitae)
Completed investigator financial disclosure form from the principal investigator, where
required
Signed and dated Clinical Trial Agreement, which includes the financial agreement
Any other documentation required by local regulations
The following documents must be provided to the sponsor or designee before enrollment of the
first participant:
Completed investigator financial disclosure forms from all sub-investigators
Documentation of sub-investigator qualifications (eg, curriculum vitae)
Name and address of any local laboratory conducting tests for the study, and a dated copy of
current laboratory normal ranges for these tests, if applicable
Local laboratory documentation demonstrating competence and test reliability
(eg, accreditation/license), if applicable
Independent Ethics Committee or Institutional Review Board
Before the start of the study, the investigator (or sponsor where required) will provide the IEC/IRB
with current and complete copies of the following documents (as required by local regulations):
Final protocol and, if applicable, amendments
Sponsor-approved ICF (and any other written materials to be provided to the participants)
Investigator's Brochure (or equivalent information) and amendments/addenda
Sponsor-approved participant recruiting materials
Information on compensation for study-related injuries or payment to participants for
participation in the study, if applicable

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
129
Approved, Date: 11 November 2023
Investigator's curriculum vitae or equivalent information (unless not required, as documented
by the IEC/IRB)
Information regarding funding, name of the sponsor, institutional affiliations, other potential
conflicts of interest, and incentives for participants
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after the IEC/IRB has given full approval of the final protocol,
amendments (if any, excluding the ones that are purely administrative, with no consequences for
participants, data or study conduct, unless required locally), the ICF, applicable recruiting
materials, and participant compensation programs, and the sponsor or designee has received a copy
of this approval. This approval letter must be dated and must clearly identify the IEC/IRB and the
documents being approved.
Approval for the collection of optional samples for research and for the corresponding ICF must
be obtained from the IEC/IRB. Approval for the protocol can be obtained independent of this
optional research component.
During the study the investigator (or sponsor where required) will send the following documents
and updates to the IEC/IRB for their review and approval, where appropriate:
Protocol amendments (excluding the ones that are purely administrative, with no
consequences for participants, data or study conduct)
Revision(s) to ICF and any other written materials to be provided to participants
If applicable, new or revised participant recruiting materials approved by the sponsor
Revisions to compensation for study-related injuries or payment to participants for
participation in the study, if applicable
New edition(s) of the IB and amendments/addenda
Summaries of the status of the study at intervals stipulated in guidelines of the IEC/IRB (at
least annually)
Reports of AEs that are serious, unlisted/unexpected, and associated with the study
intervention
New information that may adversely affect the safety of the participants or the conduct of the
study
Deviations from or changes to the protocol to eliminate immediate hazards to the participants
Report of deaths of participants under the investigator's care
Notification if a new investigator is responsible for the study at the site
Development Safety Update Report and Line Listings, where applicable
Any other requirements of the IEC/IRB

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
130
Approved, Date: 11 November 2023
For all protocol amendments (excluding the ones that are purely administrative, with no
consequences for participants, data or study conduct), the amendment and applicable ICF revisions
must be submitted promptly to the IEC/IRB for review and approval before implementation of the
change(s).
At least once a year, the IEC/IRB will be asked to review and reapprove this study, where required.
At the end of the study, the investigator (or sponsor where required) will notify the IEC/IRB about
the study completion (if applicable, the notification will be submitted through the head of
investigational institution).
Country Selection
This study will only be conducted in those countries where the intent is to launch or otherwise help
ensure access to the developed product if the need for the product persists, unless explicitly
addressed as a specific ethical consideration in Section 4.2.4, Study-Specific Ethical Design
Considerations.
Other Ethical Considerations
For study-specific ethical design considerations, refer to Section 4.2.4.
FINANCIAL DISCLOSURE
Investigators and sub-investigators will provide the sponsor or designee with sufficient, accurate
financial information in accordance with local regulations to allow the sponsor to submit complete
and accurate financial certification or disclosure statements to the appropriate regulatory
authorities. Investigators are responsible for providing information on financial interests during
the course of the study and for 1 year after completion of the study.
Refer to Required Prestudy Documentation (above) for details on financial disclosure.
INFORMED CONSENT PROCESS
For each participant, his or her parent(s) (preferably both parents, if available) or legally acceptable
representative(s), as required by local regulations, must give written consent (permission)
according to local requirements after the nature of the study has been fully explained and before
the performance of any study-related assessments. Assent must be obtained from children (minors)
capable of understanding the nature of the study, typically participants 7 years of age and older,
depending on the institutional policies and national/local guidelines. The ICF(s) must be signed
before performance of any study-related activity. The ICF(s) that is/are used must be approved by
both the sponsor or designee and by the reviewing IEC/IRB and be in a language that the
participant can read and understand. The informed consent should be in accordance with principles
that originated in the Declaration of Helsinki, current ICH and GCP guidelines, applicable
regulatory requirements, and sponsor policy.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
131
Approved, Date: 11 November 2023
Before enrollment in the study, the investigator or an authorized member of the studysite personnel
must explain to potential participants the aims, methods, reasonably anticipated benefits, and
potential hazards of the study, and any discomfort participation in the study may entail.
Participants will be informed that their participation is voluntary and that they may withdraw
consent to participate at any time. They will be informed that choosing not to participate will not
affect the care the participant will receive. Finally, they will be told that the investigator will
maintain a participant identification register for the purposes of long-term follow-up if needed and
that their records may be accessed by health authorities and authorized sponsor or designee
personnel without violating the confidentiality of the participant, to the extent permitted by the
applicable law(s) or regulations. By signing the ICF the participant is authorizing such access. It
also denotes that the participant agrees to allow his or her study physician to recontact the
participant for the purpose of obtaining consent for additional safety evaluations, and subsequent
disease-related treatments, if needed.
There will be a second consent/assent process for the optional Usability Assessment Substudy
which will utilize the same procedures as the primary study consent/assent process.
The participant will be given sufficient time to read the ICF and the opportunity to ask questions.
After this explanation and before entry into the study, consent should be appropriately recorded
by means of the participant's personally dated signature. After having obtained the consent, a copy
of the ICF must be given to the participant.
A participant may be rescreened 1 time. Participants who are rescreened are required to sign a new
ICF. In rare cases, a participant may be screened a third time after discussion with the medical
monitor.
Completion of screening and randomization procedures within the specified approximately 6-week
window is required. If a participant is approaching the completion of that period, the medical
monitor can be contacted to discuss eligibility.
If any delay leads to the expiration of time-specific assessments (eg, TB, chest radiograph, stool
analysis), the participant will be considered a screen failure because he/she will not meet eligibility
criteria, and the expired assessments (along with the non-time-specific laboratory tests) will have
to be repeated on rescreening.
A limited number of study sites will be asked by the Sponsor to obtain informed consent/assent
using a validated electronic system instead of a paper-based process.  If both parties (Sponsor and
the study site) agree, and if participation is allowed by local regulations and EC/IRB requirements,
the Sponsor will provide an eTablet device (eg, iPad®) to the study site to use for the electronic
informed consent/assent. Overall the consent/assent process will remain the same, as described in
this section; however, at the study sites utilizing electronic informed consent/assent, participants
or their legally acceptable representatives will be able to review the entire informed consent/assent
form content on the eTablet. The ability for participants or their legally acceptable representatives
to review the paper informed consent/assent form is always an option at sites utilizing electronic
informed consent/assent. Depending on local regulations and EC/IRB requirements, the

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
132
Approved, Date: 11 November 2023
participants or their legally acceptable representatives and person obtaining consent/assent will
either apply their handwritten signature electronically directly onto the eTablet or apply their
handwritten signature to a printed paper copy of the informed consent/assent in accordance with
local regulations.
DATA PROTECTION
Privacy of Personal Data
The collection and processing of personal data from participants enrolled in this study will be
limited to those data that are necessary to fulfill the objectives of the study.
These data must be collected and processed with adequate precautions to ensure confidentiality
and compliance with applicable data privacy protection laws and regulations. Appropriate
technical and organizational measures to protect the personal data against unauthorized disclosures
or access, accidental or unlawful destruction, or accidental loss or alteration must be put in place.
Sponsor personnel whose responsibilities require access to personal data agree to keep the identity
of participants confidential.
The informed consent obtained from the participant includes explicit consent for the processing of
personal data and for the investigator/institution to allow direct access to his or her original medical
records (source data/documents) for study-related monitoring, audit, IEC/IRB review, and
regulatory inspection. This consent also addresses the transfer of the data to other entities and to
other countries.
The participant has the right to request through the investigator access to his or her personal data
and the right to request rectification of any data that are not correct or complete. Reasonable steps
will be taken to respond to such a request, taking into consideration the nature of the request, the
conditions of the study, and the applicable laws and regulations.
Exploratory biomarker, PK, and immunogenicity tests are only for research. They will not be used
for medical care of the participant or to make a diagnosis about the participant’s health.  In
addition, the sponsor cannot make decisions as to the significance of any findings resulting from
exploratory research. Therefore, exploratory research data will not be returned to participants or
investigators, unless required by law or local regulations. Privacy and confidentiality of data
generated in the future on stored samples will be protected by the same standards applicable to all
other clinical data.
LONG-TERM RETENTION OF SAMPLES FOR ADDITIONAL FUTURE RESEARCH
Samples collected in this study may be stored for up to 15 years (or according to local regulations)
for additional research. The start of the storage period is defined as last participant last visit.
Samples will only be used to understand golimumab and infliximab, to understand UC, to
understand differential intervention responders, and to develop diagnostic tests to identify UC
populations that may be responsive or non-responsive to treatment with golimumab or infliximab.
The research may begin at any time during the study or the poststudy storage period.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
133
Approved, Date: 11 November 2023
Stored samples will be coded throughout the sample storage and analysis process and will not be
labeled with personal identifiers. Participants may withdraw their consent for their samples to be
stored for research (refer to Section 7.2.1, Withdrawal from the Use of Research Samples).
COMMITTEES STRUCTURE
Data Monitoring Committee
Details regarding an internal DMC are presented in Section 9.5.
PUBLICATION POLICY/DISSEMINATION OF CLINICAL STUDY DATA
All information, including but not limited to information regarding golimumab or the sponsor's
operations (eg, patent application, formulas, manufacturing processes, basic scientific data, prior
clinical data, formulation information) supplied by the sponsor to the investigator and not
previously published, and any data, including pharmacogenomic or exploratory biomarker
research data, generated as a result of this study, are considered confidential and remain the sole
property of the sponsor. The investigator agrees to maintain this information in confidence and use
this information only to accomplish this study and will not use it for other purposes without the
sponsor's prior written consent.
The investigator understands that the information developed in the study will be used by the
sponsor in connection with the continued development of golimumab, and thus may be disclosed
as required to other clinical investigators or regulatory agencies. To permit the information derived
from the clinical studies to be used, the investigator is obligated to provide the sponsor with all
data obtained in the study.
The results of the study will be reported in a Clinical Study Report (CSR) generated by the sponsor
and will contain eCRF data transmitted from a central laboratory, ePRO, and IWRS data from all
study sites that participated in the study into the sponsor's database, as per protocol. Recruitment
performance or specific expertise related to the nature and the key assessment parameters of the
study will be used to determine a coordinating investigator for the study. Results of
pharmacogenomic and exploratory biomarker analyses performed after the CSR has been issued
will be reported in a separate report and will not require a revision of the CSR.
Study participant identifiers will not be used in publication of results. Any work created in
connection with performance of the study and contained in the data that can benefit from copyright
protection (except any publication by the investigator as provided for below) shall be the property
of the sponsor as author and owner of copyright in such work.
Consistent with Good Publication Practices and International Committee of Medical Journal
Editors (ICMJE) guidelines, the sponsor shall have the right to publish such primary (multicenter)
data and information without approval from the investigator. The investigator has the right to
publish study site-specific data after the primary data are published. If an investigator wishes to
publish information from the study, a copy of the manuscript must be provided to the sponsor for
review at least 60 days before submission for publication or presentation. Expedited reviews will
be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
134
Approved, Date: 11 November 2023
writing, the investigator will withhold such publication for up to an additional 60 days to allow for
filing of a patent application. In the event that issues arise regarding scientific integrity or
regulatory compliance, the sponsor will review these issues with the investigator. The sponsor will
not mandate modifications to scientific content and does not have the right to suppress information.
For multicenter study designs and substudy approaches, secondary results generally should not be
published before the primary endpoints of a study have been published. Similarly, investigators
will recognize the integrity of a multicenter study by not submitting for publication data derived
from the individual study site until the combined results from the completed study have been
submitted for publication, within 18 months after the study end date, or the sponsor confirms there
will be no multicenter study publication. Authorship of publications resulting from this study will
be based on the guidelines on authorship, such as those described in the ICMJE Recommendations
for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, which
state that the named authors must have made a significant contribution to the conception or design
of the work; or the acquisition, analysis, or interpretation of the data for the work; and drafted the
work or revised it critically for important intellectual content; and given final approval of the
version to be published; and agreed to be accountable for all aspects of the work in ensuring that
questions related to the accuracy or integrity of any part of the work are appropriately investigated
and resolved.
Registration of Clinical Studies and Disclosure of Results
The sponsor will register and disclose the existence of and the results of clinical studies as required
by law.
DATA QUALITY ASSURANCE
Data Quality Assurance/Quality Control
Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified
investigators and appropriate study sites, review of protocol procedures with the investigator and
studysite personnel before the study, periodic monitoring visits by the sponsor, direct transmission
of clinical laboratory data from a central laboratory as well as direct transmission of IWRS data to
the sponsor’s database, and direct transmission of PRO and self-injection data to the electronic
patient-reported outcome (ePRO) vendor database and then to the sponsor’s database.
Guidelines for eCRF completion will be provided and reviewed with study site personnel before
the start of the study.
The sponsor or designee will review eCRF for accuracy and completeness during on-site
monitoring visits and after transmission to the sponsor; any discrepancies will be resolved with the
investigator or designee, as appropriate. After upload of the data into the study database they will
be verified for accuracy and consistency with the data sources.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
135
Approved, Date: 11 November 2023
DATA COLLECTION
Data for each study participant will be collected in the eCRF or ancillary data collection systems
such as the IWRS, patient-reported outcome (PRO) tablets, laboratory database, and imaging
database. Case report forms are prepared and provided by the sponsor for each participant in eCRF.
Collectively, all data collection via eCRFs and ancillary systems will comprise what is referred to
in this protocol as the DCS.
All DCS entries, corrections, and alterations must be made by the investigator or authorized study
site personnel.
The investigator must verify that all data entries in the eCRF are accurate and correct.
Study data will be transcribed by study site personnel from source documentation to an eCRF or
the appropriate ancillary DCS, as applicable. Study-specific data from each source will be
transmitted in a secure manner to the sponsor.
Worksheets may be used as source documentation to capture data and facilitate completion of the
eCRF or entry of data into the applicable ancillary data system. Data must be entered into the DCS
in English. The eCRF must be completed as soon as possible after a participant visit and the forms
should be available for review at the next scheduled monitoring visit.
Necessary eCRF or ancillary data modifications can only be made by the investigator or
appropriate site personnel using eCRF system functionality and/or ancillary data revision
procedures. All data changes will be recorded in an audit trail.
SOURCE DOCUMENTS
At a minimum, source documents consistent in the type and level of detail with that commonly
recorded at the study site as a basis for standard medical care must be available for the following:
participant identification, eligibility, and study identification; study discussion and date of signed
informed consent; dates of visits; results of safety and efficacy parameters as required by the
protocol; record of all AEs and follow-up of AEs; concomitant medication; intervention
receipt/dispensing/return records; study intervention administration information; and date of study
completion and reason for early discontinuation of study intervention or withdrawal from the
study, if applicable.
The author of an entry in the source documents should be identifiable.
Specific details required as source data for the study and source data collection methods will be
reviewed with the investigator before the study and will be described in the monitoring guidelines
(or another equivalent document).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
136
Approved, Date: 11 November 2023
The minimum source documentation requirements for Section 5.1, Inclusion Criteria and
Section 5.2, Exclusion Criteria that specify a need for documented medical history are as follows:
Referral letter from treating physician or
Complete history of medical notes at the site
Discharge summaries
Inclusion and exclusion criteria not requiring documented medical history must be verified at a
minimum by participant interview or other protocol-required assessment (eg, physical
examination, laboratory assessment) and documented in the source documents.
Participant- and investigator-completed scales and assessments designated by the sponsor
including PRO assessments (PUCAI and IMPACT III) will be recorded into an electronic tablet
device during the visit at the study site. These data will be considered electronic source
documentation.
An electronic source (eSource) system may be utilized, which contains data traditionally
maintained in a hospital or clinic record to document medical care (eg, electronic source
documents) as well as the clinical study-specific data fields as determined by the protocol. This
data is electronically extracted for use by the sponsor. If eSource is utilized, references made to
the eCRF in the protocol include the eSource system but information collected through eSource
may not be limited to that found in the eCRF.
MONITORING
The sponsor designee will perform on-site monitoring visits as frequently as necessary. The
monitor will record dates of the visits in a study site visit log that will be kept at the study site, as
allowed by local regulation. The first postinitiation visit will be made as soon as possible after
enrollment has begun. At these visits, the monitor will compare the data entered into the applicable
DCS component (as defined in the monitoring guidelines) with the source documents
(eg, hospital/clinic/physician’s office medical records). The nature and location of all source
documents will be identified to ensure that all sources of original data required to complete the
applicable DCS component are known to the sponsor or designee and study site personnel and are
accessible for verification by the sponsor study site contact. If electronic records are maintained at
the study site, the method of verification must be discussed with the study site personnel.
Direct access to source documents (medical records) must be allowed for the purpose of verifying
that the recorded data are consistent with the original source data. Findings from this review will
be discussed with the studysite personnel. The sponsor or designee expects that, during monitoring
visits, the relevant study site personnel will be available, the source documents will be accessible,
and a suitable environment will be provided for review of study-related documents. The monitor
will meet with the investigator on a regular basis during the study to provide feedback on the study
conduct.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
137
Approved, Date: 11 November 2023
In addition to on-site monitoring visits, remote contacts can occur. It is expected that during these
remote contacts, study site personnel will be available to provide an update on the progress of the
study at the site.
Central monitoring will take place for data identified by the sponsor or designee as requiring
central review.
ON-SITE AUDITS
Representatives of the sponsor's (or sponsor designee’s) clinical quality assurance department may
visit the study site at any time during or after completion of the study to conduct an audit of the
study in compliance with regulatory guidelines and company policy. These audits will require
access to all study records, including source documents, for inspection. Participant privacy must,
however, be respected. The investigator and study site personnel are responsible for being present
and available for consultation during routinely scheduled study site audit visits conducted by the
sponsor or its designees.
Similar auditing procedures may also be conducted by agents of any regulatory body, either as part
of a national GCP compliance program or to review the results of this study in support of a
regulatory submission. The investigator should immediately notify the sponsor or designee if he
or she has been contacted by a regulatory agency concerning an upcoming inspection.
RECORD RETENTION
In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all eCRF
and all source documents that support the data collected from each participant, as well as all study
documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical
Trial, and all study documents as specified by the applicable regulatory requirement(s). The
investigator/institution will take measures to prevent accidental or premature destruction of these
documents.
Essential documents must be retained until at least 2 years after the last approval of a marketing
application in an ICH region and until there are no pending or contemplated marketing applications
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical
development of the investigational product. These documents will be retained for a longer period
if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the
responsibility of the sponsor to inform the investigator/institution as to when these documents no
longer need to be retained.
If the responsible investigator retires, relocates, or for other reasons withdraws from the
responsibility of keeping the study records, custody must be transferred to a person who will accept
the responsibility. The sponsor must be notified in writing of the name and address of the new
custodian. Under no circumstance shall the investigator relocate or dispose of any study documents
before having obtained written approval from the sponsor or designee.
If it becomes necessary for the sponsor or the appropriate regulatory authority to review any
documentation relating to this study, the investigator/institution must permit access to such reports.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
138
Approved, Date: 11 November 2023
STUDY AND SITE CLOSURE
Study Termination
The sponsor reserves the right to close the study site or terminate the study at any time for any
reason at the sole discretion of the sponsor. Study sites will be closed upon study completion. A
study site is considered closed when all required documents and study supplies have been collected
and a study site closure visit has been performed.
The investigator may initiate study site closure at any time, provided there is reasonable cause and
sufficient notice is given in advance of the intended termination.
Reasons for the early closure of a study site by the sponsor or investigator may include but are not
limited to:
Failure of the investigator to comply with the protocol, the requirements of the IEC/IRB or
local health authorities, the sponsor's procedures, or GCP guidelines
Inadequate recruitment of participants by the investigator
Discontinuation of further study intervention development

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
139
Approved, Date: 11 November 2023
10.13. Appendix 13: Liver Safety: Suggested Actions and Follow-up
Assessments
Guideline Algorithm for Monitoring, Assessment & Evaluation of Abnormal
Liver Tests in Participants with no Underlying Liver Disease and normal
baseline ALT, AST, Alkaline Phosphatase and Bilirubin
Although this algorithm is still applicable across all populations, it has been developed assuming normal liver
function at baseline.  For populations with preexisting liver disease and/or AT increases at baseline, product
teams are strongly encouraged to consult with Hepatic Safety Group for further guidance particularly for
discontinuation criteria.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
140
Approved, Date: 11 November 2023
10.14. Appendix 14: Contraceptive and Barrier Guidance and Collection of
Pregnancy Information
Participants must follow contraceptive measures as outlined in Section 5.1, Inclusion Criteria.
Pregnancy information will be collected and reported as noted in Section 8.3.5 (Pregnancy), and
Appendix  16 (Section 10.16; Adverse Events: Definitions and Procedures for Recording,
Evaluating, Follow-up, and Reporting).
Definitions
Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal unless
permanently sterile (see below).
Woman Not of Childbearing Potential
premenarchal
A premenarchal state is one in which menarche has not yet occurred.
postmenopausal
A postmenopausal state is defined as no menses for 12 months without an alternative medical
cause. A high follicle stimulating hormone (FSH) level (>40 IU/L or mIU/mL) in the
postmenopausal range may be used to confirm a postmenopausal state in women not using
hormonal contraception or hormonal replacement therapy (HRT), however in the absence of
12 months of amenorrhea, a single FSH measurement is insufficient. If there is a question
about menopausal status in women on HRT, the woman will be required to use one of the
non-estrogen-containing hormonal highly effective contraceptive methods if she wishes to
continue HRT during the study.
permanently sterile
Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal
occlusion/ligation procedures, and bilateral oophorectomy.
Note: If the childbearing potential changes after start of the study (eg, a premenarchal woman
experiences menarche) or the risk of pregnancy changes (eg, a woman who is not heterosexually
active becomes active), a woman must begin a highly effective method of contraception, as
described throughout the inclusion criteria.
If reproductive status is questionable, additional evaluation should be considered.
As noted in inclusion criterion #12, study participants who are girls of childbearing potential or
female partners of boys must be practicing a highly effective method of contraception and remain
on a highly effective method while receiving study intervention and until 6 months after last dose.
Examples of highly effective methods of contraception are provided below; however, the method
selected must meet local/regional regulations/guidelines for highly effective contraception.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
141
Approved, Date: 11 November 2023
Examples of Contraceptives
EXAMPLES OF CONTRACEPTIVESa ALLOWED DURING THE STUDY INCLUDE:
USER-INDEPENDENT
Highly Effective Methods That Are User-Independent Failure rate of ≤1% per year when used consistently
and correctly.
Implantable progestogen-only hormone contraception associated with inhibition of ovulationb
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomized partner
(Vasectomized partner is a highly effective contraceptive method provided that the partner is the sole sexual
partner of the woman of childbearing potential and the absence of sperm has been confirmed. If not,
additional highly effective method of contraception should be used. Spermatogenesis cycle is approximately
74 days.)
USER-DEPENDENT
Highly Effective Methods That Are User-Dependent Failure rate of <1% per year when used consistently
and correctly.
Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of
ovulationb
oral
intravaginal
transdermal
injectable
Progestogen-only hormone contraception associated with inhibition of ovulationb
oral
injectable
Sexual abstinence
(Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual
intercourse during the entire period of risk associated with the study intervention. The reliability of sexual
abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle
of the participant.)
NOT ALLOWED AS SOLE METHOD OF CONTRACEPTION DURING THE STUDY (not considered
to be highly effective - failure rate of >1% per year)
Progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of
action.
Male or female condom with or without spermicidec
Cap, diaphragm, or sponge with spermicide
A combination of male condom with either cap, diaphragm, or sponge with spermicide (double-barrier
methods)c
Periodic abstinence (calendar, symptothermal, postovulation methods)
Withdrawal (coitus-interruptus)
Spermicides alone
Lactational amenorrhea method (LAM)
a) Typical use failure rates may differ from those when used consistently and correctly. Use should be
consistent with local regulations regarding the use of contraceptive methods for participants in clinical
studies.
b) Hormonal contraception may be susceptible to interaction with the study intervention, which may reduce the
efficacy of the contraceptive method. In addition, consider if the hormonal contraception may interact with
the study intervention.
c) Male condom and female condom should not be used together (due to risk of failure with friction).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
142
Approved, Date: 11 November 2023
Pregnancy during the study
All initial reports of pregnancy in female participants or partners of male participants must be
reported to the sponsor or designee by the study site personnel within 24 hours of their knowledge
of the event using the appropriate pregnancy notification form. Abnormal pregnancy outcomes
(eg, spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy) are
considered SAEs and must be reported using the Serious Adverse Event Form. Any participant
who becomes pregnant during the study must discontinue further study intervention.
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the
infant will be required.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
144
Approved, Date: 11 November 2023
10.16. Appendix 16: Adverse Events: Definitions and Procedures for Recording,
Evaluating, Follow-up, and Reporting
ADVERSE EVENT DEFINITIONS AND CLASSIFICATIONS
Adverse Event
An adverse event is any untoward medical occurrence in a clinical study participant administered
a medicinal (investigational or non-investigational) product. An adverse event does not necessarily
have a causal relationship with the intervention. An adverse event can therefore be any unfavorable
and unintended sign (including an abnormal finding), symptom, or disease temporally associated
with the use of a medicinal (investigational or non-investigational) product, whether or not related
to that medicinal (investigational or non-investigational) product. (Definition per International
Council on Harmonisation [ICH] Technical Requirements for Pharmaceuticals for Human Use).
This includes any occurrence that is new in onset or aggravated in severity or frequency from the
baseline condition, or abnormal results of diagnostic procedures, including laboratory test
abnormalities.
Note: The sponsor collects adverse events starting with the signing of the ICF (refer to All Adverse
Events under Section 8.3.1, Time Period and Frequency for Collecting Adverse Events and Serious
Adverse Events Information, for time of last adverse event recording).
Serious Adverse Event
A serious adverse event based on ICH and EU Guidelines on Pharmacovigilance for Medicinal
Products for Human Use is any untoward medical occurrence that at any dose:
Results in death
Is life threatening
(The participant was at risk of death at the time of the event. It does not refer to an event that
hypothetically might have caused death if it were more severe)
Requires inparticipant hospitalization or prolongation of existing hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect
Is a suspected transmission of any infectious agent via a medicinal product
Is Medically Important*
*Medical and scientific judgment should be exercised in deciding whether expedited reporting is
also appropriate in other situations, such as important medical events that may not be immediately
life threatening or result in death or hospitalization but may jeopardize the participant or may
require intervention to prevent one of the other outcomes listed in the definition above. These
should usually be considered serious.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
145
Approved, Date: 11 November 2023
Unlisted (Unexpected) Adverse Event/Reference Safety Information
An adverse event is considered unlisted if the nature or severity is not consistent with the applicable
product reference safety information. For golimumab and for infliximab, the expectedness of an
adverse event will be determined by whether or not it is listed in the IB for golimumab or for
infliximab, respectively.
Adverse Event Associated With the Use of the Intervention
An adverse event is considered associated with the use of the intervention if the attribution is
possible, probable, or very likely by the definitions listed below (see Attribution Definitions).
ATTRIBUTION DEFINITIONS
Not Related
An adverse event that is not related to the use of the intervention.
Doubtful
An adverse event for which an alternative explanation is more likely, eg, concomitant treatment(s),
concomitant disease(s), or the relationship in time suggests that a causal relationship is unlikely.
Possible
An adverse event that might be due to the use of the intervention. An alternative explanation,
eg, concomitant treatment(s), concomitant disease(s), is inconclusive. The relationship in time is
reasonable; therefore, the causal relationship cannot be excluded.
Probable
An adverse event that might be due to the use of the intervention. The relationship in time is
suggestive (eg, confirmed by dechallenge). An alternative explanation is less likely,
eg, concomitant treatment(s), concomitant disease(s).
Very Likely
An adverse event that is listed as a possible adverse reaction and cannot be reasonably explained
by an alternative explanation, eg, concomitant treatment(s), concomitant disease(s). The
relationship in time is very suggestive (eg, it is confirmed by dechallenge and rechallenge).
SEVERITY CRITERIA
An assessment of severity grade will be made using the following general categorical descriptors:
Mild: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not
interfering with everyday activities.
Moderate: Sufficient discomfort is present to cause interference with normal activity.
Severe: Extreme distress, causing significant impairment of functioning or incapacitation.
Prevents normal everyday activities.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
146
Approved, Date: 11 November 2023
The investigator should use clinical judgment in assessing the severity of events not directly
experienced by the participant (eg, laboratory abnormalities).
SPECIAL REPORTING SITUATIONS
Safety events of interest on a sponsor study intervention in an interventional study that may require
expedited reporting or safety evaluation include, but are not limited to:
Overdose of a sponsor study intervention
Suspected abuse/misuse of a sponsor study intervention
Accidental or occupational exposure to a sponsor study intervention
Any failure of expected pharmacologic action (ie, lack of effect) of a sponsor study
intervention
Unexpected therapeutic or clinical benefit from use of a sponsor study intervention
Medication error involving a sponsor product (with or without participant/participant
exposure to the sponsor study intervention, eg, name confusion)
Exposure to a sponsor study intervention from breastfeeding
Special reporting situations should be recorded in the eCRF. Any special reporting situation that
meets the criteria of a serious adverse event should be recorded on the serious adverse event page
of the eCRF.
PROCEDURES
All Adverse Events
All adverse events, regardless of seriousness, severity, or presumed relationship to study
intervention, must be recorded using medical terminology in the source document and the eCRF.
Whenever possible, diagnoses should be given when signs and symptoms are due to a common
etiology (eg, cough, runny nose, sneezing, sore throat, and head congestion should be reported as
"upper respiratory infection"). Investigators must record in the eCRF their opinion concerning the
relationship of the adverse event to study therapy. All measures required for adverse event
management must be recorded in the source document and reported according to sponsor
instructions.
For all studies with an out participant phase, including open-label studies, the participant must be
provided with a "wallet (study) card" and instructed to carry this card with them for the duration
of the study indicating the following:
Study number
Statement, in the local language(s), that the participant is participating in a clinical study
Investigator's name and 24-hour contact telephone number
Local sponsor's or designee’s name and 24-hour contact telephone number (for medical staff
only)

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
147
Approved, Date: 11 November 2023
Site number
Participant number
Any other information that is required to do an emergency breaking of the blind
Serious Adverse Events
All serious adverse events that have not resolved by the end of the study, or that have not resolved
upon discontinuation of the participant's participation in the study, must be followed until any of
the following occurs:
The event resolves
The event stabilizes
The event returns to baseline, if a baseline value/status is available
The event can be attributed to agents other than the study intervention or to factors unrelated
to study conduct
It becomes unlikely that any additional information can be obtained (participant or health care
practitioner refusal to provide additional information, lost to follow-up after demonstration of
due diligence with follow-up efforts)
Suspected transmission of an infectious agent by a medicinal product will be reported as a serious
adverse event. Any event requiring hospitalization (or prolongation of hospitalization) that occurs
during the course of a participant's participation in a study must be reported as a serious adverse
event, except hospitalizations for the following:
Hospitalizations not intended to treat an acute illness or adverse event (eg, social reasons such
as pending placement in long-term care facility)
Surgery or procedure planned before entry into the study (must be documented in the eCRF).
Note: Hospitalizations that were planned before the signing of the ICF, and where the
underlying condition for which the hospitalization was planned has not worsened, will not be
considered serious adverse events. Any adverse event that results in a prolongation of the
originally planned hospitalization is to be reported as a new serious adverse event.
The cause of death of a participant in a study within 16 weeks of the last dose of study intervention,
whether or not the event is expected or associated with the study intervention, is considered a
serious adverse event.
CONTACTING SPONSOR REGARDING SAFETY
The names (and corresponding telephone numbers) of the individuals who should be contacted
regarding safety issues or questions regarding the study are listed in the Contact Information
page(s), which will be provided as a separate document.
PRODUCT QUALITY COMPLAINT HANDLING
A PQC is defined as any suspicion of a product defect related to manufacturing, labeling, or
packaging, ie, any dissatisfaction relative to the identity, quality, durability, or reliability of a

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
148
Approved, Date: 11 November 2023
product, including its labeling or package integrity. A PQC may have an impact on the safety and
efficacy of the product. Timely, accurate, and complete reporting and analysis of PQC information
from studies are crucial for the protection of participants, investigators, and the sponsor, and are
mandated by regulatory agencies worldwide. The sponsor has established procedures in
conformity with regulatory requirements worldwide to ensure appropriate reporting of PQC
information; all studies conducted by the sponsor or its affiliates will be conducted in accordance
with those procedures.
All PFP-V associated with device-related PQCs will be investigated including the return of the
device to the sponsor for inspection. PFS-U should be retained for further investigation if requested
by the sponsor.
Procedures
All initial PQCs must be reported to the sponsor or designee by the study site personnel within
24 hours after being made aware of the event.
If the defect is combined with a serious adverse event, the study site personnel must report the
PQC to the sponsor designee according to the serious adverse event reporting timelines (refer to
Section 8.3.1, Time Period and Frequency for Collecting Adverse Event and Serious Adverse
Event Information). A sample of the suspected product should be maintained for further
investigation if requested by the sponsor.
Contacting Sponsor Regarding Product Quality
The names (and corresponding telephone numbers) of the individuals who should be contacted
regarding product quality issues are listed in the Contact Information page(s), which will be
provided as a separate document.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
149
Approved, Date: 11 November 2023
10.17. Appendix 17: Anticipated Events
Anticipated Event
An anticipated event is an adverse event (serious or non-serious) that commonly occurs as a
consequence of the underlying disease or condition under investigation (disease-related) or
background regimen.
For the purposes of this study, the following events will be considered anticipated events:
adverse events related to symptoms of UC
adverse events related to worsening or progression of UC
Reporting of Anticipated Events
All adverse events will be recorded in the eCRF regardless of whether considered to be anticipated
events and will be reported to the sponsor or designee as described under All Adverse Events in
Section 8.3.1 (Time Period and Frequency for Collecting Adverse Event and Serious Adverse
Event Information). Any anticipated event that meets serious adverse event criteria will be reported
to the sponsor or designee as described under Serious Adverse Events in Section 8.3.1 (Time
Period and Frequency for Collecting Adverse Event and Serious Adverse Event Information).
These anticipated events are exempt from expedited reporting as individual single cases to health
authorities, except where local regulations require expedited reporting of all SUSARs. However,
if based on an aggregate review, it is determined that an anticipated event is possibly related to
study intervention, the sponsor will report these events in an expedited manner.
Anticipated Event Review Committee (ARC)
An Anticipated Event Review Committee (ARC) will be established to perform reviews of
prespecified anticipated events at an aggregate level. The ARC is a safety committee within the
sponsor’s organization that is independent of the sponsor’s study team. The ARC will meet to aid
in the recommendation to the sponsor’s study team as to whether there is a reasonable possibility
that an anticipated event is related to the study intervention.
Statistical Analysis
Details of statistical analysis of anticipated events, including the frequency of review and threshold
to trigger an aggregate analysis of anticipated events will be provided in a separate Anticipated
Events Safety Monitoring Plan (ASMP).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
150
Approved, Date: 11 November 2023
10.18. Appendix 18: Usability Assessment Substudy
Objectives
The objective of the Substudy is to provide supportive data that the PFS-U or PFP-V as designed,
together with the appropriate training and written Instructions for Use, are suitable for at home
administration (AHA) by pediatric participants or their caregivers.
Overview of Study Design
The Usability Assessment Substudy will be conducted at Sponsor identified sites. Participants
entering the study extension who elect to administer the study intervention at home will have the
option to be enrolled in an Usability Assessment Substudy (Section 4.1). An attempt will be made
to enroll approximately 10-20 participants in the Usability Assessment Substudy at Week 58.
Similar for all AHA participants, pediatric participants or their caregivers in CNTO148UCO3003
will be trained in safe AHA the first week, and their self- or caregiver administration observed
over 2 subsequent q4w visits. Participants or their caregivers will receive face-to-face training by
study site staff on the use of the PFS-U or the PFP-V at the first training visit (at the Week 58
study visit for Usability Assessment Substudy participants). Participants will perform a training
administration using the PFS-U or the PFP-V at the clinic under the observation/supervision of
site staff. Site staff will complete an Observer Checklist at the Week 58 visit. The health care
professional will determine whether a pediatric participant or their caregiver can perform the
injections. During the 2 subsequent q4w clinic visits, administrations will be performed in a home-
like setting in the clinic by pediatric participants or caregivers and should be performed by the
same person (ie, pediatric participant or caregiver) and not switched unless participants opt to
return to the HCP administration.
Participants or caregivers performing the injection who are enrolled in the Usability Assessment
Substudywill be asked to complete an Injection Device Assessment Questionnaire (Section 10.11)
regarding their experience using the PFS-U or the PFP-V at Weeks 62 and 66 after completion of
the second and third self- or caregiver administration visits. If the injections have been performed
by the caregiver, the questionnaire will be completed by the caregiver. If the self-injections have
been performed by the pediatric participant, the participant will complete the questionnaire with
parent or caregiver assistance, if needed. Evaluation of the user experience after the second
independent self- or caregiver administration is considered adequate to evaluate how well
participants can understand and recall the dosage instructions, and to assess for any common
difficulties with injections.
Participant Population
This Substudy  population will include pediatric participants who are enrolled in the study
extension. The inclusion and exclusion criteria of the Substudy are described below.
All participants who satisfy the inclusion and exclusion criteria described in Section 5.1 and
Section 5.2 of the main protocol, respectively, as well as satisfying the following criteria:

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
151
Approved, Date: 11 November 2023
Inclusion Criteria
1. Participants must be eligible for AHA.
2. Participants and parents or caregivers of the participant must successfully demonstrate the
ability to complete a study intervention administration.
3. Must sign a separate informed consent/assent for this Substudy.
4. Agree to complete an AHA diary and return it at the next clinic visit.
5. Contact the site for any safety concerns immediately.
Exclusion Criteria
1. Unable to demonstrate the ability to complete a study intervention administration by self
or parent/caregiver. For self-administration, participants must be ≥12 years of age.
Participants <12 years of age must have study intervention administrations by the parents
or caregiver.
Criteria for Withdrawal from this Substudy
Criteria for withdrawal of participants during the Substudy will be identical to that described in
Section 7 of the main protocol.
Safety Evaluations
Participants will be observed for at least 30 minutes after the administration of study intervention
for symptoms of an injection-site reaction at the investigative site. Participants administering study
intervention at home will receive detailed instructions on how to monitor and report potential
injection-site reactions. Any adverse reaction (eg, swelling, redness/erythema, pain, tenderness,
warmth, bruising, or bleeding) should be noted on the AHA diary and in the AE page of the eCRF.
Similarly, as for all AHA participants, in addition to recording the details of the study intervention,
dosing day, time, anatomic site and if there were any complications of the injection, participants
and/or caregivers should be instructed to monitor the injection-site for any reactions, including,
but not limited to swelling, redness/erythema, pain, tenderness, warmth, bruising, or bleeding. All
dosing and adverse event (including injection-site reaction) information, as well as concomitant
medications and TB exposure will be documented in an AHA diary, that is to be returned to the
site at the upcoming visit and entered by site staff into the eCRF. For any severe injection-site
reactions, or changes at the injection-site, or any mild to moderate to severe golimumab reaction
which occur hours to days following injection, the participant/caregiver should contact the study
site for consultation. Acetaminophen, NSAIDs, and/or diphenhydramine or locally available
alternative may be administered at their direction. In case of a severe allergic reaction (eg,
anaphylaxis, difficulty breathing, light-headedness, hives, or widely spread body rash),
participants or their caregivers should call for emergency medical assistance (paramedic or
ambulance) first before contacting the study site.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
152
Approved, Date: 11 November 2023
All device complaints and device-related AEs will be captured and investigated including the
return of the device for inspection.
Schedule
Participants in this study will follow the schedule of events as outlined in Table 3 for collection of
actual use data for the PFS-U and PFP-V (Injection Device Assessment Questionnaire).
Statistical Methods
Data from the questionnaire will be descriptively summarized for PFS-U. Further details will be
provided in the SAP.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
153
Approved, Date: 11 November 2023
10.19. Appendix 19: Guidance on Study Conduct during the COVID-19 Pandemic
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on
the conduct of this clinical study due to, for example, self-isolation/quarantine by participants and
study  site personnel; travel restrictions/limited access to public places, including hospitals;
study-site personnel being reassigned to critical tasks.
In alignment with recent health authority guidance, the sponsor is providing options for
study -related participant management in the event of disruption to the conduct of the study. This
guidance does not supersede any local or government guidelines or requirements or the clinical
judgment ofthe investigator to protect the health and well-being of participants and site staff. If,
at any time, a participant’s safety is considered to be at unacceptable risk, study intervention will
be discontinued, and study follow-up will be conducted.
Scheduled visits that cannot be conducted in-person at the study site will be performed to the extent
possible remotely/virtually or delayed until such time that on-site visits can be resumed. At each
contact, participants will be interviewed to collect safety data. Key efficacy endpoint assessments
should be performed if required and as feasible. Participants will also be questioned regarding
general health status to fulfill any physical examination requirement.
Every effort should be made to adhere to protocol-specified assessments for participants on study
intervention, including follow-up. Modifications to protocol-required assessments may be
permitted via COVID-19 Appendix after consultation between the participant and investigator,
and with the agreement of the sponsor (see below).
The sponsor will continue to monitor the conduct and progress of the clinical study, and any
changes will be communicated to the sites and to the health authorities according to local guidance.
If a participant has tested positive for COVID 19, the investigator should contact the sponsor’s
responsible medical officer to discuss plans for study intervention and follow-up. Modifications
made to the study conduct as a result of the COVID-19 pandemic should be summarized in the
clinical study report.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
154
Approved, Date: 11 November 2023
ADDITIONAL ELEMENTS, WHERE APPLICABLE:
Certain protocol-mandated visits to the study site may not be possible during the COVID-19
outbreak. Therefore, temporary measures may be implemented if considered appropriate by
the sponsor and investigator to maintain continuity of participant care and study integrity.
Certain measures, such as those listed below, may be necessary and should be instituted in
accordance with applicable (including local) laws, regulations, guidelines, and procedures:
o remote (eg, by phone / telemedicine) or in-person, off-site (eg, in-home) interactions
between site staff (or designees) and participants for study procedures eg, those related
to safety monitoring / efficacy evaluation / study intervention storage and
administration (including training where pertinent)
o procurement of study intervention by participants (or designee) or shipment of study
intervention from the study site directly to participants for AHA (including the potential
for self-administration of study intervention)
o laboratory assessments using a suitably accredited local laboratory; for selected
measures (eg, urine pregnancy), home testing may be employed
o other procedures, eg, imaging, may be conducted at an appropriate facility
Missed assessments/visits will be captured in the clinical trial management system for
protocol deviations.  Discontinuations of study interventions and withdrawal from the
study should be documented with the prefix “COVID-19-related” in the case report form
(CRF).
o other relevant study data elements impacted by the pandemic should also be
documented / labeled as “COVID-19-related” in CRFs and / or other study systems,
as directed by detailed sponsor guidance. These may include missed / delayed /
modified study visits / assessments / dosing, and instances where temporary
measures such as those above are implemented.
The Sponsor will evaluate the totality of impact of COVID-19 on collection of key study
data and additional data analyses will be outlined in study SAP(s).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
155
Approved, Date: 11 November 2023
10.20. Appendix 20: Protocol Amendment History
The Protocol Amendment Summary of Changes Table for the current amendment is located
directly before the Table of Contents (TOC).
DOCUMENT HISTORY
Document 
Date
Amendment 5 
14 October 2022
Amendment 4 
16 March 2021
Amendment 3 
8 July 2019
Amendment 2 
13 May 2019
Amendment 1 
27 June 2018
Original Protocol 
17 May 2018
Amendment 5 (14 October 2022)
Overall Rationale for the Amendment: Upon implementation of Amendment 5, no new participants will
be enrolled. The sample size is being reduced from n=90 to n=60 golimumab-treated participants as
60 participants will provide sufficient safety, efficacy, and PK data.
The changes made to the clinical protocol CNTO148UCO3003 as part of Protocol Amendment 5 are listed
below, including the rationale of each change and a list of all applicable sections. Changes made in previous
protocol amendments are listed in Section 10.20 Appendix 20: Protocol Amendment History.
Section Number 
and Name
Description of Change 
Brief Rationale
1.1 Synopsis NUMBER OF
PARTICIPANTS;
4.1 Overall Design
Upon 
implementation 
of
Amendment 5, no new participants
will be enrolled. Approximately 10070
participants will participate in this
study (at least 90 60 participants will
receive 
golimumab, 
at 
least
10 participants will receive infliximab).
Of the 90 60 golimumab participants, at
least 24 15 will have a body weight <45
kg and at least 5 will have a body
weight <30 kg.
The sample size of n=60 for
golimumab-treated participants for
clinical efficacy and PK data will
be sufficient to obtain interpretable
results based on the totality of
evidence to establish the efficacy,
dosing, and safety of golimumab
for the treatment of pediatric UC.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
156
Approved, Date: 11 November 2023
Section Number
and Name
Description of Change 
Brief Rationale
1.1 Synopsis STATISTICAL
METHODS, Sample Size
Calculation;
9.3 Sample Size Determination
Sample size calculations were based on
the need to have a sufficient number of
participants assigned to the golimumab
treatment arm to achieve the criteria
defined in Section 9.2. In addition,
collecting sufficient PK data to
adequately characterize the PK of
golimumab in participants with UC
is also considered.
A sample size of 90 60 participants in
the golimumab arm will ensure that the
lower bound of the 90% CI for the
pediatric golimumab remission rate is
above 10.0% (ie, the upper bound of the
95% CI for the historical placebo
control) as long as the observed
remission rate is at least 16.518.3%.
The probability 
of observing 
a
remission rate of ≥16.518.3%, given
different assumptions for the true rate
of clinical remission is shown in
Table II below.
With 
90 
60 
golimumab-treated
participants, 
the 
probability 
of
observing 
a 
remission 
rate 
of
≥16.518.3% ranges from 6550% (ifthe
golimumab adult UC remission rate of
17.8% is assumed) to greater than 99%
(if the remission rate of 42.9% from the
first golimumab study in pediatric UC
is assumed). It is reasonable to assume
that the true remission rate in pediatric
UC participants is greater than the
remission rate observed in the adult UC
study, as the remission rate in the first
golimumab pediatric UC study was at
least twice that observed in the adult
UC study. Therefore, if we assume only
a slight increase from  the adult UC
remission rate to a rate ofbe 20 22.5%,
then the probability of observing a
remission rate of ≥16.518.3% is at least
80% (Table II).
Table II: 
Probability of
Observing a Clinical
Remission Rate of
≥16.518.3% With
Differing
Assumptions for the
True Remission
Rate
The reduction in sample size is
justified based on the calculations
for the probability of observing a
clinical remission rate for the
success of the primary endpoint.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
157
Approved, Date: 11 November 2023
Section Number 
and Name
Description of Change 
Brief Rationale
Clinical Remission 
as Assessed by the 
Mayo Score 
Probability
of
Observing
≥16.5
18.3%
N=60
15.0%  
37%
17.8% (observed 
adult remission rate;
C0524T17)
5065%
20.0%  
6882%
22.5% 
8293%
25.0% 
9198%
42.9% (observed 
pediatric remission
rate;
CNTO148UCO1001)
>99.9%
The precision (ie, half width of the CI)
based on this sample size of90 60
golimumab participants is 6.78.1%
(assuming a clinical remission rate of
17.8% at Week 6) and 8.610.5%
(assuming a clinical remission rate at
Week 6 of 42.9%).
Furthermore, the Fisher Information
Matrix-based optimal design analysis
indicates that PK data from a total of
60 
participants 
(including 
45
participants in the ≥45 kg subgroup
and 15 participants in the <45 kg
subgroup) would be sufficient to
adequately characterize the PK of
golimumab in pediatric participants
with UC.
1.2 Schema 
Figure 1 was updated to indicate that at 
least n=60 participants will be treated 
with golimumab 
Figure updated to reflect change in
sample size of golimumab-treated
participants from n=90 to n=60.
1.1 Synopsis OVERALL 
DESIGN; 
4.1 Overall Design; 
10.18 Appendix 18: Usability 
Assessment Substudy
An attempt will be made to enroll 
aApproximately 1510-20 participants 
will be enrolledin the Usability 
Assessment Substudy at Week 58.
The reduction in sample size
reflects the reduced sample size in
the overall study.
1.3 Schedule of Activities, 
Table 3, footnote a 
Approximately 1510-20 participants 
entering the study extension who elect 
to administer the study intervention at 
home will have the option to be
enrolled in an Usability Assessment
Substudy at Week 58.
The reduction in sample size
reflects the reduced sample size in
the overall study.
10.9 Appendix 9: PFS-U and 
PFP-V Actual Use Data 
Collection  
Approximately the first 1510-20 
participants from Sponsor identified 
sites who choose AHA will enter the 
Usability Assessment Substudy at
The reduction in sample size in
this substudy reflects the reduced
sample size in the overall study.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
158
Approved, Date: 11 November 2023
Section Number 
and Name
Description of Change 
Brief Rationale
Week 58 and complete an injection
device Usability Questionnaire at
Weeks 62 and 66 after completion of
the second and third self- or caregiver
administration visits.
1.3 Schedule of Activities, 
Table 2 
Efficacy assessments (IMPACT III, 
CRP, fecal calprotectin) have been 
removed from the Study Schedule of 
Activities in the study extension. Only 
PUCAI score will be assessed during
the study extension.
Efficacy assessments were
removed because efficacy data can
be extrapolated from adults and to
reduce participant burden.
9.4.1.4. Analyses of Study 
Extension  
The proportion of participants in 
clinical remission based on the PUCAI 
score will be summarized over time. 
The change from study extension 
baseline in the PUCAI score, fecal
calprotectin, CRP, and IMPACT III
will be summarized over time.
Treatment failure and missing data
rules will be detailed in the SAP.
Efficacy assessments were
removed because efficacy data can
be extrapolated from adults and to
reduce participant burden.
1.3 Schedule of Activities, Table 
2, footnote a 
a. All pParticipants who discontinue 
the study and are not continuing 
golimumab treatment after exiting 
the study must return for final safety 
visit (ie, 16 weeks after last 
administration) for this study.
Participants who are planning to
continue golimumab treatment after
exiting the study should have all
final safety visit assessments done
during the last study visit while on
study golimumab.
Clarification provided that only
participants who are discontinuing
study and not transitioning to
commercially available golimumab
must return for a final safety visit.
6.7 Intervention After the End of 
the Study  
Participants who discontinue the 
study and are not transitioning to 
commercially available golimumab
must complete a final safety check
visit at the study site about 8 weeks
(infliximab) or 16 weeks (golimumab)
after the last dose of study
intervention, unless the participant has
died, is lost to follow-up, is
continuing golimumab after exiting
the study, or has withdrawn consent.
Participants who are planning to
continue golimumab treatment after
exiting the study should have all
final safety visit assessments done
during the last study visit while on
study golimumab. If the participant
has died, the date and cause of death
will be collected and documented on
the eCRF.
Clarification provided on timing of
final safety visit.
1.3 Schedule of Activities, 
Table 2, footnote o 
o. Required only if participant is ≥10 
years of age at Week 0. Samples 
should be collected every 6 months
Sample collection changed to
annual frequency in Year 2 of the

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
159
Approved, Date: 11 November 2023
Section Number 
and Name
Description of Change 
Brief Rationale
during Year 1 of the study extension 
and, starting at Week 108, annually 
thereafter.
study extension to reduce
participant burden.
1.1 Synopsis Endpoints; 
3.1 ENDPOINTS; 
9.4.1.2. Major Secondary 
Endpoints 
8. Clinical remission at Week 54, as 
assessed by the Mayo score, for 
participants who are in clinical 
remission at Week 6 (based on Mayo 
endoscopy subscore assigned by the
local endoscopist).
9. Participants who were not
receiving corticosteroids for at least
12 Weeks prior to Week 54 and in
clinical remission at Week 54, as
assessed by the Mayo score (based
on Mayo endoscopy subscore
assigned by the local endoscopist).
These endpoints were moved from
Other Endpoints to Major
Secondary Endpoints based on
Health Authority Feedback.
9.4.1.3. Other Endpoints 
4. Clinical remission at Week 54, as 
assessed by the Mayo score, for 
participants who are in clinical 
remission at Week 6 (based on Mayo 
endoscopy subscore assigned by the
local endoscopist).
13. Participants who were not
receiving corticosteroids for at least 12
weeks prior to Week 54 and in clinical
remission at Week 54, as assessed by
the Mayo score (based on Mayo
endoscopy subscore assigned by the
local endoscopist).
These endpoints were moved from
Other Endpoints to Major
Secondary Endpoints based on
Health Authority Feedback.
Throughout the protocol 
Minor grammatical, formatting, or 
spelling changes were made.
Minor errors were noted
Amendment 4 (16 March 2021)
Overall Rationale for the Amendment: Upon implementation of Amendment 4, no additional participants
will be randomized to infliximab; all newly enrolled participants will receive golimumab. Participants
already randomized to the infliximab arm prior to Amendment 4 implementation will continue treatment
and remain in the study, but no newly enrolled participants will be randomized to infliximab.
The reasons for terminating enrollment into the infliximab arm are the following: interpretable golimumab
study data will be available without the infliximab arm, limited ability to interpret the infliximab data, and
updated study feasibility assessments.
Corrections reflecting this change, together with other edits to improve structure and readability of the
document, have been made.
Section number 
and Name
Description of Change 
Brief Rationale
Synopsis Overall 
Design, Number of 
Participants, 
Statistical Methods; 
OVERALL DESIGN  
This is a multicenter, randomized, open-label 
golimumab study in pediatric participants aged 
2 to 17 years with moderately to severely active 
UC, defined as a baseline Mayo score of 6 through 
12, inclusive, with an endoscopy subscore of ≥2.
Enrollment into the infliximab arm
will be terminated due to robust
totality of the golimumab data,
limited utility of infliximab data,
and updated study feasibility
assessments.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
160
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
Prior to Amendment 4, central randomization
was implemented in this study. Participants
≥30 kg were randomized in a 3:1 ratio across
intervention groups, golimumab and infliximab,
respectively. Upon implementation of
Amendment 4, no additional participants will be
randomized to infliximab; all newly enrolled
participants will receive golimumab.
In this study, the remission rate of golimumab in
pediatric participants will be formally compared
with a historical placebo remission rate derived
from a meta-analysis of 2 adult Phase 2/3 studies
of golimumab for UC and 5 adult Phase 3 studies
of other products approved in this indication
utilizing similar populations and endpoints.
This study will also include an reference
infliximab arm. for the purpose of determining
assay sensitivity only if the success criteria are not
met (versus historical placebo). No formal
comparisons between golimumab and infliximab
will be performed.
NUMBER OF PARTICIPANTS
Prior to Amendment 4, Aapproximately
125 participants who satisfy inclusion/exclusion
criteria were to will be included in the study at
sites located globally, including in North and South
America, Asia, and Europe. At least 24 golimumab
participants with body weight <45 kg, and at least
5 golimumab participants with body weight <30 kg
will be included.
In order to ensure at least 5 participants with body
weight <30 kg receive golimumab, participants
who weigh <30 kg will were to only be allocated
to the golimumab treatment arm. The remaining
120 participants were to will be randomized in a
3:1 ratio to golimumab or infliximab, respectively.
Upon implementation of Amendment 4, no
additional participants will be randomized to
infliximab; all newly enrolled participants will
receive golimumab.
Approximately 100 participants will participate
in this study (at least 90 participants will receive
golimumab, at least 10 participants will receive
infliximab). Of the 90 golimumab participants,
at least 24 will have a body weight <45 kg and at
least 5 will have a body weight <30 kg.
STATISTICAL METHODS
To ensure that 90 participants are treated with
golimumab, at least 90 participants who are at least

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
161
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
1.2. Schema;
2. Introduction;
30 kg will be randomized into the golimumab arm,
and at least 5 additional participants who are less
than 30 kg will also be enrolled.
A sample size of 30 participants for infliximab was
determined sufficient to serve as a reference arm to
assess assay sensitivity. With 30 infliximab treated
participants, the probability of observing a clinical
remission rate at Week 6 (based on the PUCAI
score) of ≥25%, given the assumed rate of 32.0%
(from Remicade pediatric study [C0168T72]), is
approximately 80%. Table III below provides the
probability of observing a certain remission rate or
higher based on the assumed true remission rate of
32.0%.
Table III deleted
Study schema for CNTO148UCO3003 updated:
Figure 1: Study Schema for CNTO148UCO3003
(Modified in Amendment 4)
1) Sample sizes changed
Golimumab (n = at least 90)
Infliximab (n= 30 at least 10)
2) “X**” added to arrow pointing to infliximab
3) Footnote added: **Upon implementation of
Amendment 4, no new participants will be
randomized to the infliximab arm.
4) Reference arm: Comparison to infliximab
pediatric data (assay sensitivity); nNo formal
comparison to golimumab
This Phase 3 study (CNTO148UCO3003) will be a
multicenter, randomized, open-label golimumab
study in pediatric participants aged 2 to 17 years
with moderately to severely active UC. This study
will assess the efficacy, safety, and
pharmacokinetics (PK) of SC golimumab in
pediatric participants. The remission rate of
golimumab in these pediatric participants will be
formally compared with a historical placebo
remission rate derived from a meta-analysis of
2 adult Phase 2/3 studies of golimumab for UC and
5 adult Phase 3 studies of other products approved
for this indication utilizing similar populations and
endpoints. Additionally, the study will include an
infliximab reference arm. Upon implementation
of Amendment 4, no additional participants will
be randomized to the infliximab arm; all newly
enrolled participants will receive golimumab.
for the purpose of demonstrating assay sensitivity

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
162
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
2.1. Study
Rationale;
4.1. Overall Design;
(ifneeded; see Section 9.4.1.4) and will also
include a study extension for eligible golimumab
treated participants.
CNTO148UCO3003 (this study): A multicenter,
randomized, open-label study to assess the
efficacy, safety, and PK of golimumab treatment in
pediatric participants from 2 to 17 years of age
with moderately to severely active UC. In this
study, the remission rate on golimumab in these
pediatric participants will be formally compared
with a historical placebo remission rate derived
from a meta-analysis of 2 adult Phase 2/3 studies
of golimumab for UC and 5 adult Phase 3 studies
of other products approved in this indication
utilizing similar populations and endpoints.
Additionally, open label infliximab will serve as a
reference arm to demonstrate assay sensitivity if
the formal comparison for the primary endpoint of
this study is not successful; no formal comparisons
between golimumab and infliximab will be
performed. A study extension is included for
eligible golimumab-treated participants. In this
study extension, participants ≥45 kg will be
eligible for at home administration (AHA).
Participants entering the study extension who elect
to administer the study intervention at home will
have the option to be enrolled in a Usability
Assessment Substudy (Appendix 18
[Section 10.18]).
This study will also includes an reference
infliximab arm. Upon implementation of
Amendment 4, no additional participants will be
randomized to the infliximab arm; all newly
enrolled participants will receive golimumab.
for the purpose of determining assay sensitivity if
the formal comparison for the primary endpoint  of
this study is not successful (for additional details,
see Section 4.2.2 and Section 9.4.1.4). No formal
comparisons between golimumab and infliximab
will be performed.
Prior to Amendment 4, Aapproximately
125 participants who satisfy inclusion/exclusion
criteria will were to be included in the study at
sites located globally, including in North and South
America, Asia, and Europe. At least 24 golimumab
participants with body weight <45 kg, and at least
5 golimumab participants with body weight <30 kg
will be included.
In order to ensure that at least 5 participants <30 kg
will receive golimumab, participants who weigh
<30 kg will were to only be allocated to the
golimumab treatment arm. The remaining

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
163
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
4.2.2. Infliximab;
120 participants will were to be randomized in a
3:1 ratio to golimumab or infliximab, respectively.
Upon implementation of Amendment 4, no
additional participants will be randomized to
infliximab; all newly enrolled participants will
receive golimumab.
Approximately 100 participants will participate
in this study (at least 90 participants will receive
golimumab, at least 10 participants will receive
infliximab). Of the 90 golimumab participants,
at least 24 will have a body weight <45 kg and at
least 5 will have a body weight <30 kg.
Short-term Phase (Weeks 0 to 6)
Prior to Protocol Amendment 4, the
randomization scheme below was followed.
At Week 0, participants ≥30 kg wereill be
randomized 3:1 to either Group 1 or Group 2. All
participants <30 kg wereill be placed in Group 1.
Group 1 - golimumab SC at Weeks 0 and 2
Participants with body weight ≥45 kg will
receive fixed induction doses of 200 mg at
Week 0 and 100 mg at Week 2.
Participants with body weight <45 kg will
receive body-surface area (BSA)-adjusted
induction doses of 120 mg/m2 (up to a
maximum of 200 mg) at Week 0 and 60 mg/m2
(up to a maximum of 100 mg) at Week 2.
Group 2 - Infliximab 5 mg/kg IV at Weeks 0 and 2
(participants ≥30 kg only)
Upon implementation of Amendment 4, no
additional participants will be randomized to
infliximab; all newly enrolled participants will
receive golimumab.
In response to a request from health authorities, an
infliximab reference arm wasis included in this
proposed study to assess assay sensitivity
(primarily relying on PUCAI and partial Mayo
scores) in comparison to historical data from the
infliximab C0168T72 pediatric UC study. Upon
implementation of Amendment 4, no additional
participants will be randomized to infliximab;
all newly enrolled participants will receive
golimumab, and assay sensitivity will not be
assessed. This amendment to the infliximab arm
was discussed with health authorities and it was
accepted that enrollment into the infliximab
arm could be stopped. The determination of assay

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
164
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
4.3.1.
Randomization;
6.3. Measures to
Minimize Bias:
Randomization and
Blinding;
sensitivity will only be explored if the primary
analysis of this study is not successful. Assay
sensitivity refers to the ability of a clinical study to
detect the efficacy of a study intervention. In this
Phase 3 study, assay sensitivity will be
demonstrated by showing that the efficacy for the
infliximab arm is similar to the efficacy shown in a
past study of infliximab in the same participant
population (C0168T72), thereby demonstrating
that the current study has the ability to detect
efficacy. Details on how assay sensitivity will be
determined are presented in Section 9.4.1.4 and
will be included in the Statistical Analysis Plan
(SAP). Side by side summaries of the infliximab
data from this study and the infliximab data from
the prior pediatric UC infliximab study
(C0168T72) will be provided regardless of the
outcome of the primary analysis for this study. No
formal comparisons of infliximab to golimumab
will be performed.
Prior to Amendment 4, cCentral randomization
was ill to be implemented in this study.
Participants ≥30 kg were ill be randomized in a 3:1
ratio across intervention groups, golimumab and
infliximab, respectively. Randomization was to ill
be used to minimize bias in the assignment of
participants to intervention groups and to increase
the likelihood that known and unknown participant
attributes (eg, demographic and baseline
characteristics) are evenly balanced across
intervention groups.
Participants <30 kg were not to ill not be
randomized and offered only golimumab. This was
implementedis to ensure that the Sponsor
enrolleds at least 5 participants who weigh <30 kg
and will received golimumab as this is a rare
subpopulation.
Upon implementation of Amendment 4, no
additional participants will be randomized to
infliximab; all newly enrolled participants will
receive golimumab.
Procedures for Randomization and Stratification
Prior to implementation of Amendment 4,
pParticipants weighing ≥30 kg were toill be
randomly assigned to 1 of 2 intervention groups
based on a computer-generated randomization
schedule prepared before the study by or under the
supervision of the sponsor. Participants were toill
be randomized in a 3:1 ratio to golimumab or
infliximab. Based on this randomization

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
165
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
9.3. Sample Size
Determination;
9.4.1. Efficacy
Analyses;
code, study intervention wasill be assigned and
administered to each participant.
Permuted block randomization wasill be used. The
interactive web response system (IWRS) will
assigned a unique treatment code, which will
dictated the treatment assignment and matching
study intervention kit for the participant. The
requestor must used his or her own user
identification and personal identification number
when contacting the IWRS and gave will then give
the relevant participant details to uniquely identify
the participant.
Participants <30 kg were not to ill not be
randomized and offered only golimumab. This is to
ensured that at least 5 participants who weighed
<30 kg will received golimumab treatment.
Upon implementation of Amendment 4, no
additional participants will be randomized to
infliximab; all newly enrolled participants will
receive golimumab.
To ensure that 90 participants are treated with
golimumab, at least 90 participants who are at least
30 kg will be randomized into the golimumab arm,
and at least 5 additional participants who are less
than 30 kg will also be enrolled.
Upon implementation of Amendment 4, no
additional participants will be randomized to
infliximab; all newly enrolled participants will
receive golimumab. A sample size of 30
participants for infliximab was determined
sufficient to serve as a reference arm in
demonstrating assay sensitivity. With 30
infliximab treated participants, the probability of
observing a clinical remission rate at Week 6 based
on the PUCAI score of ≥25%, given the assumed
rate of 32.0% (from Remicade pediatric UC study
[C0168T72]), is approximately 80%. Table 7
provides the probability of observing a certain
remission rate or higher based on the assumed true
remission rate of 32.0%.
Deleted Table 7.
A formal comparison is planned for the primary
endpoint. Summary statistics will be provided for
all efficacy endpoints for golimumab and
infliximab. Unless otherwise specified, all
endpoints that involve the Mayo endoscopy
subscore will be based on the subscore assigned by
the local endoscopists.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
166
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
9.4.1.4. Analyses to
Assess for Assay
Sensitivity
In addition, as a response to a request from health
authorities, an infliximab reference arm is included
in this study to assess assay sensitivity. The
determination ofassay sensitivity will only be
explored if the primary analysis of this study is not
successful. No comparisons of infliximab to
golimumab will be performed. Side by side
summaries of the infliximab data from this study
and the infliximab data from the prior pediatric UC
infliximab study (C0168T72) will be provided
regardless of the outcome of the primary analysis
for this study.
Upon implementation of Amendment 4,
participants will not be randomized to the
infliximab arm. However, summary statistics
will still be provided for the infliximab group.
Section 9.4.1.4 was deleted, and cascading sections
were renumbered.
The determination of assay sensitivity will only be
explored if the primary analysis of this study is not
successful.
To demonstrate assay sensitivity in this trial,
efficacy measures based on the PUCAI score and
partial Mayo score will be examined for all
participants who received infliximab during the
short term phase, for side by side evaluation with
the prior pediatric UC infliximab study
(C0168T72). No formal testing will be performed.
Summaries for the following endpoints will be
provided:
Clinical remission at Week 6 as assessed by the
PUCAI score
Change from baseline in the PUCAI and the Partial
Mayo score at Week 6
Details will be provided in the SAP.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
167
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
Synopsis 
Intervention Groups 
and Duration; 
1.3. Schedule of 
Activities (SoA),
Table 1, footnotes 
cc and dd; 
4.1. Overall Design;
4.2.2. Infliximab; 
Infliximab 
After the Week 8 visit and before the 
Week 54 visit, participants in the infliximab 
arm will only require study visits on treatment
days. All other nontreatment visits during this
time period will be optional.  All participants
must have the Week 54 or Early Termination
visit.
Finally, while dose escalation should be based on
clinical criteria as described above, investigators at
their discretion may utilize infliximab serum levels
to assist their decision making. This approach was
chosen as it most closely mimics clinical practice
in treatment of pediatric UC, allowing investigators
some flexibility in dosing to treat their patients.
Also, if an investigator wants to dose-escalate
using a different regimen than listed above,
discuss the plan with the medical monitor. After
the Week 54 evaluations, participants receiving
infliximab will be transitioned off the study to
standard medical care.
Added footnote “cc” to “Administer IV
infliximab” and Weeks 10, 18, 26, 34, 36, 42, 50
cc. For infliximab patients only: Visits at
Week 10, 18, 26, 34, 36, 42, 50 and associated
study procedures are optional, and only
required if investigator implements flexible
dosing and is administering infliximab at these
time points.
Added footnote “dd” to “Hematology, Chemistry”
and “ANA and anti-dsDNA antibodies,” Week 26
dd. Infliximab participants who do not have a
dosing visit at Week 26 should have hematology,
chemistry, ANA, and anti-dsDNA antibodies
performed at Week 22 visit.
After the Week 8 visit and before the Week 54
visit, participants in the infliximab arm will
only require study visits on treatment days.  All
other nontreatment visits during this time
period will be optional. All participants must
have the Week 54 or Early Termination visit.
Participants who experience a flare in their UC
disease (defined in Section 6.5.3) after Week 6
may initiate this step-wise dose escalation at any
time to the maximum of 10 mg/kg (capped at 1
gm) q4w. Participants who dose-escalate in
response to a UC flare will be reassessed after 2
administrations at the final new higher dose.
Clarified study procedure to
indicate that participants in the
infliximab arm only require study
visits on treatment days.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
168
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
6.1. Study
Interventions
Administered
Participants in partial Mayo response (ie, a
decrease from flare baseline of ≥2 in the partial
Mayo score) will continue receiving open-label
infliximab through Week 46 at the escalated
dosage. Participants who have not achieved a
partial Mayo response will be discontinued from
study intervention administration and should return
for a final safety visit at least 8 weeks after their
last infliximab administration. After the Week 8
visit and before the Week 54 visit, participants
in the infliximab arm will only require study
visits on treatment days.  All other
nontreatment visits during this time period will
be optional.  All participants must have
Week 54 or Early Termination visit.
Importantly, while escalation should be based on
clinical criteria as described above, investigators,
may utilize infliximab serum levels to assist their
decision making in this flexible dosing approach.
Additionally, a step-wise flexible dose escalation
approach (to a maximum dose of 10 mg/kg
[capped at 1 gm] at an interval of q4w) will be
permitted in the infliximab arm, at the
investigator’s discretion, for those participants not
in clinical response at Week 6 (defined by the
Mayo score), or participants who were in response
at Week 6 but have a worsening of their UC signs
and symptoms during the study period. This
approach was chosen as it most closely mimics
clinical practice in treatment of pediatric UC,
allowing investigators some flexibility in dosing to
treat their patients. Also, if an investigator wants
to dose-escalate using a different regimen than
listed above, discuss the plan with the medical
monitor.
After the Week 54 efficacy and safety evaluations,
participants receiving infliximab will be
transitioned to standard medical care. At the
investigator’s discretion a separate blood sample
may be obtained and submitted to the central
laboratory to evaluate infliximab dose levels and
anti-infliximab antibodies (at a maximum of
2 timepoints at Week 6 or later) to inform dose
escalations.
Infliximab will be supplied in a 20 mL disposable
glass vial. Infliximab will be administered as an IV
infusion by qualified study site personnel and the
details ofeach administration will be recorded in
the source notes and in the eCRF (including date,
start and stop times of the IV infusion, and volume
infused).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
169
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
After the Week 8 visit and before the Week 54
visit, participants in the infliximab arm will
only require study visits on treatment days.  All
other nontreatment visits during this time
period will be optional.  All participants must
have Week 54 or Early Termination visit.
Synopsis
Objectives, Overall
Design;
1.3. Schedule of
Activities (SoA),
Table 2, footnote l;
Additional Objective (Usability Assessment
Substudy)
To evaluate the potential for at home use of
golimumab in the participant population ≥45kg
during the Usability Assessment Substudy.
OVERALL DESIGN
Beginning at Week 58, participants who are
eligible to continue receiving golimumab in the
study extension will be offered the option for self-
administration (at least 12 years old and body
weight ≥45 kg) or caregiver administration (any
age but body weight ≥45 kg). At home
administration (AHA)This is optional; if a
pediatric participant or caregiver elects against
self- or caregiver administration, the health care
professional will continue to administer injections
in this study.
At select sites, participants entering the study
extension who elect to administer the study
intervention at home will have the option to be
enrolled in a Usability Assessment Substudy.
Approximately 15-20 participants will be enrolled
in the Usability Assessment Substudy at Week 58.
The objective of the Substudy is to provide
supportive data that the Pprefilled Ssyringe with
UltraSafe (PFS-U) and Prefilled Pen (PFP-V) as
designed, together with the appropriate training
and written Instructions for Use, isare suitable for
AHA by pediatric participants or their caregivers.
l. At Week 58, all participants who are ≥12 years of
age and are ≥45 kg are eligible for AHAs of study
intervention. Participants who are <12 years of age
but are ≥45 kg are eligible for AHAs of study
intervention by parent(s)/caregivers; participants
Updates made to include at home
administration for all participants
during the study extension.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
170
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
1.3. Schedule of
Activities (SoA),
Table 3;
2.1. Study
Rationale;
3. Objectives and
Endpoints;
4.1. Overall Design;
>12 years of age are eligible for AHA by self or
parent(s)/caregivers.
Completion of the Prefilled Syringe Injection
Device Assessment Questionnaire after completion
of the second and third self- or caregiver
administration visits by Substudy participants
(Appendix 11 [Section 10.11])
CNTO148UCO3003 (this study): A multicenter,
randomized, open-label study to assess the
efficacy, safety, and PK of golimumab treatment in
pediatric participants from 2 to 17 years of age
with moderately to severely active UC. In this
study, the remission rate on golimumab in these
pediatric participants will be formally compared
with a historical placebo remission rate derived
from a meta-analysis of 2 adult Phase 2/3 studies
of golimumab for UC and 5 adult Phase 3 studies
of other products approved in this indication
utilizing similar populations and endpoints.
Additionally, open label infliximab will serve as a
reference arm to demonstrate assay sensitivity if
the formal comparison for the primary endpoint of
this study is not successful; no formal comparisons
between golimumab and infliximab will be
performed. A study extension is included for
eligible golimumab-treated participants. In this
study extension, participants ≥45 kg will be
eligible for at home administration (AHA).
Participants entering the study extension who elect
to administer the study intervention at home will
have the option to be enrolled in a Usability
Assessment Substudy (Appendix 18
[Section 10.18]).
Additional Objective (Usability Assessment
Substudy)
To evaluate the potential for at home use of
golimumab in the participant population ≥45kg
during the Usability Assessment Substudy.
At Home Administration
At any time after Week 54 (Week 58 at the
earliest), participants who are eligible to continue
receiving golimumab in the study extension will be
offered the option for self-administration (at least
12 years old and body weight ≥45 kg) or caregiver
administration (any age but body weight ≥45 kg;
Appendix 18 [Section 10.18]). This is optional; if a
pediatric participant or caregiver elects against
self- or caregiver administration, the health care
professional (HCP) will continue to administer
injections in this study.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
171
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
6.1. Study
Interventions
Administered;
All participants who elect AHA of the study
intervention will receive a face-to-face training
from study site staff on the use of the Pprefilled
Ssyringe with UltraSafe (PFS-U) or the Prefilled
Pen (PFP-V). Training for AHA will occur over 3
q4w administration visits beginning as early as
Week 58. Participants will complete a training
administration at the first visit, using the PFS-U or
the PFP-V device at the clinic under the
observation/supervision of site staff. Site staff will
complete an observer checklist (Appendix 10
[Section 10.10]). An HCP will determine whether a
participant (≥12 years of age and ≥45 kg) or their
caregiver (participant may be any age but must be
≥45 kg) can perform the injections. The
2 remaining self- or caregiver-dose administrations
will be performed in the clinic by the participants
or their caregivers, with site staff available for any
questions, and should be performed by the person
who received the appropriate training. Participants
may elect at any time during the study extension to
have golimumab administered by an HCP or return
entirely to HCP administration of study
intervention. If a participant is <45 kg during a
visit (ie, and requires a dose less than 100 mg), that
participant will no longer qualify to receive AHA,
unless the participant weight is ≥45 kg at a follow
up visit.
Golimumab
In the study extension beginning at Week 58
participants ≥45 kg will have the option of AHA of
golimumab by participants and/or their caregivers
after being properly trained.
At Home Administration
Beginning at Week 58, for eligible participants
≥45 kg in the golimumab treatment arm,
participants/caregivers will have the option to
receive training to administer golimumab at home;
the training must be documented. Training of the
participants/caregivers will occur at the
investigative site under the supervision of a health
care professional.
Participants/caregivers who are unable or unwilling
to administer golimumab at home will return to the
investigative site for each administration of
golimumab. If a participant is <45 kg during a
visit, that participant will no longer qualify to
receive AHA, unless the participant weight is
≥45 kg at a subsequent visit.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
172
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
10.9. Appendix 9:
PFS-U and PFP-V
Actual Use Data
Collection;
10.9. Appendix 9: Prefilled Syringe with UltraSafe
(PFS-U) and PFP-V Actual Use Data Collection
Introduction
The PFS-U and PFP-V Actual Use Data
Collection is designed to capture and document
real-life PFS handling and use experience data
from injections administered by pediatric
participants or caregivers in a home-like setting,
including complaints and failures in use. The
actual use data to be collected is intended as
additional support of the human factors and
labeling comprehension data obtained during
Summative Human Factors Studies but is not itself
considered a human factors study. Following the
second independent self- or caregiver-
administration by appropriately trained pediatric
participants capable of self-administration or their
caregivers, all study participants performing the
injection will be asked to complete a questionnaire
(provided below) regarding their experience using
either the PFS-U or the PFP-V. Evaluation of the
user experience after the second independent
administration is considered adequate to evaluate
how well participants can understand and recall the
dosage instructions, and to assess for any common
difficulties with injections.
The Schedule of Activities (Table 2) summarizes
the setup of data collection. Pediatric participants
aged 12 and older and who weigh at least 45 kg, or
caregivers of participants of any age who weigh at
least 45 kg will be offered the option for self- or
caregiver administration after the Week 54 study
evaluations. This is optional; if a pediatric
participant or caregiver elects against self- or
caregiver administration, the HCP will administer
injections in this study. If a pediatric participant or
caregiver does elect self- or caregiver
administration, the pediatric participant or
caregiver will perform a training administration no
earlier than Week 58. Pediatric participants or
caregivers will receive face-to-face training by
study site staff on the use of the PFSinjection
device. The training will include a review of the
IFU with site staff, a demonstration with the PFS a
device Trainer (when available) performed by the
site staff, and ‘hands-on’ practice injections
performed by the pediatric participants and/or their
caregivers using the PFSdevice Trainer. An
Observer Checklist will be completed by the
trainer in order to determine that the user is able to
correctly administer the injection. Based on this
information, the HCP will determine whether the
pediatric participant, or their caregiver, is able to

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
173
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
10.10. Appendix 10:
Injection Device
Observer Injection
Checklist;
10.11. Appendix 11:
Injection Device
Assessment
Questionnaire;
administer the injection in a home-like setting at
the site.
Self- or caregiver training injections will occur in 2
subsequent study intervention administrations, the
second and third self- or caregiver administration
visits. Injections will be performed independently
in a home-like setting in the clinic, with the IFU
available for reference. Approximately the first 15-
20 participants from Sponsor identified sites who
choose AHA will enter the Usability Assessment
Substudy at Week 58 and complete an injection
device PFS Usability Questionnaire at Weeks 62
and 66 after completion of the second and third
self- or caregiver administration visits (Sections
4.1 and 6.1).
Appendix 10: Prefilled Syringe Injection Device
Observer Injection Checklist
Prefilled Syringe Injection Device Observer
Injection Checklist
Type of Injection Device: 
 PFS-U 
PFP-V
Appendix 11: Prefilled Syringe Injection Device
Assessment Questionnaire
Added a question to the form:
Which type of injection device did you use for
this injection?
Were you able to successfully inject using the
injection device (PFS-U or PFP-V) Prefilled
Syringe?
Ease of Use of the Prefilled SyringeInjection
Device
The following questions ask about the ease of use
of the injection device (PFS-U or PFP-
V)Prefilled Syringe.
How difficult or easy was it to:
position the Prefilled Syringeinjection device at
the injection-site?
press the plunger on the Prefilled Syringeinjection
device to inject the liquid?
hold the Prefilled Syringeinjection device during
the injection?
Appendix 18: Usability Assessment Substudy
The objective of the Substudy is to provide
supportive data that the PFS-U or PFP-V as

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
174
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
10.18. Appendix 18: 
Usability 
Assessment 
Substudy 
designed, together with the appropriate training
and written Instructions for Use, isare suitable for
at home administration (AHA) by pediatric
participants or their caregivers.
Similar for all AHA participants, pediatric
participants or their caregivers in
CNTO148UCO3003 will be trained in safe AHA
the first week, and their self- or caregiver
administration observed over 2 subsequent q4w
visits. Participants or their caregivers will receive
face-to-face training by study site staff on the use
of the PFS-U or the PFP-V at the first training
visit (at the Week 58 study visit for Usability
Assessment Substudy participants). Participants
will perform a training administration using the
PFS-U or the PFP-V at the clinic under the
observation/supervision of site staff. Site staff will
complete an Observer Checklist at the Week 58
visit. The health care professional will determine
whether a pediatric participant or their caregiver
can perform the injections. During the 2
subsequent q4w clinic visits, administrations will
be performed in a home-like setting in the clinic by
pediatric participants or caregivers and should be
performed by the same person (ie, pediatric
participant or caregiver) and not switched unless
participants opt to return to the HCP
administration.
Participants or caregivers performing the injection
who are enrolled in the Usability Assessment
Substudy will be asked to complete an Prefilled
Syringe Injection Device Assessment
Questionnaire (Section 10.11) regarding their
experience using the PFS-U or the PFP-V at
Weeks 62 and 66 after completion of the second
and third self- or caregiver administration visits. If
the injections have been performed by the
caregiver, the questionnaire will be completed by
the caregiver. If the self-injections have been
performed by the pediatric participant, the
participant will complete the questionnaire with
parent or caregiver assistance, if needed.
Evaluation of the user experience after the second
independent self- or caregiver administration is
considered adequate to evaluate how well
participants can understand and recall the dosage
instructions, and to assess for any common
difficulties with injections.
Participant Population
This Substudy population will include pediatric
participants ≥45 kg who are enrolled in the study

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
175
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
extension. The inclusion and exclusion criteria of
the Substudy are described below.
Exclusion Criteria
1. Unable to demonstrate the ability to complete
a study intervention administration by self or
parent/caregiver. Participants weighing <45kg
will not be eligible for AHA or this Substudy. For
self-administration, participants must be ≥12
years of age. AND  weigh ≥45 kg. However,
pParticipants <12 years of age but who weigh
≥45 kg may receive must have study
intervention administrations by the parents or
caregiver and be eligible for this Substudy.
Schedule
Participants in this study will follow the schedule of
events as outlined in Table 3 for collection of actual
use data for the PFS-U  and PFP-V  (Prefilled
Syringe 
Injection 
Device 
Assessment
Questionnaire).
Synopsis Statistical
Methods;
Criteria for Success 
The success of the study will ultimately be based 
on the totality of evidence. The primary analysis
will be based on the proportion of golimumab
pediatric participants in clinical remission at
Week 6 based on the Mayo score and its associated
90% confidence interval (CI). The study will be
considered successful and the criteriaon for the
primary analysis for determining that golimumab
is effective in the treatment of UC in pediatric
participants will have been met if the lower limit of
the two-sided 90% CI for the proportion of
golimumab participants in clinical remission at
Week 6 is >10.0% (ie, the upper limit of the 95%
CI for the proportion of placebo participants in
clinical remission at Week 6 derived from a
meta-analysis of 7 adult UC studies including 2
adult Phase 2/3 studies of golimumab and 5 adult
Phase 3 studies of other products approved in this
indication utilizing similar populations and
endpoints).
Primary Efficacy Analysis
The primary analysis population includes all
participants (including the youngest weight cohort
[<30 kg]) who were treated with golimumab. The
primary analysis will be based on the proportion of
pediatric participants who received golimumab and
who were in clinical remission at Week 6 based on
the Mayo score (endoscopy subscore assigned by
local endoscopist) and its associated 90% CI. The
Clarification has been made that
the success of the study will be
based on the totality of evidence.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
176
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
9.2. Criteria for
Success;
9.4.1.1. Primary
Endpoint
study will be considered successful and the
criterion for determining that golimumab is
effective in the treatment of UC in pediatric
participants The criteria for the primary analysis
will have been met if the lower limit of the two-
sided 90% CI for the proportion of pediatric
golimumab participants in clinical remission at
Week 6 is greater than the upper limit of the 95%
CI for the proportion of placebo participants in
clinical remission at Week 6 (ie, >10.0%) derived
from a meta-analysis of 7 adult UC studies
including 2 Phase 2/3 studies of golimumab and 5
Phase 3 studies of other products approved in this
indication utilizing similar populations and
endpoints.
The success of the study will ultimately be based
on the totality of evidence. The primary analysis
will be based on the proportion of golimumab
pediatric participants in clinical remission at
Week 6 based on the Mayo score and its associated
90% CI. The study will be considered successful
and the criteriaon for the primary analysis
determining that golimumab is effective in the
treatment of UC in pediatric participants will have
been met if the lower limit of the two-sided 90%
CI for the proportion of golimumab participants in
clinical remission at Week 6 is >10.0% (ie, the
upper limit of the 95% CI for the proportion of
placebo participants in clinical remission at
Week 6 derived from a meta-analysis of 7 adult
UC studies including 2 adult Phase 2/3 studies of
golimumab for UC and 5 adult Phase 3 studies of
other products approved in this indication utilizing
similar populations and endpoints).
The primary analysis population includes all
participants (including the youngest weight cohort
[<30 kg]) who were treated with golimumab. The
success of the study will ultimately be based on
the totality of evidence. The primary analysis will
be based on the proportion of pediatric participants
who received golimumab and who were in clinical
remission at Week 6 based on the Mayo score
(endoscopy subscore assigned by local
endoscopist) and its associated 90% CI. The study
will be considered successful and tThe criteriaon
for the primary analysis determining that
golimumab is effective in the treatment of UC in
pediatric participants will have been met if the
lower limit of the two-sided 90% CI for the
proportion of pediatric golimumab participants in
clinical remission at Week 6 is greater than the
upper limit of the 95% CI for the proportion of
placebo participants in clinical remission at
Week 6 (ie, >10.0%) derived from a meta-analysis

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
177
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
of 7 adult UC studies (2 adult Phase 2/3 UC studies
of golimumab and 5 adult Phase 3 studies of other
products approved in this indication utilizing
similar populations and endpoints).
1.3. Schedule of
Activities (SoA),
Table 1, TB test row
and footnotes i and
j;
1.3. Schedule of
Activities (SoA),
Table 2, footnote g;
5.1. Inclusion
Criteria, Criterion
#17;
5.2. Exclusion
Criteria, Criterion
#44;
7.1. Discontinuation
of Study
Intervention, #11;
QuantiFERON  -TB or T-Spot testi
i. A tuberculin skin test is required if the
QuantiFERON-TB 
or T-Spot test 
is 
not
approved/registered in that country, OR the
tuberculin skin test is mandated by local health
authorities.
j. Chest radiograph should be obtained during the
screening period unless one was obtained within
6months before screening and the findings
recorded in the study source documents. Chest
radiographs should be reviewed to assess for
potential undiagnosed pulmonary pathologies that
may include manifestations of IBD, malignancies,
and prior or current infection (eg, latent TB). Chest
radiographs must be obtained in all cases when the
QuantiFERON-TB or T-Spot test and/or the
tuberculin skin test for TB is positive or repeatedly
indeterminate.
g. See Section 8.3.6 for TB evaluations. If TB is
suspected at any time, a chest x-ray and
QuantiFERON-TB or T-Spot test, or TST
tuberculin skin test should be performed.
During the screening period have a negative
QuantiFERON®-TB test or T-Spot® test result.
Within 1 month, prior to the first study intervention
administration, a negative tuberculin skin test is
additionally required if the QuantiFERON-TB test
or T-Spot test is not approved/registered in that
country or the tuberculin skin test (Appendix 3
[Section 10.3]) is mandated by local health
authorities. The results of the T-Spot test will be
acceptable in place of the QuantiFERON-TB
test. If the QuantiFERON-TB or T-Spot test
cannot be obtained, the tuberculin skin test can
be performed instead after discussion with the
medical monitor.
Have persistently indeterminate (indeterminate on
repeat sampling) QuantiFERON-TB or T-Spot test
results. Indeterminate results should be handled as
outlined in Section 8.3.6.
A participant undergoing evaluation has a chest
radiograph with evidence of current active TB
and/or a positive QuantiFERON-TB or T-Spot test
result (and/or a positive tuberculin skin test result
in countries in which the QuantiFERON-TB or
T-Spot test is not approved/registered or the
Clarifications regarding the use of
the T-Spot test have been made.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
178
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
8.3.6.1. Initial
Tuberculosis
Evaluation;
tuberculin skin test is mandated by local health
authorities), unless active TB can be ruled out and
appropriate treatment for latent TB can be initiated
prior to the next study intervention administration
and continued to completion (see also
Section 8.3.6, and Appendix 3 [Section 10.3]).
Indeterminate QuantiFERON-TB test or T-Spot
test results should be handled as in Section 8.3.6.
A participant whose first QuantiFERON-TB test
result or T-Spot test result is indeterminate should
have the test repeated. In the event that the second
QuantiFERON-TB or T-Spot test result is also
indeterminate, the participant should be excluded
from the study.
Participants with a negative QuantiFERON-TB or
T-Spot test result (and/or a negative tuberculin
skin test result in countries in which the
QuantiFERON-TB test is not approved/registered
or the tuberculin skin test is mandated by local
health authorities) are eligible to continue with
prerandomization procedures. Participants with a
newly identified positive QuantiFERON-TB or
T-Spot (or tuberculin skin) test result must be
excluded from the study (see Appendix 3
[Section 10.3]).
If the QuantiFERON-TB or T-Spot cannot be
obtained, the tuberculin skin test can be
performed instead after discussion with the
medical monitor. The tuberculin skin test will
be required in addition to the QuantiFERON-
TB or T-Spot in countries where
QuantiFERON-TB or T-Spot is not
registered/approved or if the tuberculin skin
test is mandated by local health authorities.
Investigators have the option to use both 2 TB
screening tests (selecting from the
QuantiFERON-TB test, the T-Spot test, and the
tuberculin skin test)to screen for latent TB if they
believe, based on their judgment, that the use of
both 2 tests is clinically indicated in order to
evaluate a participant who has high risk of having
latent TB. If a single test either the
QuantiFERON TB test or the tuberculin skin test is
positive, the participant is considered to have latent
TB infection for the purposes of eligibility for this
study and must be excluded from the study.
A participant whose first QuantiFERON-TB or
T-Spot or tuberculin skin test result is
indeterminate should have the test repeated. In the
event that the second QuantiFERON-TB or
T-Spot or tuberculin skin test result is also

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
179
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
8.3.6.2. Ongoing
Tuberculosis
Evaluation
indeterminate, the participant should be excluded
from the study.
In select circumstances as approved by the
Sponsor, a local laboratory may be used to perform
the QuantiFERON-TB or T-Spot test.
Participants who experience close contact with an
individual with active TB during the conduct of the
study must have a chest radiograph, a repeat
QuantiFERON-TB or T-Spot test, a repeat
tuberculin skin test in countries in which the
QuantiFERON-TB or T-Spot test is not
approved/registered or the tuberculin skin test is
mandated by local health authorities, and if
possible, referral to a physician specializing in TB
to determine the participant’s risk of developing
active TB and whether treatment for latent TB is
warranted. If the QuantiFERON-TB or T-Spot test
result is indeterminate, the test should be repeated.
In the event that the second QuantiFERON-TB or
T-Spot test result is also indeterminate, the
participant must immediately discontinue
further administration of study intervention
and should be discussed with the Sponsor.
Participants should be encouraged to return for all
subsequent scheduled study visits according to the
protocol.
1.3. Schedule of
Activities (SoA),
Table 1,
immunization
screening row and
footnote l;
5.1. Inclusion
Criteria, Criterion
#19
Screening for up-to-date immunizations per local
guidelinesacceptable evidence of immunity to
measles, mumps, rubella, and varicellal
l. Refer to local immunization guidelines for
immunosuppressed 
participants 
prior 
to
Week 0.Titers for measles and varicella only
required if adequate documentation of complete
vaccination schedule or healthcare provider
verification of previous infection is unavailable.
Participants must be up to date with all
immunizations (ie, measles, mumps, rubella,
and varicella) in agreement with current local
immunization guidelines for immunosuppressed
participants before Week 0.
Participants must have acceptable evidence of
immunity to measles, mumps, rubella, and varicella,
which includes any one of the following:
a. Healthcare provider documentation of age
appropriate vaccination for varicella* and
measles, mumps, and rubella that includes
both doses of each vaccine;
OR
Varicella and measles titers are no
longer required in the absence of
documented infection or
vaccination for the following
reasons: 1) the serology titers are
not reliable predictors of protective
immunity especially in vaccinated
individuals; 2) there is wide
variability among laboratory
procedures, results, and
interpretation of antibody levels
across the literature; 3) follows
current practice of bringing patients
up to date with all vaccinations
prior to initiating anti-TNF therapy;
and 4) accurately reflects
golimumab and infliximab product
label vaccination language.
Participants will be required to be
up to date with all immunizations
per local immunization guidelines
for immunocompromised
participants.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
180
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
b. Documentation of past varicella and
measles infection by a healthcare provider;
OR
c. In the absence of (a) or (b) above, must
have positive protective antibody titers to
varicella and measles prior to the first
administration of study intervention. If
antibody titers are checked for any reason
and are negative, the participant must be
excluded from the study until they have
been re vaccinated and can demonstrate
positive antibody titers.
*If required or recommended in the country in
which the participant is receiving study
treatments.
1.3. Schedule of
Activities (SoA),
Table 1, footnote r
r. Optional at the discretion of the investigator. Only
if decision is made to escalate the dose of infliximab
to 10 mg/kg q8w, and only if participant was given
5 mg/kg Week 6, may the participant receive a dose
at Week 8 of infliximab at 5 mg/kg, with subsequent
doses of 10 mg/kg starting at Week 14. Infliximab
infusions are capped at 1 gm maximum per
administration. Additional details are available in
Section 4, Study Design. If participant receives
infliximab infusion at Week 8, they will need a urine
pregnancy test in addition to the other assessments
collected from all study participants.
Clarification regarding the
administration of infliximab has
been made.
1.3. Schedule of
Activities (SoA),
Table 2;
6.5. Concomitant
Therapy;
8.2.4. Concomitant
Medication Review
Every 6 months 12 weeks starting Week 66 for all
participants
Added footnote k to Table 2 and changed
cascading footnotes accordingly:
k. After Week 54, only include concomitant
medications in eCRF that are associated with AE
and SAEs (ie, used to treat event or suspected in
causing event) and/or with the treatment of UC.
All concomitant medications will be recorded in
the eCRF through Week 54. After Week 54,
only concomitant medications associated with
AEs and SAEs (ie, used to treat event or
suspected in causing event) and/or with the
treatment of UC will be recorded in the eCRF.
All concomitant medications will be recorded in
the eCRF through Week 54. After Week 54,
only concomitant medications associated with
AEs and SAEs (ie, used to treat event or
suspected in causing event) and/or with the
treatment of UC will be recorded in the eCRF.
Minor edits made to streamline the
study extension.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
181
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
5. Study Population; 
5.4. Screen Failures 
10.12 Appendix 12: 
Regulatory, Ethical, 
and Study Oversight 
Considerations 
Screening for eligible participants will should be 
performed within 6 weeks before administration of 
the study intervention. Refer to Section 5.4 Screen 
Failures for conditions under which the repeat of 
any screening procedures is allowed. On a
case-by-case basis, and after consultation with
the medical monitor, retesting procedures may
exceed the 6-week window and will not be
considered protocol deviations.
Completion of sScreening and randomization
enrollment procedures should typically be
completed within the specified screening window
of within 6 weeks.; extensions can be discussed
with the medical monitor.
Rescreening
Participants who do not meet the criteria for
participation in this study (screen failure) may be
rescreened 1 time. In rare cases, a participant
may be screened a third time after discussion
with the medical monitor. Participants who are
rescreened will be assigned a new participant
number, undergo the informed consent/assent
process, and then start a new screening phase. On a
case-by-case basis, after consultation with the
medical monitor, rescreening procedures may
exceed the 6-week window and will not be
considered protocol deviations.
INFORMED CONSENT PROCESS
A participant may be rescreened 1 time.
Participants who are rescreened are required to
sign a new ICF. In rare cases, a participant may
be screened a third time after discussion with
the medical monitor.
Clarification added to indicate that
extensions to the typical screening
window can be discussed with the
medical monitor.
5.1. Inclusion 
Criteria 
Criterion #12; 
Criterion #20 
Before enrollment randomization, a girl must be 
either: 
a. Not of childbearing potential defined as:
1) Premenarchal
a) A premenarchal state is one in which menarche
has not yet occurred.
2) Permanently sterile
a) Permanent sterilization methods include
hysterectomy, bilateral salpingectomy, bilateral
tubal occlusion/ligation procedures, and bilateral
oophorectomy.
For participants who have not completed the
recommended vaccination schedule for varicella,
Clarifications of inclusion criteria
have been made.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
182
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
measles, mumps, and rubella, and the subsequent
vaccination falls within the next 4 years, an
accelerated vaccination schedule must be
completed prior to study enrollment, per local or
professional guidelines. if available and required
or strongly recommended for the country. If live,
attenuated viral vaccine is utilized, it is necessary
for at least 4 weeks (or longer as indicated on
the package insert of the relevant vaccine) 8
weeks to elapse between the vaccination and
receipt of study intervention. Once study
intervention has been initiated, at least a 16-
week period must elapse after last dose before a
live vaccine is utilized. For additional
restrictions regarding Bacille Calmette-Guerin
(BCG) vaccination, see Exclusion Criterion 41
in Section 5.2.
5.2. Exclusion
Criteria
Criterion #8;
Criterion #34, added
note to exclusion
criterion;
Criterion #46;
Criterion #47
Received an investigational vaccine or used an 
invasive investigational medical device within 
3 months before the planned first dose of study
intervention or is currently enrolled in an
investigational study. Receipt of an
investigational vaccine for COVID-19 is not an
automatic exclusion criterion, discuss with the
medical monitor.
Has a stool culture or other examination positive
for an enteric pathogen, including Clostridium
difficile toxin in the previous 4 months, unless a
repeat examination is negative and there are no
signs of ongoing infection with that pathogen.
Note: For participants who have a positive C.
difficile test during the screening period,
participant may be treated and retested during
the screening period (extensions of the screening
period can be discussed with the medical
monitor). If repeat test is negative and there are
no signs of ongoing infection, participant can be
considered for enrollment. If repeat C. difficile
test remains positive during the screening
period, the participant must be a screen failure
and may be treated and rescreened.
Have had 2 or more serious infections requiring
hospitalization or treatment with parenteral
antibiotics within the past year. Less serious
infections (eg, acute upper respiratory tract
infection, simple urinary tract infection) need not
be considered exclusionary at the discretion of the
investigator. Prior parenteral antibiotics
administered for the indication of UC are
acceptable and not a reason for exclusion.
Must not have received, or are expected to receive,
any live virus or bacterial vaccination within
Clarifications of exclusion criteria
have been made.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
183
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
8 weeks (or longer as indicated in the package
insert of the relevant vaccine) prior to the first
administration of study intervention, during the
study, or within 16 weeks (more than 5.5 half-lives
of SC golimumab) after the last administration of
study intervention. Receipt of a live SARS-CoV-2
vaccine (against the virus that causes COVID-
19) is not automatically an exclusion criterion
and must be discussed with the medical
monitor.
5.2. Exclusion
Criteria
New exclusion
criterion added
(Criterion #61)
Infections or predisposition to infections
During the 6 weeks prior to baseline, have had
ANY of:
a. 
Confirmed 
SARS-CoV-2 
(COVID-19)
infection (test positive);
OR
b. Suspected SARS-CoV-2 infection (clinical
features without documented test results);
OR
c. Close contact with a person with known or
suspected SARS-CoV-2 infection.
•Exception: may be included with a documented
negative result for a validated SARS-CoV-2 test:
1) obtained at least 2 weeks after conditions (a),
(b), (c) above (timed from resolution of key
clinical features if present, eg, fever, cough,
dyspnea);
AND
2) with absence of ALL conditions (a), (b), (c)
above during the period between the negative
test result and the baseline study visit.
NOTES on COVID-19-related exclusion:
•The field of COVID-19-related testing (for
presence of, and immunity to, the SARS-CoV-2
virus) is rapidly evolving. Additional testing
may be performed as part of screening and/or
during the study, if deemed necessary by the
investigator and in accordance with current
regulations/guidance from authorities/standards
of care.
Additional exclusion criterion
regarding SARS-CoV-2 has been
added.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
184
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
•Precaution: for those who may carry a higher
risk for severe COVID-19 illness, follow
guidance from local health authorities when
weighing the potential benefits and risks of
enrolling in the study, and during participation
in the study.
8. Study
Assessments and
Procedures
Details about who will perform and/or complete 
the assessments/data and the order of completion 
are provided in Section 8.1. Information about how
and when data are filed, stored, and transmitted to
or from the study site is provided in the electronic
patient-reported outcome (ePRO) electronic tablet
device and User Manual.
Sentence deleted to align with
Section 8.1.
10.19. Appendix 19:
Guidance on Study
Conduct during the
COVID-19
Pandemic
An appendix for guidance on study conduct during
the Coronavirus Disease of 2019 (COVID-19)
pandemic was added.
COVID-19-related guidance on
study conduct during the pandemic
was added.
Throughout the
protocol
Minor grammatical, formatting, or spelling
changes were made.
Minor errors were noted.
Amendment 3 (8 Jul 2019)
Overall Rationale for the Amendment: To incorporate the following changes: 1) changed the allowable
timeframe for a chest radiograph prior to screening for assessment of undiagnosed medical conditions in
the exclusion criteria and clarified the rationale for having a chest radiograph; and 2) clarified permitted
allowable nutrition in the inclusion criteria for participants with UC who may enroll in the study.
Section number 
and Name
Description of Change 
Brief Rationale
Section 1.3 
Schedule of 
Activities Table 1
Serum pregnancy test added back in to Schedule of 
Activities (SoA) at screening. 
Serum pregnancy test was deleted
in error.
Section 1.3 
Schedule of 
Activities Table 1,
footnote j
Revised SoA footnote text to read: “Chest
radiograph should be obtained during the
screening period unless one was obtained within
6 months before screening and the findings
recorded in the study source documents. Chest
radiographs should be reviewed to assess for
potential undiagnosed pulmonary pathologies that
may include manifestations of IBD, malignancies,
and prior or current infection (eg, latent TB). Chest
radiographs must be obtained in all cases when the
QuantiFERON-TB test and/or the tuberculin skin
test for TB is positive or repeatedly indeterminate.”
Clarified the chest radiograph
requirements at screening.
Section 1.3
Schedule of
Activities Table 1,
footnote n
Revised SoA footnote to read: “HIV testing in
study participants who weigh less than 30 kg are
less than 6 years of age is not universally
required. It is required in those study participants
who weigh <30 kg are less than 6 years of age
and the birth history is unknown (ie adopted) or has
Changed testing for HIV from a
weight-based to an age-based
requirement depending on birth
history, exposure risks, or at
discretion of the study investigator.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
185
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
exposure risks (parents with HIV or with risk
factors) or at the discretion of the study
investigator. In subjects who weigh <30 kg are less
than 6 years of age where testing would be
required, if there is a record of a negative HIV test
at birth this is acceptable at the discretion of the
study physician as long as it is entered into the
study record.”
Section 5.1.
Inclusion criterion
#6
Revised text to read: 
“Criterion modified per Amendment 3.
6.1. Prior or current medication for UC must
include at least 1 of the following (Appendix 2
[Section 10.2]):
a.  Current treatment with at least 1 of the
following therapies: oral or intravenous
corticosteroids, or the immunomodulators
6-MP, MTX, or AZA.”
Deleted intravenous corticosteroids
from current treatment for UC.
Section 5.1
Inclusion criterion
#7
Revised text to read: 
“Criterion modified per Amendment 3.
7.1. Must meet concomitant medication dose 
stability prior to the first administration of 
study intervention:
a.  Corticosteroids:
1)  If receiving oral or IV corticosteroids,
the dose (in prednisone equivalents)
must have been stable for at least 2
weeks prior to Week 0.”
Deleted intravenous corticosteroids
from concomitant medication dose
stability prior to the first
administration of study
intervention.
Section 5.1.
Inclusion criterion
#8
Deleted the following text: If receiving parenteral 
nutrition, must have discontinued 2 weeks prior to 
the first administration of study intervention at 
Week 0. 
Revised text to read: 
“Criterion modified per Amendment 3.
8.1. If receiving enteral nutrition, must have been
on a stable regimen for at least 2 weeks prior to
the first administration of study intervention at
Week 0. Participants who receive parenteral
nutrition are not permitted to enroll in the
trial.”
Changed for allowable nutrition to
specify that only enteral nutrition is
permitted. Participants with UC
who receive parenteral nutrition are
no longer permitted to enroll in the
trial.
Section 5.1
Inclusion criterion
#13
Added the following text: 
“Criterion modified per Amendment 3.
13.1. Boys must agree not to donate sperm for the
purpose of reproduction during the study and
for a minimum 6 months after receiving the
Requirements for use of
contraception by a boy have been
added and specified.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
186
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
last dose of study intervention. “During the
study and for a minimum of 6 months after
receiving the last dose of study
intervention, in addition to the highly
effective method of contraception, a boy:
a.  Who is sexually active with a girl of
childbearing potential must agree to use
a barrier method of contraception (eg,
condom with spermicidal
foam/gel/film/cream/suppository).
b.   Who is sexually active with a girl who
is pregnant must use a condom.”
Section 5.2.
Exclusion criterion
#42
Deleted the following text: Have a chest radiograph 
within 3 months prior to the first study intervention 
administration that shows an abnormality 
suggestive of a malignancy or current active 
infection, including TB. 
Revised text to read:
“Criterion modified per Amendment 3.
42.1. Have a chest radiograph during screening or
6 months prior to screening that shows an
abnormality suggestive of an undiagnosed
pulmonary pathology that may include
manifestations of IBD, malignancy, prior
or current active infection, including TB.”
Changed the allowable timeframe
for a previous chest radiograph in
exclusion criterion #42 and
clarified the rationale for a chest
radiograph.
Section 6.5.3.
Rescue Medication
Revised the text to read: “During the long-term 
phase of the study, participants who meet the 
following criteria will be considered to be in 
clinical flare:
For study subjects who responded at Week 6-
an increase of the partial Mayo score from
Week 6 of at least 2 points and an absolute
partial Mayo score ≥4; or an absolute partial
Mayo score ≥7 points, or
For study subjects who did not have a
Week 6 response but achieved a response at
Week 14 or 22 (after additional discretionary
doses of golimumab or infliximab
[Section 4.1])-an increase in the partial Mayo
score from Weeks 14 or 22 of at least 2 points
and an absolute partial Mayo score ≥4; or an
absolute partial Mayo score ≥7 points.
However, the basis for this determination should be
consistent with the criteria used in the long-term
phase, namely an increase in the partial Mayo
score by 2 points and an absolute partial Mayo
score ≥4; or an absolute partial Mayo score of
≥7 and based on the study participant (or
Expanded the criteria used to
determine the onset of a UC flare in
the study extension.
Added the need for use of
parenteral (IV) steroids for UC
during the study as a reason for
discontinuation from further study
intervention administration.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
187
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
caregiver)-reported stool frequency and degree of
rectal bleeding, as well as a global assessment of
UC disease activity made by a study primary- or
sub-investigator.”
Revised last paragraph to read: “However, any
participant who uses UC-prohibited medications
(Section 6.5.2) or requires more than 2 courses of
corticosteroids (including budesonide) or requires
parenteral (IV) steroids for UC during the
54-week study will be discontinued from further
administration of study intervention.”
Secton 6.5.3. 
Rescue Medication
Added the following sentence: 
“In the study extension, the determination that a
subject is in clinical flare will be at the discretion
of the investigator.”
Added sentence regarding clinical
flare determination for study
extension.
Section 7.1. 
Discontinuation of 
Study Intervention 
Discontinuation of a participant’s study 
intervention must be strongly considered under the 
following conditions:
1. Persistent inadequate response or worsening of 
UC: 
f. Revised the text to read: “Participants in
the long-term or study extension phases of
the study who meet the criteria as defined
Section 6.5.3 will be considered to be in
clinical flare. A sigmoidoscopy (or
colonoscopy) can be considered to aid
clinical judgment and should be
performed using study software and
submitted for central review.”
Revised last paragraph to read: “If a participant
discontinues study intervention for any reason
before Week 6, they should return for all scheduled
visits through Week 14 (including endoscopy at
Week 6) and a final safety visit, 16 weeks after the
last dose of golimumab or 8 weeks after the last
dose of infliximab.”
Revised to be consistent with
Section 6.5.3.
Clarified time points when
participant needs to return for visits
after discontinuation including for
an endoscopy.
Section 7.1 
Discontinuation of 
Study Intervention  
Revised the following text: 
“3.  The participant requires the addition of 
parenteral (IV) steroids immunomodulators (ie, 
6 MP, AZA, or MTX) or more than 2 courses
of corticosteroids (including budesonide) for
UC flares during the 54-week study.”
Modified the statement to exclude
IV steroids and other
immunomodulators.
Section 8.1.7.1. 
TUMMY-UC and 
Observer TUMMY- 
UC
Revised sentence text to read: 
“It includes 6 components similar to the PUCAI 
index and ranges from 0 to 56114.” 
The scoring range for the
TUMMY-UC and Observer
TUMMY-UC has been changed.
Section 8.2.3. 
• 
Revised text to read: “Serology for HIV at 
screening: HIV testing in study participants who 
weigh less than 30 kg is are less than 6 years of 
Changed serology for HIV from a
weight-based to an age-based
requirement depending on birth

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
188
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
Clinical Safety
Laboratory
Assessments
age is not universally required. It is required in 
those study participants who weigh <30 kg are less 
than 6 years of age and the birth history is
unknown (ie adopted) or has exposure risks
(parents with HIV or with risk factors) or at the
discretion of the study investigator. In subjects who
weigh <30 kg are less than 6 years of age where
testing would be required, if there is a record of a
negative HIV test at birth this is acceptable at the
discretion of the study physician as long as it is
entered into the study record.”
history, exposure risks, or at
discretion of the study investigator.
Throughout the
protocol
Minor grammatical, formatting, or spelling changes 
were made.
Minor errors were noted.
Amendment 2 (13 May 2019)
Overall Rationale for the Amendment: To incorporate the following changes: 1) expansion of the
Usability Assessment Substudy to additional countries instead of US only; 2) added a major secondary
endpoint and modified the order of the major secondary endpoints per FDA request; and 3) updated the
blood sampling scheme to comply with allowable blood sample volumes with the EU guideline on clinical
trials conducted with minors. Clarification of wording and editorial updates were made to improve
readability.
Section number 
and Name
Description of Change 
Brief Rationale
1.1 Synopsis 
Overall Design  
Revised the following text: “In this study, the remission rate 
of golimumab in pediatric participants will be formally 
compared with a historical placebo remission rate derived 
from a meta-analysis of 2 adult Phase 2/3 studies of 
golimumab for UC and 5 adult Phase 3 studies of other
products approved in this indication utilizing similar
populations and endpoints.”
Phases of the studies
that contribute to the
meta-analysis were
updated.
1.1 Synopsis 
Overall Design  
Revised the following text: “At select sites, participants 
from North American entering the study extension at 
select sites who elect to administer the study intervention at 
home will have the option to be enrolled in an Usability 
Assessment Substudy.” 
Specification for
North American sites
removed to allow for
possibility of
participants from
other countries to join
the substudy.
1.1 Synopsis 
Number of Participants 
Revised the following text: “Approximately 125 participants 
who satisfy the inclusion/exclusion criteria will be included 
in the study at sites located globally, including in North and  
South America, Asia, and Europe.
In order to ensure at least 5 participants with body weight
<30 kg receive golimumab, participants who weigh <30 kg
will only be allocated to the golimumab treatment arm.”
Included South
America for global
protocol.
Revised sentence
regarding enrollment
of participants with
body weight <30 kg.
1.1 Synopsis 
Efficacy Evaluations 
Modified the following bullet: 
• TUMMY-UC and Observer TUMMY-UC  
Added the
terminology for
“Observer”
TUMMY-UC
questionnaire for

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
189
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
efficacy/exploratory
measurements for
participants less than
8 years old.
1.1 Synopsis
Endpoints
Major secondary
endpoints
Modified the following bulleted list: 
Symptomatic remission at Week 54 
Clinical remission at Week 54 as assessed by the Mayo 
score (based on Mayo endoscopy subscore assigned by 
the local endoscopist). 
Clinical remission at Week 54 as assessed by the 
PUCAI score. 
Clinical remission at Week 6 as assessed by the PUCAI 
score. 
Clinical response at Week 6 as assessed by the Mayo 
score (based on Mayo endoscopy subscore assigned by
the local endoscopist). 
Endoscopic healing at Week 6 (based on the Mayo 
endoscopy subscore assigned by the local endoscopist). 
Endoscopic healing at Week 54 (based on the Mayo
endoscopy subscore assigned by the local endoscopist).
Added the definition of symptomatic remission:
“The definitions of the major secondary endpoints are
provided below:
• Symptomatic remission: Mayo stool frequency
subscore of 0 or 1 and a rectal bleeding subscore of 0.”
Added symptomatic
remission and clinical
remission (Mayo) at
Week 54 as major
secondary endpoints
and revised the order
and description of all
major secondary
endpoints to align
with the SAP.
Added definition for
“symptomatic
remission.”
1.1 Synopsis
STATISTICAL
METHODS
Statistical Hypothesis
Revised the following text: “The historical placebo control 
is based on a meta-analysis of 7 adult UC studies including 
infliximab Phase 3 (C0168T37 and C0168T46), golimumab 
Phase 2/3 (C0524T16 and C0524T17), adalimumab Phase 3 
(ULTRA 1 and ULTRA 2), and vedolizumab Phase 3
(GEMINI 1).”
Phases of the studies
that contribute to the
meta-analysis were
updated.
1.1 Synopsis
STATISTICAL
METHODS
Criteria for Success
Revised the following text: “The study will be considered 
successful and the criterion for determining that golimumab 
is effective in the treatment of UC in pediatric participants 
will have been met if the lower limit of the two-sided 90% 
CI for the proportion of golimumab participants in clinical
remission at Week 6 is >10.0% (ie, the upper limit of the
95% CI for the proportion of placebo participants in clinical
remission at Week 6 derived from a meta-analysis of 7 adult
UC studies including 2 adult Phase 2/3 studies of
golimumab and 5 adult Phase 3 studies of other products
approved in this indication utilizing similar populations
and endpoints).”
Phases of the studies
that contribute to the
meta-analysis were
updated.
1.1 Synopsis
STATISTICAL
METHODS
Sample Size Calculation
Primary Efficacy
Analysis
Revised the following text: “The study will be considered 
successful and the criterion for determining that golimumab 
is effective in the treatment of UC in pediatric participants 
will have been met if the lower limit of the two-sided 90% 
CI for the proportion of pediatric golimumab participants in
clinical remission at Week 6 is greater than the upper limit
of the 95% CI for the proportion of placebo participants in
clinical remission at Week 6 (ie, >10.0%) derived from a
meta-analysis of 7 adult UC studies including 2 Phase 2/3
studies of golimumab and 5 Phase 3 studies of other
products approved in this indication utilizing similar
populations and endpoints.”
Phases of the studies
that contribute to the
meta-analysis were
updated.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
190
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
1.1 Synopsis
STATISTICAL
METHODS
Sample Size Calculation
Major Secondary
Efficacy Analyses
Deleted the following 2 sentences: “A formal comparison is
only planned for the primary endpoint. No comparisons are
planned for any other efficacy endpoints.”
Deleted first 2
sentences ofthe
paragraph.
1.3 Schedule of
Activities Table 1,
Screening/Administrative
Revised the following text, “Confirmation of prestudy
diagnostic UC biopsy results” in list of
Screening/Administrative activities.
Clarification of
prestudy biopsy
assessment for UC.
1.3 Schedule of
Activities Table 1,
Efficacy assessments,
Footnote bb added
Added “Mayo Patient Diary completed” to list of Efficacy
assessements.
Added footnote “bb: Mayo Patient Diary is completed for
7 continuous days within the 14 days prior to the
screening visit. For the screening visit, the Mayo diary will
be provided at screening and collected at the Week 0
visit.”
Mayo Patient Diary
had been omitted in
error to the SoA list
of efficacy
evaluations; an
explanatory footnote
has been added.
1.3 Schedule of
Activities Table 1, Study
procedures, HIV testing
Footnote cc added
Added footnote for HIV testing: “cc. HIV testing in study
participants who weigh less than 30 kg is not universally
required.  It is required in those study participants who
weigh <30 kg and the birth history is unknown (ie
adopted) or has exposure risks (parents with HIV or
with risk factors) or at the discretion of the study
investigator.  In subjects who weigh <30 kg where testing
would be required, if there is a record of a negative HIV
test at birth this is acceptable at the discretion of the
study physician as long as it is entered into the study
record.”
Added limits on
testing for HIV in the
smallest or youngest
children.
1.3 Schedule of
Activities Table 1
Footnote e
Revised the following text: “Should be performed within 2
weeks prior to the administration of study intervention
at Week 0, within 2 weeks prior to Week 54, and within 7
days prior to study intervention for Week 6. All study
endoscopies (sigmoidoscopy preferred unless
colonoscopy clinically indicated) must be performed with
study software to permit central reads and scoring in
addition to local study scoring. A colonoscopy will
replace a sigmoidoscopy if screening for dysplasia is
required. The Sponsor suggests that at least 48 hours
must elapse between a colonoscopy with polypectomy or
multiple biopsies and the study intervention
administration (Week 0) visit.”
Clarification to
include “prior to” for
Week 54 and
Week 6.
1.3 Schedule of
Activities Table 1
Footnote f
Changed footnote f to read: “Previous assessment must be
consistent with a diagnosis of UC (eg, crypt distortion,
crypt abscess, goblet cell depletion, and continuous
distribution).”
Clarification of
screening biopsy
requirements.
1.3 Schedule of
Activities Table 1
Footnote k
Removed indication for footnote k next to serum pregnancy
test (footnote k is correctly listed for urine pregnancy test).
Editorial correction:
Footnote k was
indicated next to
serum pregnancy
sample in error.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
191
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
1.3 Schedule of
Activities Table 1
Footnote n clarified with
updated information
Revised the following text: “Blood sampling in participants 
with a body weight of 10 kg to 24 kg must be divided 
between visits during the screening period. Contact 
Sponsor for details ofrecommended sampling sequence.” 
Update in blood
sampling scheme to
comply for allowable
blood sample
volumes with the EU
guideline on clinical
trials conducted with
minors (see ref 12).
1.3 Schedule of 
Activities Table 1 
Footnote v added for 
“Blood RNA” 
Updated the following text: “The RNA blood sample 
should not be collected at any time point for any 
participant who at Screening has a body weight of 10 kg 
to <12.3 kg, even if the weight increases to above 12.3 kg 
during the study. For participants who weighed more at 
Screening but whose body weight falls to between 10 kg 
to <12.3 kg, the RNA blood sample should not be 
collected, and blood draws are not to exceed 8.0 mL at 
any one visit for this weight group.”
Update in blood
sampling scheme to
comply for allowable
blood sample
volumes with the EU
guideline on clinical
trials conducted with
minors (see ref 12).
1.3 Schedule of 
Activities Table 1 
Footnote x  
Updated the following text: “x. For additional details, refer 
to Appendix 8 (Section 10.8).” 
Added updated
examples of the
TUMMY-UC and the
Observer TUMMY-
UC questionnaires in
the appendix.
1.3 Schedule of 
Activities Table 3, 
Events 
Revised the following text: “Administration of golimumab 
by self or caregiver; or continued administration at the site, 
if desired” 
Clarification of study
agent to be
administered.
2. Introduction 
Modified the following text: “The remission rate of 
golimumab in these pediatric participants will be formally 
compared with a historical placebo remission rate derived 
from a meta-analysis of 2 adult Phase 2/3 studies of 
golimumab for UC and 5 adult Phase 3 studies of other
products approved for this indication utilizing similar
populations and endpoints.”
Phases of the studies
that contribute to the
meta-analysis were
updated.
2.1 Study Rationale 
Modified the following text: 
“The second study is: 
CNTO148UCO3003 
(this 
study): 
A multicenter, 
randomized, open-label study to assess the efficacy, 
safety, and pharmacokinetics of golimumab treatment in
pediatric participants from 2 to 17 years of age with
moderately to severely active UC.  In this study, the
remission rate on golimumab in these pediatric
participants will be formally compared with a historical
placebo remission rate derived from a meta-analysis of 2
adult Phase 2/3 studies of golimumab for UC and 5
adult Phase 3 studies of other products approved in
this indication utilizing similar populations and
endpoints.”
Phases of the studies
that contribute to the
meta-analysis were
updated.
3.1 Endpoints 
Major Secondary 
Endpoints 
Modified the following bulleted list: 
1. Symptomatic remission at Week 54 
2. Clinical remission at Week 54 as assessed by the Mayo 
score (based on Mayo endoscopy subscore assigned by 
the local endoscopist). 
3. Clinical remission at Week 54 as assessed by the
PUCAI score.
Added symptomatic
remission and clinical
remission (Mayo) at
Week 54 as major
secondary endpoints
and revised the order
and description of all

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
192
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
4. Clinical remission at Week 6 as assessed by the PUCAI 
score. 
5. Clinical response at Week 6 as assessed by the Mayo 
score (based on the Mayo endoscopy subscore assigned
by the local endoscopist). 
6. Endoscopic healing at Week 6 (based on the Mayo 
endoscopy subscore assigned by the local endoscopist). 
7. Endoscopic healing at Week 54 (based on the Mayo
endoscopy subscore assigned by the local endoscopist).
Added the definition of symptomatic remission:
“The efficacy endpoint definitions are as follows:
• Symptomatic remission: Mayo stool frequency
subscore of 0 or 1 and a rectal bleeding subscore of 0.”
major secondary
endpoints to align
with the SAP.
Added definition for
“symptomatic
remission.”
4.1 Overall Design  
Revised the following text: “In this study, the remission rate 
on golimumab in pediatric participants will be formally 
compared with a historical placebo remission rate derived 
from a meta-analysis of 2 adult Phase 2/3 UC studies of 
golimumab and 5 adult Phase 3 studies ofother biologic
products approved in this indication utilizing similar
populations and endpoints. For additional details see
Sections 4.2.1, 9.1, and 9.2.” 
Added the following text regarding participant body weight 
limit: “If a study participant’s weight is not at least 10 kg
at Week 0, or falls below 10 kg after Week 10, the study
intervention must be withheld until their body weight is
≥10 kg.  If they miss 2 consecutive doses of golimumab 
because of body weight below this 10 kg limit, the study 
participant should be withdrawn from the study.” 
Added the following text: “For participants receiving 5-
ASAs at Week 0, the dose must remain stable through
Week 54 (except for weight-based adjustments, as
treatment for a documented UC flare after Week 6, or if
investigator judgment requires dose reduction or
cessation because of toxicity or medical necessity
(Section 6.5.3). For participants receiving
immunomodulators at Week 0, the dose should not be
increased (except for weight-based adjustments) through
Week 6. Although immunomodulators may be discontinued
or the dose reduced at any time during the study, it is
preferred, at the discretion of the investigator, that they be
continued at least through Week 14. For participants
receiving corticosteroids, the steroids may be tapered
beginning at Week 0, although it would be preferable to
delay the stopping of steroids until after the Week 6
evaluation if clinically reasonable. UC-specific medical
therapies (ie, oral/rectal corticosteroids, oral/rectal 5-
aminosalicylate [5-ASA] compounds, or the
immunomodulators 6-MP, AZA, or methotrexate
[MTX]) may not be initiated or their dose increased at any
Phases of the studies
that contribute to the
meta-analysis were
updated.
Addressed issue of
withholding study
intervention from
subjects whose body
weight is NOT at
least 10 kg.
Added information
regarding the use of
UC-specific therapies
during the study or as
rescue medications.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
193
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
time after Week 6 to Week 54 except for weight-based
dose adjustments or unless there is a documented UC
flare and loss ofresponse that makes the subject eligible
for rescue medication (Section 6.5.3). For additional
details regarding UC-specific allowed concomitant
therapies, see Section 6.5.1.”
4.2.1 Historical Placebo 
Revised the following text: “The primary analysis will 
involve a formal statistical comparison to a historical adult 
placebo remission rate derived from a meta-analysis of adult 
2 adult Phase 2/3 UC studies of golimumab and 5 adult 
Phase 3 studies of other products approved in this
indication (for additional details see 9.1 and 9.2) utilizing
similar endpoints (clinical remission as assessed by the
Mayo Score), populations, and methodologies for endpoint
determination (clinical remission as determined by the local
endoscopy).”
“To ensure a robust estimate of the placebo remission rate,
the Sponsor has derived a historical adult placebo
remission rate from a meta-analysis of placebo controlled 2
Phase 2/3 adult UC studies of golimumab and 5 adult Phase
3 studies of other products approved in this indication
utilizing similar populations and endpoints studies that met
the following criteria:”
Phases of the studies
that contribute to the
meta-analysis were
updated.
4.2.3 Biomarker
Collection
Added sentence at end of section: “The RNA blood sample
should not be collected at any time point for any
participant who at Screening has a body weight of 10 kg
to <12.3 kg, even if the weight increases to above 12.3 kg
during the study. For participants who weighed more at
Screening but whose body weight falls to between 10 kg
to <12.3 kg, the RNA blood sample should not be
collected.”
Update in blood
sampling scheme to
comply for allowable
blood sample
volumes with the EU
guideline on clinical
trials conducted with
minors (see ref 12).
4.2.4 Study-Specific
Ethical Design
Considerations
Updated the following text: “For each participant, his or
her parent(s) (preferably both parents, if available) or
legally acceptable representative(s), as required by local
regulations, must give written consent (permission)
according to local requirements after the nature of the
study has been fully explained and before the
performance of any study-related assessments. Assent
must be obtained from children (minors) capable of
understanding the nature of the study, typically
participants 7 years of age and older, depending on the
institutional policies and national/local guidelines.”
Update of text
regarding how
informed consent is
to be obtained from
pediatric participants.
4.2.4 Study-Specific
Ethical Design
Considerations
Revised the following text: “The total blood volume to be
collected is considered to be an acceptable amount of blood
to be collected over this time period from the population in
this study based upon the standard of the American Red
Cross and EU guidelines. Total blood volume to be
collected in this study is in line with the allowable blood
sample volumes described in the EU guideline on clinical
trials conducted with minors (EU Guideline Ethical
Updated reference to
EU guideline on
clinical trials
conducted with
minors (see ref 12).

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
194
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
considerations for clinical trials on medicinal products
conducted with minors (Rev 1; 18 Sep 2017)).12”
5. Study Population 
Revised the following text: “On a case-by-case basis, 
rescreening retesting procedures may exceed the 6-week 
window and will not be considered protocol deviations.” 
Correction from
“rescreening” to
“retesting”.
5.1 Inclusion Criteria 
Criterion 7b, 3) 
Revised the following text: 
“3) If receiving MTX, 6-MP, or AZA compounds, the 
participant must have been taking them for ≥12 weeks 
and on a stable dose for 2 weeks prior to Week 0. If the 
MTX, 6-MP, or AZA have been recently discontinued, 
they must have been stopped for at least 2 weeks prior to 
Week 0.” 
Updated the duration
that a participant
must have been
taking MTX, 6-MP,
or AZA compounds
prior to Week 0
based on expert
advice for pediatric
studies.
5.2 Exclusion Criteria 
Criterion 25 
Have received vedolizumab within 12 weeks 4 months (16 
weeks) of the first study intervention. 
Changed the time
period for exclusion
if a participant has
received
vedolizumab.
5.4 Screen Failures 
Retesting 
Modified the following text: “Retesting can occur at an 
unscheduled visit during the screening phase, as long as this 
is done within the specified screening window of within 6 
weeks (6 weeks may be exceeded on a case-by-case 
basis).”
Clarified whether
specified screening
window can be
exceeded.
6.1 Study Interventions 
Administered 
Infliximab 
Second paragraph of subsection beginning “Additionally…” 
Added a sentence that reads: “At the investigator’s 
discretion a separate blood sample may be obtained and 
submitted to the central laboratory to evaluate
infliximab dose levels and anti-infliximab antibodies (at a
maximum of 2 timepoints at Week 6 or later) to inform
dose escalations.”
Information omitted
in error from protocol
Amendment 1.
6.1 Study Interventions 
Administered 
Usability Assessment 
Substudy  
Revised the following text: “At the North American 
Sponsor identified sites, the participant and/or caregiver 
will have the option to be enrolled in an Usability 
Assessment Substudy at Week 58. At Weeks 62 and 66, 
after self-dosing, the sponsor will collect data on their 
experience using PFS for administrations of golimumab. For 
additional details see Appendix 18 (Section 10.18).” 
Specification for
North American sites
removed to allow for
possibility of
participants from
other countries
joining the substudy.
6.5.1 Concomitant 
Therapy  
Added the following text: “For participants receiving 
5-ASAs at Week 0, the dose must remain stable through 
Week 54 (except for weight-based adjustments, as 
treatment of a documented UC flare after Week 6, or if 
investigator judgment requires dose reduction or
cessation because of toxicity or medical necessity).”
Added the following text: “Immunomodulators (ie, 6-MP,
AZA, or MTX) should not be initiated between Week 0 and
Week 6. For participants receiving immunomodulators at
Week 0, the dose should not be increased (except for
weight-based adjustments) through Week 6.”
Added the following text: “UC-specific medical therapies
(ie, oral/rectal corticosteroids, oral/rectal 5-
aminosalicylate (5-ASA) compounds, or the
immunomodulators 6-MP, AZA, or methotrexate
[MTX]) may not be initiated or their dose increased at
Added information
regarding the use of
UC-specific therapies
during the study or as
rescue medications.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
195
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
any time from Week 6 to Week 54 except for weight-
based dose adjustments or unless there is a documented
UC flare and loss of response that makes the subject
eligible for rescue medication (Section 6.5.3).”
6.5.3 Rescue Medication 
Added the following text: “In the study extension, the 
determination that a subject is in clinical flare will be at 
the discretion of the investigator. However, the basis for 
this determination should be consistent with a partial 
Mayo score of ≥7 and based on the study participant (or
caregiver)-reported stool frequency and degree of rectal
bleeding, as well as a global assessment of UC disease
activity made by a study primary- or sub-investigator.  
These findings supporting a determination of UC disease
flare in the study extension should be recorded in the
study source documents.”
Inserted text
clarifying the basis
for the determination
by the investigator of
when a participant is
experiencing a
clinical flare that
requires rescue
medication.
6.5.3 Rescue Medication 
Added the following text: “UC-specific medical therapies 
(ie, oral/rectal corticosteroids, oral/rectal 5- 
aminosalicylate (5ASA) compounds, or the 
immunomodulators 6-MP, AZA, or methotrexate 
[MTX]) may not be initiated or their dose increased at
any time from Week 6 to Week 54 except for weight-
based dose adjustments or unless there is a documented
UC flare and loss of response that makes the subject
eligible for rescue medication (Section 6.5.1).”
Added the following text: “Participants who flare while
enrolled in the study will be eligible to receive rescue
medication (ie, corticosteroids, 6-MP, AZA, MTX, and/or
5-ASAs) while continuing to receive study intervention
administration as scheduled.”
Added the following text: “Other UC-specific rescue
therapies (ie, rectal corticosteroids, oral/rectal 5-
aminosalicylate (5-ASA) compounds, or the
immunomodulators 6-MP, AZA, or methotrexate
[MTX]) may be initiated or their dose increased at the
discretion of the investigator to manage symptoms in the
setting of a documented UC flare.  The use of rectal
steroids does not count toward the permitted steroid
courses.”
Added the following text: “However, any participant who
uses UC-prohibited medications (Section 6.5.2) or
requires more than 2 courses of corticosteroids (including
budesonide) for UC during the 54-week study will be
discontinued from further administration of study
intervention.”
Added information
regarding the use of
UC-specific therapies
during the study or as
rescue medications.
7.1 Discontinuation of 
Study Intervention  
Added criterion #10 to list for discontinuation: 
10. The participant misses 2 consecutive doses of
golimumab because of body weight below the 10 kg limit.
Addressed the issue
of discontinuing
study intervention in
subjects whose body
weight is below the
10 kg limit.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
196
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
7.1 Discontinuation of
Study Intervention
Discontinuation of a
participant’s study
intervention must be
strongly considered
under the following
conditions:
Added the following text:
1.    Persistent inadequate response or worsening of UC:
a.    In the study extension, the determination that a
subject is in clinical flare will be at the discretion
of the investigator. However, the basis for this
determination should be consistent with a partial
Mayo score of ≥7 (as defined in Section 6.5.3)
and recorded in the study source documents.
b. Participants in clinical flare will be eligible to
receive rescue medication (ie, corticosteroids, 5-
ASA, 6-MP, AZA, MTX, Section 6.5.3 or
infliximab dose escalation Section 6.6) while
continuing to receive study intervention
administration as scheduled.
c.    For participants in the study extension, a clinical
response to rescue therapy will be at the
discretion of the study investigator but should be
consistent with a partial Mayo score of ≤4 based
on participant (or caregiver)-reported stool
frequency and degree of rectal bleeding, as well
as a global assessment of UC disease activity
determined by a study primary- or sub-
investigator. These findings demonstrating a
clinical response should be recorded in the study
source documents. Participants in the study
extension who do not achieve a clinical response
despite rescue medications will be discontinued
from the study interventions and should return
for a final safety visit 16 weeks after the last
administration of study drug.
Participants who are assessed as having
responded to rescue therapy will continue in the
study.
d. After the clinical flare, participants who remain in
the study will continue to be assessed for clinical
flare using the criteria based on the partial Mayo
score. Participants who subsequently meet the
criteria for clinical flare again may receive rescue
medication a second time and be assessed for partial
Mayo an adequate response and managed as
described above.
Inserted text in 1(a)
to describe the basis
for the determination
by the investigator of
a clinical flare that
requires rescue
medication.
Added information in
1(b) regarding the use
of UC-specific
therapies during the
study or as rescue
medications.
Inserted text in 1(c)
to describe the basis
for the determination
by the investigator of
a clinical response
use of rescue
medication.
Deleted text in 1(d)
to improve
readability.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
197
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
8. STUDY
ASSESSMENTS AND
PROCEDURES
Overview
Modified/updated the following text: “All visit-specific
patient-reported outcomes (PRO) assessments should be
conducted/completed after the PUCAI is administered but
before any other tests, procedures, or other consultations for
that visit to prevent influencing participant perceptions.”
Added sentence that reads: “Participants with body weight
of 10 kg to <12.3 kg will not have the RNA blood sample
collected and will have lesser total volume.”
Clarifies when PRO
assessments are to be
conducted/completed.
Update in blood
sampling scheme to
comply with
allowable blood
sample volumes with
the EU guideline on
clinical trials
conducted with
minors (see ref 12).
8. STUDY 
ASSESSMENTS AND 
PROCEDURES  
Study-Specific materials 
The following additions/changes were made to the list in-
text:
“The investigator will be provided with the following:
IFUs
Retesting and rescreening plan
eCRF guidelines
Sample ICF/assent forms
Imaging kit (laptop) and manual”
Clarification of
study-specific
materials to be
supplied to the sites.
8.1 Efficacy Assessments The following changes were made to the bullet in-text:
Tummy-UC and Observer TUMMY-UC
Added the
terminology for
“Observer TUMMY-
UC” questionnaire
for efficacy
assessments listed.
8.1.1. Mayo Score 
Revised the following text:
Mayo scores are calculated using the following:
“1. The stool frequency and rectal bleeding data collected
in a study diary over 7 consecutive days within the 14
days prior to the visit. Stool frequency and rectal
bleeding subscores will be calculated using the
average of the 3 consecutive day period in the diary
closest to the study visit. Refer to the study reference
study binder on how to proceed when a consecutive 3-
day period is not available.”
“3. The results of a sigmoidoscopy or colonoscopy.
Endoscopies are to be performed using study software
and submitted for central review. Scoring for disease
activity based on endoscopic appearance is to be
performed both by the local endoscopist and the central
reviewer. All decisions to initiate (Week 0) or continue
therapy (Weeks 6 and 54) based on mucosal disease
activity will be based on local reads.
Approaches to calculating Mayo and partial Mayo scores
in participants who have missing subscores will be
detailed in the SAP.”
Definitions and use
of Mayo scores and
subscores in
assessments
(including
participants with
missing subscores)
are provided to align
with the SAP.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
198
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
8.1.7.1. TUMMY-UC  
and Observer TUMMY- 
UC  
Revised the following text: “The TUMMY-UC is an  
exploratory noninvasive patient-reported outcome (PRO) 
for the measurement of signs and symptoms for pediatric 
UC which is undergoing validation.32 It is calculated using 
variables listed in Appendix 8 (Section 10.8). It includes 6
components similar to the PUCAI index and ranges from 0
to 56. The Observer TUMMY-UC is for participants under
age 8 and is completed by caregivers.” 
Clarification that
TUMMY-UC is a
“patient-reported”
outcome measure.
Added the
terminology
“Observer”
TUMMY-UC as an
exploratory
evaluation.
8.2.3. Clinical Safety  
Laboratory Assessments 
Added “gamma glutamyl transferase (GGT)” to list in- 
text for serum chemistry panel. 
Information omitted
from section 8.2.3. in
error from protocol
Amendment 1.
8.2.3 Clinical Safety 
Laboratory Assessments 
Added bullet to list that reads: 
“HBV DNA detection will only be performed for 
participants who test positive for core antibody and  
negative for surface antibody.” 
Added the following text to the bullet list that reads:
“Serology for HIV at screening. HIV testing in study
participants who weigh less than 30 kg is not universally
required.  It is required in those study participants who
weigh <30 kg and the birth history is unknown (ie
adopted) or has exposure risks (parents with HIV or
with risk factors) or at the discretion of the study
investigator.  In subjects who weigh <30 kg where testing
would be required, if there is a record of a negative HIV
test at birth this is acceptable at the discretion of the
study physician as long as it is entered into the study
record.”
Information omitted
from section 8.2.3. in
error from protocol
Amendment 1.
Added information
regarding
considerations for
HIV screening in the
smallest or youngest
of participants.
9.2 Criteria for Success 
Revised the following text: “The study will be considered 
successful and the criterion for determining that golimumab  
is effective in the treatment of UC in pediatric participants 
will have been met if the lower limit of the two-sided 90%  
CI for the proportion of golimumab participants in clinical
remission at Week 6 is >10.0% (ie, the upper limit of the
95% CI for the proportion of placebo participants in clinical
remission at Week 6 derived from a meta-analysis of 7 adult
UC studies including 2 adult Phase 2/3 studies of
golimumab for UC and 5 adult Phase 3 studies of other
products approved in this indication utilizing similar
populations and endpoints.”
Phases of the studies
that contribute to the
meta-analysis were
updated.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
199
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
9.4.1 Efficacy Analyses 
Revised the following text: “A formal comparison is only  
planned for the primary endpoint. Summary statistics will be 
provided for all efficacy endpoints. Unless otherwise
specified, all endpoints that involve the Mayo endoscopy 
subscore will be based on the subscore assigned by the local 
endoscopists.” 
Deleted “only” in
first sentence.
Typographical error:
Correction of
“endocopists” to
“endoscopists” in last
sentence.
9.4.1.1 Primary Endpoint Added information to a bullet in the text: 
Had protocol prohibited medication changes including 
increase above the baseline corticosteroid dose due to 
worsening UC (detailed in SAP) 
Modified the following text: “The study will be considered 
successful and the criterion for determining that golimumab 
is effective in the treatment of UC in pediatric participants
will have been met if the lower limit of the two-sided 90% 
CI for the proportion of pediatric golimumab participants in 
clinical remission at Week 6 is greater than the upper limit 
of the 95% CI for the proportion of placebo participants in 
clinical remission at Week 6 (ie, >10.0%) derived from a
meta-analysis of 7 adult UC studies (2 adult Phase 2/3 UC
studies of golimumab and 5 adult Phase 3 studies of
other products approved in this indication utilizing
similar populations and endpoints).”
Revised the bullet to
make it explicit that
steroid doses above
the baseline dose due
to worsening UC are
considered treatment
failure.
Phases of the studies
that contribute to the
meta-analysis were
updated.
9.4.1.2 Major Secondary 
Endpoints 
Modified the following bulleted list: 
1. Symptomatic remission at Week 54 
2. Clinical remission at Week 54, as assessed by the Mayo 
score (based on the Mayo endoscopy subscore assigned 
by the local endoscopist). 
3. Clinical remission at Week 54 as assessed by the PUCAI 
score 
4. Clinical remission at Week 6 as assessed by the PUCAI 
score. 
5. Clinical response at Week 6 as assessed by the Mayo 
score (based on the Mayo endoscopy subscore assigned
by the local endoscopist).
6. Endoscopic healing at Week 6 (based on the Mayo
endoscopy subscore assigned by the local endoscopist).
7. Endoscopic healing at Week 54 (based on the Mayo
endoscopy subscore assigned by the local endoscopist).
Revised the following text:
“Treatment failure rules will be applied as specified in the
primary efficacy analysis. In addition, participants who
use rescue medication for a clinical flare after Week 6
will be considered a treatment failure for endpoints after
Week 6 (detailed in the SAP). Participants who have any
treatment failure events prior to the timepoint of interest will
be considered to not have achieved the endpoints at that
timepoint. These rules will override the response status based
on the Mayo, PUCAI, and endoscopy score.
Participants who do not return for evaluation or have 
insufficient data to calculate their Mayo score or PUCAI 
Score at Week 6 or Week 54 will be considered not to be in 
Added symptomatic
remission and clinical
remission (Mayo) at
Week 54 as major
secondary endpoints
and revised the order
and description of all
major secondary
endpoints to align
with the SAP.
Added a sentence for
a reason for treatment
failure which had
been inadvertently
omitted from the
original protocol.
Revised sentence to
align with SAP for
how participants with

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
200
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
clinical response or clinical remission, and not to have 
endoscopic healing at these timepoints. Participants who 
do not have sufficient data to calculate their stool 
frequency and rectal bleeding subscores at Week 54 will 
be considered to not have achieved symptomatic 
remission at these timepoints. Approaches to participants 
with missing subscores, including those missing an
endoscopy subscore at Week 6 or Week 54, will be
detailed in the SAP.”
missing evaluations
or who have a
missing endoscopy
subscore at Week 6
or Week 54 will be
handled.
9.4.1.3 Other Endpoints
Clinical Remission
Modified the following bulleted list:
Clinical Remission
1. Symptomatic remission at Week 6.
2.  Clinical remission at Week 30, as assessed by the
PUCAI score, for participants who are in clinical
remission at Week 6.
3. Clinical remission at Week 54, as assessed by the
PUCAI score, for participants who are in clinical
remission at Week 6.
4. Clinical remission at Week 54, as assessed by the
Mayo score, for participants who are in clinical
remission at Week 6 (based on Mayo endoscopy
subscore assigned by the local endoscopist).
5. Symptomatic remission at Week 54 for participants
who are in symptomatic remission at Week 6.
6. Corticosteroid-free clinical remission at Week 54, as
assessed by the PUCAI score.
7. Corticosteroid-free clinical remission at Week 54, as
assessed by the Mayo score (based on Mayo endoscopy
subscore assigned by the local endoscopist).
8. Corticosteroid-free 
symptomatic 
remission 
at
Week 54.
9. Remission at Week 6 based on Mayo score less than or
equal to 2, with no individual subsore greater than 1,
a stool frequency subscore of 0, and a rectal bleeding
subscore of 0.
10. Partial Mayo remission at Week 6.
11. Partial Mayo remission at Week 54.
12. Participants who were not receiving corticosteroids
for at least 12 weeks prior to Week 54 and in
symptomatic remission at Week 54.
13. Participants who were not receiving corticosteroids
for at least 12 weeks prior to Week 54 and in clinical
remission at Week 54, as assessed by the Mayo score
(based on Mayo endoscopy subscore assigned by the
local endoscopist).
14. Participants who were not receiving corticosteroids
for at least 12 weeks prior to Week 54 and in clinical
remission at Week 54, as assessed by the PUCAI score.
Partial Mayo remission is defined as a Partial Mayo score
≤2.
Added additional
remission endpoints
to the list. Revised
the order and
description of the
remission endpoints
to align with the
SAP.
Added definition for
Partial Mayo
remission.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
201
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
9.4.1.3 Other Endpoints 
Other Clinical Efficacy 
Endpoints 
Modified the following bulleted list: 
Other Clinical Efficacy Endpoints 
1. Clinical response at Week 54, as assessed by the Mayo 
score (based on Mayo endoscopy subscore assigned by 
the local endoscopist). 
2. Baseline and postbaseline values and the change from
baseline in the Mayo score at Week 6 and at Week 54
(based on Mayo endoscopy subscore assigned by the
local endoscopist).
3. Baseline and postbaseline values in the Mayo
subscores at Week 6 and at Week 54 (based on Mayo
endoscopy subscore assigned by the local endoscopist).
4. Baseline and postbaseline values and the change from
baseline in the PUCAI score through Week 6 and
during the long-term phase through Week 54.
5. Baseline and postbaseline values and the change from
baseline in the Partial Mayo score through Week 6
and during the long-term phase through Week 54.
6. Clinically important change at Week 6 as assessed by
the PUCAI score.
7. Clinically important change at Week 30 as assessed by
the PUCAI score.
8. Clinically important change at Week 54 as assessed by
the PUCAI score.
Revised order and
description of other
clinical efficacy
endpoints to align
with the SAP.
9.4.1.3 Other Endpoints 
Modified the following text: “Additional sensitivity 
analyses in which subjects with friability present on 
endoscopy are considered nonresponders in the analysis 
are detailed in the SAP.”
Exploratory analyses of the TUMMY-UC and the Observer
TUMMY-UC scores and analyses based on different
approaches to handling missing endoscopies at Week 54
will also be performed. Details will be provided in the SAP.
Treatment failure rules will be applied as specified in the 
primary efficacy analysis. Participants who use rescue 
medication for a clinical flare after Week 6 will be 
considered a treatment failure for endpoints after 
Week 6 (detailed in the SAP). For continuous endpoints 
(ie, PUCAI score, Mayo score, partial Mayo score, fecal 
markers and CRP), the same treatment failure rules that will
be applied for the dichotomous efficacy endpoints will also 
be applied to these endpoints. The baseline value will be 
carried forward from the time the treatment failure occurs 
onward. 
Additional analyses
were added and are
detailed in the SAP.
Added terminology
“Observer” for
participants less than
8 years old who use
the TUMMY-UC
questionnaire. Also,
added analyses based
on different
approaches to
missing endoscopies
at Week 54.
Added a sentence for
a reason for treatment
failure which had
been inadvertently
omitted from the
original protocol.
Removed repetition
in the paragraph.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
202
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
9.4.1.3 Other Endpoints 
Modified the following text: “For endpoints beyond Week 6, 
analyses will also be conducted on all golimumab 
participants including partial Mayo responders at 
Week 14 and separately for all infliximab participants 
including partial Mayo responders at Week 14 or 
Week 22. be conducted for participants who are in clinical 
response at Week 6 and also for nonresponders at Week 6, 
who are in partial Mayo response at Week 14.”
Revised text to
clarify which study
intervention treated
participants will be
included in analyses
to be conducted
beyond Week 6.
9.4.1.5 Analyses of 
Study Extension 
Modified the following text: “The change from study  
extension baseline in the PUCAI score, fecal calprotectin, 
CRP, and IMPACT III will be summarized over time.” 
Revised text to
specify which
assessments
compared to baseline
in the study extension
will be summarized.
10.2 Appendix 2: 
Definitions of Inadequate 
Response to or 
Intolerance of 
Corticosteroids, MTX, or 
AZA/6 MP and 
Corticosteroid 
Dependence 
Added text to the following bullets: 
“METHOTREXATE, 6-MERCAPTOPURINE (6-MP) OR 
AZATHIOPRINE (AZA) 
Participants have failed to respond to MTX, 6-MP or AZA if 
they have had evidence of an initial inadequate response, 
recurrent disease, or a relapse despite receiving: 
At least 3 months of therapy before screening on MTX or 
at least 3 months of therapy before screening with 
1 mg/kg/day of 6-MP or 2 mg/kg/day of AZA.
OR
At least 3 months before screening at lower dosage of 6-
MP or AZA when country or local guidelines specify a
different treatment regimen. (In such an event, the country
or local guidelines needs to be included in the source
document).
OR
At least 3 months before screening at a dosage of 6-MP
or AZA confirmed to be therapeutic for the participant
with whole blood thioguanine nucleotide levels
>200 pmol/8 x 108 red blood cells.
OR
At least 3 months before screening at the highest
tolerated dosage due to leukopenia, elevated liver
enzymes, or nausea.”
Added text to clarify
criteria for
determination of
participant failure of
response to MTX, 6-
MP, or AZA
therapies prior to
study screening.
10.5 Appendix .5: 
Pediatric Ulcerative 
Colitis Activity Index
(PUCAI)
Minor typographical corrections were made for consistency 
with the copyrighted version. 
Minor typographical
errors were corrected.
10.8 Appendix 8: 
Examples of the 
TUMMY-UC and 
Observer TUMMY-UC 
Questionnaires 
Added updated examples of the TUMMY-UC and the 
Observer TUMMY-UC Questionnaires (Version 1.9 
23.3.2019). 
Added updated
version of 2 pediatric
ulcerative colitis
assessment
questionnaires.
10.9Appendix 9: 
Prefilled Syringe with 
UltraSafe (PFS) Actual 
Use Data Collection 
Modified the following text: “Approximately the first 15-20 
participants from Sponsor identified sites who choose AHA 
will enter the Usability Assessment Substudy at Week 58 
and complete a PFS Usability Questionnaire at Weeks 62
and 66 after completion of the second and third self- or
caregiver administration visits.”
Deleted reference to
US or North
American sites.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
203
Approved, Date: 11 November 2023
Section number
and Name
Description of Change 
Brief Rationale
10.12 Appendix 12:
Regulatory, Ethical, and
Study Oversight
Considerations
INFORMED CONSENT
PROCESS
Updated the following text: “For each participant, his or
her parent(s) (preferably both parents, if available) or
legally acceptable representative(s), as required by local
regulations, must give written consent (permission)
according to local requirements after the nature of the
study has been fully explained and before the
performance of any study-related assessments. Assent
must be obtained from children (minors) capable of
understanding the nature of the study, typically
participants 7 years of age and older, depending on the
institutional policies and national/local guidelines.”
Update of text
regarding how
informed consent is
to be obtained from
pediatric participants.
10.18 Appendix 18:
Usability Assessment
Substudy
Overview of Substudy
Design
Revised first sentence to read: “The Usability Assessment
Substudy will be conducted at US Sponsor identified sites.”
Specification for US
sites has been
removed to allow for
possibility of
participants from
other countries
joining the substudy.
Throughout the protocol 
Minor grammatical, formatting, or spelling changes were
made.
Minor errors were
noted.
Amendment 1 (27 June 2018)
Overall Rationale for the Amendment: An important exclusion criterion was inadvertently included as
an inclusion criterion. This correction together with other changes to improve structure and readability of
the document have been made.
Section number 
and Name
Description of Change 
Brief Rationale
Section 5.1 Inclusion criteria 
#18 
Has a stool culture or other examination 
positive for an enteric pathogen, including 
Clostridium difficile toxin, in the previous 4 
months, unless a repeat examination is 
negative and there are no signs of ongoing
infection with that pathogen.
This inclusion criterion is an
exclusion criterion and so has
been deleted from Section 5.1,
Inclusion Criteria and moved to
Section 5.2, Exclusion Criteria.
This criterion is the new
exclusion criterion # 34.
The numbering for the
inclusion and exclusion criteria
have been cascaded
appropriately.
Section 5.1 
Inclusion Criteria 
#6 
Prior or current medication for UC 
must include at least 1 of the 
following (Appendix 2 
[Section 10.2]): 
a. Current treatment with at least 1 of
the following therapies: oral or
intravenous corticosteroids, or the
immunomodulators 6-MP, MTX, or
AZA.
OR
b. Have a history of failure to respond
to or tolerate, or have a medical
MTX had been inadvertently
left out of the list of
immunomodulators in inclusion
criteria #6a and #6b.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
204
Approved, Date: 11 November 2023
Section number 
and Name
Description of Change 
Brief Rationale
contraindication to, at least 1 of the
following 
therapies: 
oral 
or
intravenous corticosteroids or the
immunomodulators 6-MP, MTX, or
AZA.
OR
c. Currently have or have had a history
of corticosteroid dependency (ie, an
inability 
to 
successfully 
taper
corticosteroids without a return of
the symptoms of UC).
OR
d. Have required more than 3 courses
of oral or intravenous corticosteroids
in the past year.
Appendix 12 
PUBLICATION 
POLICY/DISSEMINATION 
OF CLINICAL STUDY 
DATA  
The results of the study will be reported in a 
Clinical Study Report (CSR) generated by 
the sponsor and will contain eCRF data
transmitted from a central laboratory, ePRO,
eDiary, and IWRS data from all study sites
that participated in the study into the
sponsor's database, as per protocol.
Recruitment performance or specific
expertise related to the nature and the key
assessment parameters of the study will be
used to determine a coordinating investigator
for the study. Results of pharmacogenomic
and exploratory biomarker analyses
performed after the CSR has been issued will
be reported in a separate report and will not
require a revision of the CSR.
eDiary was deleted from the
paragraph as it will not be used.
Throughout the protocol 
Minor grammatical, formatting, or spelling 
changes were made.
Minor errors were noted

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
205
Approved, Date: 11 November 2023
11. 
REFERENCES
1. 
Akintimehin AO, O’Neill RS, Ring C, et al. Front. Pediar. 2018 Outcomes of a National Cohort of Children
with Acute Severe Ulcerative Colitis. Front Pediatr. 2018; Mar 8;6:48. doi: 10.3389/fped.2018.00048.
eCollection 2018.
2. 
Baldassano RN. Early Aggressive Therapy in Pediatric IBD. Gastroenterol Hepatol (N Y). 2008;4(9):613-615.
3. 
Baron JH, Connell AM, Lennard-Jones JE. Variation between observers in describing mucosal appearances in
proctocolitis. Brit Med J. 1964;1:89-92.
4. 
Ben-Horin S, Kopyloy U, Chowers Y. Optimizing anti-TNF treatments in inflammatory bowel disease.
Autoimmun Rev. 2014;13(1):24-30.
5. 
Bolia R, Rosenbaum J, Schildkraut V, et al. Secondary Loss of Response to Infliximab in Pediatric Crohn
Disease: Does It Matter How and When We Start? J Pediatr Gastroenterol Nutr. 2018;66(4):637-640.
6. 
Braegger CP, Nicholls S, Murch SH, Stephens S, MacDonald TT.  Tumour necrosis factor alpha in stool as a
marker of intestinal inflammation. Lancet. 1992;339(8785):89-91.
7. 
Buderus S, Boone J, Lyerly D, Lentze MJ.  Fecal lactoferrin: a new parameter to monitor infliximab therapy.
Digestive Diseases and Sciences.  2004;49(6):1036-1039.
8. 
Chapparo M, Martinez-Montiel P, Van Domselaar M, et al. Intensification of infliximab therapy in Crohn's
disease: efficacy and safety. J Crohns Colitis. 2012;6(1):62-67.
9. 
Costa F, Mumolo MG, Ceccarelli L, et al.  Calprotectin is a stronger predictive marker of relapse in ulcerative
colitis than in Crohn’s disease.  Gut.  2005;54:364-368.
10. Dunne J, Rodriguez WJ, Murphy MD, et al. Extrapolation of adult data and other data in pediatric drug-
development programs. Pediatrics. 2011;128(5):e1242-1249.
11. Eaden JA, Abrams KR, Mayberry JF.  The risk of colorectal cancer in ulcerative colitis: a meta-analysis.  Gut.
2001;48(4):526-535.
12. EU Guideline: Ethical considerations for clinical trials on medicinal products conducted with minors (Rev 1;
18 Sep 2017). https://ec.europa.eu/health/sites/health/files/files/eudralex/vol 10/2017 09 18 ethical consid ct
with minors.pdf. Accessed 02 Mar 2019.
13. Gibson DJ, Heetun ZS, Redmond CE, et al. An accelerated infliximab induction regimen reduces the need for
early colectomy in patients with acute severe ulcerative colitis. Clin Gastroenterol Hepatol 2015;13(2):330-35
e1.
14. Guerra I and Bermejo F. Management of inflammatory bowel disease in poor responders to infliximab. Clin
Exp Gastroenterol. 2014; 7: 359-367.
15. Hendler SA, Cohen BL, Colombel JF, et al. High-dose infliximab therapy in Crohn's disease: clinical
experience, safety, and efficacy. J Crohns Colitis. 2015;9(3):266-75.
16. Herrinton LJ, Liu L, Lafata JE et al. Estimation of the period and prevalence of IBD among nine health plans
using computerized diagnoses and outparticipant pharmacy dispensing.  Inflamm Bowel Dis. 2007;13:451–
461.
17. Ho S, Church P, Sharma A, et al. Intensification of infliximab induction regimen improves response rate in
steroid-refractory pediatric ulcerative colitis. Gastroenterology 2016;150(4 suppl 1): S131-132.
18. Hyams J, Damaraju L, Blank M, et al.  Induction and maintenance therapy with infliximab for children with
moderate to severe ulcerative colitis.  Clin Gastroenterol Hepatol.  2012;10:391–399.
19. Hyams J, Markowitz J, Lerer T, et al.  The natural history of corticosteroid therapy for ulcerative colitis in
children.  Clin Gastroenterol Hepatol. 2006;4(9):1118-1123.
20. Hyams JS.  Extraintestinal manifestations of inflammatory bowel disease in children.  J Pediatr Gastroenterol
Nutr.  1994:19(1):7-21.
21. Hyams JS, Chan, D, Adedokun, OJ et al Inflamm Bowel Dis. 2017 Dec;23(12):2227-2237.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
206
Approved, Date: 11 November 2023
22. Hyams JS, Markowitz J, Wyllie R.  Use of infliximab in the treatment of Crohn’s disease in children and
adolescents.  J Pediatr.  2000;137(2):192-196.
23. Kane SV, Sandborn WJ, Rufo PA et al.  Fecal lactoferrin is a sensitive and specific marker in identifying
intestinal inflammation.  American Journal of Gasterentology.  2003;98(6);1309-1314.
24. Kayton ML. Cancer and pediatric inflammatory bowel disease. Semin Pediatr Surg. 2007;16(3):205-213.
25. Kelsen J, Baldassano RN.  Inflammatory bowel disease: The difference between children and adults.  Inflamm.
Bowel Dis.  2008;14(S2):S9-S11.
26. Kornbluth A, Sachar DB. Practice Parameters Committee of the American College of Gastroenterology.
Ulcerative colitis practice guidelines in adults: American College OfGastroenterology, Practice Parameters
Committee. Am J Gastroenterol. 2010;105(3):501-523.
27. Kumar S, Ghoshal UC, Aggarwal R, et al.  Severe ulcerative colitis:  prospective study of parameters
determining outcome.  J Gastroenterol Hepatol.  2004;19(11):1247-1252.
28. Loftus CG, Loftus EV Jr, Harmsen WS, et al. Update on the incidence and prevalence of Crohn’s disease and
Ulcerative Colitis in Olmsted County, Minnesota, 1940-2000. Inflamm Bowel Dis.  2007:13:254-261.
29. Loftus EV Jr, Sandborn WJ. Epidemiology of inflammatory bowel disease. Gastoenterol-Clin N Am.
2002;31:1-20.
30. Mackey AC, Green L, Leptak C, Avigan M. Hepatosplenic T cell lymphoma associated with infliximab use in
young participants treated for inflammatory bowel disease: update. J Pediatr Gastroenterol Nutr. 2009;48:386-
388.
31. Maeda M, Watanabe N, Neda H, et al.  Serum tumor necrosis factor activity in inflammatory bowel disease.
Immunopharmacol Immunotoxicol.  1992;14(3):451-461.
32. Marcovitch V, Nissan A, Mack, D, et al. Item Generation and Reduction Toward Developing a Participant-
reported Outcome for Pediatric Ulcerative Colitis (TUMMY-UC). J Pediatr Gastroenterol
Nutr. 2017;64(3):373-377.
33. Mehrotra N, Garnett C, Zhang L, et al. Role of exposure-response analysis to guide dose selection in pediatric
drug development when extrapolating efficacy from adults. IBD Abstracts. 2011;S5-S6.
34. Neurath MF, Fuss I, Pasparakis M, et al.  Predominant pathogenic role of tumor necrosis factor in experimental
colitis in mice.  Eur J Immunol.  1997;27(7):1743-1750.
35. Ng SC, Kamm MA. Therapeutic strategies for the management of ulcerative colitis. Inflamm Bowel Dis.
2009;15(6):935-950.
36. Otley A, Smith C, Nicholas D, et al. The IMPACT questionnaire: a valid measure of health-related quality of
life in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2002 Oct;35(4):557-563.
37. Rosen MJ, Minar P, Vinks AA Review article: applying pharmacokinetics to optimise dosing of anti-TNF
biologics in acute severe ulcerative colitis. Aliment Pharmacol Ther 2015;41(11):1094-1103.
38. Rostholder E, Ahmed A, Cheifetz AS, et al. Outcomes after escalation of infliximab therapy in ambulatory
patients with moderately active ulcerative colitis. Aliment Pharmacol Ther. 2012 Mar; 35(5):562-567.
39. Sauer CG, Kugathasan S.  Pediatric Inflammatory Bowel Disease: Highlighting pediatric differences in IBD.
Gastroenterol Clin North Am. 2009:38(4):611-628.
40. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately
active ulcerative colitis. A randomized study. N Engl J Med.  1987;317(26):1625-1629.
41. Seow CH, Newman A, Irwin SP, et al. Trough serum infliximab: a predictive factor of clinical outcome for
infliximab treatment in acute ulcerative colitis. Gut. 2010; 59(1):49-54.
42. Solem CA, Loftus EV, Tremaine WJ, et al.  Correlation of C-reactive protein with clinical, endoscopic,
histologic, and radiographic activity in inflammatory bowel disease.  Inflamm Bowel Dis.
2005;11(8):707-712.
43. Stenson WF.  Inflammatory bowel disease.  In: Goldman l, Bennett, JC, eds.  Cecil Textbook of Medicine, 21st
ed.  Philadelphia, PA: WB Saunders Co;2000;722-729.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
207
Approved, Date: 11 November 2023
44. Taxonera C, Barreiro-de Acosta M, Calve, M, et al. Infliximab Dose Escalation as an Effective Strategy for
Managing Secondary Loss of Response in Ulcerative. Dig Dis Sci. 2015; 60:3075-3084.
45. Torii H, Nakano M, Yano T, et al. Efficacy and safety of dose escalation of infliximab therapy in Japanese
patients with psoriasis: Results of the SPREAD study. J Dermatol. 2017;44(5):552-559.
46. Truelove SC, Witts LJ. Cortisone in ulcerative colitis: final report on a therapeutic trial.  Brit Med J. 1955;
2:1041-1048.
47. Turner D, Otley A, deBruijne J, et al. Development of a pediatric ulcerative colitis activity index (PUCAI)
[abstract]. J Pediatr Gastroenterol Nutr. 2006;43(4):E47.
48. Turner D, Ruemmele FM, Orlanski-Meyer E, et al. Management of paediatric ulcerative colitis, Part 2: acute
severe colitis; an evidence-based consensus guideline from ECCO and ESPGHAN. J Pediatr Gastroenterol
Nutr. 2018; under review.
49. Turner D. Severe Acute Ulcerative Colitis: The Pediatric Perspective. Dig Dis. 2009;27(3):322-326.
50. Uchida K, Araki T, Inoue M, et al. Poor Catch-up Growth After Proctocolectomy in pediatric participants with
ulcerative colitis receiving prolonged steroid therapy.  Pediatr Surg Int. 2010;26(4):373-377.
51. Ungar B, Mazor Y, WeisshofR, et al. Induction infliximab levels among patients with acute severe ulcerative
colitis compared with patients with moderately severe ulcerative colitis. Aliment Pharmacol Ther
2016;43(12):1293-1299.
52. van Limbergen J, Russell RK, Drummond HE, et al. Definition of phenotypic characteristics of childhood-
onset inflammatory bowel disease. Gastroenterology. 2008; 135(4):1114-1122.
53. Vermeire S, Van Assche G, Rutgeerts P.  C-reactive protein as a marker of inflammatory bowel disease.
Inflamm Bowel Dis.  2004;10(5):661-665.
54. www.cdc.gov/growthcharts. Accessed 01 Mar 2019.

SIMPONI (golimumab)
Clinical Protocol CNTO148UCO3003 Amendment 6
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
208
Approved, Date: 11 November 2023
INVESTIGATOR AGREEMENT
I have read this protocol and agree that it contains all necessary details for carrying out this study. I will
conduct the study as outlined herein and will complete the study within the time designated.
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who
assist in the conduct of this study. I will discuss this material with them to ensure that they are fully informed
regarding the study intervention, the conduct of the study, and the obligations of confidentiality.
Coordinating Investigator (where required):
Name (typed or printed):
Institution and Address:
Signature: 
Date:
(Day Month Year)
Principal (Site) Investigator:
Name (typed or printed):
Institution and Address:
Telephone Number:
Signature: 
Date:
(Day Month Year)
Sponsor's Responsible Medical Officer:
Name (typed or printed): 
Institution: 
Janssen Research & Development
Signature: electronic signature appended at the end of the protocol 
Date:
(Day Month Year)
Note: If the address or telephone number of the investigator changes during the study, written notification will be
provided by the investigator to the sponsor, and a protocol amendment will not be required.
PPD

Signature
User 
Date 
Reason
 
13-Nov-2023
17:06:26
(GMT)
Document Approval
PPD

CONFIDENTIAL – FOIA Exemptions Apply in U.S.
1
Status: Approved,  Date: 20 April 2020
Janssen Research & Development *
Clinical Protocol
COVID-19 Appendix
Protocol Title
A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and 
Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα Monoclonal Antibody, 
Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active 
Ulcerative Colitis
PURSUIT 2
A Study of the Efficacy and Safety of Golimumab in Pediatric Participants
with Moderately to Severely Active Ulcerative Colitis
Protocol CNTO148UCO3003; Phase 3
SIMPONI ®  (golimumab)
*Janssen Research & Development is a global organization that operates through different legal entities in
various countries. Therefore, the legal entity acting as the sponsor for Janssen Research & Development
studies may vary, such as, but not limited to Janssen Biotech, Inc.; Janssen Products, LP; Janssen Biologics,
BV; Janssen-Cilag International NV; Janssen, Inc; Janssen Pharmaceutica NV; Janssen Sciences Ireland
UC; Janssen Biopharma Inc.; or Janssen Research & Development, LLC. The term “sponsor” is used
throughout the protocol to represent these various legal entities; the sponsor is identified on the Contact
Information page that accompanies the protocol.
Status:
Approved
Date:
20 April 2020
Prepared by:
Janssen Research & Development, LLC  
EDMS number:
EDMS-RIM-36445
THIS APPENDIX APPLIES TO ALL CURRENT APPROVED VERSIONS OF PROTOCOL
CNTO148UCO3003 Amendment 3
CNTO148UCO3003  Amendment ITA-3
GCP Compliance: This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory 
requirements. 
Confidentiality Statement
The information provided herein contains Company trade secrets, commercial or financial information that the Company 
customarily holds close and treats as confidential.  The information is being provided under the assurance that the recipient
will maintain the confidentiality of the information under applicable statutes, regulations, rules, protective orders or 
otherwise.
NCT03596645

COVID-19 Appendix
SIMPONI ® (golimumab)
Clinical Protocol CNTO148UCO3003
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
2
Status: Approved,  Date: 20 April 2020
COVID-19 APPENDIX
GUIDANCE ON STUDY CONDUCT DURING THE COVID-19 PANDEMIC
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on 
the conduct of this clinical study due to, for example, self-isolation/quarantine by participants and 
study-site personnel; travel restrictions/limited access to public places, including hospitals; study 
site personnel being reassigned to critical tasks. 
In alignment with recent health authority guidance, the Sponsor is providing options for study 
related participant management in the event of disruption to the conduct of the study. This guidance 
does not supersede any local or government requirements or the clinical judgement of the 
investigator to protect the health and well-being of participants and site staff. If, at any time, a 
participant’s safety is considered to be at risk, study intervention will be discontinued, and study 
follow-up will be conducted.
Scheduled visits that cannot be conducted in person at the study site will be performed to the extent 
possible remotely/virtually or delayed until such time that on-site visits can be resumed. At each 
contact, participants will be interviewed to collect safety data. Key efficacy endpoint assessments 
should be performed if required and as feasible. Participants will also be questioned regarding 
general health status to fulfill any physical examination requirement. 
Every effort should be made to adhere to protocol-specified assessments for participants on study 
intervention, including follow up. Modifications to protocol-required assessments may be 
permitted via COVID-19 Appendix after consultation between the participant and investigator, 
and with the agreement of the Sponsor (see below).
The Sponsor will continue to monitor the conduct and progress of the clinical study, and any 
changes will be communicated to the sites and to the health authorities according to local guidance.  
If a participant has tested positive for COVID 19, the investigator should contact the Sponsor’s 
responsible medical officer to discuss plans for study intervention and follow-up. Modifications 
made to the study conduct as a result of the COVID-19 pandemic should be summarized in the 
clinical study report.

COVID-19 Appendix
SIMPONI ® (golimumab)
Clinical Protocol CNTO148UCO3003
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
3
Status: Approved,  Date: 20 April 2020
ADDITIONAL ELEMENTS, WHERE APPLICABLE:

Certain protocol-mandated visits to the study site may not be possible during the COVID-19 
outbreak. Therefore, temporary measures may be implemented if considered appropriate by 
the Sponsor and Investigator to maintain continuity of participant care and study integrity. 
Certain measures, such as those listed below, may be necessary and should be instituted in 
accordance with applicable (including local) laws, regulations, guidelines, and procedures:
o
remote (eg, by phone / telemedicine) or in-person, off-site (eg, in-home) interactions 
between site staff (or designees) and participants for study procedures e.g. those related 
to safety monitoring / efficacy evaluation / study intervention storage and 
administration (including training where pertinent)
o
procurement of study intervention by participants (or designee) or shipment of study 
intervention from the study site directly to participants for at home administration 
(including the potential for self-administration of study intervention)
o
laboratory assessments using a suitably accredited local laboratory; for selected 
measures (eg, urine pregnancy), home testing may be employed
o
other procedures, eg, imaging, may be conducted at an appropriate facility

Missed assessments/visits will be captured in the clinical trial management system for 
protocol deviations.  Discontinuations of study interventions and withdrawal from the 
study should be documented with the prefix “COVID-19-related” in the case report form 
(CRF).  
o
other relevant study data elements impacted by the pandemic should also be 
documented / labeled as “COVID-19-related” in CRFs and / or other study systems, 
as directed by detailed Sponsor guidance. These may include missed / delayed / 
modified study visits / assessments / dosing, and instances where temporary 
measures such as those above are implemented.  

The Sponsor will evaluate the totality of impact of COVID-19 on collection of key study 
data and additional data analyses will be outlined in study SAP(s). 

Exclusion: a potential participant with the following features will be excluded from 
participating in the study protocol:
o
During the 6 weeks prior to baseline, have had ANY of (a) confirmed SARS-CoV-
2 (COVID-19) infection (test positive), OR (b) suspected SARS-CoV-2 infection 
(clinical features without documented test results), OR (c) close contact with a 
person with known or suspected SARS-CoV-2 infection 

COVID-19 Appendix
SIMPONI ® (golimumab)
Clinical Protocol CNTO148UCO3003
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
4
Status: Approved,  Date: 20 April 2020

Exception: may be included with a documented negative result for a 
validated SARS-CoV-2 test
(i) obtained at least 2 weeks after conditions (a), (b), (c) above (timed from 
resolution of key clinical features if present, e.g. fever, cough, dyspnea)
AND
(ii) with absence of ALL conditions (a), (b), (c) above during the period 
between the negative test result and the baseline study visit 

NOTES on COVID-related exclusion:
1. If a participant is excluded due to recent COVID-19-related features, the reason for 
screen failure should be documented in the case report form under the exclusion 
criterion of having a condition for which participation would not be in the participant’s 
interest or could confound study assessments. 
2. The field of COVID-related testing (for presence of, and immunity to, the SARS-CoV-
2 virus) is rapidly evolving. Additional testing may be performed as part of screening 
and/or during the study if deemed necessary by the investigator and in accordance with 
current regulations / guidance from authorities / standards of care. 

Precaution: for those who may carry a higher risk for severe COVID-19 illness, follow 
guidance from local health authorities when weighing the potential benefits and risks of 
enrolling in the study, and during participation in the study. 

COVID-19 Appendix
SIMPONI ® (golimumab)
Clinical Protocol CNTO148UCO3003
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
5
Status: Approved,  Date: 20 April 2020
INVESTIGATOR AGREEMENT
I have read this protocol and agree that it contains all necessary details for carrying out this study. 
I will conduct the study as outlined herein and will complete the study within the time designated.
I will provide copies of the protocol and all pertinent information to all individuals responsible to 
me who assist in the conduct of this study. I will discuss this material with them to ensure that they 
are fully informed regarding the study intervention, the conduct of the study, and the obligations 
of confidentiality.
Coordinating Investigator (where required):
Name (typed or printed):
Institution and Address:
Signature:
Date:
(Day Month Year)
Principal (Site) Investigator:
Name (typed or printed):
Institution and Address:
Telephone Number:
Signature:
Date:
(Day Month Year)
Sponsor's Responsible Medical Officer:
Name (typed or printed):
Institution:
Janssen Research & Development
Signature:
[electronic signature appended at the end of the protocol]
Date:
(Day Month Year)
Note: If the address or telephone number of the investigator changes during the course of the study, written 
notification will be provided by the investigator to the sponsor, and a protocol amendment will not be required.

Signature
User
Date
Reason
20-Apr-2020
13:42:40
(GMT)
Document Approval
PPD