A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants With Active Psoriatic Arthritis
Phase: PHASE3
Conditions: Arthritis, Psoriatic
Sponsor: Janssen Research & Development, LLC

CONFIDENTIAL – FOIA Exemptions Apply in U.S.
1
Status: Approved,  Date: 04 May 2022
Janssen Research & Development *
Clinical Protocol
Protocol Title
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating 
the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the 
Signs and Symptoms and Inhibiting Radiographic Progression in Participants with Active
Psoriatic Arthritis.
APEX
Short Title
A Study of the Efficacy and Safety of Guselkumab in Participants with Active Psoriatic 
Arthritis
Protocol CNTO1959PSA3004; Phase 3b
AMENDMENT 2
CNTO 1959  (guselkumab)
*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.
United States (US) sites of this study will be conducted under US Food & Drug Administration
Investigational New Drug (IND) regulations (21 CFR Part 312).
Regulatory Agency Identifier Number(s):
IND:  124177
EudraCT No: 2020-004981-20
Status:
Approved
Date:
04 May 2022
Prepared by:
Janssen Research & Development, LLC  
EDMS number:
EDMS-RIM-163298, 3.0
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.
NCT04882098

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSA3004 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
2
Status: Approved,  Date: 04 May 2022
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE
DOCUMENT HISTORY
Document
Date
Amendment 2
04 May 2022
Amendment 1
07 April 2021
Original Protocol
6 January 2021
Amendment 2 (04 May 2022)
Overall Rationale for the Amendment: To clarify timing of radiographs for participants who discontinue 
study intervention prior to Week 24, add high radiographic variability (HRV) stratification information, 
update exclusion criteria for participants who are seropositive for hepatitis C virus (HCV) antibodies, clarify 
start time for recording of concomitant therapies, and update COVID-19 related information.
Section Number
and Name
Description of Change
Brief Rationale
1.3. Schedule of 
Activities;
7.2. Participant 
Discontinuation/ 
Withdrawal from 
the Study; 
8.1.1.6. Imaging 
Evaluation
Table1 (footnote v) and text updated to specify that 
participants who discontinue study intervention 
prior to Week 24 should have radiographs of hands 
and feet performed at Week 24.
Table 1 (footnote v) also updated to specify that 
participants who discontinue study intervention 
prior to Week 24 should return for all visits 
through Week 24. 
To align with a health authority 
recommendation: discontinuation 
of study intervention should not 
change the timing of x-ray, and 
participants who discontinue study 
intervention should remain in the 
study for regularly scheduled visits 
(including Week 24 visit).
4.1. Overall Design
Added detailed stratification criteria for 
participants with and without HRV.
To provide detailed stratification 
criteria per health authority request.
5.2. Exclusion 
Criteria (#38)
Updated exclusion criteria for participants who are 
seropositive for HCV antibodies.
To clarify exclusion criteria 
regarding hepatitis C virus 
screening.
6.8. Concomitant 
Therapy
The timing of start of recording of concomitant 
therapies was updated to “after the time of 
informed consent”.
To provide clarification of the 
recording of concomitant therapies.
6.8.4. Biologic 
Agents, Cytotoxic 
Drugs, JAK 
Inhibitors, or 
Investigational 
Agents
Added text to explain that limited use of a 
biologic/cyotoxic/JAKi/investigational agent for 
COVID treatment may be allowed on a case-by-
case basis and should be discussed with the 
medical monitor. This use does not necessarily 
require permanent study agent discontinuation. 
Such cases should be discussed with Sponsor.
To provide clarification on the 
limited concomitant use of agents
for treatment of COVID-19
infection.
1.1. Synopsis; 
3. Objectives and
Endpoints
Removed “infusion reactions” from Other 
Secondary Endpoint of evaluation of safety.
Typographic update.
1.1. Synopsis;
6.1. Study 
Intervention(s) 
Administered
The dosage level for Arm B in the Description of 
Interventions table was updated to remove an extra 
‘8’: 100 mg at Weeks 0, 4, 8 then q8w.
Typographic correction.
1.3. Schedule of 
Activities
Footnote g updated to specify options for study 
intervention administration available are per local 
regulations.
To accommodate different 
regulations in different 
countries/regions.
4.1. Overall Design;
9.2. Sample Size 
Determination
Added text to allow replacement of participants 
discontinued due to Major Disruption (eg, the 
disruption involving Ukraine and neighboring 
countries/territories beginning 24 February 2022).
To allow replacement of
participants impacted by Major 
Disruption.

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSA3004 Amendment 2
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Status: Approved,  Date: 04 May 2022
Section Number
and Name
Description of Change
Brief Rationale
5.1. Inclusion 
Criteria (#15)
The text description of the spermicidal 
foam/gel/cream/suppository to be used with barrier 
methods of birth control was updated to remove “if 
available in their locale”.
To provide clarification on 
contraception guidance.
5.1. Inclusion 
Criteria (#16)
Removed text referring to description of handling 
of indeterminate TB test results in the full protocol.
Not applicable; this is the full 
protocol.
6.8 Concomitant 
Therapy
Updated text referring to protocol: “full protocol”.
Not applicable; this is the full 
protocol.
6.4. Study 
Intervention 
Compliance
Text added to specify that study intervention 
administrations must be at least 14 days apart.
To provide clarification on the time 
required between study intervention 
administrations.
8.2.6 Electronic 
Columbia-Suicide 
Severity Rating 
Scale
Text describing timing of eC-SSRS assessment at 
screening was updated to “after the joint 
assessment and physician’s global assessment of 
disease activity (after signing informed consent)” 
and for subsequent sC-SSRS the timing was 
updated to prior to all PROs.
To be consistent with the Schedule 
of Activities.
9.3. Population for 
Analysis Sets
Updated definition of the Full Analysis Set: “All 
participants who were randomized in the study and 
received at least one (complete or partial) 
administration of study intervention. This analysis 
set will be used for the efficacy analyses.”
To align with health authority 
recommendations on the analysis of 
study data.
9.3. Population for 
Analysis Sets
Added Modified Full Analysis Set to population 
sets for efficacy analysis.
To provide efficacy analysis 
excluding participants replaced due 
to Major Disruption or Natural 
Disaster.
1.1. Synopsis;
9.4.2. Primary 
Endpoint
Incorporated Major Disruption into the ICEs and 
missing data handling rules.
To account for the disruption 
involving Ukraine and neighboring 
countries/territories beginning 
February 24, 2022.
1.1. Synopsis;
9.4.3. Secondary 
Endpoints
Removed detailed descriptions of secondary 
endpoint analyses.
Detailed analysis description 
relocated to SAP.
10.5. Appendix 5: 
Contraceptive and 
Barrier Guidance
Table title updated to clarify that the examples of 
contraceptives are for female participants.
To provide clarification on 
contraception guidance.
10.9. Appendix 9: 
Study Conduct 
During a Natural 
Disaster
Updated guidance on study conduct during the 
COVID-19 pandemic. 
To clarify the guidance regarding 
study conduct during the 
COVID-19 pandemic.
1.1 Synopsis;
6.1 Study 
Intervention(s) 
Administered
In the Description of Interventions table, 
Group/Arm Names were updated to align with 
treatment group labels in text.
Typographic correction.
8.2.4. 
Electrocardiograms
Updated text describing the timing of ECG: “A 12-
lead electrocardiogram (ECG) will be performed at 
screening as specified in the SoA (Section 1.3)”.
Typographic changes.
1.1 Synopsis
Text regarding Study Population was relocated 
under Overall Design.
To align with the template.
Throughout the 
protocol
Minor grammatical, formatting, or spelling changes 
were made.
Minor errors were noted.

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSA3004 Amendment 2
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Status: Approved,  Date: 04 May 2022
TABLE OF CONTENTS
PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE ............................................................... 2
TABLE OF CONTENTS ............................................................................................................................... 4
LIST OF IN-TEXT TABLES AND FIGURES................................................................................................ 8
1.
PROTOCOL SUMMARY ..................................................................................................................... 9
1.1.
Synopsis........................................................................................................................................... 9
1.2.
Schema .......................................................................................................................................... 19
1.3.
Schedule of Activities (SoA)........................................................................................................... 20
2.
INTRODUCTION................................................................................................................................ 27
2.1.
Study Rationale.............................................................................................................................. 27
2.2.
Background .................................................................................................................................... 27
2.2.1.
Disease Background................................................................................................................... 27
2.2.1.1.
Phase 3 Studies: CNTO1959PSA3001 and CNTO1959PSA3002 ......................................... 28
2.2.1.1.1.
Study design......................................................................................................................... 28
2.2.1.1.2.
Efficacy results ..................................................................................................................... 29
2.2.1.1.3.
Safety results........................................................................................................................ 29
2.3.
Benefit-Risk Assessment ............................................................................................................... 30
2.3.1.
Risks for Study Participation....................................................................................................... 30
2.3.2.
Benefits for Study Participation .................................................................................................. 33
2.3.3.
Benefit-Risk Assessment for Study Participation ....................................................................... 33
3.
OBJECTIVES AND ENDPOINTS ..................................................................................................... 33
4.
STUDY DESIGN ................................................................................................................................ 37
4.1.
Overall Design................................................................................................................................ 37
4.2.
Scientific Rationale for Study Design............................................................................................. 39
4.2.1.
Study-Specific Ethical Design Considerations ........................................................................... 41
4.3.
Justification for Dose...................................................................................................................... 41
4.4.
End of Study Definition................................................................................................................... 43
5.
STUDY POPULATION ...................................................................................................................... 43
5.1.
Inclusion Criteria ............................................................................................................................ 43
5.2.
Exclusion Criteria ........................................................................................................................... 48
5.3.
Lifestyle Considerations................................................................................................................. 53
5.4.
Screen Failures .............................................................................................................................. 54
5.5.
Criteria for Temporarily Delaying Administration of Study Intervention ......................................... 55
6.
STUDY INTERVENTION AND CONCOMITANT THERAPY............................................................ 55
6.1.
Study Intervention(s) Administered................................................................................................ 55
6.1.1.
Combination Products ................................................................................................................ 56
6.2.
Preparation/Handling/Storage/Accountability ................................................................................ 56
6.3.
Measures to Minimize Bias: Randomization and Blinding.............................................................57
6.4.
Study Intervention Compliance...................................................................................................... 59
6.5.
Dose Modification........................................................................................................................... 60
6.6.
Continued Access to Study Intervention After the End of the Study ............................................. 60
6.7.
Treatment of Overdose .................................................................................................................. 60
6.8.
Concomitant Therapy..................................................................................................................... 60
6.8.1.
Non-biologic DMARDs................................................................................................................ 62
6.8.1.1.
Permitted Non-biologic DMARDs ............................................................................................ 62
6.8.1.2.
Prohibited Non-biologic DMARDs and Apremilast .................................................................. 63
6.8.1.3.
Systemic Immunosuppressive Drugs ......................................................................................63
6.8.2.
Corticosteroids............................................................................................................................ 64
6.8.2.1.
Oral Corticosteroids................................................................................................................. 64
6.8.2.2.
Corticosteroids – Intravenous, Intramuscular, or Epidural Administration .............................. 64

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSA3004 Amendment 2
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Status: Approved,  Date: 04 May 2022
6.8.2.3.
Corticosteroids – Intra-articular Injection................................................................................. 64
6.8.2.4.
Corticosteroids – Other Routes of Administration ................................................................... 64
6.8.3.
Nonsteroidal Anti-inflammatory Drugs and Other Analgesics .................................................... 65
6.8.4.
Biologic Agents, Cytotoxic Drugs, JAK Inhibitors, or Investigational Agents ............................. 65
6.8.5.
Complementary Therapies ......................................................................................................... 66
6.8.6.
Topical Therapy and Ultraviolet B Light...................................................................................... 66
6.8.6.1.
Systemic Therapy for Psoriasis............................................................................................... 66
6.8.7.
Vaccinations (Including COVID-19)............................................................................................ 66
7.
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ...............................................................................................67
7.1.
Discontinuation of Study Intervention ............................................................................................ 67
7.1.1.
Liver Chemistry Stopping Criteria............................................................................................... 68
7.2.
Participant Discontinuation/Withdrawal from the Study................................................................. 69
7.2.1.
Withdrawal from the Use of Research Samples.........................................................................70
7.3.
Lost to Follow-up............................................................................................................................ 71
8.
STUDY ASSESSMENTS AND PROCEDURES ...............................................................................71
8.1.
Efficacy Assessments .................................................................................................................... 73
8.1.1.
Psoriatic Arthritis Response Evaluations.................................................................................... 73
8.1.1.1.
Joint Count (Tender and Swollen)........................................................................................... 73
8.1.1.2.
Nonevaluable Joints ................................................................................................................ 74
8.1.1.3.
American College of Rheumatology Response....................................................................... 74
8.1.1.4.
Dactylitis Score........................................................................................................................ 74
8.1.1.5.
Enthesitis Assessments........................................................................................................... 75
8.1.1.6.
Imaging Evaluation .................................................................................................................. 75
8.1.1.7.
Disability Index of the Health Assessment Questionaire......................................................... 76
8.1.1.8.
Minimal Disease Activity.......................................................................................................... 76
8.1.1.9.
Very Low Disease Activity ....................................................................................................... 76
8.1.1.10.
Disease Activity Score 28........................................................................................................ 76
8.1.1.11.
Modified Composite Psoriatic Disease Activity Index .............................................................77
8.1.1.12.
Disease Activity Index for Psoriatic Arthritis ............................................................................ 78
8.1.1.13.
Psoriatic Arthritis Responder Criteria ...................................................................................... 78
8.1.1.14.
Modified Nail Psoriasis Severity Index .................................................................................... 78
8.1.1.15.
Physician’s Global Assessment of Fingernail Psoriasis..........................................................78
8.1.2.
Psoriasis Response Evaluations ................................................................................................ 78
8.1.2.1.
Psoriasis Area and Severity Index .......................................................................................... 78
8.1.2.2.
Investigator’s Global Assessment of Psoriasis........................................................................79
8.1.2.3.
Dermatology Life Quality Index ............................................................................................... 79
8.1.3.
Other Patient Reported Outcomes ............................................................................................. 79
8.1.3.1.
PsA Impact of Disease-12....................................................................................................... 79
8.1.3.2.
Functional Assessment of Chronic Illness Therapy - Fatigue ................................................. 79
8.2.
Safety Assessments....................................................................................................................... 80
8.2.1.
Physical Examinations................................................................................................................ 80
8.2.2.
Vital Signs................................................................................................................................... 80
8.2.3.
Height and Weight ...................................................................................................................... 80
8.2.4.
Electrocardiograms..................................................................................................................... 80
8.2.5.
Clinical Safety Laboratory Assessments .................................................................................... 81
8.2.6.
Electronic Columbia-Suicide Severity Rating Scale ................................................................... 81
8.2.7.
Concomitant Medication Review ................................................................................................ 83
8.2.8.
Injection-Site Reactions.............................................................................................................. 83
8.2.9.
Hypersensitivity Reactions.......................................................................................................... 83
8.2.10.
Infections .................................................................................................................................... 83
8.2.11.
Tuberculosis Evaluations............................................................................................................ 83
8.2.11.1.
Initial Tuberculosis Evaluation................................................................................................. 83
8.2.11.2.
Ongoing Tuberculosis Evaluation............................................................................................ 84
8.2.12.
Pregnancy Testing...................................................................................................................... 85
8.3.
Adverse Events, Serious Adverse Events, and Other Safety Reporting ....................................... 85

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSA3004 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
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Status: Approved,  Date: 04 May 2022
8.3.1.
Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event 
Information.................................................................................................................................. 86
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 and Anticipated 
Events......................................................................................................................................... 87
8.3.5.
Pregnancy................................................................................................................................... 87
8.3.6.
Adverse Events of Special Interest............................................................................................. 88
8.4.
Pharmacokinetics........................................................................................................................... 88
8.4.1.
Evaluations ................................................................................................................................. 88
8.4.2.
Analytical Procedures................................................................................................................. 88
8.4.3.
Pharmacokinetic Parameters and Evaluations...........................................................................88
8.5.
Pharmacogenomics (DNA) Evaluations.........................................................................................89
8.6.
Biomarkers ..................................................................................................................................... 89
8.6.1.
Pharmacodynamics .................................................................................................................... 90
8.6.2.
Serum and Plasma Biomarkers.................................................................................................. 90
8.6.3.
Whole Blood Gene Expression Profile ....................................................................................... 90
8.6.4.
Peripheral Blood Mononuclear Cells .......................................................................................... 90
8.7.
Immunogenicity Assessments ....................................................................................................... 90
8.8.
Health Economics .......................................................................................................................... 91
9.
STATISTICAL CONSIDERATIONS..................................................................................................91
9.1.
Statistical Hypotheses.................................................................................................................... 91
9.2.
Sample Size Determination ........................................................................................................... 91
9.2.1.
Primary Endpoint – ACR 20 Response at Week 24................................................................... 92
9.2.2.
Key Major Secondary Endpoint – Change from Baseline in Modified vdH-S Score at 
Week 24...................................................................................................................................... 92
9.3.
Populations for Analysis Sets ........................................................................................................ 94
9.4.
Statistical Analyses ........................................................................................................................ 94
9.4.1.
General Considerations.............................................................................................................. 94
9.4.2.
Primary Endpoint ........................................................................................................................ 94
9.4.3.
Secondary Endpoints.................................................................................................................. 96
9.4.4.
Safety Analyses .......................................................................................................................... 96
9.4.5.
Other Analyses ........................................................................................................................... 97
9.5.
Interim Analysis.............................................................................................................................. 98
10.
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............................ 99
10.1.
Appendix 1: Abbreviations ............................................................................................................. 99
10.2.
Appendix 2: Clinical Laboratory Tests ......................................................................................... 101
10.3.
Appendix 3: Tuberculin Skin Testing ........................................................................................... 102
10.4.
Appendix 4: Hepatitis B Virus (HBV) Screening with HBV DNA Testing..................................... 104
10.5.
Appendix 5: Contraceptive and Barrier Guidance .......................................................................105
10.6.
Appendix 6: Regulatory, Ethical, and Study Oversight Considerations....................................... 108
10.6.1.
Regulatory and Ethical Considerations .................................................................................... 108
10.6.2.
Financial Disclosure.................................................................................................................. 111
10.6.3.
Informed Consent Process ....................................................................................................... 111
10.6.4.
Data Protection ......................................................................................................................... 112
10.6.5.
Long-Term Retention of Samples for Additional Future Research .......................................... 113
10.6.6.
Committees Structure............................................................................................................... 113
10.6.7.
Publication Policy/Dissemination of Clinical Study Data ..........................................................113
10.6.8.
Data Quality Assurance............................................................................................................ 115
10.6.9.
Case Report Form Completion................................................................................................. 115
10.6.10.
Source Documents ................................................................................................................... 116
10.6.11.
Monitoring ................................................................................................................................. 116
10.6.12.
On-Site Audits........................................................................................................................... 117
10.6.13.
Record Retention...................................................................................................................... 117
10.6.14.
Study and Site Start and Closure ............................................................................................. 118

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSA3004 Amendment 2
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10.7.
Appendix 7: Adverse Events, Serious Adverse Events, Product Quality Complaints, and 
Other Safety Reporting: Definitions and Procedures for Recording, Evaluating, Follow-up, 
and Reporting............................................................................................................................... 119
10.7.1.
Adverse Event Definitions and Classifications ......................................................................... 119
10.7.2.
Attribution Definitions................................................................................................................ 120
10.7.3.
Severity Criteria ........................................................................................................................ 120
10.7.4.
Special Reporting Situations .................................................................................................... 121
10.7.5.
Procedures ............................................................................................................................... 121
10.7.6.
Product Quality Complaint Handling......................................................................................... 122
10.7.7.
Contacting Sponsor Regarding Safety, Including Product Quality........................................... 123
10.8.
Appendix 8: Liver Safety: Suggested Actions and Follow-up Assessments................................ 124
10.9.
Appendix 9: Study Conduct During a Natural Disaster................................................................130
10.10.
Appendix 10: Protocol Amendment History .................................................................................132
11.
REFERENCES................................................................................................................................. 135
INVESTIGATOR AGREEMENT ............................................................................................................... 138

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSA3004 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
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Status: Approved,  Date: 04 May 2022
LIST OF IN-TEXT TABLES AND FIGURES 
TABLES
Table 1:
Core study (from Screening through Week 48)........................................................................ 20
Table 2:
Long term extension ................................................................................................................. 24
Table 3:
Permitted Concomitant Medications for PsA and the Maximum Allowed Doses During 
the Study................................................................................................................................... 61
Table 4:
Protocol Requirements of the Permitted Non-biologic DMARDs ............................................. 62
Table 5:
DAS Response ......................................................................................................................... 77
Table 6:
Statistical Power for Treatment Difference in ACR 20 Response at Week 24......................... 92
Table 7:
Statistical Power for Treatment Difference in Modified vdH-S Change from Baseline at 
Week24 for Guselkumab 100mg q4w vs Placebo (N=250, 350).............................................. 93
Table 8:
Statistical Power for Treatment Difference in Modified vdH-S Change from Baseline at 
Week 24 for Guselkumab 100mg q8w vs Placebo (N=350, 350)............................................. 93

CNTO 1959 (guselkumab)
Clinical Protocol CNTO1959PSA3004 Amendment 2
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
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Status: Approved,  Date: 04 May 2022
1.
PROTOCOL SUMMARY
1.1.
Synopsis
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and 
Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting 
Radiographic Progression in Participants with Active Psoriatic Arthritis.
Guselkumab (TREMFYA®, CNTO 1959) is a fully human immunoglobulin G1 lambda (IgG1λ) 
monoclonal antibody (mAb) that binds to the p19 protein subunit of interleukin (IL)-23 with high affinity. 
By binding to the p19 protein subunit of IL-23, guselkumab blocks the binding of extracellular IL-23 to the 
cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular signaling, activation, and cytokine 
production.
OBJECTIVES AND ENDPOINTS
Objectives
Endpoints
Primary
!
To evaluate the efficacy of guselkumab 
treatment in participants with active 
psoriatic arthritis (PsA) by assessing the 
reduction in signs and symptoms of PsA.
!
Proportion of participants with American College 
of Rheumatology (ACR) 20 response at Week 24
Major Secondary
!
To evaluate the inhibition of progression 
of structural damage in participants with 
active PsA.
!
Change from baseline in PsA modified van der 
Heijde-Sharp (vdH-S) score at Week 24.
Other Secondary 
!
To evaluate the safety in participants 
with active PsA.
!
Frequency and type of adverse events (AEs), 
serious adverse events (SAEs), reasonably related 
AEs, AEs leading to discontinuation of study 
intervention, 
infections, 
and 
injection-site 
reactions.  
!
Laboratory 
abnormalities 
(chemistry, 
hematology), 
maximum 
toxicity 
(Common 
Terminology Criteria for Adverse Events [CTCAE 
5.0]) grades.
!
To evaluate the pharmacokinetics (PK) 
and immunogenicity in participants with 
active PsA.
!
Serum guselkumab concentration.
!
Incidence of antibodies to guselkumab.
Other 
Endpoints Related to Reduction of Signs and Symptoms and Physical Function
!
Proportions of participants who achieve ACR 20, ACR 50, and ACR 70 responses by visit over time 
through Week 156.
!
Proportion of participants who maintain an ACR 20 response at Week 48, Week 96, and Week 156 
among the participants who achieved an ACR 20 response at Week 24.
!
Proportion of participants who maintain an ACR 50 response at Week 48, Week 96, and Week 156 
among the participants who achieved an ACR 50 response at Week 24.

CNTO 1959 (guselkumab)
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Status: Approved,  Date: 04 May 2022
!
Proportion of participants who maintain an ACR 70 response at Week 48, Week 96, and Week 156 
among the participants who achieved an ACR 70 response at Week 24.
!
Change, and percent change from baseline in ACR components by visit over time through 
Week 156.
!
Change from baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) score 
by visit over time through Week 156.
!
Proportion of participants who achieve a clinically meaningful improvement (a ≥0.35 improvement 
from baseline) in HAQ-DI score by visit over time through Week 156 among those participants with 
HAQ-DI score ≥0.35 at baseline.
!
Proportion of participants who maintain a HAQ-DI response (ie, ≥0.35 improvement from baseline 
in HAQ-DI score) at Week 48, Week 96, and Week 156 among the participants who achieved a 
HAQ-DI response at Week 24.
!
Proportion of participants who achieve a Disease Activity Score 28 (DAS28) C-reactive protein 
(CRP) response by visit over time through Week 156.
!
Proportion of participants who achieve a DAS28 (CRP) remission by visit over time through 
Week 156.
!
Change from baseline in DAS28 (CRP) by visit over time through Week 156.
!
Proportion of participants who achieve a response based on modified Psoriatic Arthritis Response 
Criteria (PsARC) by visit over time through Week 156.
!
Proportion of participants with resolution of enthesitis (based on Leeds Enthesitis Index [LEI]) by 
visit over time through Week 156 among the participants with enthesitis at baseline.
!
Change from baseline in enthesitis score (based on LEI) by visit over time through Week 156 among 
the participants with enthesitis at baseline.
!
Proportion of participants with resolution of dactylitis by visit over time through Week 156 among 
the participants with dactylitis at baseline.
!
Change from baseline in dactylitis score by visit over time through Week 156 among the participants 
with dactylitis at baseline.
!
Change from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) scores 
by visit over time through Week 156.
!
Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score by 
visit over time through Week 156.
!
Change from baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) score by visit over 
time through Week 156.
!
Proportion of participants who achieve DAPSA low disease activity by visit over time through 
Week 156. 
!
Proportion of participants who achieve DAPSA remission by visit over time through Week 156.
!
Proportion of participants who achieve minimal disease activity (MDA) by visit over time through 
Week 156.
!
Proportion of participants who achieve very low disease activity (VLDA) by visit over time through 
Week 156.

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Endpoints Related to Skin Disease
!
Proportions of participants who achieve ≥75%, ≥90%, and 100% improvement in Psoriatic Area 
and Severity Index (PASI) score from baseline by visit over time through Week 156 among the 
participants with ≥3% body surface area (BSA) psoriatic involvement and an Investigator’s Global 
Assessment (IGA) score of ≥2 (mild) at baseline.
!
Proportion of participants with a psoriasis response of an IGA (ie, an IGA-psoriasis score of 0 
[cleared] or 1 [minimal] AND ≥2-grade reduction from baseline) by visit over time through 
Week 156 among the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 
(mild) at baseline.
!
Proportion of participants with an IGA score of 0 (cleared) by visit over time through Week 156 
among the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at 
baseline.
!
Change and percent change from baseline in PASI score by visit over time through Week 156 among 
the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
!
Proportion of participants who achieve both PASI 75 and ACR 20 responses by visit over time 
through Week 156 among the participants with ≥3% BSA psoriatic involvement and an IGA score 
of ≥2 (mild) at baseline.
!
Proportion of participants who achieve both PASI 75 and modified PsARC response by visit over 
time through Week 156 among the participants with ≥3% BSA psoriatic involvement and an IGA 
score of ≥2 (mild) at baseline.
!
Proportion of participants who achieve a Dermatology Life Quality Index (DLQI) score of 0 or 1 
by visit through Week 156 among the participants with baseline DLQI score >1 and with ≥3% BSA 
psoriatic involvement and an IGA score of ≥2 (mild) at baseline. 
!
Proportion of participants who achieve ≥5-point improvement from baseline in DLQI score by visit 
through Week 156 among the participants with baseline DLQI score ≥5 and with ≥3% BSA psoriatic 
involvement and an IGA score of ≥2 (mild) at baseline. 
!
Change from baseline in DLQI score by visit through Week 156 among the participants with ≥3% 
BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
Endpoints Related to Psoriasis of the Nails
!
Percent change from baseline in total fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 
score by visit over time through Week 156 among the participants with total fingernail mNAPSI 
score >0 at baseline.
!
Proportions of participants who achieve total fingernail mNAPSI 50/75/100 response by visit over 
time through Week 156 among the participants with total fingernail mNAPSI score >0 at baseline.
!
Proportion of participants who achieve Physician’s Global Assessment of Fingernails Psoriasis
(PGA-F) score of 0 [cleared] or 1 [minimal] AND ≥2-grade reduction from baseline by visit over 
time through Week 156 among the participants with PGA-F score ≥2 at baseline.
Endpoints Related to Joint Structural Damage
!
Change from baseline in modified vdH-S score by visit over time through Week 156.
!
Change in modified vdH-S score from Week 24 to Weeks 48, 96, 156; from Week 48 to Weeks 96 
and 156; and from Week 96 to Week 156.

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!
Change from baseline in modified vdH-S erosion score and joint space narrowing (JSN) score by 
visit over time through Week 156.
!
Change in modified vdH-S erosion score and JSN score from Week 24 to Weeks 48, 96, 156; from 
Week 48 to Weeks 96 and 156; and from Week 96 to Week 156.
!
Change from baseline in modified vdH-S score by region and type of damage (ie, hand erosion, 
hand JSN, foot erosion, foot JSN subscores) by visit over time through Week 156.
!
Proportion of participants with a change of ≤0 from baseline, and proportion of participants with a 
change of ≤0.5 from baseline in modified vdH-S score by visit over time through Week 156.
!
Proportion of participants with a change of ≤0 from baseline, and proportion of participants with a 
change of ≤0.5 from baseline in modified vdH-S erosion score and JSN score by visit over time 
through Week 156.
!
Proportion of participants with radiographic progression (based on the smallest detectable change 
[SDC]) from baseline by visit over time through Week 156.
!
Proportion of participants with radiographic joint erosion progression and radiographic JSN 
progression (based on SDC) from baseline by visit over time through Week 156.
!
Proportion of participants with pencil in cup or gross osteolysis deformities by visit over time 
through Week 156.
Endpoints Related to Health-Related Quality of Life
!
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) 
by visit over time through Week 156. 
!
Proportion of participants who achieve ≥4-point improvement from baseline in FACIT-F score 
improvement by visit over time through Week 156.
!
Change from baseline in PsA Impact of Disease (PsAID)-12 by visit over time through Week 156.
Endpoint Related to Pharmacodynamic effect
!
Change from baseline in serum interleukin (IL-17) cytokines by visit over time through Week 48. 
Hypothesis
The primary hypothesis is that the guselkumab 100 mg every 4 weeks (q4w) group is superior to placebo 
as assessed by the proportion of participants achieving an American College of Rheumatology (ACR) 20
response at Week 24.
OVERALL DESIGN
This is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled, 3-arm study in participants 
with active psoriatic arthritis (PsA) who are biologic naïve and have had inadequate response to current 
standard therapies (eg, disease-modifying antirheumatic drugs [DMARDs]/apremilast, corticosteroids, 
nonsteroidal anti-inflammatory drugs [NSAIDs]).  
Stable doses (as defined below) of concomitant NSAIDs, oral corticosteroids (≤ 10 mg/day prednisone 
equivalent, 
selected 
non-biologic 
DMARDs 
(methotrexate
[MTX], 
sulfasalazine
[SSZ], 
hydroxychloroquine [HCQ], leflunomide [LEF]) will be allowed but are not required.
!
NSAIDs and other analgesics: Maximum marketed dose approved in in the country where the study is 
being conducted

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!
Oral Corticosteroids: Equivalent to 10 mg/day of prednisone
!
Selected non-biologic DMARDs:
∀
MTX:25 mg/week
∀
SSZ: 3 g/day
∀
HCQ: 400 mg/day
∀
LEF: 20 mg/day
STUDY POPULATION
The target study population is participants with active PsA who are biologic naïve and have had an 
inadequate response to standard therapies (eg, non-biologic DMARDs, apremilast, and/or NSAIDs). This 
population is appropriate to provide relevant efficacy and safety information for the intended use of 
guselkumab in PsA. Additionally, a biologic naïve population with ≥2 joints with erosions at baseline is
planned to enrich the population for those more likely to experience radiographic progression and therefore 
increase the power for detection of a treatment effect on radiographic endpoints. 
NUMBER OF PARTICIPANTS
A target of 950 participants will be randomly assigned in this study with 350 participants planned in each 
of the placebo and guselkumab 100 mg every 8 weeks (q8w) groups, and 250 participants in the guselkumab 
100 mg q4w group. 
INTERVENTION GROUPS AND DURATION
Participants who satisfy all inclusion and exclusion criteria will be randomly assigned to one of the 
following 3 treatment groups in a 7:5:7 ratio using permuted block randomization with stratification defined 
by a combined factor of baseline radiographic variability, corticosteroid use, number of joints with erosion, 
and the most recent available C-reactive protein (CRP) value prior to randomization into 4 strata levels 
(high radiographic variability [HRV], no progression [NP], low to moderate progression [LMP], and rapid 
progression [RP]). All participants with HRV will be assigned to the HRV stratum, and the rest of 
participants will be assigned to the other strata based on probability of NP, LMP, and RP.
!
Group I (n=350): Participants will receive subcutaneous (SC) guselkumab 100 mg at Weeks 0, 4, 12, 
20, 28, 36 and 44 and placebo at Weeks 8, 16, 24, 32, 40 and 48 to maintain the blind.
!
Group II (n=250): Participants will receive SC guselkumab 100 mg at Weeks 0, 4, 8, 12, 16, 20, 24, 
28, 32, 36, 40, 44 and 48.
!
Group III (n=350): Participants will receive SC placebo at Weeks 0, 4, 8, 12, 16 and 20, and will 
cross over at Week 24 to receive SC guselkumab 100 mg at Weeks 24, 28, 32, 36, 40, 44 and 48. 
At Week 16, all participants in Groups I, II, and III with <20% improvement from baseline in both tender 
and swollen joint counts will qualify for early escape (EE) and will be allowed to initiate or increase the 
dose of one of the permitted concomitant medications up to the maximum allowed dose, as selected by the 
investigator.
At Week 48, participants who have not discontinued will be eligible to enter a long-term extension (LTE) 
for a period of up to approximately two years (ie, Week 48 through Week 156).
Database locks (DBLs) are scheduled at Weeks 24, 48, 96 and end of study (Week 168). 
The end of study is considered as the last visit for the last participant in the study. 

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Description of Interventions
Group/Arm Name
Group II
Group I
Group III
Intervention Name
Guselkumab
Guselkumab
Placebo
Dose Formulation
Guselkumab 100 mg and matching 
liquid placebo for guselkumab will 
be provided in a single-use prefilled 
syringe (PFS) assembled with the 
UltraSafe PLUSTM Passive Needle 
Guard (PFS-U).
Guselkumab 100 mg and matching 
liquid placebo for guselkumab will 
be provided in a single-use 
prefilled syringe (PFS) assembled 
with the UltraSafe PLUSTM 
Passive Needle Guard (PFS-U).
Unit Dose 
Strength(s)
100 mg
100 mg
Dosage Level(s)
100 mg q4w
100 mg at Weeks 0 and 4, then 
q8w
Route of 
Administration
subcutaneous
subcutaneous
subcutaneous
EFFICACY EVALUATIONS
Efficacy assessments (joint count [tender and swollen], nonevaluable joints, ACR Response, dactylitis 
score, enthesitis assessments, imaging evaluation, Disability Index of the Health Assessment Questionnaire
[HAQ-DI], Minimal Disease Activity [MDA], Very Low Disease Activity [VLDA], Disease Activity Score 
[DAS] 28, modified Composite Psoriatic Disease Activity Index [mCPDAI], Disease Activity Index for 
Psoriatic Arthritis [DAPSA], modified Psoriatic Arthritis Responder Criteria [PsARC], modified Nail 
Psoriasis Severity Index [mNAPSI], Physician’s Global Assessment of Fingernail Psoriasis [PGA-F]) will 
be performed at visits according to the Schedule of Activities.
Psoriasis response evaluations (Psoriasis Area and Severity Index [PASI], Investigator’s Global 
Assessment [IGA] of Psoriasis and Dermatology Life Quality Index [DLQI]) will be performed at visits 
according to the Schedule of Activities.
Patient-reported outcomes (PsA Impact of Disease [PsAID] and Functional Assessment of Chronic Illness 
Therapy - Fatigue [FACIT-F]) will be performed at visits according to the Schedule of Activities.
PHARMACOKINETIC AND IMMUNOGENICITY EVALUATIONS
Venous blood samples will be collected for measurement of serum concentrations of guselkumab and 
antibodies to guselkumab at the time points shown in the Schedule of Activities. Serum samples will also 
be collected at the final visit from participants who discontinue study intervention or were withdrawn from 
the study.
PHARMACOGENOMIC (DNA) EVALUATIONS
Participation in pharmacogenomic research is optional. A pharmacogenomic blood sample will be collected 
from participants who consent separately to this component of the study to allow for pharmacogenomic 
research, where local regulations permit. 
BIOMARKER EVALUATIONS
Biomarker assessments will be made to examine the biologic response to treatment and to identify 
biomarkers that are relevant to guselkumab treatment and/or PsA, where local regulations permit. 

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Assessments may include the evaluation of relevant biomarkers in serum, plasma, and whole blood 
collected as specified in the Schedule of Activities, where local regulations permit.
HEALTH ECONOMICS EVALUATIONS
The Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP):
PsA will be used to study the impact of PsA on work and other daily activities during the past 7 days.
SAFETY EVALUATIONS
Safety assessments (physical examinations, vital sign, height and weight, electrocardiograms, clinical
safety laboratory assessments, suicidal ideation or behavior using the electronic Columbia-Suicide Severity 
Rating Scale [eC-SSRS], concomitant medication review. injection-site reactions, hypersensitivity 
reactions, infections, tuberculosis evaluations and pregnancy testing) will be performed by the investigator 
or designated physician as specified in the Schedule of Activities.
STATISTICAL METHODS
Sample Size Determination
The sample size selection was determined based on the primary endpoint of proportion of participants who 
achieve an ACR 20 response at Week 24 and the major secondary endpoint of change from baseline in 
modified vdH-S score at Week 24. The assumptions are based on the PSA3002 study. 
Primary Endpoint – ACR 20 Response at Week 24
In the PSA3002 study, the ACR 20 response rates at Week 24 were 33.1%, 64.6%, and 63.7%, respectively, 
for the placebo, guselkumab 100 mg SC at Weeks 0, 4, then q8w, and guselkumab 100 mg SC q4w 
treatment groups.  
For this study, assuming a 60% ACR 20 response rate in the guselkumab group and a 35% ACR 20 response 
rate in the placebo group, a sample size of 250 or 350 participants in the guselkumab group and 350 
participants in the placebo group will provide a power of approximately >99% to detect a significant 
treatment difference at a 2-sided significance level of α=0.05 using a 2-sided Chi-square test.  
Key Major Secondary Endpoint – Change from Baseline in Modified vdH-S Score at Week 24
For change from baseline in modified vdH-S score, participants in each treatment group can be considered 
a mixture of two subpopulations: one subpopulation (Spop 1) with a change score of 0 regardless of 
treatment and another subpopulation (Spop2) with a change score sampled from a normal distribution.  
Therefore, the distribution of the vdH-S change scores is determined by 3 parameters: the probability that 
a participant has a change score of 0, the mean of the normal distribution, and the standard deviation (SD) 
of the normal distribution. The overall mean (ie, crude mean) of the change scores for a treatment group is 
the overall average of the change scores among all participants (including both Spops 1 and 2) in that 
treatment group.
In the PSA3002 study, the following statistics were observed for change from baseline in modified vdH-S 
score at Week 24 for each treatment group:
The overall mean (SD) of change from baseline in modified vdH-S score at Week 24 was 0.90 (3.14), 
0.25 (2.52), and 0.45 (2.38) respectively, for the placebo, guselkumab 100 mg q4w, and guselkumab 
100 mg q8w treatment groups. The assumptions for power calculations in this study are based in part on 
these data, adjusted for the difference in enrichment criteria between studies.
For this study, assuming an overall mean (SD) of change from baseline in modified vdH-S score as 
1.13 (3.2), 0.25 (3.1), and 0.45 (3.1) respectively in the placebo, guselkumab 100 mg q4w, and guselkumab 

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100 mg q8w groups, a sample size of 350/250/350 participants (ie, 7:5:7 ratio, 950 in total) will provide a 
power of at least 90% and 80% to detect a significant treatment difference at a 2-sided significance level of 
α=0.05 for guselkumab q4w vs placebo and guselkumab q8w vs placebo comparisons respectively. 
The statistical power for each comparison was estimated based on 10000 simulations with treatment 
comparison performed at each simulation using an analysis of variance (ANOVA) test on the van der 
Waerden normal score. Under these assumptions, the power ranges approximately from 83% to 96% for 
the guselkumab q4w vs placebo comparison, and from 69% to 89% for the guselkumab q8w vs placebo
comparison.
Statistical Analyses
In general, descriptive statistics, such as mean, SD, median, inter quartile range, minimum, and maximum 
for continuous variables, and counts and percentages for discrete variables will be used to summarize most 
data.  
For binary response efficacy endpoints, treatment comparisons will generally be performed using a 
Chi-square test or a Cochran-Mantel-Haenszel (CMH) test. For continuous endpoint of efficacy data, 
treatment comparisons will be performed using an analysis of covariance (ANCOVA), a mixed model for 
repeated measures (MMRM) model or a constrained longitudinal data analysis (cLDA) Model. 
In general, statistical testing will be performed using 2-sided tests. The overall type I error will be controlled 
among the primary and major secondary endpoints at 5%. 
Primary Endpoint
The primary endpoint is the proportion of participants who achieved an ACR 20 response at Week 24. The 
primary analysis of this endpoint will be based on the adjusted composite estimand defined by the 
5 components:
!
Population: Participants with active PsA who are biologic naïve, and were randomized and treated 
with study intervention
!
Treatment: 
∀
Placebo
∀
Guselkumab
!
Variable: ACR20 composite binary response variable at Week 24, where a responder is defined as a 
participant who achieves ACR20 response at Week 24 and does not experience ICE categories 1 to 3.
!
Intercurrent Events (ICEs): ICE categories 1 to 3 will follow the composite strategy, where participants 
who meet them prior to Week 24 will be considered as treatment failures and will be treated as non-
responders regardless of the observed ACR20 response status. The ICE categories 4 and 5 will follow 
the hypothetical strategy postulating a scenario where a Natural Disaster (eg, the Coronavirus Disease 
2019 [COVID-19] pandemic), or Major Disruption (eg, the disruption involving Ukraine and 
neighboring countries/territories beginning 24 February 2022; specific details to be included in the 
statistical analysis plan [SAP]), and ICEs directly resulting from them, did not occur, and observed 
data through Week 24 after meeting these ICEs will not be used and will be assumed to be Missing at
Random (MAR). For participants experiencing multiple ICEs, an ICE in categories 1 to 3 will 
supersede an ICE in categories 4 and 5.
1.
Discontinued study intervention injections due to any reason except due to a Natural Disaster or 
Major Disruption.
2.
Initiated or increased the dose of non-biologic DMARDs (MTX, SSZ, HCQ, LEF) or oral 
corticosteroids over baseline for PsA.

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3.
Initiated protocol prohibited medications/therapies for PsA.
4.
Discontinued study intervention injections due to a Natural Disaster or Major Disruption.
5.
Severe treatment non-compliance (to be defined in the SAP) due to a Natural Disaster or Major 
Disruption.
!
Population level summary: difference in proportion of responders between guselkumab group and 
placebo group.
Data from all participants in the modified full analysis set (mFAS) will be analyzed according to 
randomized treatment group regardless of the treatment actually received. Missing data for any reason other 
than a Natural Disaster or Major Disruption will be considered non-responders, while missing data due to
a Natural Disaster or Major Disruption or data not used due to ICE categories 4 or 5 will be assumed to be
MAR and imputed using multiple imputation (MI). For each guselkumab dose versus placebo comparison, 
a CMH test stratified by the randomization strata levels will be conducted for each imputation set, and the 
Wilson-Hilferty transformation will be applied to the CMH statistics across the imputation sets before 
combining them for the final p-values. The magnitude of the effect will be estimated by the difference in 
ACR 20 response rates between the guselkumab and placebo groups with the 95% confidence interval 
calculated based on Wald statistics.
To evaluate the robustness of the primary endpoint analysis results, the exhaustive scenario tipping point 
sensitivity analyses will be performed by varying the amount of non-responder imputation for missing data. 
Additional sensitivity/supplemental analyses which vary how intercurrent events (eg, alternative estimand) 
are handled, how observed data are used, and how missing data are treated will be specified in the SAP to 
further address the robustness of treatment effect of ACR 20 at Week 24.
Subgroup Analyses
Subgroup analysis will be performed to evaluate consistency in the primary efficacy endpoint by 
demographic characteristics, baseline disease characteristics, and baseline medications. Interaction test 
between the subgroups and treatment group will also be provided if appropriate.
Secondary Endpoints 
The estimand, analysis method, and data handling rules for major secondary endpoints, as well as the 
approach to control the type I error for multiplicity will be specified in SAP.
Safety Analyses
All safety analyses will be made on the Safety Population. Safety data, including but not limited to, adverse 
events (AEs), serious adverse events (SAEs), infections, injection site reactions, hypersensitivity reactions, 
tuberculosis evaluations, pregnancy testing, changes in laboratory assessments and vital signs will be 
summarized.
Other Analyses
Pharmacokinetic Analyses
Serum guselkumab concentrations over time will be summarized for each treatment group using descriptive 
statistics. All concentrations below the lowest quantifiable sample concentration of the assay (BQL) or 
missing data will be labeled as such in the concentration data listing or statistical analysis system dataset. 
The BQL concentrations will be treated as zero in the summary statistics.
Population pharmacokinetics (PK) modeling will be conducted when appropriate. 

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Immunogenicity Analyses
The incidence and titers of antibodies to guselkumab will be summarized for all participants who receive 
at least 1 dose of guselkumab and have appropriate samples for detection of antibodies to guselkumab
(ie, participants with at least 1 sample obtained after their first dose of guselkumab).
The incidence of neutralizing antibodies (NAbs) to guselkumab will be summarized for participants who 
are positive for antibodies to guselkumab and have samples evaluable for NAbs to guselkumab.
Biomarker/Pharmacodynamic Analyses 
The biomarker analyses will be used to understand PsA, characterize the effects of guselkumab to identify
pharmacodynamics (PD) markers and biomarkers relevant to treatment, and to determine if these markers 
can predict response to guselkumab. The biomarker analyses may include but are not limited to serum 
T helper (Th17) cytokines, inflammatory markers, whole blood RNA profile, and other categories of 
biomarkers potentially involved in the development and the progression of PsA.
Pharmacokinetic/Pharmacodynamic Analyses 
If data permit, the relationships between serum concentrations of guselkumab and the efficacy measures 
and/or relevant PD endpoints may be explored when appropriate. If any visual trend is observed, additional 
analyses may be conducted. Analyses results may be summarized in a separate technical report.
Pharmacogenomic Analyses 
Genetic (DNA) analyses may be conducted only in participants who sign the consent form to participate in 
the pharmacogenomic sampling. These analyses are considered exploratory. 
Health Economics Analysis
The change from baseline in impact of disease on work productivity and daily activity via WPAI 
Questionnaire: PsA will be descriptively summarized by treatment group over time and compared between 
treatment groups.

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1.2.
Schema
Schematic Overview of the Study

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Footnotes: 
a: The screening visit is to occur within 6 weeks prior to administration of study intervention at Week 0. The screening visit may be completed in a single visit or may 
be divided into more than 1 visit. It is recommended that after obtaining informed consent, the investigator complete all laboratory tests at the first visit. The 
participant may then return for the remainder of the screening procedures only if the participant is eligible for the study, as determined by the central laboratory test 
results. Every effort to complete screening in 6 weeks should be made; If additional time (up to 2 weeks) is needed a discussion with Sponsor/designee is required. 
b: All post-baseline visits up to and including Week 24 will have a visit window of ±4 days counting from Week 0 as Day 1. After Week 24, all visits will have a visit 
window of ±7 days.
c: Participants must fast (ie, no food or beverages [except water]) for at least 8 hours before blood is drawn for the lipid panel (Week 0). All other visits can be 
nonfasting.
d: If a participant discontinues study drug intervention, they should be encouraged to return for all remaining core study visits; It is particularly important to return for 
all visits through Week 24. If a participant discontinues study intervention at or after Week 24 and is unable to return for all visits through Week 48, the final 
efficacy visit should occur at the time of discontinuation or as soon as possible and all assessments under the Week 48/final efficacy should be performed including 
radiographs of hands and feet (refer to footnote v below), with the exception of study intervention administration. The participant should also return for a final safety 
visit approximately 12 weeks after the last study intervention administration.
e: Must be signed before first study-related activity. 
f:
To participate in the optional DNA research component of this study, participants must sign the DNA research ICF indicating willingness to participate. Blood 
samples for pharmacogenomic and epigenetic research will be collected only from participants who give informed consent for DNA research. 
g: Study intervention will be administered q4w SC at the site by a health care professional during visits to the site until the participant (or caregiver) is trained for 
self-administration. Study intervention will be administered by site personnel at Weeks 0 and 4. Beginning at Week 8, at the discretion of the investigator and 
participant, and after appropriate and documented training, participants may self-administer study intervention at the investigative site under the supervision of a 
health care professional. A caregiver may also be trained to administer study intervention. Safety and efficacy assessments, including blood samples for clinical 
laboratory and pharmacokinetics/immunogenicity, should be performed prior to study intervention administration. At any time point, where there is no study visit, 
participants have the option to come to the site for study intervention administration or may self- administer or can have another health care provider or a caregiver 
administer at home per local regulations.
h: PsA evaluations for arthritis include joint assessments (swollen and tender joint counts), patient’s assessment of pain, patient’s global assessment of disease activity 
(arthritis), and physician’s global assessment of disease activity on VAS. These procedures should be performed prior to study intervention administration at each 
visit, as applicable.
i: All participant questionnaires should be completed before any other tests, procedures, or evaluations on the day of the visit for baseline and post-baseline visits.
j:
Vital signs include blood pressure and heart rate.
k: 12-lead ECG must be done prior to the first administration of study intervention.
l:
The chest radiograph may be taken within 3 months prior to the first administration of study intervention.
m: 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.  
n: Females of childbearing potential must have a negative serum pregnancy test prior to randomization and a negative urine pregnancy test at all dosing visits prior to 
administration of study intervention.
o: Laboratory tests are listed in Section 8.2.5. 
p: A tuberculin skin test is additionally required if the QuantiFERON®-TB test is not approved/registered in the country in which this study is being conducted, with the 
exception noted in Inclusion Criterion 16. All participants will undergo QuantiFERON®-TB testing. If the QuantiFERON®-TB test is not approved/registered in the 
country in which this protocol is being conducted or the tuberculin skin test is mandated by local health authorities, a negative tuberculin skin test result is also 

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required. The frequency of TB testing can be increased depending on local health authority requirements. In Ukraine, while the QuantiFERON®-TB test is not 
approved/registered, it is accepted, and a tuberculin skin test is not required.
q: This test is optional. It can be done if needed to confirm whether CASPAR criteria are met. 
r:
Prior to randomization, FSH is only required for female participants with amenorrhea for less than 12 months. Two FSH measurements are needed to confirm 
amenorrhea in these participants. This test should NOT be done for any female participant of childbearing potential or female participants with amenorrhea for at 
least 12 months. 
s: All blood samples must be collected before study intervention administration at visits when a study intervention administration is scheduled. Blood collected from
one venipuncture will be divided into multiple aliquots of serum for the measurement of guselkumab concentration, antibodies to guselkumab, and a back-up sample. 
t:
The pharmacogenomic (DNA) sample should be collected at the specified time point; however, if necessary, it may be collected at a later time point without 
constituting a protocol deviation.
u: To minimize unnecessary x-rays, it is recommended that participants have the baseline radiographs of hands and feet taken after the inclusion and exclusion criteria 
have been checked and the participant appears eligible to enter the study. All eligible participants should have radiographs taken approximately 2 weeks but not 
greater than 4 weeks prior to randomization.
v: Week 24 radiographs should be taken within ±2 weeks of the Week 24 visit. For participants who discontinue study intervention prior to Week 24, radiographs of 
the hands and feet should be performed at the Week 24 visit. The participants should make every effort to return to the study site for all visits through Week 24 
despite the early discontinuation. 
w: This final safety visit/Week 60 is for participants who do not enter long term extension. Visit window is +/- 14 days.
x: PBMCs will be collected at sites where logistically feasible.
y: Study intervention administration at Week 48 (final [core study] efficacy visit) will be considered part of the LTE and is captured in the LTE SoA (Table 2).
z: Only performed for participants who are dosed at the site.
aa. The eC-SSRS should be performed after the joint assessment and physician’s global assessment of disease activity at the screening visit (after signing informed 
consent). At Week 0/baseline and at all post-baseline visits, the eC-SSRS should be the first assessment/questionnaire that the participant completes prior to study 
intervention administration.
ab. The frequency of HIV testing can be increased depending on local health authority requirements.
ac. At Week 16, all subjects who qualify for early escape will continue on the dosing regimen they were randomized to and will be allowed to initiate or increase the 
dose of one of the permitted concomitant medication interventions up to the maximum dose as specified in Table 3, at the discretion of the investigator. Titration to a 
stable dose of the medication should be completed for subjects qualifying for early escape by the Week 24 visit.
Abbreviations:
AEs = adverse events; BSA = body surface area; CASPAR = ClASsification criteria for Psoriatic Arthritis; CRP = C-Reactive protein; 
DLQI = Dermatology Life Quality Index; DNA = deoxyribonucleic acid; ECG = electrocardiogram; eC-SSRS=electronic Columbia-Suicide Severity Rating Scale;
EDTA = ethylenediaminetetraacetic acid; FACIT = Functional Assessment of Chronic Illness Therapy; FSH = follicle stimulating hormone; HAQ-DI = Disability 
Index of the Health Assessment Questionnaire; HIV = human immunodeficiency virus; ICF = informed consent form; IGA = Investigator’s Global Assessment; LEI 
= Leeds Enthesitis Index; LTE = Long-term extension; mNAPSI = modified Nail Psoriasis Severity Index; PASI = Psoriatic Area and Severity Index; PGA-
F = Physician’s Global Assessment of Fingernails Psoriasis; PBMC = peripheral blood mononuclear cell; PsA = Psoriatic Arthritis; PsAID = Psoriatic Arthritis
Impact of Disease; q4w =every 4 weeks; RNA = ribonucleic acid; SC=subcutaneous; TB = tuberculosis; VAS = visual analogue scale; WPAI = Work Productivity 
and Activity Impairment.

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m: Only performed for participants who are dosed at the site.
n: The eC-SSRS should be performed after the joint assessment and physician’s global assessment of disease activity at the screening visit (after signing informed 
consent). At Week 0/baseline and at all post-baseline visits, the eC-SSRS should be the first assessment/questionnaire that the participant completes prior to study 
intervention administration.
Abbreviations:
AEs = adverse events; CRP = C-Reactive protein; DLQI = Dermatology Life Quality Index; DNA = deoxyribonucleic acid; eC-SSRS=electronic 
Columbia-Suicide Severity Rating Scale; FACIT = Functional Assessment of Chronic Illness Therapy; HAQ-DI = Disability Index of the Health Assessment 
Questionnaire; IGA = Investigator’s Global Assessment; LEI = Leeds Enthesitis Index; LTE = Long-term extension; mNAPSI = modified Nail Psoriasis Severity 
Index; PASI = Psoriatic Area and Severity Index; PGA-F = Physician’s Global Assessment of Fingernails Psoriasis; PBMC = peripheral blood mononuclear cell; 
PsA = Psoriatic Arthritis; PsAID = Psoriatic Arthritis Impact of Disease; q4w =every 4 weeks; RNA = ribonucleic acid; SC=subcutaneous; TB = tuberculosis; VAS 
= visual analogue scale; WPAI = Work Productivity and Activity Impairment.

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2.
INTRODUCTION
Guselkumab (TREMFYA®, CNTO 1959) is a fully human immunoglobulin G1 lambda (IgG1λ) 
monoclonal antibody (mAb) that binds to the p19 protein subunit of interleukin (IL)-23 with high 
affinity. By binding to the p19 protein subunit of IL-23, guselkumab blocks the binding of 
extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-mediated intracellular 
signaling, activation, and cytokine production.
The clinical development program for guselkumab includes completed, ongoing or planned studies 
in adult participants with psoriatic arthritis (PsA), psoriasis, lupus nephritis, inflammatory bowel 
disease, rheumatoid arthritis, palmoplantar pustulosis, generalized pustular psoriasis, 
erythrodermic psoriasis and familial adenomatous polyposis, giant cell arteritis, hidradenitis 
suppurativa as well as psoriasis in pediatric participants.
For the most comprehensive nonclinical and clinical information regarding guselkumab, refer to 
the latest version of the guselkumab Investigator's Brochure (IB).
The term “study intervention” throughout the protocol, refers to study drug.
Studies “PSA3001” and “PSA3002” throughout this protocol, refers to “CNTO1959PSA3001 
[DISCOVER 1]” and “CNTO1959PSA3002 [DISCOVER 2]” 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
Based on the results of the PSA3001 and PSA3002 studies, guselkumab is the first IL-23 inhibitor 
approved for use in patients with active PsA, offering an alternative to currently used biologics 
and conventional and targeted synthetic disease-modifying antirheumatic drugs (DMARDs). 
Guselkumab doses of 100 mg subcutaneous (SC) at Weeks 0, 4 and every 8 weeks (q8w) or every 
4 weeks (q4w) produced clinically meaningful benefit on the improvement in the signs and 
symptoms of PsA. Additionally, less progression as measured by van der Heijde-Sharp (vdH-S) 
score was observed in both dose groups (q4w and q8w) compared to placebo in the PSA3002
study. However, only the q4w dose demonstrated a statistically significant change in vdH-S score 
compared with placebo at Week 24. Therefore, the current study is intended to provide additional 
data on impact of different guselkumab doses on signs and symptoms and on radiographic 
progression in patients with active PsA.
2.2.
Background
2.2.1.
Disease Background
Psoriatic arthritis is a chronic inflammatory arthropathy of the peripheral and axial joints that 
affects approximately 0.02% to 0.25% of the general population (Setty 2007). In patients with 
psoriasis, the prevalence of PsA ranges from 6% to 48%; however, arthritis is not correlated with 
extent of psoriasis skin disease (Gladman 2009). Psoriatic arthritis is a multi-faceted disease that 

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impacts the joints, soft tissues, and skin, all of which affect quality of life (Gladman 1987; Ritchlin 
2008). The burden of disease can be severe, with some patients developing destructive arthritis 
leading to bony erosion and loss of joint architecture; some patients require surgical intervention 
to alleviate pain and restore function of severely damaged joints (Zangger 1998). Psoriatic arthritis 
not only results in functional impairment and reduced quality of life, but is associated with 
premature mortality (Gladman 1998; Sokoll 2001; Torre 1991; Wong 1997).
Clinical Studies
Guselkumab has been approved for the treatment of adult patients with chronic moderate to severe 
plaque psoriasis in the United States (US), European Union (EU), and other countries worldwide. 
The approved dose of guselkumab for the treatment of plaque psoriasis is 100 mg administered 
SC at Week 0, Week 4, and q8w thereafter. This was primarily based on two large, Phase 3, 
placebo-controlled clinical Studies CNTO1959PSO3001 and CNTO1959PSO3002 in participants 
with moderate to severe plaque psoriasis.
The clinical development program for guselkumab in the treatment of active PsA includes a 
completed Phase 2 global Study CNTO1959PSA2001 [hereafter referred to as PSA2001]) and two 
Phase 3 global Studies PSA3001(completed) and PSA3002 (ongoing).
For Studies PSA3001 and PSA3002, results obtained through Week 24 demonstrated favorable 
efficacy and safety profiles for both the guselkumab 100 mg q4w and q8w dose regimens for the 
treatment of active PsA. These results have led to the approval of guselkumab to treat adult patients 
with active PsA in several countries.
The study design, preliminary efficacy and safety results for Studies PSA3001 and PSA3002 are 
presented in Section 2.2.1.1. For the most comprehensive clinical information regarding 
guselkumab, refer to the latest version of the guselkumab IB.
2.2.1.1.
Phase 3 Studies: CNTO1959PSA3001 and CNTO1959PSA3002
2.2.1.1.1.
Study design
PSA3001 and PSA3002 had similar study designs. Some differences in study population, sample 
size, and study duration, reflected the additional study objective in PSA3002 to assess the efficacy 
of guselkumab on the inhibition of progression of radiographic structural damage.
The completed PSA3001 and ongoing PSA3002 studies are global, multicenter, randomized, 
double-blind, placebo-controlled, 3-arm studies of guselkumab in participants with active PsA who 
had inadequate response to standard therapies (eg, non-biologic DMARDs, apremilast, or 
nonsteroidal anti-inflammatory drugs [NSAIDs]). Both studies included a screening phase of up 
to 6 weeks and a treatment period including a placebo-controlled period from Week 0 to Week 24, 
and both have an active treatment period that began at Week 24 and a safety follow-up period of 
12 weeks after the last administration of study treatment. Stable doses of concomitant NSAIDs, 
oral corticosteroids, and selected DMARDs (limited to methotrexate [MTX], sulfasalazine [SSZ], 
hydroxychloroquine [HCQ], and leflunomide [LEF]) were allowed but not required.

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The PSA3001 study allowed approximately 30% of participants who had prior exposure to 
anti-tumor necrosis factor (TNF)-α agents to enroll, ie, participants who had been previously 
treated with up to 2 anti-TNFα agents. In the PSA3002 study, participants were required to be 
naïve to biologic agents. A higher C-reactive protein (CRP) and joint count was requirement for 
enrollment in PSA3002, listed below, which was intended to enrich the population for participants 
at greater risk for structural damage progression so that the impact of guselkumab on radiographic 
parameters could be assessed:
!
PSA3001: ≥3 swollen joints and ≥3 tender joints at screening and baseline, and 
CRP ≥0.3 mg/dL at screening
!
PSA3002: ≥5 swollen joints and ≥5 or more tender joints at screening and baseline, and 
CRP ≥0.6 mg/dL at screening
2.2.1.1.2.
Efficacy results
Through Week 24
The guselkumab 100 mg q4w and q8w dose regimens demonstrated efficacy in improving articular 
manifestations of PsA and psoriasis, physical function, enthesitis, dactylitis and health-related 
quality of life (HRQoL). Results from the assessment of the change from baseline in total modified 
vdH-S score at Week 24 demonstrated significant inhibition of structural damage in participants 
treated with the guselkumab 100 mg q4w dose regimen compared with those in the placebo group 
that was statistically significant based on both the global (ex-US) and US-specific multiplicity 
testing procedures. Refer to the latest version of the guselkumab IB for detailed efficacy results of 
PSA3001 and PSA3002 through Week 24.
Through Week 52
The results of PSA3001 and PSA3002 studies (from Week 24 through Week 52) demonstrated 
that guselkumab 100 mg SC q8w and guselkumab 100 mg SC q4w were both effective in the 
maintenance of clinical responses through 1 year in the 3 major manifestations of psoriatic disease 
(joint, soft tissue, and skin), and physical function and HRQoL improvement in adults with active 
PsA. In the PSA3002 study, inhibition of radiographic progression as measured by mean change 
in total modified vdH-S was also maintained post Week 24 through Week 52 (0.62) compared to 
baseline to Week 24 (0.46) in the guselkumab 100 mg q4w group.
2.2.1.1.3.
Safety results
Through Week 24
Refer to the latest version of the guselkumab IB for detailed safety results of PSA3001 and 
PSA3002.
Through Week 52
Focusing on the pooled data (through 60 weeks for PSA3001 and through 52 weeks for PSA3002), 
guselkumab 100 mg SC administered at Weeks 0 and 4 and then q8w or q4w was well tolerated 

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in participants with active PsA through 1 year of treatment, and the guselkumab safety profile in 
the PsA population was generally comparable with that established in the psoriasis population.
Through 1-year, similar proportions of participants in the guselkumab q8w and q4w groups 
experienced adverse events (AEs), serious adverse events (SAEs), AEs leading to study 
discontinuation, AEs with severe intensity, infections, serious infections, and injection-site 
reactions. Frequencies of events of suicidal ideation, malignancy, and major adverse 
cardiovascular event were low and comparable in the guselkumab q8w and q4w groups. There 
were no events of opportunistic infections, active tuberculosis (TB), anaphylaxis or serum sickness 
reactions, or suicidal behavior or self-injurious behavior without suicidal intent in 
guselkumab-treated participants in either of the PSA3001 or PSA3002 studies through 1 year. The 
proportion of participants experiencing increases in transaminases was slightly higher in the 
guselkumab q4w group compared with the q8w group. 
In addition, the number of participants with AEs, SAEs, AEs leading to discontinuation of study 
intervention, infections, and serious infections per 100 subject-years of follow-up were generally 
comparable between the guselkumab 100 mg q8w and q4w groups through 1 year and the 
placebo-controlled period through Week 24.
2.3.
Benefit-Risk Assessment
More detailed information about the known and expected benefits and risks of guselkumab may 
be found in the IB.
2.3.1.
Risks for Study Participation
Potential Risks of 
Clinical 
Significance
Summary of Data/
Rationale for Risk
Mitigation Strategy
Potential Risks Due to Study Intervention Guselkumab
Serious infections 
and reactivation of 
latent infections
Available animal and human data 
suggest that blockade of interleukin 
(IL)-23 may be associated with an 
increased infection risk.
•
Participants with a history of, or ongoing, 
chronic or recurrent infectious disease, 
including human immunodeficiency virus 
(HIV), Hepatitis B virus (HBV) or
Hepatitis C virus (HCV), will be excluded 
from the study. Similarly, participants with 
evidence of active or untreated latent 
tuberculosis (TB) will be excluded from 
the study (Section 5.2).
•
Participants who have received a live viral 
or bacterial vaccination within 12 weeks of 
baseline will be excluded from the study. 
In addition, participants must agree not to 
receive a live viral or live bacterial
vaccination during the study and for 12 
weeks after receiving the last dose of study 
intervention (Section 5.2).
•
Participants will be instructed to seek 
medical attention if they develop signs or 
symptoms suggestive of an infection, and 

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Potential Risks of 
Clinical 
Significance
Summary of Data/
Rationale for Risk
Mitigation Strategy
investigators are instructed in the protocol 
to monitor for signs or symptoms of 
infections, including TB (Sections 8.2.10
and 8.2.11). 
•
Discontinuation of a participant’s study 
intervention must be strongly considered if 
the participant develops a serious 
infection, including but not limited to 
sepsis or pneumonia. In addition, any 
serious infection should be discussed with 
the medical monitor or designee, and study 
intervention should be withheld until the 
clinical assessment is complete 
(Section 7.1).
Hypersensitivity 
reactions, including 
serious 
hypersensitivity 
reactions
Serious hypersensitivity reactions 
including anaphylaxis have been 
reported in postmarketing experience 
with guselkumab in psoriasis patients.
•
Participants with known allergy, 
hypersensitivity, or intolerance to 
guselkumab or its excipients will be 
excluded from the study (Section 5.2).
•
Sites are instructed that before any 
administration of study intervention, 
appropriately trained personnel and 
medications (eg, injectable epinephrine) 
must be available to treat hypersensitivity 
reactions, including anaphylaxis. In 
addition, all participants must be observed 
carefully for signs and symptoms of a 
hypersensitivity reaction (eg, urticaria, 
pruritis, angioedema, wheezing, dyspnea, 
or hypotension) (Section 8.2.9).
•
Any participant who develops a serious 
hypersensitivity reaction such as 
anaphylaxis must discontinue study 
intervention (Section 7.1).
Malignancy
The preponderance of preclinical data 
suggests that blockade of endogenous 
IL-23 would not be detrimental and 
may in fact be beneficial in tumor 
immunosurveillance and host 
protection; however, a risk of 
malignancy cannot be excluded.
•
Those participants who currently have a 
malignancy or have a history of 
malignancy within 5 years prior to 
screening (with exceptions noted in 
Section 5.2) will be excluded from the 
study. Additionally, participants who have 
a history of lymphoproliferative disease, 
including lymphoma; a history of 
monoclonal gammopathy of undetermined 
significance or signs and symptoms 
suggestive of possible lymphoproliferative 
disease, such as lymphadenopathy or 
splenomegaly will be excluded from the 
study (Section 5.2). 
•
During the conduct of the study, 
participants will undergo regular clinical 
monitoring including routine safety labs to 
assess for any changes in health status that 
may indicate a possible malignancy.

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Potential Risks of 
Clinical 
Significance
Summary of Data/
Rationale for Risk
Mitigation Strategy
•
Participants who develop a malignancy 
during the study (with the exception of no 
more than 2 localized basal cell skin 
cancers that are treated with no evidence 
of recurrence or residual disease) will be 
discontinued from study intervention 
(Section 7.1).
Liver injury
A serious adverse event (SAE) of 
‘toxic hepatitis’ was reported in the 
ongoing Phase 2/3 guselkumab 
Crohn’s disease (CD) program in a 
participant who received guselkumab 
 intravenous (IV) at Weeks 0, 
4, and 8, and 
 subcutaneous 
(SC) at Week 12. Based on the 
hepatocellular pattern of injury, 
temporal relationship of the event to 
guselkumab exposure, and the 
exclusion of alternative etiologies, this 
event may represent drug-induced liver 
injury possibly related to guselkumab.
A review of available guselkumab 
Phase 2 and 3 clinical trial data across 
multiple indications (psoriasis, 
psoriatic arthritis [PsA], rheumatoid 
arthritis [RA], palmoplantar pustulosis 
[PPP], and CD) was performed by the 
Sponsor
- demonstrated previously noted 
association between guselkumab 
exposure and mild (≤3 x upper limit of 
normal [ULN]) elevations in liver
transaminases at exposures of 100 mg 
q4w or higher
- significant elevations of alanine 
aminotransferase [ALT] (>5 x ULN) or 
cases satisfying the biochemical 
criteria for Hy’s Law during 
guselkumab exposure have been 
infrequent. These cases have been 
confounded by concomitant 
medications, alcohol use, medical 
history, and/or concurrent diagnoses.
•
During the conduct of the study, liver 
function tests will be monitored at baseline 
and regular intervals. In addition, the doses 
included in this study will not exceed 
100 mg SC every 4 weeks (q4w). 
•
Participants with marked liver enzyme 
elevations or symptoms or signs of liver 
dysfunction (eg, jaundice), should undergo 
a thorough investigation for possible 
causes of liver injury. A participant must 
have their study intervention discontinued 
if the participant has severe liver test 
abnormalities that are not transient and are 
not explained by other etiologies 
(Section 7.1).
Risks Due to Study Procedures
Radiation
Participants will be exposed to 
radiation during radiography of 
hands/feet collected at Weeks 0, 24, 48, 
96 and 156. A total of 0.012 mSV 
radiation exposure is expected from 
these procedures, which is comparable 
to ~3 days of exposure to natural 
Exposure to radiation through radiographs is 
kept to a minimum by not requiring a chest X-
ray be performed at screening if one is 
available from within 12 weeks prior to the 
first administration of study intervention and 
not requiring radiographs of hands and feet be 
CCI
CCI

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Rationale for Risk
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background radiation. Additionally, 
one chest X-ray may be performed at 
screening if the participant does not 
have a chest X-ray within 12 weeks 
prior to the first administration of study 
intervention. The exposure from 1 
standard chest X-ray is 
0.1 mSV, comparable to 10 days of 
exposure to natural background 
radiation (https:// www .acr.org/).
done within 6 weeks of another set of 
radiographs.
2.3.2.
Benefits for Study Participation
As guselkumab has demonstrated improvement in the signs and symptoms of PsA, individual 
patients may benefit from participation in the study (see Section 2.1). Additionally, participation 
will help to obtain additional data on the impact of guselkumab on joint damage, and in the general 
knowledge of the treatment and natural history of PsA.
Participants may also experience some benefit from the participation in a clinical study irrespective 
of receiving study intervention, due to regular visits and assessments monitoring their overall 
health.
2.3.3.
Benefit-Risk Assessment for Study Participation
Data through 1 year of treatment from the PSA3001 and PSA3002 studies support an overall 
favorable benefit-to-risk profile for the use of guselkumab in active PsA.
Potential risks of guselkumab, including those of serious infection and malignancy and liver injury, 
are being addressed via judicious inclusion/exclusion criteria, frequent study visits to allow for
close monitoring of patient safety, guidelines for participant management (including monitoring 
of clinical laboratory tests and treatment discontinuation criteria), detailed description of allowed 
and prohibited concomitant medications, and comprehensive medical monitoring of data by the 
Sponsor during the conduct of the studies. 
Taking into account the measures taken to minimize risk to participants of this study, the potential 
risks identified in association with guselkumab are justified by the potential benefits to participants 
with PsA.
3.
OBJECTIVES AND ENDPOINTS
Objectives
Endpoints
Primary
!
To evaluate the efficacy of guselkumab
treatment in participants with active 
psoriatic arthritis (PsA) by assessing the 
reduction in signs and symptoms of PsA.
!
Proportion of participants with American College 
of Rheumatology (ACR) 20 response (American 
College of Rheumatology 2020) at Week 24

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Major Secondary
!
To evaluate the inhibition of progression 
of structural damage in participants with 
active PsA.
!
Change from baseline in PsA modified van der 
Heijde-Sharp (vdH-S) score at Week 24.
Other Secondary 
!
To evaluate the safety in participants 
with active PsA.
!
Frequency and type of adverse events (AEs), 
serious adverse events (SAEs), reasonably related 
AEs, AEs leading to discontinuation of study 
intervention, 
infections, 
and 
injection-site 
reactions.  
!
Laboratory 
abnormalities 
(chemistry, 
hematology), 
maximum 
toxicity 
(Common 
Terminology Criteria for Adverse Events [CTCAE 
5.0]) grades.
!
To evaluate the pharmacokinetics (PK) 
and immunogenicity in participants with 
active PsA.
!
Serum guselkumab concentration.
!
Incidence of antibodies to guselkumab.
Other 
Endpoints Related to Reduction of Signs and Symptoms and Physical Function
!
Proportions of participants who achieve ACR 20, ACR 50, and ACR 70 responses by visit over time 
through Week 156.
!
Proportion of participants who maintain an ACR 20 response at Week 48, Week 96, and Week 156 
among the participants who achieved an ACR 20 response at Week 24.
!
Proportion of participants who maintain an ACR 50 response at Week 48, Week 96, and Week 156 
among the participants who achieved an ACR 50 response at Week 24.
!
Proportion of participants who maintain an ACR 70 response at Week 48, Week 96, and Week 156 
among the participants who achieved an ACR 70 response at Week 24.
!
Change, and percent change from baseline in ACR components by visit over time through 
Week 156.
!
Change from baseline in Disability Index of the Health Assessment Questionnaire (HAQ-DI) score 
by visit over time through Week 156.
!
Proportion of participants who achieve a clinically meaningful improvement (a ≥0.35 improvement 
from baseline) in HAQ-DI score by visit over time through Week 156 among those participants with 
HAQ-DI score ≥0.35 at baseline.
!
Proportion of participants who maintain a HAQ-DI response (ie, ≥0.35 improvement from baseline 
in HAQ-DI score) at Week 48, Week 96, and Week 156 among the participants who achieved a 
HAQ-DI response at Week 24.
!
Proportion of participants who achieve a Disease Activity Score 28 (DAS28) C-reactive protein 
(CRP) response by visit over time through Week 156.
!
Proportion of participants who achieve a DAS28 (CRP) remission by visit over time through 
Week 156.
!
Change from baseline in DAS28 (CRP) by visit over time through Week 156.

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!
Proportion of participants who achieve a response based on modified Psoriatic Arthritis Response 
Criteria (PsARC) by visit over time through Week 156.
!
Proportion of participants with resolution of enthesitis (based on Leeds Enthesitis Index [LEI]) by 
visit over time through Week 156 among the participants with enthesitis at baseline.
!
Change from baseline in enthesitis score (based on LEI) by visit over time through Week 156 among 
the participants with enthesitis at baseline.
!
Proportion of participants with resolution of dactylitis by visit over time through Week 156 among 
the participants with dactylitis at baseline.
!
Change from baseline in dactylitis score by visit over time through Week 156 among the participants 
with dactylitis at baseline.
!
Change from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) scores 
by visit over time through Week 156.
!
Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score by 
visit over time through Week 156.
!
Change from baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) score by visit over 
time through Week 156.
!
Proportion of participants who achieve DAPSA low disease activity by visit over time through 
Week 156.
!
Proportion of participants who achieve DAPSA remission by visit over time through Week 156.
!
Proportion of participants who achieve minimal disease activity (MDA) by visit over time through 
Week 156.
!
Proportion of participants who achieve very low disease activity (VLDA) by visit over time through 
Week 156.
Endpoints Related to Skin Disease
!
Proportions of participants who achieve ≥75%, ≥90%, and 100% improvement in Psoriatic Area 
and Severity Index (PASI) score from baseline by visit over time through Week 156 among the 
participants with ≥3% body surface area (BSA) psoriatic involvement and an Investigator’s Global 
Assessment (IGA) score of ≥2 (mild) at baseline.
!
Proportion of participants with a psoriasis response of an IGA (ie, an IGA-psoriasis score of 0 
[cleared] or 1 [minimal] AND ≥2-grade reduction from baseline) by visit over time through 
Week 156 among the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 
(mild) at baseline.
!
Proportion of participants with an IGA score of 0 (cleared) by visit over time through Week 156 
among the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at 
baseline.
!
Change and percent change from baseline in PASI score by visit over time through Week 156 among 
the participants with ≥3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
!
Proportion of participants who achieve both PASI 75 and ACR 20 responses by visit over time 
through Week 156 among the participants with ≥3% BSA psoriatic involvement and an IGA score 
of ≥2 (mild) at baseline.

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!
Proportion of participants who achieve both PASI 75 and modified PsARC response by visit over 
time through Week 156 among the participants with ≥3% BSA psoriatic involvement and an IGA
score of ≥2 (mild) at baseline.
!
Proportion of participants who achieve a Dermatology Life Quality Index (DLQI) score of 0 or 1 
by visit through Week 156 among the participants with baseline DLQI score >1 and with ≥3% BSA 
psoriatic involvement and an IGA score of ≥2 (mild) at baseline. 
!
Proportion of participants who achieve ≥5-point improvement from baseline in DLQI score by visit 
through Week 156 among the participants with baseline DLQI score ≥5 and with ≥3% BSA psoriatic 
involvement and an IGA score of ≥2 (mild) at baseline. 
!
Change from baseline in DLQI score by visit through Week 156 among the participants with ≥3% 
BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
Endpoints Related to Psoriasis of the Nails
!
Percent change from baseline in total fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 
score by visit over time through Week 156 among the participants with total fingernail mNAPSI
score >0 at baseline.
!
Proportions of participants who achieve total fingernail mNAPSI 50/75/100 response by visit over 
time through Week 156 among the participants with total fingernail mNAPSI score >0 at baseline.
!
Proportion of participants who achieve Physician’s Global Assessment of Fingernails Psoriasis
(PGA-F) score of 0 [cleared] or 1 [minimal] AND ≥2-grade reduction from baseline by visit over 
time through Week 156 among the participants with PGA-F score ≥2 at baseline.
Endpoints Related to Joint Structural Damage
!
Change from baseline in modified vdH-S score by visit over time through Week 156.
!
Change in modified vdH-S score from Week 24 to Weeks 48, 96, 156; from Week 48 to Weeks 96 
and 156; and from Week 96 to Week 156.
!
Change from baseline in modified vdH-S erosion score and joint space narrowing (JSN) score by 
visit over time through Week 156.
!
Change in modified vdH-S erosion score and JSN score from Week 24 to Weeks 48, 96, 156; from 
Week 48 to Weeks 96 and 156; and from Week 96 to Week 156.
!
Change from baseline in modified vdH-S score by region and type of damage (ie, hand erosion, 
hand JSN, foot erosion, foot JSN subscores) by visit over time through Week 156.
!
Proportion of participants with a change of ≤0 from baseline, and proportion of participants with a 
change of ≤0.5 from baseline in modified vdH-S score by visit over time through Week 156.
!
Proportion of participants with a change of ≤0 from baseline, and proportion of participants with a 
change of ≤0.5 from baseline in modified vdH-S erosion score and JSN score by visit over time 
through Week 156.
!
Proportion of participants with radiographic progression (based on the smallest detectable change 
[SDC]) from baseline by visit over time through Week 156.
!
Proportion of participants with radiographic joint erosion progression and radiographic JSN 
progression (based on SDC) from baseline by visit over time through Week 156.
!
Proportion of participants with pencil in cup or gross osteolysis deformities by visit over time 
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Endpoints Related to Health-Related Quality of Life
!
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) 
by visit over time through Week 156. 
!
Proportion of participants who achieve ≥4-point improvement from baseline in FACIT-F score 
improvement by visit over time through Week 156.
!
Change from baseline in PsA Impact of Disease (PsAID)-12 by visit over time through Week 156.
Endpoint Related to Pharmacodynamic effect
!
Change from baseline in serum interleukin (IL-17) cytokines by visit over time through Week 48.
Abbreviations: ACR = American College of Rheumatology; AEs = adverse events; BSA = body surface area; 
CRP = C-Reactive protein; CTCAE = Common Terminology Criteria for Adverse Events; DAPSA = Disease 
Activity Index for Psoriatic Arthritis; DAS = Disease Activity Score; DLQI = Dermatology Life Quality 
Index; FACIT-F = Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI = Disability Index of 
the Health Assessment Questionnaire; IGA = Investigator’s Global Assessment; IL = interleukin; JSN = joint 
space narrowing; LEI = Leeds Enthesitis Index; mCPDAI = modified Composite Psoriatic Disease Activity 
Index; MDA = minimal disease activity; mNAPSI = modified Nail Psoriasis Severity Index; PASI = Psoriatic 
Area and Severity Index; PGA-F = Physician’s Global Assessment of Fingernails Psoriasis; 
PK = pharmacokinetics; PsA = Psoriatic Arthritis; PsAID = Psoriatic Arthritis Impact of Disease; 
PsARC = Psoriatic Arthritis Response Criteria; SAEs = serious adverse events; SDC = smallest detectable 
change; vdH-S = van der Heijde-Sharp; VLDA= very low disease activity; WPAI = Work Productivity and 
Activity Impairment.
Refer to Section 8, Study Assessments and Procedures for evaluations related to endpoints.
HYPOTHESIS
The primary hypothesis is that the guselkumab 100 mg q4w group is superior to placebo as 
assessed by the proportion of participants achieving an American College of Rheumatology (ACR)
20 response at Week 24.
4.
STUDY DESIGN
4.1.
Overall Design
This is a Phase 3b, multicenter, randomized, double-blind, placebo-controlled, 3-arm study in 
participants with active PsA who are biologic naïve and have had inadequate response to current 
standard therapies (eg, DMARDs/apremilast, corticosteroids, NSAIDs).  
A target of 950 participants will be randomly assigned in this study with 350 participants planned 
in each of the placebo and guselkumab 100 mg q8w groups, and 250 participants in the guselkumab 
100 mg q4w group. Participants impacted by major disruptions may be replaced. Stable doses of
concomitant NSAIDs, oral corticosteroids (≤10 mg/day prednisone equivalent), selected 
non-biologic DMARDs (MTX, SSZ, HCQ, LEF) will be allowed but are not required (see 
Table 4).
Participants who satisfy all inclusion and exclusion criteria will be randomly assigned to one of 
the following 3 treatment groups in a 7:5:7 ratio using permuted block randomization with 
stratification defined by a combined factor of baseline radiographic variability, corticosteroid use, 

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number of joints with erosion, and the most recent available CRP value prior to randomization into 
4 strata levels (high radiographic variability [HRV], no progression [NP], low to moderate 
progression [LMP], and rapid progression [RP]). All participants with HRV will be assigned to 
HRV stratum, and the rest of participants will be assigned to the other strata based on probability 
of NP, LMP, and RP.
 HRV:     R_DIFF_ERN = Yes
 RP:        [(CRP>=2.1 and ERN>=16) OR (CRP>=5.7)] AND (R_DIFF_ERN = No)

NP:        [(CRP<5.7 and ERN<=5) OR (CRP<5.7 and 5<ERN<16 and COR=Yes)] AND 
(R_DIFF_ERN = No)
 LMP:     [Other] AND (R_DIFF_ERN = No)
Abbreviations: COR=the subject's baseline oral corticosteroid use; ERN=the subject's 
baseline number of joints with erosion; R_DIFF_ERN=(Yes/No) if the absolute reader 
difference for number of joints with erosions at baseline was >8; CRP=the subject's most 
recent screening CRP Level in mg/dL
Group I (n=350)
Participants will receive SC guselkumab 100 mg at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo 
at Weeks 8, 16, 24, 32, 40 and 48 to maintain the blind.
Group II (n=250)
Participants will receive SC guselkumab 100 mg at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 
44, and 48.
Group III (n=350)
Participants will receive SC placebo at Weeks 0, 4, 8, 12, 16, and 20, and will cross over at 
Week 24 to receive SC guselkumab 100 mg at Weeks 24, 28, 32, 36, 40, 44, and 48.
At Week 16, all participants in Groups I, II, and III with <20% improvement from baseline in both 
tender and swollen joint counts will qualify for early escape (EE) and will be allowed to initiate or 
increase the dose of one of the permitted concomitant medications up to the maximum allowed 
dose as specified in Table 3, as selected by the investigator.
At Week 48, participants who have not discontinued will be eligible to enter a long-term extension 
(LTE) for a period of up to approximately two years (ie, Week 48 through Week 156).
The study blind will be maintained during the LTE until the last participant has completed the 
Week 48 visit evaluations or discontinued prior to Week 48 and the Week 48 data base has been 
locked. Therefore, in order to maintain the blind, participants will continue to receive study 

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intervention every 4 weeks until that time. After the study is unblinded to the investigative sites, 
participants receiving guselkumab q8w will no longer be required to dose with placebo to maintain 
the blind.
Database locks (DBLs) are scheduled at Weeks 24, 48, 96, and end of study (Week 168). The first 
DBL will occur when all randomized participants have either completed the Week 24 assessments 
or terminated study participation prior to the Week 24 visit (referred to as Week 24 DBL). The 
second DBL will occur when all randomized participants have either completed the Week 48 
assessments or terminated study participation prior to the Week 48 visit (referred to as Week 48 
DBL). The third DBL will occur when all randomized participants have either completed the 
Week 96 assessments or terminated study participation prior to the Week 96 visit (referred to as 
Week 96 DBL). The fourth and final DBL will occur when all randomized participants have either 
completed their final safety visit or have terminated study participation.
A diagram of the study design is provided in Section 1.2, Schema.
4.2.
Scientific Rationale for Study Design
Study Population
The target study population is participants with active PsA who are biologic naïve and have had 
an inadequate response to standard therapies (eg, non-biologic DMARDs, apremilast, and/or 
NSAIDs). This population is appropriate to provide relevant efficacy and safety information for 
the intended use of guselkumab in PsA. Additionally, a biologic naïve population with ≥2 joints 
with erosions at baseline is planned to enrich the population for those more likely to experience 
radiographic progression and therefore increase the power for detection of a treatment effect on 
radiographic endpoints.
This study design is based primarily on PSA3002 in which the q4w dose regimen demonstrated 
statistically significantly less radiographic progression compared with placebo as measured by the 
mean change from baseline in modified vdH-S score. The q8w dose regimen in PSA3002 
demonstrated numerically less radiographic progression compared with placebo. This study is 
designed to further investigate the structural damage benefit for both the q4w and q8w guselkumab 
dose regimens.
Blinding, Control, Study Phase/Periods, Intervention Groups
A placebo control will be used to establish the frequency and magnitude of changes in endpoints 
that may occur in the absence of active intervention. 
Randomization will be used to minimize bias in the assignment of participants to intervention
groups, to increase the likelihood that known and unknown participant attributes (eg, demographic 
and baseline characteristics) are evenly balanced across intervention groups, and to enhance the 
validity of statistical comparisons across intervention groups. 
Blinded intervention will be used to reduce potential bias during data collection and evaluation of 
endpoints.

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Study Phases and Duration of Treatment 
There will be 5 phases in this study: Screening, double-blind placebo-controlled, double-blind 
active treatment, LTE and safety follow-up. 
!
The screening phase of up to 6 weeks will allow for sufficient time to perform screening study 
evaluations and determine study eligibility.  
!
The second phase of the study will be the double-blind, placebo-controlled phase from Week 0 
to Week 24. The primary endpoint will be evaluated at Week 24.
!
The third phase of the study will be the double-blind, active treatment phase from Week 24 
through Week 48. This duration will provide adequate time to evaluate the maintenance of 
efficacy and long-term safety of guselkumab in PsA over a 48-week exposure period.
!
The fourth phase of the study will be the LTE from Week 48 through Week 156.
!
The final phase of the study will be the safety follow-up phase and will be 12 weeks from the 
last administration of study intervention to the final safety visit (whether in the core study or 
LTE). The safety follow-up period allows for monitoring of participants for a period 
equivalent to approximately 5 times the half-life of guselkumab.  
The placebo-controlled period is limited to 24 weeks.  An EE option is included in the study design 
to provide additional treatment options for participants who have <20% improvement in swollen 
and tender joint counts at Week 16. 
Study Evaluations 
Efficacy evaluations chosen for this study were established in previous studies of therapeutic 
biologic agents for the treatment of PsA.  Patient-reported outcomes (PROs) chosen for this study 
are also consistent with clinically relevant measurements that are accepted in the medical literature 
for other studies in PsA and applicable US/EU regulatory guidance documents.
Safety evaluations include collecting information on AEs, review of concomitant medications, 
vital signs, laboratory assessments, physical exams, and early detection of TB. 
Serum samples will be collected to evaluate the pharmacokinetics (PK) of guselkumab, as well as 
the immunogenicity of guselkumab (antibodies to guselkumab) as described in the SoA
(Section 1.3).
DNA and Biomarker Collection
Optional pharmacogenomic samples may be obtained from participants only when specific consent 
is provided by signing the optional genetic research informed consent form (ICF). It is recognized 
that genetic variation can be an important contributory factor to interindividual differences in 
intervention distribution and response and can also serve as a marker for disease susceptibility and 
prognosis. Pharmacogenomic research may help to explain interindividual variability in clinical 
outcomes and may help to identify population subgroups that respond differently to an 
intervention. The goal of the pharmacogenomic component is to collect deoxyribonucleic acid 
(DNA) to allow the identification of genetic factors that may influence the PK, pharmacodynamics 

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(PD), efficacy, safety, or tolerability of guselkumab and to identify genetic factors associated with 
PsA.
Biomarker samples will be collected to evaluate the mechanism of action of guselkumab or help 
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 guselkumab and aid in evaluating the intervention-clinical response 
relationship.
DNA and biomarker samples may be used to help address emerging issues and to enable the 
development of safer, more effective, and ultimately individualized therapies.
Collection of biomarker samples, including samples from the optional pharmacogenomic 
collection, will only occur where local regulations permit and may not occur at all clinical sites.
4.2.1.
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 AEs of the study, and provide their consent voluntarily will be enrolled.
The primary ethical concern is that participants with active disease may receive placebo for 
24 weeks. However, the placebo control is necessary to capture the change in clinical endpoints 
that may occur in the absence of active treatment and is recommended by regulatory authorities. 
The disease activity of each participant will be closely monitored during the study and EE has been 
incorporated in the study design to allow participants to receive additional concomitant 
medications for PsA at the investigator’s discretion if the EE criterion is met. The duration of the 
placebo exposure is limited to 24 weeks.
The total blood volume to be collected is 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 
for blood donation (American Red Cross 2020).
4.3.
Justification for Dose
The two dose regimens which were evaluated in the Phase 3 PSA3001 and PSA3002 studies 
(100 mg at Weeks 0 and 4 then q8w and 100 mg q4w) and which demonstrated clinically 
meaningful benefits across domains of PsA were selected to be evaluated in this study. 
Guselkumab 100 mg at Weeks 0 and 4 then q8w is now the approved dose regimen in the US, 
Canada, and several other countries worldwide for PsA, while both guselkumab q8w and q4w dose 
regimens have been approved in Brazil, Ecuador and the EU for PsA.
Efficacy results from PSA3001 and PSA3002 demonstrated that both guselkumab q8w and q4w 
dose regimens were effective in treating the signs and symptoms of PsA, as measured by ACR 

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responses, Disease Activity Score 28 (DAS28; CRP), dactylitis, enthesitis, Investigator’s Global 
Assessment (IGA) and Psoriatic Area and Severity Index (PASI) responses, improving overall 
physical function measured by Disability Index of the Health Assessment Questionnaire 
(HAQ-DI) and HRQoL as measured by the 36-item Short Form Health Survey (SF-36) Physical 
Component Summary (PCS). The benefit of both guselkumab dose regimens in treating signs and 
symptoms compared to placebo were consistent among all endpoints common to both studies and 
for the pooled data. While the cumulative evidence from PSA3001 and PSA3002 does not indicate 
a consistent difference between guselkumab q8w and q4w dose regimens in treating signs and 
symptoms of PsA, there were some numerical differences between the two dose regimens in 
certain endpoints. Specifically, in study PSA3001, a greater proportion of participants in the 
guselkumab q4w group achieved an ACR 20, ACR 50, ACR 70, an IGA 0, or PASI 90 response 
through Week 24 compared with the q8w group. However, no differences in efficacy were 
observed in the larger PSA3002 study between the guselkumab q8w and q4w dose regimens in 
either ACR responses or psoriasis responses. Including both dose regimens in this study will 
provide additional data on the relative efficacy of the q8w and q4w dosing regimens on signs and 
symptoms in bio-naïve PsA participants.
In addition to clinical signs and symptoms, an important outcome in PsA is inhibition of structural 
damage. Analyses of radiographic data in PSA3002 demonstrated that the guselkumab 100 mg 
q4w dose regimen significantly inhibited structural damage progression compared with placebo. 
While structural damage progression was numerically lower for the guselkumab 100 mg q8w dose 
regimen compared with placebo, it did not reach statistical significance. Since many patients with 
PsA do not experience joint damage (approximately two thirds of the participants in PSA3002 did 
not progress regardless of treatment group), additional analyses were conducted to identify risk 
factors that predicted which participants are at increased risk of structural damage progression. 
Risk factor analyses using placebo data from previous Sponsor-conducted PsA studies with other 
therapeutic agents identified the number of joints with erosion as the baseline risk factor most 
predictive for an increased risk of structural damage progression. In high-risk participants (ie, those 
with baseline risk factors), while both guselkumab dose regimens had less structural damage 
progression than placebo, there appeared to be a dose response trend with the guselkumab 100 mg 
q4w dose regimen showing greater benefit than the 100 mg q8w dose regimen in inhibiting 
structural damage progression. 
Overall, the two proposed dose regimens demonstrated clinically meaningful efficacy and were 
well tolerated with an acceptable safety profile in participants with active PsA. This study is 
expected to provide additional clinical safety and efficacy data (especially for the evaluation of 
inhibition of structural damage) in participants with PsA. Inclusion of both the 100 mg at Week 0 
and 4 and then q8w dose regimen and the 100 mg q4w dose regimen will allow a relative 
benefit-risk assessment of the q4w dose regimen.

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4.4.
End of Study Definition
End of Study Definition
The end of study is considered as the last visit for the last participant in the study. The final data 
from the study site will be sent to the Sponsor (or designee) after completion of the final participant 
visit at that study site, in the time frame specified in the Clinical Trial Agreement.
Study Completion Definition
A participant will be considered to have completed the main study if the participant has completed
assessments at:
!
Week 48 and the 12-week safety follow-up visit at Week 60 for participants that do not enter 
LTE
Participants who prematurely discontinue study intervention for any reason prior to Week 48 will 
not be considered to have completed the study unless they complete the safety follow-up.
A participant will be considered to have completed the LTE if the participant has completed 
assessments at:
!
Week 156 and the 12-week safety follow-up visit at Week 168 for participants that choose to 
enter the LTE.
5.
STUDY POPULATION
Screening for eligible participants will be performed within 6 weeks prior to administration of the 
study intervention. Refer to Section 5.4, Screen Failures, for conditions under which the repeat of 
any screening procedures are allowed.
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 prior to enrolling a participant in the study.  Waivers are not 
allowed. 
For a discussion of the statistical considerations of participant selection, refer to Section 9.2, 
Sample Size Determination.
5.1.
Inclusion Criteria
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1.
Be at least 18 years of age (or the legal age of consent in the jurisdiction in which the 
study is taking place).
2.
Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID 
therapy.

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!
Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at 
least 3 months or evidence of intolerance.
!
Apremilast therapy is defined as taking apremilast at the marketed dose approved in 
the country where the study is being conducted for at least 3 months or evidence of 
intolerance.
!
NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of 
intolerance.  
3.
Have a diagnosis of PsA for at least 6 months prior to the first administration of study 
intervention and meet ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria 
at screening.
4.
Criterion modified per Amendment 1
4.1. Have active PsA as defined by:
a.
At least three swollen joints and three tender joints at screening and at 
baseline
-AND-
b.
CRP ≥0.3 mg/dL at screening from the central laboratory.
NOTE: A one-time repeat assessment of CRP level is allowed during the 6-week 
screening phase and the investigator may consider the participant eligible if the 
test result is within acceptable range on repeat testing in the central laboratory.
5.
Have ≥2 joints with erosions on baseline radiographs of the hands and feet as determined
by central read.
6.
Have at least one of the following PsA subsets: distal interphalangeal joint involvement, 
polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral 
arthritis, or spondylitis with peripheral arthritis.
7.
Have active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter and/or 
nail changes consistent with psoriasis.
8.
If currently using non-biologic DMARDs (limited to MTX, SSZ, HCQ, or LEF), 
participants should have started treatment at least 3 months and the dose must be stable 
for at least 4 weeks before first administration of study intervention and should have no 
serious toxic side effects attributable to the non-biologic DMARD.  If currently not using 
MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first 
administration of study intervention. If currently not using LEF, must not have received 
for at least 12 weeks before first administration of study intervention.  
a.
If using MTX, the route of administration and dose must be stable and the dose 
must be ≤25 mg/week.
b.
If receiving SSZ, the dose must be ≤3g/day. 

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c.
If receiving HCQ, the dose must be ≤400 mg/day. 
d.
If receiving LEF, the dose must be ≤20 mg/day.
9.
If using NSAIDs or other analgesics for PsA at baseline, participants must be on a stable 
dose for at least 2 weeks prior to the first administration of study intervention. If currently 
not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other 
analgesics for PsA within 2 weeks prior to the first administration of study intervention.
10.
If using oral corticosteroids at baseline, participants must be on a stable dose equivalent 
to ≤10 mg of prednisone/day for at least 2 weeks prior to the first administration of study 
intervention. If not currently using oral corticosteroids, the participant must not have 
received oral corticosteroids within 2 weeks prior to the first administration of study 
intervention.
11.
Criterion modified per Amendment 1
11.1. Before randomization, a woman must be 
!
Not of childbearing potential OR
!
Of childbearing potential and practicing (if heterosexually active) a highly effective 
method of contraception (failure rate of <1% per year when used consistently and 
correctly) and agrees to remain on a highly effective method while receiving study 
intervention and until 12 weeks after last dose - the end of relevant systemic 
exposure. The investigator should evaluate the potential for contraceptive method 
failure (eg, non-compliance, recently initiated) in relationship to the first dose of 
study intervention. Examples of highly effective methods of contraception are 
provided in Appendix 5 (Section 10.5).
NOTE: If a female participant’s childbearing potential changes after start of the study 
(eg, a woman who is not heterosexually active becomes active, a premenarchal woman 
experiences menarche), she must begin practicing a highly effective method of birth 
control, as described above.
12.
A woman of childbearing potential must have a negative serum pregnancy test at 
screening and a negative urine pregnancy test at Week 0.
13.
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted 
reproduction during the study and for at least 12 weeks after receiving the last 
administration of study intervention.
14.
All men must agree not to donate sperm from the first administration of study intervention 
through at least 12 weeks after receiving the last administration of study intervention.
15.
Criterion updated per Amendment 2.
15.1. A man who is sexually active with a woman of childbearing potential and who has 
not had a vasectomy must agree to use a barrier method of birth control (eg, either a 

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condom [with spermicidal foam/gel/film/cream/suppository] or a partner with an 
occlusive 
cap 
[diaphragm 
or 
cervical/vault 
caps] 
plus 
spermicidal 
foam/gel/film/cream/suppository), during the study and for at least 12 weeks after 
receiving the last administration of study intervention.
16.
Criterion updated per Amendment 2.
16.1. Are considered eligible according to the following TB screening criteria:
a.
Have no history of latent or active TB before screening. An exception is made for 
participants who have a history of latent TB and:
o
are currently receiving treatment for latent TB, OR
o
will initiate treatment for latent TB before the first administration of study 
intervention, OR
o
have documentation of having completed appropriate treatment (as per local 
guidelines) for latent TB within 5 years before the first dose of study 
intervention. It is the responsibility of the investigator to verify the adequacy 
of 
previous 
anti-tuberculous 
treatment 
and 
provide 
appropriate 
documentation. Participants with a history and documentation of having 
completed appropriate treatment for latent TB more than 5 years before the 
first dose of study intervention are not eligible. 
b.
Have no signs or symptoms suggestive of active TB upon medical history and/or 
physical examination.
c.
Have had no known recent close contact with a person with active TB or, if there has 
been such contact, will be referred to a physician specializing in TB to undergo 
additional evaluation and, if warranted, receive appropriate treatment for latent TB 
before the first administration of study intervention.
d.
Within 8 weeks before the first administration of study intervention, have a negative 
QuantiFERON®-TB test result, or have a newly identified positive QuantiFERON®-
TB test result in which active TB has been ruled out and for which appropriate 
treatment for latent TB has been initiated before the first administration of study 
intervention.
NOTE: A negative tuberculin skin test result is required if the 
QuantiFERON-TB® test is not approved/registered in the country in which this 
protocol is being conducted. The frequency of TB testing can be increased 
depending on local health authority requirements. In Ukraine, while the 
QuantiFERON-TB® test is not approved/registered, it is acceptable, and an 
additional tuberculin skin test is not required. The QuantiFERON-TB® test and 
the tuberculin skin test are not required at screening for participants with a 
history of latent TB, if active TB has been ruled out, and if appropriate treatment 
has been initiated/completed as described above in Inclusion Criterion 16a.
e.
Have a chest radiograph (both posterior-anterior and lateral views, or per country 
regulations where applicable), taken within 12 weeks before the first administration 
of study intervention and read by a radiologist or qualified pulmonologist, with no 

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evidence of current, active TB or old, inactive TB. A chest CT scan is also acceptable 
if already available or obtained outside of the study protocol. Participants with 
persistently indeterminate QuantiFERON-TB® test results may continue without 
treatment for latent TB if active TB is ruled out, their chest radiograph shows no 
abnormality suggestive of TB (active or old, inactive TB) and the participant has no 
additional risk factors for TB as determined by the investigator. This determination 
must be promptly reported to the medical monitor or designee and recorded in the 
participant's source documents and initialed by the investigator.
17.
Agree not to receive a live virus or live bacterial vaccination during the study, or within 
12 weeks after the last administration of study intervention. 
18.
Agree not to receive a bacillus Calmette-Guérin (BCG) vaccination during the study, and 
within 12 weeks after the last administration of study intervention.
19.
Criterion modified per Amendment 1
19.1. Have screening laboratory test results within the following parameters:
a.
Hemoglobin
≥8.5 g/dL
(SI: ≥85 g/L) 
b.
White blood cells≥3.5 x 103/μL
(SI: ≥3.5 GI/L)
c.
Neutrophils
≥1.5 x 103/μL
(SI: ≥1.5 GI/L)
d.
Platelets
≥100 x 103/μL
(SI: ≥100 GI/L)
e.
Serum creatinine      ≤1.5 mg/dL
(SI: ≤133 μmol/L)
f.
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline 
phosphatase levels must be ≤1.5 times the upper limit of normal (ULN) range for the 
central laboratory conducting the test.
NOTE: A one-time repeat of screening laboratory tests (a-e) is allowed during the 6-week 
screening phase and the investigator may consider the participant eligible if the previously 
abnormal laboratory test result is within acceptable the range on repeat testing in the 
central laboratory. No retesting for ineligible ALT or AST is permitted.
20.
Agree to avoid prolonged sun exposure and agree not to use of tanning booths or other
ultraviolet (UV) light sources during study (for participants with skin lesions or with 
documented history of psoriasis).
21.
Are willing to refrain from the use of complementary therapies for PsA or psoriasis 
including ayurvedic medicine, traditional Taiwanese, Korean, or Chinese medication(s) 
and acupuncture within 2 weeks prior to the first study intervention administration and 
through Week 48.
22.
Be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
23.
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23.1. Must sign an ICF indicating that the participant understands the purpose of and 
procedures required for the study and is willing to participate in the study.
24.
Criterion modified per Amendment 1
24.1. Must sign a separate ICF if the participant agrees to provide an optional DNA 
sample for research (where local regulations permit).  Refusal to provide consent for the 
optional DNA research sample does not exclude a participant from study participation.
25.
It is recommended that participants are up-to-date on all age-appropriate vaccinations 
prior to screening as per routine local medical guidelines. For study participants who 
recently received locally-approved (including emergency use-authorized) Coronavirus 
Disease 2019 (COVID-19) vaccines prior to study entry, follow applicable local vaccine 
labelling, guidelines, and standard of care for participants receiving immune-targeted 
therapy when determining an appropriate interval between vaccination and study 
enrolment (Section 6.8.7).
5.2.
Exclusion Criteria
Any potential participant who meets any of the following criteria will be excluded from 
participating in the study:
1.
Criterion modified per Amendment 1
1.1. Has known allergies, hypersensitivity, or intolerance to study intervention or its 
excipients (refer to IB).
2.
Has other inflammatory diseases that might confound the evaluations of benefit of 
guselkumab therapy, including but not limited to RA, axial spondyloarthritis 
(AS)/non-radiographic 
axial 
spondyloarthritis 
(nr-axSpA), 
systemic 
lupus 
erythematosus, or Lyme disease (confirmed by Western blot).
3.
Has the arthritis mutilans subset of PsA.
4.
Has previously received any biologic treatment including, but not limited to, 
guselkumab, ustekinumab, secukinumab, anti-TNFα agents (such as adalimumab, 
etanercept, infliximab, golimumab SC or intravenous (IV), certolizumab pegol, or their 
respective biosimilars), tildrakizumab, ixekizumab, brodalumab, risankizumab or other 
investigative biologic treatment for PsA or psoriasis.
5.
Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, 
upadacitinib or any other Janus kinase (JAK) inhibitor.   

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6.
Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 
6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) 
within 4 weeks of the first administration of study intervention.
7.
Criterion modified per Amendment 1
7.1. Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 
4 weeks before the first administration of study intervention.
8.
Is receiving 3 or more non-biologic DMARDs specified in Table 3 at baseline. Note: 
participants cannot be on concomitant MTX and LEF.
9.
Has received phototherapy or any systemic medications/treatments that could affect 
psoriasis evaluations (including, but not limited to, retinoids, 1,25-dihydroxy vitamin 
D3 and analogues, psoralens, fumaric acid derivatives, with the exception of those in 
Table 3) within 4 weeks of the first administration of study intervention. 
10.
Has used topical medications/treatments that could affect psoriasis evaluations 
(including, but not limited to, topical or intralesional injection of corticosteroids, 
anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, 
methoxsalen, trimethylpsoralens, pimecrolimus, tacrolimus, or topical traditional 
Taiwanese, Korean, or Chinese medicines) within 2 weeks of the first administration of 
any study intervention. Low-potency topical corticosteroids on the face or groin are 
allowed at any time.
11.
Has received epidural, intra-articular, intramuscular (IM), or IV corticosteroids, 
including adrenocorticotropic hormone during the 4 weeks prior to the first 
administration of study intervention.
12.
Has received lithium within 4 weeks of the first administration of study intervention.
13.
Has received an experimental antibody or biologic therapy (other than those listed 
everywhere else in this section) within 6 months prior to the first administration of study 
intervention, or received any other experimental therapy, including an investigational 
medical device, or new investigational agent within 90 days or five half-lives 
(whichever is longer) prior to the first administration of study intervention or is 
currently enrolled in another study using an investigational intervention or procedure.
14.
Has unstable suicidal ideation or suicidal behavior in the last 6 months, that may be 
defined as an electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) rating at 
screening of: 
!
Ideation level 4: Some intent to act, no plan; OR 
!
Ideation level 5: Specific plan and intent; OR
!
Any of the following suicidal behaviors:

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∀
Actual suicide attempts
∀
Interrupted attempts 
∀
Aborted attempts 
∀
Preparatory actions 
AND
is confirmed to be at risk by the investigator based on an evaluation by a mental health 
professional. The final decision on excluding a participant will be made at the judgment 
of the investigator.
15.
Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, 
hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, 
hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or 
metabolic disturbances.
16.
Has unstable cardiovascular disease, defined as a recent clinical deterioration 
(eg, unstable angina, rapid atrial fibrillation, or transient ischemic attack) in the last 
3 months prior to screening or a cardiac hospitalization within the last 3 months prior 
to screening.
17.
Currently has a malignancy or has a history of malignancy within 5 years prior to 
screening (with the exception of a nonmelanoma skin cancer that has been adequately 
treated with no evidence of recurrence for at least 3 months prior to the first study 
intervention administration or cervical carcinoma in situ that has been adequately 
treated with no evidence of recurrence for at least 3 months prior to the first study 
intervention administration).
18.
Has a history of lymphoproliferative disease, including lymphoma; a history of 
monoclonal gammopathy of undetermined significance; or signs and symptoms 
suggestive of possible lymphoproliferative disease, such as lymphadenopathy or 
splenomegaly.
19.
Has a history of chronic or recurrent infectious disease, including but not limited to 
chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary 
tract infection (eg, recurrent pyelonephritis or chronic non-remitting cystitis), fungal 
infection (eg, mucocutaneous candidiasis), or open, draining, or infected skin wounds 
or ulcers.
20.
Is currently undergoing or has previously undergone allergy immunotherapy for a 
history of anaphylactic reactions.
21.
Has a transplanted organ (with exception of a corneal transplant >3 months prior to the 
first administration of study intervention).

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22.
Has a history of an infected joint prosthesis or has ever received antibiotics for a 
suspected infection of a joint prosthesis, if that prosthesis has not been removed or 
replaced.
23.
Has or has had a serious infection (eg, sepsis, pneumonia, or pyelonephritis) or has been 
hospitalized or received IV antibiotics for an infection within 2 months prior to 
screening.
24.
Has or has had a herpes zoster infection within 2 months before screening.
25.
Is pregnant, nursing, or planning a pregnancy (both men and women) within 12 weeks 
after receiving the last administration of study intervention.
26.
Has a nonplaque form of psoriasis (eg, erythrodermic, guttate, or pustular).
27.
Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of 
psoriasis from beta blockers, calcium channel blockers, or lithium).
28.
Has received, or is expected to receive, any live virus or bacterial vaccination within 
3 months prior to the first administration of study intervention.
29.
Has had a BCG vaccination within 12 months of first administration of study 
intervention.
30.
Has known intolerance or hypersensitivity to any biologic medication, or known 
allergies or clinically significant reactions to murine, chimeric, or human proteins, 
mAbs, or antibody fragments.
31.
Criterion deleted per Amendment 1
32.
Has a history of active granulomatous infection, including histoplasmosis, or 
coccidioidomycosis, before screening. 
33.
Has a chest radiograph within 3 months prior to the first administration of study 
intervention that shows an abnormality suggestive of a malignancy, significant 
cardiovascular or pulmonary disease or current active infection, including TB.
34.
Has ever had a nontuberculous mycobacterial infection or opportunistic infection 
(eg, cytomegalovirus, pneumocystis, aspergillosis).
35.
Has persistently indeterminate (indeterminate on repeat sampling) QuantiFERON®-TB 
test results. Indeterminate results should be handled as described in Section 8.2.11.
36.
Is infected with human immunodeficiency virus (HIV, a confirmed positive serology 
for HIV antibody).

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37.
During the 6 weeks prior to baseline, have had ANY of 
a) confirmed severe acute respiratory syndrome coronavirus 2 (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 –SoV – 2 
infection.
An exception to this criterion maybe granted if a participant has a documented negative 
result for a validated SARS-CoV-2 test:
∀
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
∀
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:
!
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.
38.
Criterion modified per Amendment 2.
38.1. a) Tests positive for hepatitis B virus (HBV) infection (see Appendix 4 in 
Section 10.4) OR 
b) iIs seropositive for antibodies to hepatitis C virus (HCV) at screening, unless 
the participant meets 1 of the following conditions:
i.
Has a history of successful treatment (defined as being negative for HCV 
RNA at least 12 weeks after completing antiviral treatment) and has a 
negative HCV RNA test result at screening, OR
ii.
While seropositive has a negative HCV RNA test result at least 12 weeks 
prior to screening and a negative HCV RNA test result at screening.
39.
Has had major surgery (eg, requiring general anesthesia and hospitalization) within 
8 weeks prior to screening, or will not have fully recovered from such surgery, or has 

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such surgery planned during the time the participant is expected to participate in the 
study (168 weeks). 
Note: Participants with planned surgical procedures to be conducted under local 
anesthesia may participate.
40.
Is known to have had a substance abuse (drug or alcohol) problem within the previous 
12 months prior to the first administration of study intervention. 
41.
Is unable or unwilling to undergo multiple venipunctures because of poor tolerability 
or lack of easy access to veins.
42.
Lives in an institution on court or authority order.
43.
Has any condition that, in the opinion of the investigator, would make participation not 
be in the best interest (eg, compromise the well-being) of the participant or that could 
prevent, limit, or confound the protocol-specified assessments.
44.
Is an 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.
45.
Is an employee of the Sponsor.
NOTE: Investigators should ensure that all 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 prior to the first dose of study intervention is given 
such that the participant no longer meets all eligibility criteria, then the participant should be 
excluded from participation in the study, Section 5.4, describes options for retesting. The required 
source documentation to support meeting the enrollment criteria are noted in Appendix 6
(Section 10.6).
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 6.8, 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.
Must not receive guselkumab outside of this protocol or participate in any other clinical 
study with an investigational agent while in this study and must terminate study 
participation if they do. 

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5.4.
Screen Failures
If, during the screening phase, the participant has not met all inclusion criteria or met any exclusion 
criteria, or is unable or unwilling to adhere to the prohibitions and restrictions of the study, the 
participant is considered to be a screen failure and is not eligible to be randomized at that time.
Participant Identification, Enrollment, and Screening Logs
The investigator agrees to complete a participant identification and enrollment log 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 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.
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened on one occasion only after consultation with the Sponsor or designee (ie, study 
responsible physician, scientists). 
Rescreening
If a participant was a screen failure in the past but currently the participant is expected to be able 
to meet the participant eligibility criteria, the participant may be screened again on one occasion 
only after consultation with the Sponsor (ie, study responsible physician, scientists, or designee).
For the second screening, the participant will be assigned a new participant number, and must 
undergo the informed consent process and all other screening procedures again as per the SoA
(Section 1.3).
Chest x-rays and radiographs of hands and feet, if done within the specified allowed time, are not 
required to be repeated.
If the QuantiFERON®-TB test and/or the tuberculin skin test was positive in the first screening, 
these tests should not be repeated.  Also, if the QuantiFERON®-TB test and tuberculin skin test 
were done within the specified allowed time, they should not be repeated.
Retesting
Retesting of abnormal laboratory values that may lead to exclusion will be allowed once with the 
exception of AST and ALT. Retesting can occur at an unscheduled visit during the specified 
screening phase.
If a laboratory abnormality occurs, the site is encouraged to wait for all laboratory tests to be 
completed to ensure other laboratory tests do not need to be repeated, as only 1 retest of laboratory 
tests is allowed.

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5.5.
Criteria for Temporarily Delaying Administration of Study Intervention
Guidelines for study intervention administration affected by the COVID-19 pandemic are found 
in Appendix 9 (Section 10.9).
6.
STUDY INTERVENTION AND CONCOMITANT THERAPY
6.1.
Study Intervention(s) Administered
Study intervention administration must be captured in the source documents and the electronic 
case report form (eCRF). Study site personnel will instruct participants on how to store study 
intervention for at-home use as indicated for this protocol. 
Guselkumab and placebo will be manufactured and provided under the responsibility of the 
Sponsor. Refer to the guselkumab IB for a list of excipients.
Detailed instructions on the administration of study intervention will be provided in the Site 
Investigational Product Procedures Manual (IPPM).
For a definition of study intervention overdose, refer to Section 6.7.
Guidelines for study intervention administration affected by the COVID-19 pandemic are found 
in Appendix 9 (Section 10.9).

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Description of Interventions
Group/Arm 
Name
Group II
Group I
Group III
Intervention 
Name
Guselkumab
Guselkumab
Placebo
Dose 
Formulation
Guselkumab 100 mg and matching 
liquid placebo for guselkumab will be 
provided in a single-use prefilled 
syringe (PFS) assembled with the 
UltraSafe PLUSTM Passive Needle 
Guard (PFS-U).
Guselkumab 100 mg and matching 
liquid placebo for guselkumab will be 
provided in a single-use prefilled 
syringe (PFS) assembled with the 
UltraSafe PLUSTM Passive Needle 
Guard (PFS-U).
Unit Dose 
Strength(s)
100 mg
100 mg
Dosage Level(s)
100 mg q4w
100 mg at Weeks 0 and 4, then q8w
Route of 
Administration
subcutaneous
subcutaneous
subcutaneous
6.1.1.
Combination Products
!
For this protocol, the term combination product refers to the single integral drug-device 
combination.
!
The Sponsor-manufactured combination product for use in this study is the prefilled syringe 
(PFS) assembled in an UltraSafe Plus™ Passive Needle Guard (PFS-U). Additional details on 
the PFS-U are provided in Section 6.2 and the guselkumab IB.
!
All combination product deficiencies (including failure, malfunction, improper or inadequate 
design, manufacturer error, use error, and inadequate labeling) shall be documented and 
reported by the investigator throughout the study. For studies in combination product, these 
deficiencies will be reported as product quality complaints (PQC) (see Appendix 7
[Section 10.7].
6.2.
Preparation/Handling/Storage/Accountability
Preparation/Handling/Storage
For SC administration, guselkumab will be supplied as a 100 mg/mL sterile liquid in a single dose 
PFS-U. For SC administration, placebo for guselkumab will be supplied as a 1 mL sterile liquid in 
a single dose PFS-U. 
Guselkumab and placebo for guselkumab should be clear and colorless to light yellow solution 
that may contain small translucent particles. Do not use guselkumab or placebo for guselkumab if 
the liquid is cloudy or discolored or has large particles. Protection from light is not required during 
the preparation and administration of the study intervention material but avoid direct exposure to 

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sunlight. Aseptic procedures must be used during the preparation and administration of the study 
intervention material.
After Week 24, participants who are able and who have been appropriately trained in the self-
administration of study intervention may self-administer study intervention at home, as per SoA
(Section 1.3). Study personnel will instruct participants on how to transport, store, and administer 
study intervention for at-home use as indicated for this protocol.
Refer to the study Site IPPM for additional guidance on study intervention preparation, handling, 
and storage.
Accountability
The investigator is responsible for ensuring that all study intervention received at the site is 
inventoried and accounted for throughout the study. 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.
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 must be available for verification by the 
Sponsor's or designee’s study site monitor during on-site monitoring visits. The return to the 
Sponsor of unused study intervention 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.
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 intervention accountability purposes. 
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. 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. 
Further guidance and information for the final disposition of unused study interventions are 
provided in the Site IPPM.
6.3.
Measures to Minimize Bias: Randomization and Blinding
Intervention Allocation
Procedures for Randomization and Stratification
Central randomization will be implemented in this study. Participants will be randomly assigned 
to 1 of 3 intervention groups based on a computer-generated randomization schedule prepared 

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before the study by or under the supervision of the Sponsor. The randomization will be balanced 
by using randomly permuted blocks and will be stratified by a combined factor of baseline 
radiographic variability, corticosteroid use, number of joints with erosion, and the most recent 
available CRP value prior to randomization into 4 strata levels (HRV, NP, LMP, and RP). All 
participants with HRV will be assigned to HRV stratum, and the rest of participants will be 
assigned to the other strata based on probability of NP, LMP, and RP.
The interactive web response system (IWRS) will assign a unique intervention code, which will 
dictate the intervention assignment and matching study intervention kit for the participant. The 
requestor must use his or her own user identification and personal identification number when
contacting the IWRS and will then give the relevant participant details to uniquely identify the 
participant.
Blinding
To maintain the study blind, the study intervention container will have a label containing the study 
name, study intervention number, reference number and storage instructions. The label will not 
identify the study intervention in the container. However, if it is necessary for a participant's safety, 
the study blind may be broken and the identity of the study intervention ascertained. The study 
intervention number will be entered in the eCRF when the study intervention is administered. The 
study interventions will be identical in appearance and will be packaged in identical containers.
The investigator will not be provided with randomization codes. The codes will be maintained 
within the IWRS, which has the functionality to allow the investigator to break the blind for an 
individual participant.
Data that may potentially unblind the intervention assignment (ie, study intervention serum 
concentrations, anti-guselkumab antibodies) will be handled with special care to ensure that the 
integrity of the blind is maintained and the potential for bias is minimized. This can include making 
special provisions, such as segregating the data in question from view by the investigators, clinical 
team, or others as appropriate until the time of DBL and unblinding.
Under normal circumstances, the blind should not be broken until all participants have completed
Week 48 or discontinued prior to Week 48 and the Week 48 DBL has occurred. The investigator 
may in an emergency determine the identity of the intervention by contacting the IWRS. While 
the responsibility to break the intervention code in emergency situations resides solely with the 
investigator, it is recommended that the investigator contact the Sponsor or its designee if possible,
to discuss the particular situation, before breaking the blind. Telephone contact with the Sponsor 
or its designee will be available 24 hours per day, 7 days per week. In the event the blind is broken, 
the Sponsor must be informed as soon as possible. The date and reason for the unblinding must be 
documented IWRS in the appropriate section of the eCRF and in the source document. The 
documentation received from the IWRS indicating the code break must be retained with the 
participant's source documents in a secure manner.
Participants who have had their intervention assignment unblinded should continue to return for 
scheduled evaluations, and may not be eligible for further treatment.

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6.4.
Study Intervention Compliance
When participants self-administer study intervention at home, compliance with study intervention 
will be assessed at each visit. Compliance will be assessed by direct questioning during the site 
visits and documented in the source documents and eCRF. Deviation(s) from the prescribed dosage 
regimen must be recorded in the eCRF.
Participants will receive instructions on compliance with study treatment when they begin 
self-administration of study intervention at home. When participants begin self-administration at 
home, the investigator or designated study personnel will maintain a log of all study intervention 
dispensed and returned.
When study intervention is self-administered by participants at home, participants will record all 
study intervention administrations on a diary card.
During 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.
Compliance with the treatment schedule is strongly encouraged.  It is understood that treatment 
may be interrupted for health-related or safety reasons.  Therefore, if for any reason a participant 
cannot receive a dose of study intervention at the scheduled visit, the participant must make every 
effort to still come in for the scheduled assessments for that visit.  The dose should be administered 
within 2 weeks of that scheduled visit. Study intervention administrations must be at least 14 days 
apart. The participant should then resume the normal study schedule relative to the baseline visit
(Week 0).  In the case when a participant does not come into the investigational site for a scheduled 
visit, the site will follow-up with that participant.  Due diligence could include telephone calls, 
certified letters, and email requests. Measures taken to obtain follow-up information must be 
documented.
Study-site personnel will keep a log of all study intervention dispensed and will compare the 
amount of study intervention dispensed with the amount returned.  
All post-baseline visits up to and including Week 24 will have a visit window of ±4 days counting 
from Week 0 as Day 1. After Week 24, all visits will have a visit window of ±7 days. The 
Week 168 visit or the final safety visit (12 weeks after the last dose in participants who 
discontinued study treatment) will have a visit window of ±14 days. If a study visit occurs outside 
this window, the Sponsor should be consulted about how the participant should resume his or her 
normal dose schedule.
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 entries on the eCRFs to ensure accuracy.

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6.5.
Dose Modification
Not applicable
6.6.
Continued Access to Study Intervention After the End of the Study
Participants will be instructed that study intervention will not be made available to them after they 
have completed/discontinued study intervention and that they should return to their primary 
physician to determine standard of care.
Local regulations on continued access will always take precedence. Plans for continued access 
stated in this protocol may change if new information on the benefit-risk profile of guselkumab
becomes available during the study or program.
6.7.
Treatment of Overdose
For this study, any dose of guselkumab greater than the highest dose at a single dosing visit will 
be considered an overdose. The Sponsor does not recommend specific treatment for an overdose.
In the event of an overdose, the investigator or treating physician should:
!
Contact the Medical Monitor immediately.
!
Evaluate the participant to determine, in consultation with the Medical Monitor, whether study 
intervention should be interrupted or whether the dose should be reduced.
!
Closely monitor the participant for AE/SAE and laboratory abnormalities.
!
Obtain a serum sample for PK analysis if requested by the Medical Monitor (determined on a 
case-by-case basis).
!
Document the quantity of the excess dose as well as the duration of the overdosing in the 
eCRF.
6.8.
Concomitant Therapy
Prestudy therapies administered after the time of informed consent must be recorded at screening.
Concomitant therapies must be recorded throughout the study beginning with start of the first dose 
of study intervention to after the last dose of study intervention. Concomitant therapies should also 
be recorded beyond that point only in conjunction with SAEs that meet the criteria outlined in the 
protocol.
All therapies (prescription or over-the-counter medications, including vaccines, vitamins, herbal 
supplements; non-pharmacologic therapies such as electrical stimulation, acupuncture, special 
diets, exercise regimens, or other specific categories of interest) different from the study 
intervention must be recorded in the eCRF.
Recorded information will include a description of the type of therapy, treatment period, dosage, 
route of administration and indication. Modification of an effective preexisting therapy should not 
be made for the explicit purpose of entering a participant into the study.

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The Sponsor or designee must be notified in advance (or as soon as possible thereafter) of any 
instances in which prohibited therapies are administered.
Every effort should be made to keep participants’ concomitant medications for PsA stable through 
Week 24 or as specified in the following sections. The concomitant medication dose may be 
reduced or temporarily discontinued because of abnormal laboratory values, adverse effects or 
intolerance, concurrent illness, or the performance of a surgical procedure but the change and 
reason for the change should be clearly documented in the participant’s medical record.
Participants may not be receiving more than two non-biologic DMARDs from baseline (see 
Exclusion Criterion 8) through Week 48 (with the exception of participants who are eligible for 
EE at Week 16, who may receive up to 3 non-biologic DMARDs). After Week 48 and through the 
end of the study, participants may receive up to 3 protocol permitted non-biologic DMARDs.
Note: participants cannot be on concomitant MTX and LEF.
Permitted concomitant medications for PsA and the maximum allowed doses during the study as 
specified in the following sections are summarized in Table 3.
Table 3:
Permitted Concomitant Medications for PsA and the Maximum Allowed Doses During the 
Study
Permitted Concomitant Medications
for Psoriatic Arthritis (PsA)a
Maximum Allowed Dose
NSAIDs and other analgesics
Maximum marketed dose approved in in the country 
where the study is being conducted
Oral corticosteroids
Equivalent to 10 mg/day of prednisone
Methotrexate (MTX)b
25 mg/week
Sulfasalazine (SSZ)
3 g/day
Hydroxychloroquine (HCQ)
400 mg/day
Leflunomide (LEF)
20 mg/day
a
Permitted concomitant medications are not supplied by the Sponsor.
b
It is recommended that all participants taking MTX in this study receive at least 5 mg oral folate or 5 mg folinic 
acid weekly. Guidelines for dose adjustment in the event of MTX toxicity are included in the Trial Center File.
Abbreviations: HCQ = Hydroxychloroquine; LEF = Leflunomide; MTX = Methotrexate; PsA = psoriatic arthritis; 
SSZ = Sulfasalazine
Participants should not initiate any new treatment for PsA through Week 48, except at Week 16 
for those participants who have <20% improvement from baseline in both tender and swollen joint 
counts (EE criteria). Participants who meet EE criteria will be allowed to initiate or increase the 
dose of one of the permitted concomitant medications up to the maximum allowed dose as 
specified in Table 3, as selected by the investigator.  Titration to a stable dose of the medication 
should be completed for participants qualifying for EE by the Week 24 visit.
Beginning at Week 48, the treatment options in Table 3 are allowed to be initiated or dose 
increased up to the maximum allowed dose specified in Table 3 for participants with ongoing PsA 

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disease activity at the investigator’s judgment; the rationale should be clearly documented in the 
participant’s medical record. Note: participants cannot be on concomitant MTX and LEF.
Concomitant medication review will occur at study visits identified in the SoA (Section 1.3).
6.8.1.
Non-biologic DMARDs
6.8.1.1.
Permitted Non-biologic DMARDs
Participants are permitted to enter the study on a stable dose of up to 2 non-biologic DMARDs
(limited to MTX, SSZ, HCQ, or LEF) up to the maximum allowed dose specified in Table 3. Only 
up to 2 of these non-biologic DMARDs are allowed from baseline through Week 48 (with the 
exception of participants who are eligible for EE at Week 16, who may receive up to 3 non-biologic 
DMARDs); participants receiving 3 or more non-biologic DMARDs at baseline are excluded from 
study participation. After Week 48 and through the end of the study, participants may receive up 
to 3 non-biologic DMARDs.
At any time during the study, the dose of the permitted non-biologic DMARD may be reduced or 
temporarily discontinued due to abnormal laboratory values, side effects, concurrent illness, or the 
performance of a surgical procedure. 
Refer to Table 4 for protocol requirements of the permitted non-biologic DMARDs.
Table 4:
Protocol Requirements of the Permitted Non-biologic DMARDs
Permitted Non-
biologic DMARDs
Baseline 
Usage
Prior to Week 0
Week 0 through 
Week 48
Week 48 through Week 
168
Methotrexate (MTX)
Used 
Treatment should 
have started at least 3 
months prior to the 
first administration of 
study intervention. 
Methotrexate routes 
of administration and 
doses should be stable 
for at least 4 weeks 
prior to the first 
administration of the 
study intervention.
Stable dose and 
route of 
administration (oral, 
intramuscular, or 
subcutaneous 
permitted) required 
unless early escape 
(EE) or 
unacceptable side 
effects.
Dose changes allowed 
up to the maximum dose 
specified in Table 3 or 
change of the route of 
administration, at the 
investigator’s discretion.
Not Used
Discontinued at least 
4 weeks prior to the 
first administration of 
study intervention.
Not allowed unless 
EE.
Allowed up to the 
maximum dose specified 
in Table 3 at 
investigator’s discretion.

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Table 4:
Protocol Requirements of the Permitted Non-biologic DMARDs
Permitted Non-
biologic DMARDs
Baseline 
Usage
Prior to Week 0
Week 0 through 
Week 48
Week 48 through Week 
168
Sulfasalazine (SSZ) or 
Hydroxychloroquine 
(HCQ)
Used 
Treatment should 
have started at least 3 
months prior to the 
first administration of 
study intervention. 
Dose should be stable 
for at least 4 weeks 
prior to the first 
administration of the 
study intervention.
Stable dose required 
unless EE or 
unacceptable side 
effects.
Dose changes allowed 
up to the maximum dose 
specified in Table 3, at 
the investigator’s 
discretion.
Not Used
Discontinued at least 
4 weeks prior to the 
first administration of 
study intervention.
Not allowed unless 
EE.
Allowed up to the 
maximum dose specified 
in Table 3 at 
investigator’s discretion.
Leflunomide (LEF)
Used 
Treatment should 
have started at least 3 
months prior to the 
first administration of 
study intervention. 
Dose should be stable 
for at least 4 weeks 
prior to the first 
administration of the 
study intervention.
Stable dose required 
unless EE or 
unacceptable side 
effects.
Dose changes allowed 
up to the maximum dose 
specified in Table 3 at 
the investigator’s 
discretion.
Not Used
Discontinued at least 
12 weeks prior to the 
first administration of 
study intervention. 
Not allowed unless 
EE.
Allowed up to the 
maximum dose specified 
in Table 3 at 
investigator’s discretion.
Abbreviations: DMARDs = disease-modifying antirheumatic drugs; EE = early escape; 
HCQ = Hydroxychloroquine; LEF = Leflunomide; MTX = Methotrexate; PsA = psoriatic arthritis; 
SSZ = Sulfasalazine
6.8.1.2.
Prohibited Non-biologic DMARDs and Apremilast
All other non-biologic DMARDs (including, but not limited to chloroquine, gold preparations, 
penicillamine) and apremilast must be discontinued at least 4 weeks prior to the first administration 
of study intervention and remain prohibited through Week 168.
6.8.1.3.
Systemic Immunosuppressive Drugs
Systemic immunosuppressants (including, but not limited to azathioprine, cyclosporine, 
6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, or tacrolimus) must be 
discontinued at least 4 weeks prior to the first administration of study intervention and remain 
prohibited through Week 168.  If any of these systemic immunosuppressants is initiated during the 
study, study intervention must be permanently discontinued.
Systemic immunosuppressants do not refer to corticosteroids; see Section 6.8.2 for restrictions 
regarding the use of corticosteroids.

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6.8.2.
Corticosteroids
6.8.2.1.
Oral Corticosteroids
Participants using oral corticosteroids at baseline for PsA must be on a stable dose equivalent to 
≤10 mg prednisone per day for at least 2 weeks prior to the first administration of study 
intervention and continue on this dose through Week 24 unless EE at Week 16.  
Starting at Week 24, the dose and type of oral corticosteroid may be adjusted, at the discretion of 
the investigator (up to the maximum dose in Table 3), for participants with ongoing PsA disease 
activity.  
Otherwise, throughout the study, the dose and type of oral corticosteroid may be changed at the 
discretion of the investigator only if the participant develops unacceptable side effects. 
Participants not using oral corticosteroids at baseline for PsA must have discontinued oral 
corticosteroids at least 2 weeks prior to the first administration of study intervention and must not 
receive oral corticosteroids through Week 24 of the study for PsA. An exception is made for 
participants who qualify for EE at Week 16.
6.8.2.2.
Corticosteroids – Intravenous, Intramuscular, or Epidural 
Administration 
Intravenous, IM, or epidural administration of corticosteroids for the treatment of PsA are not 
allowed through Week 48.
Long-term, (>2 weeks), oral or IV corticosteroid use for indications other than PsA or psoriasis is 
not allowed through Week 48. Short-term (≤2 weeks) oral, IV, IM, or epidural corticosteroid used 
for indications other than PsA should be limited to situations where, in the opinion of the 
investigator, there are no adequate alternatives.
6.8.2.3.
Corticosteroids – Intra-articular Injection 
Attempts should be made to avoid intra-articular corticosteroid injections for PsA, especially 
during the first 24 weeks of the study.  However, if necessary, participants may receive up to 
2 intra-articular, tendon sheath, or bursal corticosteroid injections in no more than 2 affected sites 
within any 24-week period of the study.  In the case of severe tenderness or swelling in a single 
joint, it is suggested that the participant be evaluated for infection prior to receiving an 
intra-articular corticosteroid injection.
6.8.2.4.
Corticosteroids – Other Routes of Administration
Inhaled, otic, ophthalmic, intranasal, and other routes of mucosal delivery of corticosteroids for 
indications other than PsA and/or psoriasis are allowed throughout the course of the study.

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6.8.3.
Nonsteroidal Anti-inflammatory Drugs and Other Analgesics
For participants receiving NSAIDs, including aspirin and selective cyclooxygenase two inhibitors, 
or other analgesics for PsA at baseline, treatment with a stable dose of NSAIDs or other analgesics 
should have been initiated at least 2 weeks prior to the first administration of study intervention 
and continue through Week 24 unless EE at Week 16.  The dose administered should be the usual 
marketed dose approved in the country where the study is being conducted. 
The use of topical analgesics including capsaicin and diclofenac is allowed and should be recorded 
in the eCRF. For topical and analgesic patches, the dose should be stable through Week 24 and 
may be changed only if the participant develops unacceptable side effects.
Participants not receiving NSAIDs or other analgesics for PsA at baseline must have discontinued 
NSAIDs or other analgesics at least 2 weeks prior to the first administration of study intervention 
and must not receive NSAIDs or other analgesics for PsA through Week 24 of the study.  An 
exception is made for participants who qualify for EE at Week 16.
Starting at Week 24, participants with ongoing PsA disease activity can initiate or increase the 
dose of NSAIDs or other analgesics based on the investigator’s clinical judgment.
At any time during the study, the dose of NSAIDs or other analgesics may be reduced or 
temporarily discontinued due to abnormal laboratory values, side effects, concurrent illness, or the 
performance of a surgical procedure.
Use of NSAIDs and other analgesics for indications other than PsA are permitted throughout the 
study.
6.8.4.
Biologic Agents, Cytotoxic Drugs, JAK Inhibitors, or Investigational 
Agents
The concomitant use of biologic agents, cytotoxic agents, JAK inhibitors, and/or investigational 
drugs is not allowed, with the exception of limited emergency use for treatment of COVID-19 
infection. Biologic agents include, but are not limited to golimumab, anakinra, etanercept, 
adalimumab, infliximab, ustekinumab, alefacept, efalizumab, rituximab, natalizumab, 
certolizumab pegol, tildrakizumab, secukinumab, ixekizumab, brodalumab, and respective 
biosimilars as applicable. Cytotoxic agents include, but are not limited to chlorambucil, 
cyclophosphamide, nitrogen mustard, and other alkylating agents. JAK inhibitors include, but are 
not limited to tofacitinib, baricitinib, filgotinib, peficitinib, upadacitinib and decernotinib. If any 
of these medications are used, study intervention must be permanently discontinued, with the 
exception of limited emergency use for treatment of COVID-19 infection. Continuation of study 
intervention in such cases should be after an appropriate wash-out period and in consultation with 
the Sponsor’s medical monitor.

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6.8.5.
Complementary Therapies
The use of complementary therapies, including ayurvedic medicine, traditional Chinese 
medications or non-medicinal therapy such as acupuncture for PsA or psoriasis, is not allowed 
from 2 weeks prior to the first administration of study intervention through Week 48.
6.8.6.
Topical Therapy and Ultraviolet B Light
Concurrent use of topical medications/treatments for psoriasis (eg, topical or intralesional 
corticosteroids, keratolytics (with the exception of salicylic acid shampoos, which are allowed 
throughout the study), coal tar (with the exception of coal tar shampoos, which are allowed 
throughout the study), anthralin, vitamin D3 analogues, or topical tacrolimus, and retinoids) are 
not permitted through Week 24.  
Use of salicylic acid- and tar-containing shampoos is not permitted on the morning prior to a study 
visit; non-medicated shampoos may be used on the day of a study visit.
Low-potency topical corticosteroids may be used on the face and groin only. Low and mid-potency 
topical or intralesional corticosteroids (Class III-VII) may be used after Week 24 for psoriasis. 
High and ultra-high potency corticosteroids (Class I and II) are prohibited through Week 48.
Phototherapy including UVB or tanning beds are not permitted during the study through 
Week 168.  Participants should be encouraged to avoid prolonged sun exposure during the study.  
6.8.6.1.
Systemic Therapy for Psoriasis
Concurrent use of systemic therapy for psoriasis (eg, psoralen with ultraviolet light A, systemic 
retinoids, cyclosporine or tacrolimus, with the exception of those in Table 3) must be discontinued 
at least 4 weeks prior to the first administration of study intervention and is not permitted through 
Week 168; if a systemic antipsoriatic treatment (except those in Table 3) is initiated during the 
study, study intervention must be permanently discontinued.
6.8.7.
Vaccinations (Including COVID-19)
When considering use of locally-approved non-live vaccines (including emergency use-authorized 
COVID-19 vaccines) in study participants, follow applicable local vaccine labelling, guidelines, 
and standard of care for participants receiving immune-targeted therapy.
For study participants receiving a locally-approved (including emergency use-authorized) 
COVID-19 vaccine, in order to help identify acute reactions potentially related to the COVID-19 
vaccine, it is recommended where possible that the vaccine and study intervention be administered 
on different days, separated by as large an interval as is practical within the protocol.

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7.
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1.
Discontinuation of Study Intervention
A participant's study intervention must be discontinued if:
!
The participant withdraws consent to receive study intervention.
!
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.
!
The participant becomes pregnant or plans to become pregnant within the study period. Refer 
to Appendix 5 [Section 10.5].
!
A systemic opportunistic infection.
!
The participant is unable to adhere to the study visit schedule or comply with protocol 
requirements.
!
The participant is deemed ineligible according to the following TB screening criteria:
∀
A diagnosis of active TB is made.
∀
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 test result and/or 2 indeterminate 
QuantiFERON®-TB test results on repeat testing (refer to Section 8.2.11) (and/or a 
positive 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).
∀
The frequency of TB testing can be increased depending on local health authority 
requirements.
Note: In Ukraine, while the QuantiFERON-TB®
test is not 
approved/registered, it is acceptable, and an additional tuberculin skin test is not required.
∀
A participant receiving treatment for latent TB discontinues this treatment prematurely 
or is noncompliant with the therapy.
!
The participant has a serious adverse reaction that is temporally related to an injection 
including a hypersensitivity reaction resulting in bronchospasm, wheezing and/or dyspnea that 
requires ventilatory support OR that results in symptomatic hypotension with a decrease in 
systolic blood pressure of 30% from a participant’s baseline value or systolic blood pressure 
<90 mm Hg (Sampson 2006). In general, discontinuation of study intervention administration 
must be considered for participants who develop a severe injection-site reaction.
!
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.

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!
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, after 
consultation with Sponsor medical monitor or designee.
!
The participant has severe liver test abnormalities that are not transient and are not explained 
by other etiologies, as described in Appendix 8 (Section 10.8).
!
The Sponsor may elect to terminate the study at any time, and if the Sponsor decides not to 
continue development for any reason, study medication/drug will no longer be provided to 
any participants, including those in the LTE.
Discontinuation of a participant’s study intervention should be considered under the 
following conditions: 
!
If the participant initiates treatment with prohibited therapies, the medical monitor or designee 
should be notified for possible discontinuation of study intervention. 
!
Recurrent or chronic serious infection.
!
The participant develops a serious infection, including but not limited to sepsis or pneumonia.
Note: Any serious infection should be discussed with the medical monitor or designee, and 
study intervention should be withheld until the clinical assessment is complete.
!
Discontinuation of study treatment should be considered for participants who report suicidal 
Ideation level 4 (some intent to act, no plan), Ideation level 5 (specific plan and intent), or any 
suicidal behavior (actual suicide attempts, interrupted attempts, aborted attempts, or 
preparatory actions) on a postbaseline (after Week 0) eC-SSRS assessment. Discussion of 
such participants with the medical monitor or designee is required.
!
The participant develops a severe injection-site reaction, but not meeting criteria specified 
above. 
If a participant discontinues study intervention for any reason before the end of the double-blind 
phase, they should be encouraged to continue in the study. 
Study intervention assigned to the participant who discontinued study intervention may not be 
assigned to another participant. Additional participants may be entered to ensure the 
protocol-specified number of patients complete the study.
7.1.1.
Liver Chemistry Stopping Criteria
Discontinuation of study intervention for abnormal liver tests is required by the investigator when 
a participant meets one of the conditions in Appendix 8A (Section 10.8) or in the presence of 
abnormal liver chemistries not meeting protocol-specified stopping rules if the investigator 
believes that it is in best interest of the participant.
Refer to Appendix 8B (Section 10.8) for follow-up assessments (and study intervention restart 
guidelines) following abnormal liver test results. Study Sponsor must provide written approval 
before study intervention is restarted.

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7.2.
Participant Discontinuation/Withdrawal from the Study
A participant will be withdrawn from the study for any of the following reasons:
!
Lost to follow-up
!
Withdrawal of consent
!
Death
!
Sponsor decision (eg, participating in any other clinical study with an investigational agent)
When a participant withdraws before study completion, the reason for withdrawal is to be 
documented in the eCRF and in the source document. If the reason for withdrawal from the study 
is withdrawal of consent, then no additional assessments are allowed.
Discontinuation of Study Drug Intervention
If a participant discontinues study drug intervention, they should be encouraged to return for all 
remaining core study visits; It is particularly important to return for all visits through Week 24.
Prior to Week 24
If a participant discontinues study intervention before the Week 24 visit, the participant should 
return for all visits through Week 24. The final safety assessments will be conducted at the next 
scheduled visit that occurs approximately 12 weeks after the last dose of study administration of 
study intervention. If a participant discontinues before the Week 24 visit and after the Week 12 
study intervention administration, the participant should return for the Week 24 visit and also 
12 weeks after the last administration of study intervention for a final safety visit.
For participants who discontinue study intervention prior to Week 24, radiographs of the hands 
and feet should still be performed at the Week 24 visit.
At or After Week 24 and Prior to Week 48
If a participant discontinues study intervention at or after Week 24 and is unable to return for all 
visits through Week 48, the final efficacy visit should occur at the time of discontinuation or as 
soon as possible and all assessments under the Week 48/final efficacy should be performed 
including radiographs of hands and feet, (unless another set of radiographs has been obtained 
within the past 6 weeks) with the exception of study intervention administration. The participant 
should also return for a final safety visit approximately 12 weeks after the last study intervention 
administration.
At or After Week 48 and Prior to Week 156
If a participant discontinues study intervention at or after Week 48 and is unable to return for all
visits through Week 156, the final efficacy visit should occur at the time of discontinuation or as
soon as possible and all assessments under the Week 156/final efficacy should be performed
including radiographs of hands and feet, (unless another set of radiographs has been obtained
within the past 6 weeks) with the exception of study intervention administration. The participant

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should also return for a final safety visit approximately 12 weeks after the last study intervention
administration.
Withdrawal of Consent
A participant declining to return for scheduled visits does not necessarily constitute withdrawal of 
consent. Alternate follow-up mechanisms that the participant agreed to when signing the consent 
form apply as local regulations permit.
Withdrawal of consent should be an infrequent occurrence in clinical studies (Rodriguez 2015),
therefore, prior to the start of the study the Sponsor and the investigator should discuss and reach 
a clear understanding of what constitutes withdrawal of consent in the context of the available 
reduced follow-up mechanisms listed.
Circumstances for Reduced Follow-up
In the situation where a participant may be at risk for withdrawal of consent and is unable to return 
for scheduled visits at the protocol-defined frequency, the investigator may consider options for 
reduced follow-up with consultation of the Sponsor/designee and/or medical monitor. These may 
include (as local regulations permit):
!
Less frequent clinical visits
!
Telephone, email, letter, social media, fax, or other contact with:
∀
participant
∀
relatives of the participant
∀
participant’s physicians (general or specialist)
!
Review of any available medical records
Details regarding these contacts must be properly documented in source records including 
responses by participants. 
7.2.1.
Withdrawal from the Use of Research Samples
A participant who withdraws from the study will have the following options regarding the optional 
research samples:
!
The collected samples will be retained and used in accordance with the participant's original 
separate informed consent for optional research samples.
!
The participant may withdraw consent for optional research samples, in which case the 
samples 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 optional research 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.

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Withdrawal from the Optional Research Samples While Remaining in the Main Study
The participant may withdraw consent for optional research samples while remaining in the study. 
In such a case, the optional research samples will be destroyed. The sample destruction process 
will proceed as described above.
Withdrawal from the Use of Samples in Future Research
The participant may withdraw consent for use of samples for research (refer to Appendix 6
[Section 10.6.5]). 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 and in the 
separate ICF for optional research samples.
7.3.
Lost to Follow-up
To reduce the chances of a participant being deemed lost to follow-up, prior to randomization 
attempts should be made to obtain contact information from each participant, eg, home, work, and 
mobile telephone numbers and email addresses for both the participant as well as appropriate 
family members.
A participant will be considered lost to follow-up if the participant repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. A participant cannot be deemed 
lost to follow-up until all reasonable efforts made by the study site personnel to contact the 
participant are deemed futile. The following actions must be taken if a participant fails to return to 
the study site for a required study visit:
!
The study site personnel must attempt to contact the participant to reschedule the missed visit 
as soon as possible, to counsel the participant on the importance of maintaining the assigned 
visit schedule, to ascertain whether the participant wishes to or should continue in the study.
!
Before a participant is deemed lost to follow up, the investigator or designee must make every 
reasonable effort to regain contact with the participant (where possible, 3 telephone calls, 
e-mails, fax, and, if necessary, a certified letter to the participant’s last known mailing address, 
or local equivalent methods). These contact attempts should be documented in the 
participant’s medical records.
!
Should the participant continue to be unreachable, they will be considered to have withdrawn 
from the study.
Should a study site close, eg, for operational, financial, or other reasons, and the investigator cannot 
reach the participant to inform them, their contact information will be transferred to another study 
site.
8.
STUDY ASSESSMENTS AND PROCEDURES
Overview
The SoA (Section 1.3) summarizes the frequency and timing of efficacy, PK, immunogenicity, 
PD, biomarker, pharmacogenomic, and safety measurements applicable to this study.

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To minimize unnecessary x-rays, it is recommended that participants have the baseline radiographs 
of hands and feet taken after the other inclusion and exclusion criteria have been checked and the 
participant appears eligible to enter the study.  All eligible participants should have radiographs 
taken approximately 2 weeks but not greater than 4 weeks prior to randomization.
All PRO assessments should be conducted/completed before any tests, procedures, or other 
consultations to prevent influencing participant responses. Refer to the PRO completion guidelines 
for instructions on the administration of PROs.
Urine and blood collections for PK and PD assessments should be kept as close to the specified 
time as possible. Other measurements may be done earlier than specified time points if needed. 
Actual dates and times of assessments will be recorded in the source documentation and eCRF.
Health economics data will be collected. Refer to Section 8.8, for details.
The total blood volume to be collected from each participant will be approximately 500 mL.
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 SoA (Section 1.3) 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 that will be provided. 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 supplies:
!
Investigator Site File (includes protocol and IB for guselkumab)
!
Study site investigational product and procedures manual
!
Laboratory manual and laboratory supplies
!
ePRO device and user manual 
!
IWRS Manual
!
Sample ICF
!
eCRF completion instructions
!
Participant recruitment materials

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!
Participant diary cards
!
Imaging manual
8.1.
Efficacy Assessments
8.1.1.
Psoriatic Arthritis Response Evaluations
8.1.1.1.
Joint Count (Tender and Swollen)
 
An independent joint assessor (IJA) with adequate training and experience in performing joint 
assessments will be designated at each study site to perform all joint assessments. The IJA should 
preferably be a rheumatologist but if a rheumatologist is not available, it should be a health care 
provider with at least 1 year of experience in performing joint assessments.  Health care providers 
with less than 1 year of experience may serve as an IJA based upon the discretion and approval of 
the Sponsor. It is strongly recommended that the designated IJA identify an appropriate back-up 
IJA for coverage in the event of absences of the designated IJA. It is strongly recommended that 
the same IJA who performs the baseline joint assessments for a participant should also perform 
the joint assessments for that participant at every subsequent visit through Week 156. 
Through Week 156, the IJA should have no other contact (other than joint assessments) with the 
participant once the participant is randomized, should not be the treating physician, should not 
discuss the participant’s clinical status with the participant or other site personnel during the joint 
assessment, and will not be permitted to review the participants medical records or the eCRFs, or 
any of the previous joint assessments. The IJA should maintain a neutral attitude during joint
assessment and should limit interactions with the participant only to activities associated with 
performing joint assessment or enthesitis or dactylitis assessments.
The IJA will perform only joint assessments and enthesitis and dactylitis assessments; this 
individual will not perform or assist in any other assessments in this study including but not limited 
to administering participant and/or performing physician global assessments or administering 
study intervention.
The Sponsor will provide training for each site’s designated IJA prior to the screening of the first 
participant at each site. A back-up IJA must complete training before performing a joint assessment 
for a participant’s study visit.  
If an IJA was trained by the Sponsor (with joint assessments) in a previous clinical study within 
the last 3 years and there is adequate documentation of this training (certification), that training 
will be considered adequate for this study; however, repeat training prior to start of the study is 
encouraged. Training documentation of each IJA must be maintained at the study site.
All IJA performing the joint evaluation at a site must be listed on the Delegation Log at the study
site.
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8.1.1.5.
Enthesitis Assessments
 
 
The Sponsor will provide enthesitis assessment training.  Documentation of this training will be 
maintained in the study site’s training files. Previous enthesitis assessment (LEI) training by the 
Sponsor within the last 3 years with adequate documentation (eg, training certification) will be 
considered adequate for this study; however, repeat training prior to start of the study is 
encouraged.
It is strongly recommended that the same person who performs the baseline enthesitis assessments 
for a participant should also perform the enthesitis assessments for that participant at every 
subsequent visit through Week 156.
8.1.1.6.
Imaging Evaluation
Single radiographs of the hands (posteroanterior) and feet (anteroposterior) will be performed at 
visits as specified in the SoA (Section 1.3). To minimize unnecessary x-rays, it is recommended 
that participants have the baseline radiographs of hands and feet taken after the other inclusion and 
exclusion criteria have been checked and the participant appears eligible to enter the study. All 
eligible participants should have radiographs taken approximately 2 weeks but not greater than 
4 weeks prior to randomization; and at Week 24, Week 48, Week 96, and Week 156 within 
± 2 weeks of the scheduled visit.
Participants who Discontinue Study Intervention
For participants who discontinue study intervention prior to Week 24, radiographs of the hands 
and feet should be performed at Week 24.
For participants who permanently discontinue study intervention after Week 24 but prior to 
Week 156, radiographs of hands and feet should be performed at the time of discontinuation of 
study intervention or as soon as possible unless another set of radiographs has been obtained within 
the past 6 weeks.
Participants Who Discontinue Study Participation
For participants who discontinue study participation at any time during the study radiographs of 
the hands and feet should be performed at the time of study discontinuation unless another set of 
radiographs has been obtained within the past 6 weeks.
The radiographs will be evaluated by central independent readers and scored using total modified 
vdH-S score. Total modified vdH-S is an original vdH-S score (Van der Heijde 1992), modified 
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for the purpose of PsA radiological damage assessment, by addition of distal interphalangeal joints 
of the hands and assessment of pencil in cup and gross osteolysis deformities. The total modified 
vdH-S score includes the joint erosion score and the JSN score. The joint erosion score is a 
summary of erosion severity in 40 joints of the hands and 12 joints in the feet. Each hand joint is 
scored, according to surface area involved, from 0 indicating no erosion through 5 indicating 
extensive loss of bone from more than one half of the articulating bone.  Because each side of the 
foot joint is graded on this scale, the maximum erosion score for a foot joint is 10. Thus, the 
maximal erosion score is 320.  The JSN score summarizes the severity of JSN in 40 joints in the 
hands and 12 joints of the feet. Assessment of JSN is scored from 0 through 4, with 0 indicating 
no JSN and with 4 indicating complete loss of joint space, bony ankylosis, or complete luxation. 
Thus, the maximal JSN score is 208 and 528 is the worst possible total modified vdH-S score for 
PsA.
Detailed information on the acquisition of radiographs will be provided in an Imaging Manual and 
the Central Read Campaigns will be defined in the Imaging Charter.
8.1.1.7.
Disability Index of the Health Assessment Questionaire 
 
 
 
 
 
 
 
 
8.1.1.8.
Minimal Disease Activity
 
 
 
 
).
8.1.1.9.
Very Low Disease Activity 
 
8.1.1.10.
Disease Activity Score 28
 
 
 
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8.1.1.12.
Disease Activity Index for Psoriatic Arthritis
 
 
 
8.1.1.13.
Psoriatic Arthritis Responder Criteria
 
 
. 
8.1.1.14.
Modified Nail Psoriasis Severity Index 
 
 
 
 
8.1.1.15.
Physician’s Global Assessment of Fingernail Psoriasis 
 
 
 
 
 
8.1.2.
Psoriasis Response Evaluations
8.1.2.1.
Psoriasis Area and Severity Index 
 
 
 
.
Every effort should be made to ensure that the physician or designee who performed the PASI 
evaluations for a participant at baseline should also perform the PASI evaluations for the 
participant at all subsequent visits through Week 48. The Sponsor will provide PASI training. 
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Documentation of this training will be maintained in the site’s training files. Previous PASI 
training by the Sponsor within the last 3 years with adequate documentation (eg, training 
certification) will be considered adequate for this study; however, repeat training prior to start of 
the study is encouraged.
8.1.2.2.
Investigator’s Global Assessment of Psoriasis
 
 
 
 
Every effort should be made to ensure that the physician or designee who performed the IGA 
evaluations for a participant at baseline should also perform the IGA evaluations for the participant
at all subsequent visits through Week 156. The Sponsor will provide IGA training. Documentation 
of this training will be maintained in the site’s training files. Previous IGA training by the Sponsor 
within the last 3 years with adequate documentation (eg, training certification) will be considered 
adequate for this study; however, repeat training prior to start of the study is encouraged.
8.1.2.3.
Dermatology Life Quality Index
 
 
 
 
 
 
 
8.1.3.
Other Patient Reported Outcomes
8.1.3.1.
PsA Impact of Disease-12
 
 
 
 
).
8.1.3.2.
Functional Assessment of Chronic Illness Therapy - Fatigue
 
 
 
 
 
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8.2.
Safety Assessments
Adverse events will be reported and followed by the investigator as specified in Section 8.3 and
Appendix 7 (Section 10.7).
Any clinically relevant changes occurring during the study must be recorded on the Adverse Event 
section of the eCRF.
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 condition is reached. 
The study will include the following evaluations of safety and tolerability according to the time 
points provided in the SoA (Section 1.3).
8.2.1.
Physical Examinations
Physical examinations will be performed by the investigator or designated physician as specified 
in the SoA (Section 1.3). Any abnormalities or changes in severity noted during the review of body 
systems should be documented in the source document. 
8.2.2.
Vital Signs
Pulse/heart rate and blood pressure will be assessed at each visit.
Blood pressure and pulse/heart rate measurements will be assessed with a completely automated 
device. Manual techniques will be used only if an automated device is not available.
Wherever possible, blood pressure and pulse/heart rate measurements should be preceded by at 
least 5 minutes of rest in a quiet setting without distractions (eg, television, cell phones).
If any clinically significant changes in vital signs are noted, they must be reported as AEs and 
followed to resolution, or until reaching a clinically stable endpoint.
8.2.3.
Height and Weight
Height and weight will be measured as specified in the SoA (Section 1.3).
8.2.4.
Electrocardiograms
A 12-lead electrocardiogram (ECG) will be performed as specified in the SoA (Section 1.3).
During the collection of ECGs, participants should be in a quiet setting without distractions 
(eg, television, cell phones). Participants should rest in a supine position for at least 5 minutes 
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before ECG collection and should refrain from talking or moving arms or legs. If blood sampling 
or vital sign measurement is scheduled for the same time point as ECG recording, the procedures 
should be performed in the following order: ECG(s), vital signs, blood draw.
8.2.5.
Clinical Safety Laboratory Assessments
Blood samples for serum chemistry and hematology will be collected as noted in Appendix 2
(Section 10.2). The investigator must review the laboratory results, document this review, and 
record any clinically relevant changes occurring during the study in the AE section of the eCRF.
The laboratory reports must be filed with the source documents.
The tests that will be performed by the central laboratory unless otherwise specified or approved 
by the medical monitor are specified in Appendix 2 (Section 10.2).
8.2.6.
Electronic Columbia-Suicide Severity Rating Scale
No signal of suicidal ideation and behavior has been observed in the clinical trials of guselkumab
to date. However, in light of reports concerning suicidal ideation and behavior in patients with 
plaque psoriasis treated with an IL-17R antagonist (brodalumab), the eC-SSRS will be used as a 
screening tool to prospectively evaluate suicidal ideation and behavior among study participants. 
 
 
 
 
 
Participants will complete the eC-SSRS questionnaire using the sponsor-provided electronic 
device. Study site personnel will train the participants on how to use the electronic device. The 
eC-SSRS will be provided in the local languages in accordance with local guidelines.
The eC-SSRS will be performed during each evaluation visit according to the SoA (Section 1.3). 
During a visit, participants will be directed to a private, quiet place with the electronic device to 
complete the assessment. Participants who do not have suicidal behavior or ideation will answer a 
limited number of questions and will usually complete the assessment in about 3 minutes. 
Participants with significant suicidal ideation and behavior may require up to 10 minutes to answer 
all relevant questions. At the screening visit, the eC-SSRS should be completed after the joint 
assessment and physician’s global assessment of disease activity (after signing informed consent). 
For subsequent visits, the eC-SSRS should be completed as the first assessment/questionnaire prior 
to all PROs and before any other tests, procedures, or other consultations.
At the conclusion of each assessment, the eC-SSRS Findings Report can be viewed electronically. 
At screening (“In the last 6 months”) and Week 0, participants with an Ideation level (1-5) or any 
suicidal behaviors or with a response of “YES” for non-suicidal, self-injurious behavior must be 
determined to be not at risk by the investigator based on an evaluation by a mental health 
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to be at risk by the investigator based upon evaluation by a mental health professional. Discussion 
of such participants with the medical monitor or designee is required (see Section 7.1). The final 
decision on suitability for continuing in the study will be made by the investigator.
Any eC-SSRS findings, which in the opinion of the investigator are new or considered to be a 
worsening and clinically significant, should be reported on the AE eCRF (see Appendix 7
[Section 10.7]).
8.2.7.
Concomitant Medication Review
Concomitant medications will be reviewed at each visit and recorded in the source documents and 
eCRF.
8.2.8.
Injection-Site Reactions
A study intervention injection-site reaction is any adverse reaction at a SC study intervention 
injection-site. The injection sites will be evaluated for reactions and any injection-site reaction will 
be recorded as an AE.
8.2.9.
Hypersensitivity Reactions
Before any administration of study intervention at the study site, appropriately trained personnel 
and medications (eg, antihistamines, injectable epinephrine) must be available to treat 
hypersensitivity reactions, including anaphylaxis. All participants must be observed carefully for 
signs and symptoms of a hypersensitivity reaction (eg, urticaria, pruritis, angioedema, wheezing, 
dyspnea, or hypotension). 
8.2.10.
Infections
Investigators are required to evaluate participants for any signs or symptoms of infection at every
scheduled visit. Study intervention administration should not be given to a participant with a 
clinically significant, active infection. If a participant develops a serious infection, including but 
not limited to sepsis or pneumonia, discontinuation of study intervention must be strongly 
considered (Section 7.1). Any serious infection should be discussed with the medical monitor or 
designee, and study intervention should be withheld until the clinical assessment is complete
8.2.11.
Tuberculosis Evaluations
8.2.11.1.
Initial Tuberculosis Evaluation
Participants must undergo testing for TB (refer to Appendix 3 [Section 10.3]) 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. Investigators have the option to use both the QuantiFERON-TB® test and the tuberculin 
skin test to screen for latent TB if they believe, based on their judgment, that the use of both tests 
is clinically indicated to evaluate a participant who is high risk of having latent TB. If 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.

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Participants with a negative QuantiFERON-TB® test result (and a negative tuberculin skin test 
result in countries in which the QuantiFERON-TB® test is not approved/registered or the 
tuberculin skin is mandated by local health authorities) are eligible to continue with 
pre-randomization procedures. Participants with a newly identified positive QuantiFERON-TB®
test result must undergo an evaluation to rule out active TB and initiate appropriate treatment for 
latent TB. Appropriate treatment for latent TB is defined according to local country guidelines for 
immunocompromised patients. If no local country guidelines for immunocompromised patients 
exist, US guidelines should be followed, or the participant will be excluded from the study. 
A participant whose first QuantiFERON-TB® test result is indeterminate should have the test 
repeated. In the event that the second QuantiFERON-TB® test result is also indeterminate, the 
participant may be enrolled without treatment for latent TB if active TB is ruled out, their chest 
radiograph shows no abnormality suggestive of TB (active or old, inactive TB) and the participant 
has no additional risk factors for TB as determined by the investigator. This determination must 
be promptly reported to the Sponsor’s or designee’s medical monitor and recorded in the 
participant's source documents and initialed by the investigator.
8.2.11.2.
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 SoA in Section 1.3) or by telephone contact approximately every 8 to 12 weeks. The following 
series of questions is suggested for use during the evaluation: 
!
“Have you had a new cough of >14 days’ duration or a change in a chronic cough?”
!
“Have you had any of the following symptoms:
∀
Persistent fever?
∀
Unintentional weight loss?
∀
Night sweats?”
!
“Have you 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 repeat chest radiograph, a repeat QuantiFERON®-TB test, a repeat tuberculin 

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skin test in countries in which the QuantiFERON®-TB 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 is warranted. Study intervention administration should be interrupted during the 
investigation. A positive QuantiFERON®-TB test or tuberculin skin test result should be 
considered detection of latent TB. Participants with a newly identified positive 
QuantiFERON-TB® test result must undergo an evaluation to rule out active TB and initiate 
appropriate treatment for latent TB. Appropriate treatment for latent TB is defined according to 
local country guidelines for immunocompromised patients. If no local country guidelines for 
immunocompromised patients exist, US guidelines should be followed, or the participant will be 
excluded from the study. If the QuantiFERON-TB® test result is indeterminate, the test should be 
repeated. Participants should be encouraged to return for all subsequent scheduled study visits 
according to the protocol. Participants who discontinue treatment for latent TB prematurely or who 
are noncompliant with therapy must immediately discontinue further administration of study 
intervention and be encouraged to return for all subsequent scheduled study visits according to the 
SoA (Section 1.3).
8.2.12.
Pregnancy Testing 
Women of childbearing potential must have a negative serum pregnancy test at screening and a 
negative urine pregnancy test at baseline before randomization. Additionally, urine pregnancy 
testing is required for all women of childbearing potential at every study intervention
administration visit. Pregnancy tests must be completed, and the result must be negative before the 
administration of any intervention for that visit. All pregnancy test results must be recorded in 
study source documents.
8.3.
Adverse Events, Serious Adverse Events, and Other Safety Reporting
Timely, accurate, and complete reporting and analysis of safety information, including AEs, SAEs, 
and PQC, 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.
For study intervention that meets the definition of a combination product, malfunctions or 
deficiencies of a device constituent will be reported as PQC.
Further details on AEs, SAEs, and PQC can be found in Appendix 7 (Section 10.7).

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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
All SAEs, as well as PQC, occurring during the study must be reported to the appropriate Sponsor
or designee contact person by study site personnel within 24 hours of their knowledge of the event.
Information regarding SAEs will be transmitted to the Sponsor or designee 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 or designee within 24 hours. 
The initial and follow-up reports of an SAE should be transmitted electronically or by facsimile 
(fax). Telephone reporting should be the exception and the reporter should be asked to complete 
the appropriate form(s) first.
Any possible Hy’s law case (AST or ALT ≥3x ULN together with bilirubin ≥2X ULN or INR 
>1.5, if measured) is considered an important medical event and must be reported to the sponsor 
in an expedited manner using the SAE form, even before all other possible causes of liver injury 
have been excluded (INR criterion is not applicable to participants receiving anticoagulants).
A confirmed Hy’s law case must be reported as a SAE.
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 is the preferred method to inquire about AE occurrence. 
Solicited Adverse Events
Solicited AEs are predefined local at the injection site and systemic events for which the participant 
is specifically questioned.
Unsolicited Adverse Events
Unsolicited AEs are all AEs for which the participant is not specifically questioned.
8.3.3.
Follow-up of Adverse Events and Serious Adverse Events
The investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and evaluations as medically indicated to elucidate the nature and causality of the AE, SAE, or 
PQC as fully as possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other health care professionals.

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Adverse events, including pregnancy, will be followed by the investigator as specified in 
Appendix 7 (Section 10.7).
8.3.4.
Regulatory Reporting Requirements for Serious Adverse Events and 
Anticipated 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). 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. A SUSAR will be reported to regulatory authorities 
unblinded. Participating investigators and IEC/IRB will receive a blinded SUSAR summary, 
unless otherwise specified. 
An anticipated event is an AE that commonly occurs in the study population independent of 
exposure to the drug under investigation.  For the purposes of this study the following SAEs will 
be considered anticipated events:
!
Worsening of psoriasis
!
Worsening of PsA
These anticipated events will be periodically analyzed in aggregate by the Sponsor during study 
conduct.  The Sponsor will prepare a safety report in narrative format if the aggregate analysis 
indicates that the anticipated event occurs more frequently in the intervention group than in the 
control group and the Sponsor concludes there is a reasonable possibility that the drug under 
investigation caused the anticipated event.
The plan for monitoring and analyzing the anticipated events is specified in a separate Anticipated 
Events Safety Monitoring Plan.  The assessment of causality will be made by the Sponsor’s 
unblinded safety assessment committee.
The Sponsor assumes responsibility for appropriate reporting of the listed anticipated events 
according to the requirements of the countries in which the studies are conducted.
8.3.5.
Pregnancy
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 an SAE reporting form. Any participant who becomes 
pregnant during the study must discontinue further study intervention (see Section 7.1). 
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the 
infant will be required (see Appendix 5 [Section 10.5] and Appendix 7 [Section 10.7]).

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8.3.6.
Adverse Events of Special Interest
Any newly identified malignancy or case of active TB occurring after the first study intervention 
administration(s) in participants in this clinical study must be reported by the investigator to the 
Sponsor or designee within 24 hours after being made aware of the event, according to the 
procedures in Appendix 7 (Section 10.7). 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 an SAE.
8.4.
Pharmacokinetics
Serum samples will be used to evaluate the PK of guselkumab. Serum collected for PK may 
additionally be used to evaluate safety or efficacy aspects that address concerns arising during or 
after the study period. Genetic analyses will not be performed on these serum samples. Participant
confidentiality will be maintained.
8.4.1.
Evaluations
Venous blood samples will be collected for measurement of serum concentrations of guselkumab
and antibodies to guselkumab at the time points shown in the SoA (Section 1.3). Serum samples 
will also be collected at the final visit from participants who discontinue study intervention or were 
withdrawn from the study. At visits where PK and immunogenicity will be evaluated, 1 blood 
draw of sufficient volume can be used. Each sample will be split into 3 aliquots (1 aliquot for 
serum guselkumab concentration, 1 aliquot for antibodies to study intervention, and 1 aliquot as a 
back-up). Samples must be collected before study intervention administration at visits when a 
study intervention administration is scheduled. The exact dates and times of blood sample 
collection must be recorded in the laboratory requisition form.
Additional information about the collection, handling, and shipment of biological samples can be 
found in the Laboratory Manual.
8.4.2.
Analytical Procedures
Serum samples will be analyzed to determine serum guselkumab concentrations using a validated, 
specific, and sensitive immunoassay method by the Sponsor’s bioanalytical facility or under the 
supervision of the Sponsor. The Sponsor, or its designee, under conditions in which the 
participants’ identity remains blinded, will assay these samples.  
8.4.3.
Pharmacokinetic Parameters and Evaluations
If feasible, the apparent total systemic clearance and apparent volume of distribution of 
guselkumab will be estimated using a nonlinear mixed-effects modeling approach.
Pharmacokinetic/Pharmacodynamic Evaluations
The relationship between serum concentrations of guselkumab and efficacy measures or relevant 
biomarker(s) may be examined when appropriate.

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8.5.
Pharmacogenomics (DNA) Evaluations
Participation in pharmacogenomic research is optional. A pharmacogenomic blood sample will be 
collected from participants who consent separately to this component of the study to allow for 
pharmacogenomic research, where local regulations permit. 
Genetic (DNA) variation may be an important contributory factor to interindividual variability in 
drug response and associated clinical outcomes. Genetic and epigenetic factors may also serve as 
markers for disease susceptibility and prognosis and may identify population subgroups that 
respond differently to an intervention.
The optional pharmacogenomic samples may be analyzed for identification of genetic and 
epigenetic factors that may be associated with the disease and/or the response to the treatments. 
This research may consist of the analysis of one or more candidate genes, or the analysis of genetic 
and epigenetic markers throughout the genome, or analysis of the entire genome (as appropriate) 
in relation to the disease and the treatments. Whole blood samples of approximately 6mL will be 
collected for the genetic and pharmacogenomics analyses.
8.6.
Biomarkers
Biomarker assessments will be made to examine the biologic response to treatment and to identify 
biomarkers that are relevant to guselkumab treatment and/or PsA, where local regulations permit. 
Assessments (detailed below) will include the evaluation of relevant biomarkers in serum, plasma, 
and whole blood collected as specified in the SoA, where local regulations permit.
Data collected from these samples may be used for exploratory research that include the following 
objectives:
1.
To understand the molecular effects of guselkumab.
2.
To understand PsA pathogenesis.
3.
To understand why individual participants may respond differently to guselkumab.
4.
To develop diagnostic tests to identify PsA populations that may be responsive or non-
responsive to treatment with guselkumab.
Stopping Analysis
Biomarker analyses are dependent upon the availability of appropriate biomarker assays and 
clinical response rates. Biomarker analysis may be deferred or not performed, if during or at the 
end of the study, it becomes clear that the analysis will not have sufficient scientific value for 
biomarker evaluation, or 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.

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8.6.1.
Pharmacodynamics
Samples for the analysis of pharmacodynamic biomarkers will be collected from all participants. 
Serum level of T helper (Th17) cytokines, such as IL-17A, IL-17F, and IL-22, may be measured 
to assess the pharmacodynamic effect of guselkumab.
8.6.2.
Serum and Plasma Biomarkers
Blood samples will be collected from all participants for serum and plasma-based biomarker 
analyses, where local regulations permit. Serum and plasma may be analyzed for levels of specific 
proteins, other inflammation-related molecules, and/or broad panel of analytes relevant to PsA 
pathogenesis and guselkumab treatment.
8.6.3.
Whole Blood Gene Expression Profile
Whole blood will be collected by venipuncture from participants for RNA expression analysis, 
where local regulations permit. Total RNA will be isolated and used for differential gene 
expression analyses to identify gene expression patterns that are relevant to guselkumab treatment 
and/or PsA, and to evaluate markers that can predict clinical response. Transcriptomic studies may 
be conducted using microarray, and/or alternative equivalent technologies, which facilitate the 
simultaneous measurement of the relative abundances of multiple RNA species resulting in a 
transcriptome profile for each blood sample. The samples may also be used for targeted assessment 
of genes relevant to the disease and/or the treatment. These analyses may be used to evaluate the 
changes in gene expression profiles that may correlate with biological response relating to PsA 
and/or the action of guselkumab and may also be used to identify population subgroups that 
respond differently to an intervention.
8.6.4.
Peripheral Blood Mononuclear Cells 
Whole blood will also be collected and processed for peripheral blood mononuclear cells (PBMC)
isolation and cryopreserved for later analysis. Analysis may include but is not limited to flow 
cytometric assessment of cell populations, single cell transcriptomics, or functional assessment of 
cells in response to guselkumab treatment and/or related to PsA pathogenesis. These analyses may 
not be performed if cryopreserved PBMC samples do not meet the quality or quantity standard 
required for the assessments.
8.7.
Immunogenicity Assessments
Serum samples for detection of antibodies to guselkumab will be collected from all participants 
according to the SoA (see Section 1.3). Additionally, serum samples should also be collected at 
the final visit from participants who discontinued study intervention or were withdrawn from the 
study. Samples collected for immunogenicity analyses may additionally be used to evaluate safety 
or efficacy aspects that address concerns arising during or after the study period. Genetic analyses 
will not be performed on these serum samples. Participant confidentiality will be maintained. 
Serum samples will be used to evaluate the immunogenicity of guselkumab. Serum samples will 
be screened for antibodies binding to guselkumab and the titer of confirmed positive samples will 
be reported. Serum samples that test positive for antibodies to guselkumab will be further 

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characterized to determine if antibodies to guselkumab could neutralize the biological effects of 
guselkumab in vitro (ie, neutralizing antibodies [NAbs] to guselkumab). Other analyses may be 
performed to verify the stability of antibodies to guselkumab and/or further characterize the 
immunogenicity of guselkumab.
Analytical Procedures 
The detection and characterization of antibodies to guselkumab will be performed using a validated 
immunoassay method by or under the supervision of the Sponsor.   
8.8.
Health Economics
The Work Productivity and Activity Impairment Questionnaire - Specific Health Problem 
(WPAI-SHP) is a validated instrument that has been used to study the impact of various diseases 
on patients’ ability to work and perform daily activities (WPAI General Information 2020). The 
WPAI:PsA assesses the impact of PsA on work and other daily activities during the past 7 days. 
The WPAI: PsA consists of six questions to determine employment status, hours missed from work 
due to PsA, hours missed from work for other reasons, hours actually worked, the degree to which 
PsA affected work productivity while at work and the degree to which PsA affected activities 
outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism 
(reduced productivity while at work), an overall work impairment score that combines absenteeism 
and presenteeism and percentage of impairment in activities performed outside of work. Greater 
scores indicate greater impairment.
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 Statistical Analysis Plan (SAP).
9.1.
Statistical Hypotheses
The hypothesis for this study is that guselkumab 100 mg q4w SC is superior to placebo as assessed 
by the proportion of participants achieving an ACR 20 response at Week 24.
The method of addressing the multiplicity of hypotheses to keep the family-wise type I error 
controlled at the 0.05 level will be specified in the SAP.
9.2.
Sample Size Determination
The planned enrollment in the study is approximately 950 participants. Participants impacted by 
major disruptions may be replaced. The sample size selection was determined based on the primary 
endpoint of proportion of participants who achieve an ACR 20 response at Week 24 and the major 
secondary endpoint of change from baseline in modified vdH-S score at Week 24 by considering 
power for each comparison individually. The assumptions are based on the PSA3002 study.

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9.2.1.
Primary Endpoint – ACR 20 Response at Week 24
In the PSA3002 study, the ACR 20 response rates at Week 24 were 33.1%, 64.6%, and 63.7%, 
respectively, for the placebo, guselkumab 100 mg SC at Weeks 0, 4, then q8w, and guselkumab 
100 mg SC q4w treatment groups.  
For this study, assuming a 60% ACR 20 response rate in the guselkumab group and a 35% ACR 20 
response rate in the placebo group, a sample size of 250 or 350 participants in the guselkumab 
group and 350 participants in the placebo group will provide a power of approximately >99% to 
detect a significant treatment difference at a significance level of α=0.05 using a 2-sided 
Chi-square test.  Table 6 shows the power to detect a difference in the proportion of participants 
achieving ACR20 response between guselkumab groups and placebo group with various 
assumptions.
Table 6:
Statistical Power for Treatment Difference in ACR 20 Response at Week 24
Sample size per arm
Guselkumab/Placebo
ACR 20 Response Rate
Power
Placebo Group
Guselkumab Group
Difference (Δ) 
250/350
35%
55%
20%
>99%
250/350
35%
60%
25%
>99%
250/350
35%
65%
30%
>99%
350/350
35%
55%
20%
>99%
350/350
35%
60%
25%
>99%
350/350
35%
65%
30%
>99%
9.2.2.
Key Major Secondary Endpoint – Change from Baseline in Modified 
vdH-S Score at Week 24
For change from baseline in modified vdH-S score, participants in each treatment group can be 
considered a mixture of two subpopulations: one subpopulation (Spop 1) with a change score of 0 
regardless of treatment and another subpopulation (Spop2) with a change score sampled from a 
normal distribution.  Therefore, the distribution of the vdH-S change scores is determined by 
3 parameters: the probability that a participant has a change score of 0, the mean of the normal 
distribution, and the standard deviation (SD) of the normal distribution.  The overall mean 
(ie, crude mean) of the change scores for a treatment group is the overall average of the change 
scores among all participants (including both Spops 1 and 2) in that treatment group.
In the PSA3002 study, the following statistics were observed for change from baseline in modified 
vdH-S score at Week 24 for each treatment group:
The overall mean (SD) of change from baseline in modified vdH-S score at Week 24 was 
0.90 (3.14), 0.25 (2.52), and 0.45 (2.38) respectively, for the placebo, guselkumab 100 mg q4w, 
and guselkumab 100 mg q8w treatment groups.  The assumptions for power calculations in this 
study are based in part on these data, adjusted for the difference in enrichment criteria between 
studies.

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For this study, assuming an overall mean (SD) of change from baseline in modified vdH-S score 
as 1.13 (3.2), 0.25 (3.1), and 0.45 (3.1) respectively in the placebo, guselkumab 100 mg q4w, and 
guselkumab 100 mg q8w groups, a sample size of 350/250/350 participants (ie, 7:5:7 ratio, 950 in 
total) will provide a power of at least 90% and 80% to detect a significant treatment difference at 
a 2-sided significance level of α=0.05 for guselkumab q4w vs placebo and guselkumab q8w vs 
placebo comparisons respectively. 
Table 7 provides the statistical power for guselkumab 100mg q4w vs placebo under various 
assumptions, where the sample size is 250 in the guselkumab group and 350 in the placebo group. 
Table 7:
Statistical Power for Treatment Difference in Modified vdH-S Change from Baseline at
Week24 for Guselkumab 100mg q4w vs Placebo (N=250, 350)
Percent 
Participant 
with extra 
0
(Spop 1)
Normal
Placebo
(Spop 2)
Normal
Guselkumab
(Spop 2)
Overall
Placebo
Overall
Guselkumab
Overall 
Mean 
Difference
Power
Mean
SD
Mean
SD
Mean
SD
Mean
SD
15%
1.33
3.4
0.29
3.4
1.13
3.2
0.25
3.1
-0.88
92
15%
1.33
3.4
0.34
3.4
1.13
3.2
0.29
3.1
-0.84
89
15%
1.33
3.0
0.29
3.0
1.13
2.8
0.25
2.8
-0.88
96
15%
1.33
3.0
0.34
3.0
1.13
2.8
0.29
2.8
-0.84
95
25%
1.33
3.4
0.29
3.4
1.00
3.0
0.22
2.9
-0.78
87
25%
1.33
3.4
0.34
3.4
1.00
3.0
0.26
2.9
-0.74
83
25%
1.33
3.0
0.29
3.0
1.00
2.7
0.22
2.6
-0.78
94
25%
1.33
3.0
0.34
3.0
1.00
2.7
0.26
2.6
-0.74
91
Table 8 provides the statistical power for guselkumab 100mg q8w vs placebo under various 
assumptions, where the sample size is 350 in each group.  
Table 8:
Statistical Power for Treatment Difference in Modified vdH-S Change from Baseline at 
Week 24 for Guselkumab 100mg q8w vs Placebo (N=350, 350)
Percent 
Participant 
with extra 
0
(Spop 1)
Normal
Placebo
(Spop 2)
Normal
Guselkumab
(Spop 2)
Overall
Placebo
Overall
Guselkumab
Overall 
Mean 
Difference
Power
Mean
SD
Mean
SD
Mean
SD
Mean
SD
15%
1.33
3.4
0.53
3.4
1.13
3.2
0.45
3.1
-0.68
80
15%
1.33
3.4
0.58
3.4
1.13
3.2
0.49
3.1
-0.64
75
15%
1.33
3.0
0.53
3.0
1.13
2.8
0.45
2.8
-0.68
89
15%
1.33
3.0
0.58
3.0
1.13
2.8
0.49
2.8
-0.64
84
25%
1.33
3.4
0.53
3.4
1.00
3.0
0.40
3.0
-0.60
74
25%
1.33
3.4
0.58
3.4
1.00
3.0
0.44
3.0
-0.56
69
25%
1.33
3.0
0.53
3.0
1.00
2.7
0.40
2.6
-0.60
84
25%
1.33
3.0
0.58
3.0
1.00
2.7
0.44
2.6
-0.56
79
The statistical power for each comparison was estimated based on 10000 simulations with 
treatment comparison performed at each simulation using an analysis of variance (ANOVA) test 
on the van der Waerden normal score.  Under these assumptions, the power ranges approximately 

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from 83% to 96% for the guselkumab q4w vs placebo comparison, and from 69% to 89% for the 
guselkumab q8w vs placebo comparison.
9.3.
Populations for Analysis Sets
For the purpose of various analyses, the following populations are defined.
Population
Description
Enrolled
All participants who signed the informed consent form (ICF).
Full Analysis Set
All participants who were randomized in the study. This analysis set will be used for the 
efficacy analyses.
Modified Full 
Analysis Set
All participants who were randomized, excluding participants from sites rendered unable 
to support key study operations due to a Natural Disaster or Major Disruption. Details 
will be provided in the SAP.
Safety Analysis Set
All participants who received at least one (complete or partial) administration of study 
intervention, ie, the treated population.
Immunogenicity 
Analysis Set (IAS)
All participants who received at least one (complete or partial) administration of 
guselkumab and who had at least 1 sample obtained after their first administration of 
guselkumab. 
PK Analysis Set 
(PKAS)
All participants who received at least one complete administration of guselkumab and 
had at least valid blood sample drawn for PK analysis.
PD Analysis Set 
(PDAS)
All participants who received at least one (complete or partial) administration of study 
intervention.
9.4.
Statistical Analyses
The SAP will be finalized prior to DBL and it will include a more technical and detailed description 
of the statistical analyses described in this section. This section is a summary of the planned 
statistical analyses of the most important endpoints including primary and key secondary 
endpoints.
9.4.1.
General Considerations
In general, descriptive statistics, such as mean, SD, median, inter quartile range, minimum, and 
maximum for continuous variables, and counts and percentages for discrete variables will be used 
to summarize most data.
For binary response efficacy endpoints, treatment comparisons will generally be performed using 
a Chi-square test or a Cochran-Mantel-Haenszel (CMH) test. For continuous endpoint of efficacy 
data, treatment comparisons will be performed using an analysis of covariance (ANCOVA), a 
mixed model for repeated measures (MMRM) model or a constrained longitudinal data analysis 
(cLDA) Model. 
In general, statistical testing will be performed using 2-sided tests. The overall type I error will be 
controlled among the primary and major secondary endpoints at 5%. 
9.4.2.
Primary Endpoint
The primary endpoint is the proportion of participants who achieved an ACR 20 response at 
Week 24. The primary analysis of this endpoint will be based on the adjusted composite 
estimand defined by the 5 components:

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!
Population: Participants with active PsA who are biologic naïve, and were randomized and 
treated with study intervention
!
Treatment: 
∀
Placebo
∀
Guselkumab
!
Variable: ACR20 composite binary response variable at Week 24, where a responder is 
defined as a participant who achieves ACR20 response at Week 24 and does not experience 
ICE categories 1 to 3.
!
Intercurrent Events: ICE categories 1 to 3 will follow the composite strategy, where 
participants who meet them prior to Week 24 will be considered as treatment failures and will 
be treated as non-responders regardless of the observed ACR20 response status. The ICE 
categories 4 and 5 will follow the hypothetical strategy postulating a scenario where a Natural 
Disaster (eg, the COVID-19 pandemic) as well as Major Disruption (eg, the disruption 
involving Ukraine and neighboring countries/territories beginning 24 February 2022; specific 
details to be included in the SAP), and ICEs directly resulting from them, did not occur, and
observed data through Week 24 after meeting these ICEs will not be used and will be assumed 
to be MAR. For participants experiencing multiple ICEs, an ICE in categories 1 to 3 will 
supersede an ICE in categories 4 and 5.
1.
Discontinued study intervention injections due to any reason except due to a Natural 
Disaster or Major Disruption. 
2.
Initiated or increased the dose of non-biologic DMARDs (MTX, SSZ, HCQ, LEF) or oral 
corticosteroids over baseline for PsA.
3.
Initiated protocol prohibited medications/therapies for PsA.
4.
Discontinued study intervention injections due to a Natural Disaster or Major Disruption.
5.
Severe treatment non-compliance (to be defined in the SAP) due to a Natural Disaster or 
Major Disruption.
!
Population level summary: difference in proportion of responders between guselkumab group 
and placebo group.
Data from all participants in the mFAS will be analyzed according to randomized treatment group
regardless of the treatment actually received. Participants with missing data for any reason other 
than due to a Natural Disaster or Major Disruption will be considered non-responders, while 
missing data due to a Natural Disaster or Major Disruption or data not used due to ICE categories
4 or 5 will be assumed to be MAR and imputed using MI. For each guselkumab dose versus
placebo comparison, a CMH test stratified by the randomization strata levels will be conducted for 
each imputation set, and the Wilson-Hilferty transformation will be applied to the CMH statistics 
across the imputation sets before combining them for the final p-values. The magnitude of the 
effect will be estimated by the difference in ACR 20 response rates between the guselkumab and 
placebo groups with the 95% confidence interval calculated based on Wald statistics.

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To evaluate the robustness of the primary endpoint analysis results, the exhaustive scenario tipping 
point sensitivity analyses will be performed by varying the amount of non-responder imputation 
for missing data. 
Additional sensitivity/supplemental analyses which vary how intercurrent events (eg, alternative 
estimand) are handled, how observed data are used, and how missing data are treated will be 
specified in the SAP to further address the robustness of treatment effect of ACR 20 at Week 24.
Subgroup Analyses
Subgroup analysis will be performed to evaluate consistency in the primary efficacy endpoint by 
demographic characteristics, baseline disease characteristics, and baseline medications. Interaction 
test between the subgroups and treatment group will also be provided if appropriate.
9.4.3.
Secondary Endpoints 
The estimand, analysis method, and data handling rules for major secondary endpoints, as well as 
the approach to control the type I error for multiplicity will be specified in SAP.
9.4.4.
Safety Analyses
All safety analyses will be made on the Safety Population.
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). 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:
!
The incidence and type of AEs.
!
The incidence and type of SAEs.
!
The incidence and type of infections.
!
The incidence and type of injection site reactions.
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 severe or an 
SAE.
Clinical Laboratory Tests
Laboratory data will be summarized by type of laboratory test. Descriptive statistics will be 
calculated for selected laboratory analyte at baseline and for observed values and changes from 
baseline at each scheduled time point. Number and percentage of participants by maximum 
National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) 

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toxicity grades for laboratory analytes with  NCI-CTCAE criteria defined will also be summarized, 
and participants with maximum NCI-CTCAE Grade ≥3 will also be presented in a listing.
Vital Signs
Vital signs including pulse/heart rate and blood pressure (systolic and diastolic) will be 
summarized over time, using descriptive statistics and/or graphically. The percentage of 
participants with values beyond clinically important limits will be summarized.
9.4.5.
Other Analyses
Pharmacokinetic Analyses
The PK evaluable population is defined as all the participants who received at least 1 complete 
dose of guselkumab and had at least 1 valid blood sample drawn for PK analysis after their first 
dose of guselkumab.
Serum guselkumab concentrations over time will be summarized for each treatment group using 
descriptive statistics. All concentrations below the lowest quantifiable sample concentration of the 
assay (BQL) or missing data will be labeled as such in the concentration data listing or statistical 
analysis system dataset. The BQL concentrations will be treated as zero in the summary statistics.
Population PK modeling will be conducted when appropriate. The apparent total systemic 
clearance and apparent volume of distribution values will be estimated. The influence of important 
variables (such as body weight, antibodies to guselkumab, and concomitant medications) on the 
population PK parameter estimates may be evaluated. Details will be given in a population PK 
analysis plan and the results of the population PK analysis will be presented in a separate technical 
report.
Immunogenicity Analyses
The incidence and titers of antibodies to guselkumab will be summarized for all participants who 
receive at least 1 dose of guselkumab and have appropriate samples for detection of antibodies to 
guselkumab (ie, participants with at least 1 sample obtained after their first dose of guselkumab).
A listing of participants who are positive for antibodies to guselkumab will be provided. 
The incidence of NAbs to guselkumab will be summarized for participants who are positive for 
antibodies to guselkumab and have samples evaluable for NAbs to guselkumab.
Other immunogenicity analyses may be performed to further characterize the immune responses 
that are generated.
Biomarker/Pharmacodynamic Analyses 
The biomarker analyses will be used to understand PsA, characterize the effects of guselkumab to 
identify PD markers and biomarkers relevant to treatment, and to determine if these markers can 
predict response to guselkumab. The biomarker analyses may include but are not limited to serum 

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Th17 cytokines, inflammatory markers, whole blood RNA profile, and other categories of 
biomarkers potentially involved in the development and the progression of PsA.
Changes in biomarkers over time may be summarized by treatment group. Associations between 
baseline levels and changes from baseline in select markers and clinical response may be explored. 
Results of biomarker analyses may be presented in a separate technical report.
Planned biomarker analyses may be deferred if emerging study data show no likelihood of 
providing useful scientific information or insufficient number of samples are available for 
analyses. Any biomarker samples received by the contract vendor or Sponsor after the cutoff date 
will not be analyzed, and therefore, excluded from the biomarker analysis.
Pharmacokinetic/Pharmacodynamic Analyses 
If data permit, the relationships between serum concentrations of guselkumab and the efficacy
measures and/or relevant PD endpoints may be explored when appropriate. If any visual trend is 
observed, additional analyses may be conducted. Analyses results may be summarized in a 
separate technical report.
Pharmacogenomic Analyses 
Genetic (DNA) analyses may be conducted only in participants who sign the consent form to 
participate in the pharmacogenomic sampling. These analyses are considered exploratory. DNA
samples may be used for research related to guselkumab and/or PsA. They may also be used to 
develop tests/assays related to guselkumab and PsA. Pharmacogenomic research may consist of 
the analysis of one or more candidate genes or of the analysis of genetic markers throughout the 
genome or analysis of the entire genome (as appropriate) in relation to guselkumab or PsA clinical 
endpoints. Analyses results may be summarized in a separate technical report.
Health Economics Analysis
The change from baseline in impact of disease on work productivity and daily activity via WPAI
Questionnaire: PsA will be descriptively summarized by treatment group over time and compared 
between treatment groups.
9.5.
Interim Analysis
Not applicable

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10.
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1.
Appendix 1: Abbreviations
ACR
American College of Rheumatology
AE
adverse event
ALT
alanine aminotransferase
ANCOVA
analysis of covariance
AST
aspartate aminotransferase
BCG
bacillus Calmette-Guérin
BQL
below the lowest quantifiable sample concentration of the assay
BSA
body surface area
CASPAR
ClASsification criteria for Psoriatic Arthritis
CMH
Cochran-Mantel-Haenszel
COVID-19
Coronavirus Disease 2019
CRP
C-reactive protein
DAPSA
Disease Activity Index for Psoriatic Arthritis
DAS28
Disease Activity Score 28 
DBL
database lock
DLQI
Dermatology Life Quality Index
DMARDs
disease-modifying antirheumatic drugs
DNA
deoxyribonucleic acid
ECG
electrocardiogram
eCRF
electronic case report form(s) 
eC-SSRS
electronic Columbia-Suicide Severity Rating Scale
eDC
electronic data capture
EE
early escape
EU
European Union
FACIT-F
Functional Assessment of Chronic Illness Therapy-Fatigue
FSH
follicle stimulating hormone
GCP
Good Clinical Practice
HAQ-DI
Disability Index of the Health Assessment Questionnaire
HBV
hepatitis B virus
HCQ
Hydroxychloroquine
HCV
hepatitis C virus
HIV
Human Immunodeficiency Virus
HRQoL
health-related quality of life
HRV
high radiographic variability
IB
Investigator’s Brochure
ICE
intercurrent event
ICF
informed consent form
ICH
International Conference on Harmonisation
IEC
Independent Ethics Committee
IGA
Investigator’s Global Assessment
IJA
independent joint assessor
IL
interleukin
IM
intramuscular
IPPM
Investigational Product Procedures Manual
IRB
Institutional Review Board
IV
intravenous
IWRS
interactive web response system
JAK
Janus kinase
LEF
leflunomide
LEI
Leeds Enthesitis Index
LMP
low to moderate progression
LTE
long term extension
mAb
monoclonal antibody
MAR
missing at random

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MCP
metacarpophalangeal 
mCPDAI
modified Composite Psoriatic Disease Activity Index
MDA
minimal disease activity
mNAPSI
modified Nail Psoriasis Severity Index
MTX
methotrexate
NAb
neutralizing antibody
NCI-CTCAE
National Cancer Institute - Common Terminology Criteria for Adverse Events
NP
no progression
NSAID
nonsteroidal anti-inflammatory drug
PASI
Psoriatic Area and Severity Index
PBMC
peripheral blood mononuclear cells
PD
pharmacodynamic(s)
PFS
prefilled syringe
PFS-U
prefilled syringe with an UltraSafe PLUSTM Passive Needle Guard
PGA-F
Physician’s Global Assessment of Fingernail Psoriasis
PIP
proximal interphalangeal
PK
pharmacokinetic(s)
PQC
Product Quality Complaint
PRO
patient-reported outcome(s) 
PsA
psoriatic arthritis
PsAID
PsA Impact of Disease
PsARC
Psoriatic Arthritis Response Criteria
q4w
every 4 weeks
q8w
every 8 weeks
RP
rapid progression
SAE
serious adverse event
SAP
Statistical Analysis Plan
SARS-CoV2
severe acute respiratory syndrome coronavirus 2
SC
subcutaneous
SD
standard deviation
SSZ
sulfasalazine
SUSAR
suspected unexpected serious adverse reaction
TB
tuberculosis
Th17
T helper 17
TNFα
tumor necrosis factor alpha
US
United States
VAS
Visual Analogue Scale
VLDA
very low disease activity
vdH-S
van der Heijde-Sharp (score)
WPAI
Work Productivity and Activity Impairment Questionnaire

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10.3.
Appendix 3: Tuberculin Skin Testing
Administering the Mantoux Tuberculin Skin Test
The Mantoux tuberculin skin test (CDC 2000) is a 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) 6 mm 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 patients, 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 and Canada, 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 and Canada, country-specific guidelines for immunocompromised 
patients should be consulted for the interpretation of tuberculin skin test results. If no local country 
guidelines for immunocompromised patients exist, US guidelines must be followed.

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Treatment of Latent Tuberculosis
Local country guidelines for immunocompromised patients should be consulted for acceptable 
anti-tuberculous treatment regimens for latent TB. If no local country guidelines for 
immunocompromised patients 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.

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10.5.
Appendix 5: Contraceptive and Barrier Guidance
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 7 (Section 10.7), Adverse Events, Serious Adverse Events, Product Quality Complaints, 
and Other Safety Reporting: 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 (for the purpose of this study)
Permanent sterilization methods include hysterectomy, bilateral salpingectomy, 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.
Contraceptive (birth control) use by men or women should be consistent with local regulations 
regarding the acceptable methods of contraception for those participating in clinical studies.
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.

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Examples of Contraceptives for Female Participants
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, post-ovulation methods)
!
Withdrawal (coitus-interruptus)
!
Spermicides alone
!
Lactational amenorrhea method (LAM)

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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).

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10.6.
Appendix 6: Regulatory, Ethical, and Study Oversight Considerations
10.6.1.
Regulatory and Ethical Considerations
Investigator Responsibilities
The investigator is responsible for ensuring that the study is performed in accordance with the 
protocol, current International Conference 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 
representative listed in the Contact Information page(s), which will be provided as a separate 
document. 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 eCRF 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:

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!
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 subinvestigators
!
Documentation of subinvestigator 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)
!
IB (or equivalent information) and amendments/addenda
!
Sponsor-approved participant recruiting materials

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!
Information on compensation for study-related injuries or payment to participants for 
participation in the study, if applicable
!
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

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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 4.2.1, Study-Specific Ethical Design 
Considerations.
Other Ethical Considerations
For study-specific ethical design considerations, refer to Section 4.2.1.
10.6.2.
Financial Disclosure
Investigators and subinvestigators 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.
10.6.3.
Informed Consent Process 
Each participant must give written consent according to local requirements after the nature of the 
study has been fully explained. 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.
Before enrollment in the study, the investigator or an authorized member of the study site 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 

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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.
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.
Participants who are rescreened are required to sign a new ICF.
Participants will be asked for consent to provide optional samples for research (where local 
regulations permit). After informed consent for the study is appropriately obtained, the participant 
will be asked to sign and personally date a separate ICF indicating agreement to participate in the 
optional research component. Refusal to participate in the optional research will not result in 
ineligibility for the study. A copy of this signed ICF will be given to the participant.
Where local regulations require, a separate ICF may be used for the required DNA component of 
the study.
10.6.4.
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 

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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 DNA, PD, biomarker. PK [and] immunogenicity research is not conducted under 
standards appropriate for the return of data to participants. 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.]
10.6.5.
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. Samples will only be used to understand guselkumab, to understand PsA, 
to understand differential intervention responders, and to develop tests/assays related to 
guselkumab  and PsA. The research may begin at any time during the study or the post-study 
storage period. 
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).
10.6.6.
Committees Structure
Data Monitoring Committee
Not applicable
10.6.7.
Publication Policy/Dissemination of Clinical Study Data
All information, including but not limited to information regarding guselkumab 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 guselkumab, 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 generated by the Sponsor and 
will contain data from all study sites that participated in the study as per protocol. Recruitment 

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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 or exploratory biomarker analyses performed after the Clinical Study Report 
has been issued may be reported in a separate report and will not require a revision of the Clinical 
Study Report. 
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 (which may occur prior to final DBL if the Sponsor assesses that publication 
is not likely to have a significant impact on the safety or physical or mental integrity of the clinical 
study participants, or the scientific value of the study) 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 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 sub-study 
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. The disclosure of the final study results will be performed after the end of study in order 
to ensure the statistical analyses are relevant.

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10.6.8.
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 
study site personnel before the study, periodic monitoring visits by the Sponsor or designee, and 
direct transmission of clinical laboratory data from a central laboratory into the Sponsor's data 
base. Written instructions will be provided for collection, handling, storage, and shipment of 
samples. 
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.
10.6.9.
Case Report Form Completion
Case report forms are prepared and provided by the Sponsor for each participant in electronic 
format. All data relating to the study must be recorded in eCRF. All eCRF 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.
The study data will be transcribed by study site personnel from the source documents onto an 
eCRF, if applicable.  Study-specific data will be transmitted in a secure manner to the Sponsor.
Worksheets may be used for the capture of some data to facilitate completion of the eCRF. Any 
such worksheets will become part of the participant's source documents. Data must be entered into 
eCRF 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.
All participative measurements (eg, pain scale information or other questionnaires) will be 
completed by the same individual who made the initial baseline determinations whenever possible.
If necessary, queries will be generated in the eDC tool. If corrections to a eCRF are needed after 
the initial entry into the eCRF, this can be done in either of the following ways:
!
Investigator and study site personnel can make corrections in the eDC tool at their own 
initiative or as a response to an auto query (generated by the eDC tool).
!
Sponsor or Sponsor’s delegate can generate a query for resolution by the investigator and study 
site personnel.

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10.6.10.
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. Given that patient-reported 
outcomes (PROs) are reports of a patient's health condition that come directly from the patient, 
without interpretation by a clinician or anyone else, the responses to PRO measures entered by 
trial participants into source records cannot be overridden by site staff or investigators.
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 other equivalent document).
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.
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. These
data are 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.
10.6.11.
Monitoring
The Sponsor will use a combination of monitoring techniques central, remote, or on-site 
monitoring to monitor this study.
The Sponsor or 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. The 
first post-initiation visit will be made as soon as possible after enrollment has begun. At these 

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visits, the monitor will compare the data entered into the eCRF 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 
eCRF 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 study site 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.
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.
10.6.12.
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.
10.6.13.
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.

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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.
10.6.14.
Study and Site Start and Closure
First Act of Recruitment
The first site open is considered the first act of recruitment and it becomes the study start date.
Study/Site 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

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10.7.
Appendix 7: Adverse Events, Serious Adverse Events, Product Quality 
Complaints, and Other Safety Reporting: Definitions and Procedures for 
Recording, Evaluating, Follow-up, and Reporting
10.7.1.
Adverse Event Definitions and Classifications
Adverse Event
An AE is any untoward medical occurrence in a clinical study participant administered a 
pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have 
a causal relationship with the intervention. An AE 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 Conference on 
Harmonisation [ICH]).
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 AEs 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 AE recording).
For combination products with a device constituent, AEs include those resulting from insufficient 
or inadequate instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the device. It includes any AE resulting from use error or from intentional misuse 
of the investigational device.
Serious Adverse Event
An SAE 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 inpatient 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*

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*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.
For combination products with a device constituent, SAEs include adverse device effects that 
resulted in any of the consequences characteristic of an SAE. An unanticipated serious adverse 
device effect is a serious adverse device effect which by its nature, incidence, severity or outcome 
has not been identified in the current version of the risk analysis report (see Section 2.3).
Unlisted (Unexpected) Adverse Event/Reference Safety Information
An AE is considered unlisted if the nature or severity is not consistent with the applicable product 
reference safety information. For guselkumab, the expectedness of an AE will be determined by 
whether or not it is listed in the IB. 
10.7.2.
Attribution Definitions
Assessment of Causality
The causal relationship to study intervention is determined by the Investigator. The following 
selection should be used to assess all AEs.
Related
There is a reasonable causal relationship between study intervention administration and the AE.
Not Related
There is not a reasonable causal relationship between study intervention administration and the 
AE.
The term "reasonable causal relationship" means there is evidence to support a causal relationship.
10.7.3.
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).

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10.7.4.
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
!
Medication error, intercepted medication error, or potential medication error involving a 
Johnson & Johnson medicinal product (with or without patient exposure to the Johnson & 
Johnson medicinal product, eg, product name confusion, product label confusion, intercepted 
prescribing or dispensing errors)
!
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 an SAE should be recorded on the SAE page of the eCRF.
10.7.5.
Procedures
All Adverse Events
All AEs, 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 
AE to study therapy. All measures required for AE management must be recorded in the source 
document and reported according to Sponsor instructions.
For all studies with an outpatient 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 name and 24-hour contact telephone number (for medical 
personnel only)
!
Site number
!
Participant number
!
Any other information that is required to do an emergency breaking of the blind

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Serious Adverse Events
All SAEs that have not resolved by the end of the study, or that have not resolved upon the 
participant's discontinuation from 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 participation in the study must be reported as an SAE, except hospitalizations for the 
following:
!
Hospitalizations not intended to treat an acute illness or AE (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 SAEs. Any AE that results in a prolongation of the originally planned 
hospitalization is to be reported as a new SAE.
The cause of death of a participant in a study within 12 weeks of the last dose of study intervention, 
whether or not the event is expected or associated with the study intervention, is considered an 
SAE.
Information regarding SAEs will be transmitted to the Sponsor using an SAE reporting form and 
safety report form of the eCRF, which must be completed and reviewed by a physician from the 
study site, and transmitted in a secure manner to the Sponsor within 24 hours. The initial and 
follow-up reports of an SAE should be transmitted in a secure manner electronically or by 
facsimile (fax). Telephone reporting should be the exception and the reporter should be asked to 
complete the appropriate form(s) first.
10.7.6.
Product Quality Complaint Handling
Definition
A product quality complaint (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, reliability, or performance of a distributed product, including its labeling, drug delivery 
system, or package integrity. A PQC may have an impact on the safety and efficacy of the product.

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In addition, it includes any technical complaints, defined as any complaint that indicates a potential 
quality issue during manufacturing, packaging, release testing, stability monitoring, dose 
preparation, storage or distribution of the product or the drug delivery system.
This definition includes any PQC related to a device constituent in a combination product, 
including those used in the administration of the study intervention or the comparator. A device 
deficiency is an inadequacy of a device with respect to its identity, quality, durability, reliability, 
safety, or performance. Device deficiencies include malfunctions, use errors, and inadequate 
labeling.
Procedures
All initial PQCs must be reported to the Sponsor by the study site personnel within 24 hours after 
being made aware of the event.
A sample of the suspected product should be maintained under the correct storage conditions until 
a shipment request is received from the Sponsor.
10.7.7.
Contacting Sponsor Regarding Safety, Including Product Quality
The names (and corresponding telephone numbers) of the individuals who should be contacted 
regarding safety issues, PQC, or questions regarding the study are listed in the Contact Information 
page(s), which will be provided as a separate document.

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10.8.
Appendix 8: Liver Safety: Suggested Actions and Follow-up Assessments
A. STOPPING ALGORITHM
Liver Chemistry Stopping Criteria and Increased Monitoring Algorithm
Study intervention will be discontinued for a participant if liver chemistry stopping criteria are 
met.
Abbreviations: ALT = alanine transaminase; AST = aspartate transaminase, INR = international normalized ratio; 
SAE = serious adverse event; ULN = upper limit of normal, Tbili = Total bilirubin.
Refer to Appendix [8B]: Follow-up Assessments.

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Liver Chemistry Increased Monitoring Algorithm with Continued Study Intervention for 
Participants with ALT or AST ≥3xULN but <8xULN 
Study intervention will be discontinued for a participant if liver chemistry stopping criteria are 
met.
Abbreviations: ALT = alanine transaminase; AST = aspartate transaminase, INR = international normalized ratio; SAE = serious adverse event; 
ULN = upper limit of normal, Tbili = Total bilirubin.
Refer to Appendix [8B]: Follow-up Assessments.

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B. FOLLOW-UP ASSESSMENTS
Liver Safety: Follow-up Assessments
Phase 3-4 liver chemistry stopping criteria are designed to assure participant safety and to evaluate 
liver event etiology.
Phase 3-4 Liver Chemistry Stopping Criteria and Follow-Up assessments
Liver Chemistry Stopping Criteria
ALT or AST-
absolute
ALT or AST ∃8xULN
ALT or AST-
Increase
ALT or AST ∃5xULN but <8xULN persists for ∃2 weeks
ALT or AST ∃3xULN but <5xULN persists for ∃4 weeks
Bilirubin1, 2
ALT or AST ∃3xULN and total bilirubin ∃2xULN 
INR2
ALT or AST ∃3xULN and international normalized ratio (INR) >1.5
Cannot 
Monitor
ALT or AST ∃5xULN but <8xULN and cannot be monitored weekly for 
∃2 weeks
ALT or AST ∃3xULN but <5xULN and cannot be monitored weekly for 
∃4 weeks
Symptomatic3
ALT or AST ∃3xULN associated with symptoms (new or worsening) 
believed to be related to liver injury or hypersensitivity
Suggested Actions, Monitoring, and Follow up Assessments
Actions
Follow Up Assessments
! Immediately discontinue study 
intervention
! Report the event to the Sponsor within
24 hours
! Complete the hepatic event form and 
complete an SAE eCRF if the event 
also met the criteria for an SAE2
! Perform follow-up assessments as 
described in the Follow up 
Assessment column
! Monitor the participant until liver 
chemistry test abnormalities resolve, 
stabilize, or return to baseline
MONITORING:
If ALT or AST ∃3xULN AND total 
bilirubin ∃2xULN or INR >1.5:
! Repeat liver chemistry tests (include 
ALT, aspartate transaminase [AST], 
alkaline phosphatase, total bilirubin, 
direct bilirubin, and INR) and perform 
! Viral hepatitis serology4
! Obtain blood sample for pharmacokinetic 
(PK)5 analysis within 1 week of the event of 
ALT or AST ∃3×ULN
! Obtain serum creatine phosphokinase (CPK), 
lactate dehydrogenase (LDH), gamma-
glutamyltransferase [GGT], and glutamate 
dehydrogenase [GLDH], and serum albumin
! Fractionate bilirubin, if total bilirubin ∃2xULN
! Obtain complete blood count with differential 
to assess eosinophilia
! Record the appearance or worsening of clinical 
symptoms of liver injury, or hypersensitivity, 
on hepatic event form
! Record use of concomitant medications 
(including acetaminophen, herbal remedies, 
recreational drugs, and other over-the-counter 
medications)
! Record alcohol use on the hepatic event form

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liver event follow-up assessments 
within 24 hours
! Monitor participant twice weekly until 
liver chemistry test abnormalities 
resolve, stabilize, or return to baseline
! A specialist or hepatology 
consultation is recommended
If ALT or AST∃3xULN AND total 
bilirubin <2xULN and INR #1.5:
! Repeat liver chemistry tests (include 
ALT, AST, alkaline phosphatase, total 
bilirubin, direct bilirubin, and INR) 
and perform liver chemistry follow-up 
assessments within 24 to 72 hours
! Monitor participants weekly until liver 
chemistry abnormalities resolve, 
stabilize, or return to baseline
RESTART
! Do not restart participant with study 
intervention unless allowed per 
protocol and Sponsor approval is 
granted
! If restart is either not allowed per 
protocol or not granted, permanently 
discontinue study intervention. The 
participant may continue in the study 
for any protocol specified follow up 
assessments
If ALT or AST ∃3xULN AND total bilirubin 
∃2xULN or INR >1.5 obtain the following in 
addition to the assessments listed above:
! Anti-nuclear antibody, anti-smooth muscle 
antibody, Type 1 anti-liver kidney microsomal 
antibodies, and quantitative total 
immunoglobulin G (IgG) or gamma globulins
! Serum acetaminophen adduct assay, when 
available, to assess potential acetaminophen
(paracetamol) contribution to liver injury in 
participants with definite or likely 
acetaminophen use in the preceding week
! Liver imaging (ultrasound, magnetic 
resonance, or computerized tomography) to 
evaluate liver disease; complete liver Imaging 
form
! Liver biopsy may be considered and discussed 
with local specialist if available, for instance:
∀In patients when serology raises the 
possibility of autoimmune hepatitis (AIH)
∀In patients when suspected drug-induced 
liver injury (DILI) progresses or fails to 
resolve on withdrawal of study intervention
∀In patients with acute or chronic atypical 
presentation
! If liver biopsy conducted record in eCRF
1. Serum bilirubin fractionation should be performed if testing is available. If serum bilirubin fractionation is not 
immediately available, discontinue study intervention if ALT or AST ∃3xULN and total bilirubin ∃2xULN. 
Additionally, if serum bilirubin fractionation testing is unavailable, record the absence/presence of detectable 
urinary bilirubin on dipstick which is indicative of direct bilirubin elevations suggesting liver injury. 
2. All events of ALT or AST ∃3xULN and total bilirubin ∃2xULN or ALT or AST ∃3xULN and INR >1.5 (if 
measured), may indicate severe liver injury (possible ‘Hy’s Law’) and must be reported to sponsor in an 
expedited manner using the SAE form, even before all other possible causes of liver injury have been excluded. 
A confirmed Hy's law case must be reported as an SAE. The INR stated threshold value will not apply to 
participants receiving anticoagulants. 
3. New or worsening symptoms believed to be related to liver injury (such as fatigue, nausea, vomiting, right upper 
quadrant pain or tenderness, or jaundice) or hypersensitivity (such as fever, rash or eosinophilia).
4. Includes hepatitis A immunoglobulin M (IgM) antibody; HBsAg and HBcAb; hepatitis C RNA; hepatitis C 
antibody, cytomegalovirus IgM antibody; Epstein-Barr viral capsid antigen IgM antibody (or if unavailable, 
heterophile antibody or monospot testing); and hepatitis E IgM antibody.
5. PK sample may not be required for participants known to be receiving placebo or non-comparator interventions. 
Record the date/time of the PK blood sample draw and the date/time of the last dose of study intervention prior 
to the PK blood sample draw on the eCRF. If the date or time of the last dose is unclear, provide the participant’s 
best approximation. If the date/time of the last dose cannot be approximated OR a PK sample cannot be collected 
in the time period indicated above, do not obtain a PK sample. Instructions for sample handling and shipping are 
in the laboratory Manual.

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A participant who met liver chemistry stopping criteria cannot restart study intervention unless all 
of the following conditions are met:
!
Sponsor approval is granted (as described below)
!
Institutional Review Board/Independent Ethics Committee (IRB/IEC) approval is obtained
!
Separate ICF for intervention restart is signed by the participant
If sponsor approval to restart/rechallenge the participant with study intervention is not granted, 
then the participant must permanently discontinue study intervention and may continue in the 
study for protocol-specified follow-up assessments.
Restart Following Transient Resolving Liver Chemistry Events Not Related to Study 
Intervention
!
Restart refers to resuming study intervention following liver chemistry events for which there 
are clear underlying causes (other than DILI) (eg, biliary obstruction, pancreatic events, 
hypotension, acute viral hepatitis). Furthermore, restart is not permitted following liver 
stopping event when the underlying cause was alcohol-related hepatitis. Approval by the 
sponsor for study intervention restart can be considered when:
∀
The investigator requests consideration for study intervention restart if liver chemistry 
events have a clear underlying cause (eg, biliary obstruction, pancreatic events, 
hypotension, acute viral hepatitis) and liver chemistry tests have improved to normal or 
are within 1.5 x baseline and ALT or AST <3xULN.
∀
Possible DILI has been excluded by the investigator and the study team. This includes 
the absence of markers of hypersensitivity (otherwise unexplained fever, rash, 
eosinophilia). Where a study intervention has an identified genetic marker associated with 
liver injury (eg, lapatinib, abacavir, amoxicillin/clavulanate), the presence of the marker 
should be excluded. 
∀
There is no evidence of alcoholic-related hepatitis.
∀
IRB/IEC approval of study intervention restart has been obtained.
If restart of study intervention is approved by the [sponsor] in writing: 
!
The participant must be provided with a clear description of the possible benefits and risks of 
study intervention administration including the possibility of recurrent, more severe liver 
injury, liver transplantation or death.
!
The participant must provide signed informed consent specifically for the restart of study 
intervention. Documentation of informed consent must be recorded in the study file.
!
Study intervention must be administered at the dose specified by the sponsor.
!
Participants approved by the sponsor for restart of study intervention must return to the clinic 
twice a week for liver chemistry tests until stable liver chemistry tests have been demonstrated 
and then standard laboratory monitoring may resume as per protocol.

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!
If the participant meets protocol-defined liver chemistry stopping criteria after study 
intervention restart, study intervention should be permanently discontinued.
!
The sponsor, Medical Monitor, and the IRB/IEC, must be informed of the outcome for the 
participant following study intervention restart.
!
The sponsor must be notified of any AEs.

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10.9.
Appendix 9: Study Conduct During a Natural Disaster
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 or quarantine of participants 
and study-site personnel; travel restrictions/limited access to public places, including hospitals; 
study site personnel being unavailable, isolated, or reassigned to critical tasks. 
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 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 
unacceptable risk, study intervention will be discontinued, and study follow-up will be conducted.
If, as a result of the COVID-19 pandemic, visits cannot be conducted in-person at the study site, 
they 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 after consultation with the participant, investigator, and the sponsor. 
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 
medical officer or designee to discuss plans for administration of study intervention, performing 
study assessments, 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.
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 patient 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:

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∀
remote (eg, by phone / telemedicine) or in-person, off-site (eg, in-home) interactions 
between site staff (or designees) and patients for study procedures (eg, those related to 
safety monitoring / efficacy evaluation / study intervention storage and administration 
[including training where pertinent])
∀
procurement of study intervention by patients (or designee) or shipment of study 
intervention from the study site directly to patients for at-home administration 
∀
laboratory assessments using a suitably accredited local laboratory; for selected measures 
(eg, urine pregnancy), home testing may be employed
!
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 eCRF. 
∀
other relevant study data elements impacted by the pandemic should also be documented 
/ labeled as “COVID-19-related” in eCRFs 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).  
!
Precaution: for those who may carry a higher risk for severe COVID-19 illness (eg, those aged 
over 65 years), follow guidance from local health authorities when weighing the potential 
benefits and risks of enrolling in the study, and during participation in the study. 

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10.10. Appendix 10: Protocol Amendment History
The Protocol Amendment Summary of Changes Table for the current amendment is located 
directly before the Table of Contents (TOC).
Amendment 1 (07 April 2021)
Overall Rationale for the Amendment: To add a stratification level, revise the percentage of improvement 
from baseline in tender and swollen joint counts for early escape (EE) qualification, update definition of 
psoriatic arthritis (PsA), add COVID-19 related information, and update protocol to match with the current 
protocol template (v11.0) changes.
Section number
and Name
Description of Change
Brief Rationale
1.1. Synopsis: 
Intervention Groups and 
Duration;
4.1. Overall Design;
6.3. Measures to 
Minimize Bias: 
Randomization and 
Blinding: Intervention 
Allocation
An additional stratification level was added
and the criteria for participant assignment 
into strata was mentioned.
To ensure participants whose 
radiographic images are more 
difficult to read are randomized to 
ratio across the treatment groups.
1.1. Synopsis: 
Intervention Groups and 
Duration;
1.2. Schema;
4.1. Overall Design;
4.2. Scientific Rational 
for Study Design: Study 
Phases and Duration of 
Treatment;
6.8. Concomitant Therapy
The percentage of improvement from 
baseline in tender and swollen joint counts 
for EE qualification was updated from <5% 
to <20%.
To respond to Health Authority’s 
feedback by allowing greater 
proportion of participants EE 
treatment options.
1.1. Synopsis;
9.4.2. Primary Endpoint
The primary estimand has been changed from 
purely using the composite strategy, to 
including a hypothetical component where 
the COVID-19 pandemic and intercurrent 
event (ICE)s specifically resulting from 
COVID-19 are treated as if they did not 
happen. This includes splitting ICE category 
1 into ICE categories 1 and 4, adding ICE 
category 5, splitting missing data imputation 
depending on whether they were COVID-19 
pandemic related, as well as adjusting the 
analysis method to be able to handle multiply 
imputed data.
To reduce the impact of the 
ongoing COVID-19 pandemic on 
the analysis.
1.1. Synopsis;
9.4.3. Secondary 
Endpoints
The following text was updated to remove ‘of 
treatment failure’: The occurrence of the 
intercurrent event of treatment failure is 
irrelevant: the value for the variable of 
interest is used regardless of whether or not 
the intercurrent event occurs.
The general definition of ICEs, 
which are consistent between 
Primary and Secondary endpoints, 
was updated. They now include 
more than just criteria treated as 
treatment failure.
2.2.1. Disease 
Background;
4.3. Justification for 
Dose;
The countries where guselkumab 100 mg is 
the approved dose regimen and the related 
statement were updated.
To ensure consistency within the 
protocol.

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Section number
and Name
Description of Change
Brief Rationale
4.4. End of Study 
Definition;
5.1. Inclusion Criteria 
(#23 and #24);
Exclusion Criteria (Note);
7.3. Lost to Follow-up
The term ‘he or she’ was replaced by ‘the 
participant’.
To adhere with the current 
standards for gender inclusivity.
5.1. Inclusion Criteria 
(#4)
The definition of active psoriatic arthritis was 
updated from ‘three swollen joints’ to ‘three 
swollen joints and three tender joints’.
To be consistent with the previous 
psoriatic arthritis protocols by the 
Sponsor.
5.1. Inclusion Criteria 
(#19)
The term ‘ineligible’ was added as follows: 
No retesting for ineligible ALT or AST is 
permitted.
To provide clarity that laboratory 
tests cannot be repeated if the 
results are out of range.
5.1. Inclusion Criteria 
(#25)
A new inclusion criterion related to use of 
Coronavirus Disease 2019 (COVID-19) 
vaccine was added.
To provide guidance on the use of
COVID-19 vaccine.
5.2. Exclusion Criteria 
(#1 and # 31)
Criteria #31 was deleted and criterion #1 was 
modified to include reference to the 
Investigator’s Brochure.
To remove duplicate criterion.
6.8. Concomitant 
Therapy;
6.8.1.1. Permitted 
Non-biologic DMARDs
Changes made to correct text to indicate 
participants may enroll on up to 2 DMARDs 
at baseline, may receive up to 3 DMARDs if 
they qualify for early escape or after 
Week 48.
To align with exclusion criteria #8.
6.8.7. Vaccinations 
(including COVID-19)
A new section on the use of COVID-19 
vaccine was added.
To provide guidance on the use of 
COVID-19 vaccine.
7.1. Discontinuation of 
Study Intervention
The following criteria of study intervention 
discontinuation was deleted: The participant 
has his/her treatment assignment unblinded 
by the investigator.
To allow consideration of study 
intervention discontinuation on a 
case-by-case basis upon discussion 
with study responsible physician.
8.3.1. Time Period and 
Frequency for Collecting 
Adverse Event and 
Serious Adverse Event 
Information
Instructions for investigators on reporting 
cases of biochemical Hy’s law were included 
in the protocol.
To provide clarity on the definition, 
assessment, and expedited reporting 
of Hy's law cases.
10.8. Appendix 8: Liver
Safety: Suggested Actions 
and Follow-up 
Assessments
!
Direct bilirubin was added to the liver 
chemistry test.
!
Instructions for reporting cases of  Hy’s 
law were updated in footnote 2.
!
The term ‘(>35% direct bilirubin)’ was 
deleted from the liver chemistry stopping 
criteria table.
To provide further clarity to the 
liver chemistry stopping criteria 
and follow-up assessments and 
align with current protocol 
template.
10.8. Appendix 8: Liver 
Safety: Suggested Actions 
and Follow-up 
Assessments
Added a new footnote #4 and the previous 
footnote #4 was changed to #5.
To specify different hepatitis 
serology assessments and correct 
the typographical error.
10.9. Appendix 9: Study 
Conduct During a Natural 
Disaster
The guidance on study conduct during 
COVID-19 pandemic was updated.
To align with the updates in the 
COVID-19 appendix.

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Section number
and Name
Description of Change
Brief Rationale
Throughout the protocol
!
Minor grammatical, formatting, spelling 
changes, or corrections of 
inconsistencies were made including but 
not limited to:
!
The term Week 96 was added to ACR 20, 
ACR 50, ACR 70, and HAQ-DI endpoint 
analysis
!
The exact appendix providing examples 
of highly effective contraceptive 
methods was updated in inclusion 
criteria #11.
!
The term ‘or chloroquine’ was removed 
from the exclusion criterion #7.
!
The wording related to participant’s 
eligibility for further treatment in case of 
treatment assignment unblinding was 
rephrased.
!
The grading of modified nail psoriasis 
severity index was updated.
!
The term ‘at Week 24’ was deleted from 
the health economics analysis.
!
Updates in accordance with the latest 
protocol template were made.
Minor inconsistencies were noted

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11.
REFERENCES
American College of Rheumatology. https://www.acr.org/. Accessed on 01 December 2020.
American Red Cross. https://www.redcrossblood.org/. Accessed on 18 November 2020.
Basra MKA (2008), Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994–2007: a 
comprehensive review of validation data and clinical results. Br J Rheumatol. 2008;159:997-1035.
Cassell SE (2007), Bieber JD, Rich P et al. The modified Nail Psoriasis Severity Index: validation of an instrument 
to assess psoriatic nail involvement in patients with psoriatic arthritis. The Journal of Rheumatology. 
2007;34(1):123-129.
Cella D (2005), Yount S, Sorensen M, Chartash E, Sengupta N, Grober J. Validation of the Functional Assessment 
of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J 
Rheumatol. 2005;32(5):811-819.
Chandran V (2007), Bhella S, Schentag C, Gladman D. Functional Assessment of Chronic Illness Therapy-Fatigue 
Scale is valid in patients with psoriatic arthritis. Ann Rheum Dis. 2007;66:936-939.
Coates LC (2010), Helliwell PS. Validation of minimal disease activity criteria for psoriatic arthritis using 
interventional ta. Arthritis Care Res (Hoboken). 2010;62(7):965-969.
Coates LC (2016), Helliwell PS. Defining low disease activity states in psoriatic arthritis using novel composite 
disease instruments. J Rheumatol. 2016;43(2):371-375.
Di Carlo, M (2017), Becciolini A, Lato V et al. The 12-item Psoriatic Arthritis Impact of Disease Questionnaire: 
Construct Validity, reliability, and interpretability in a Clinical setting. J Rheumatol. 2017;44(3):279-285.
England BR (2019), Tiong BK, Bergman MJ et al. 2019 Update of the American College of Rheumatology 
Recommended Rheumatoid Arthritis Disease Activity Measures. Arthritis Care Res (Hoboken). 2019;71(12):1540-
1555.
Feldman SR (2005), Gordon KB, Bala M, et al. Infliximab treatment results in significant improvement in the 
quality of life of patients with severe psoriasis:  a double-blind placebo-controlled trial. British Journal of 
Dermatology. 2005;152:954-960.
Felson DT (1995), Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of 
improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38(6):727-735.
Finlay AY (1994), Khan GK.  Dermatology Life Quality Index (DLQI)--a simple practical measure for routine 
clinical use.  Clin Exp Dermatol.  1994;19(3):210-216.
Fransen J (2009), van Riel PLCM. The disease activity score and the EULAR response criteria. Rheum Dis Clin 
North Am. 2009;35(4):745-57, vii-viii.
Fredriksson T (1978), Pettersson U.  Severe psoriasis – oral therapy with a new retinoid.  Dermatologica.  
1978;157(4):238-244.
Fries JF (1980), Spitz P, Kraines RG, Holman HR.  Measurement of patient outcomes in arthritis. Arthritis Rheum.  
1980;23(2):137-145.
Gladman DD (2009). Psoriatic arthritis from Wright’s era until today. J Rheumatol Suppl. 2009;83:4-8.
Gladman DD (1987), Shuckett R, Russell ML, Thorne JC, Schachter RK. Psoriatic arthritis (PSA)--an analysis of 
220 patients. Q J Med. 1987;62(238):127-141.
Gladman DD (1998), Farewell VT, Wong K, Husted J. Mortality Studies In Psoriatic Patients. Results from a single 
outpatient center.  Prognostic indicators for death. Arthritis Rheum. 1998;41(6):1103-1110.
Gladman DD (2007), Inman RD, Cook RJ, et al. International spondyloarthritis interobserver reliability exercise--
the INSPIRE study: II. Assessment of peripheral joints, enthesitis, and dactylitis. J Rheumatol. 2007;34(8):1740-
1745.
Gladman DD (2013), Ziouzina O, Thavaneswaran A, Chandran V. Dactylitis in psoriatic arthritis: prevalence and 
response to therapy in the biologic era. J Rheumatol. 2013;40(8):1357-1359.

CNTO 1959 (guselkumab)
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Status: Approved,  Date: 04 May 2022
Healy PJ (2008), Helliwell PS. Measuring clinical enthesitis in psoriatic arthritis: assessment of existing measures 
and development of an instrument specific to psoriatic arthritis. Arthritis Rheum. 2008;59(5):686-691.
Helliwell PS (2014a), FitzGerald O, Fransen J. Composite disease activity and responder indices for psoriatic 
arthritis: A report from the GRAPPA 2013 Meeting on development of cutoffs for both disease activity states and 
response. J Rheum. 2014;41(6):1212-1217.
Helliwell PS (2014b), Kavanaugh A. Comparison of composite measures of disease activity in psoriatic arthritis 
using data from an interventional study with golimumab. Arthritis Care Res. 2014;66(5):749-756.
Husted JA (1998), Gladman DD, Cook RJ, Farewell VT. Responsiveness of health status instruments to changes in 
articular status and perceived health in patients with psoriatic arthritis. J Rheumatol. 1998;25(11):2146-2155. 
Khilji FA (2002), Gonzalez M, Finlay AY. Clinical meaning of change in dermatology life quality index scores. Br J 
Dermatol. 2002;147(suppl 62): 25-54.
Mease PJ (2015), van der Heijde D, Ritchlin CT et al. A Randomized, Double-Blind, Active- and Placebo-
Controlled Phase 3 Study of Efficacy and Safety of Ixekizumab, Adalimumab, and Placebo Therapy in Patients 
Naïve to Biologic Disease Modifying Anti-Rheumatic Drugs with Active Psoriatic Arthritis [abstract]. Arthritis 
Rheumatol. 2015; 67 (suppl 10).
Mease PJ (2011), Woolley JM, Bitman B, Wang BC, Globe DR, Singh A. Minimally important difference of Health 
Assessment Questionnaire in psoriatic arthritis: relating thresholds of improvement in functional ability to patient-
rated importance and satisfaction. J Rheumatol. 2011 Nov;38(11):2461-2465.
Mease PJ (2005), Gladman DD, Ritchlin CT, et al, for the Adalimumab Effectiveness in Psoriatic Arthritis Trial 
Study Group. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results 
of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005:52:3279-3289. 
Mundt JC (2013), Greist JH, Jefferson JW, et al. Prediction of suicidal behavior in clinical research by lifetime 
suicidal ideation and behavior ascertained by the electronic Columbia-Suicide Severity Rating Scale. J Clin Psych. 
2013;74(9):887-893.
Posner K (2011), Brown GK, Stanley B, et al. The Columbia-Suicide Severity Rating Scale: Initial validity and 
internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 
2011;168(12):1266-1277.
Ritchlin CT (2008). From skin to bone: translational perspectives on psoriatic disease. J Rheumatol. 
2008;35(7):1434-1437.
Rodriguez F (2015), Harrison RW, Wojdyla D, Mahaffey KW. Lost to Follow-up and Withdrawal of Consent in 
Contemporary Global Cardiovascular Randomized Clinical Trials. Crit Pathways in Cardiol. 2015;14:150-153.
Sampson HA (2006), Munoz-Furlong A, Campbell RL, et al. Second symposium on the definition and management 
of anaphylaxis: Summary report—Second National Institute of Allergy and Infectious Disease/Food Allergy and 
Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006;117:2:391-397.
Schoels M (2016), Aletaha D, Alasti F. Disease activity in psoriatic arthritis (PsA): defining remission and treatment 
success using the DAPSA score. Ann Rheum Dis. 2016;75(5):811-8.
Setty AR (2007), Choi HK. Psoriatic arthritis epidemiology. Curr Rheumatol Rep. 2007;9(6):449-454.
Sokoll KB (2001), Helliwell PS.  Comparison of disability and quality of life in rheumatoid and psoriatic arthritis.  J 
Rheumatol. 2001;28(8):1842-1846. 
Torre AJC (1991), Rodriguez Perez A, Arribas Castrillo JM, et al. Psoriatic arthritis (PsA):  a clinical, 
immunological and radiological study of 180 Patients. Br J Rheumatol. 1991;30:245-250.
van der Heijde DM (1992), van Leeuwen MA, van Riel PL, et al. Biannual radiographic assessments of hands and 
feet in a three-year prospective followup of patients with early rheumatoid arthritis. Arthritis Rheum. 1992;35(1):26-
34.

CNTO 1959 (guselkumab)
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Wong K (1997), Gladman D, Husted J, Long JA, Farewell VT. Mortality studies in psoriatic arthritis. Results from a 
single outpatient clinic. Causes and risk of death. Arthritis Rheum. 1997;40(10):1868-1872. 
WPAI General Information. http://www.reillyassociates.net/WPAI_General.html. Accessed on 01 December 2020
Zangger P (1998), Gladman DD, Bogoch ER. Musculoskeletal surgery in psoriatic arthritis. J Rheumatol 1998; 
25(4):725-729.

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Status: Approved,  Date: 04 May 2022
Janssen Research & Development *
Clinical Protocol
GUIDANCE ON STUDY CONDUCT DURING A MAJOR DISRUPTION
Protocol Title
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating 
the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the 
Signs and Symptoms and Inhibiting Radiographic Progression in Participants with Active 
Psoriatic Arthritis
APEX
Short Title
A Study of the Efficacy and Safety of Guselkumab in Participants with Active Psoriatic 
Arthritis
Protocol CNTO1959PSA3004; Phase 3b
CNTO1959  (guselkumab)
*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.
United States (US) sites of this study will be conducted under US Food & Drug Administration
Investigational New Drug (IND) regulations (21 CFR Part 312).
EudraCT NUMBER:  2020-004981-20
Status:
Approved
Date:
04 May 2022
Prepared by:
Janssen Research & Development, LLC  
EDMS number:
EDMS-RIM-713206, 1.0
THIS APPENDIX APPLIES TO ALL CURRENT APPROVED VERSIONS OF PROTOCOL
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.
NCT04882098

Guidance on Study Conduct During Major Disruption
CNTO1959 (guselkumab)
Clinical Protocol CNTO1959PSA3004
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
2
Status: Approved,  Date: 04 May 2022
STUDY CONDUCT DURING A MAJOR DISRUPTION
GUIDANCE ON STUDY CONDUCT DURING A MAJOR DISRUPTION
It is recognized that the major disruption involving Ukraine and neighboring countries/territories
may have an impact on the conduct of this clinical study due to, for example, relocation of 
participants and study site personnel; travel restrictions/limited access to public places, including 
hospitals; study site personnel being unavailable, relocated, or reassigned to critical tasks. 
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 travel to the study site is considered to be 
dangerous, study participation may be interrupted, and study follow-up conducted. If it becomes 
necessary to discontinue participation in the study, the procedures outlined in the protocol for 
discontinuing study intervention will be followed.
If, as a result of the major disruption involving Ukraine and neighboring countries/territories
scheduled visits cannot be conducted in person at the study site, they 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 after consultation with the participant, investigator, and the sponsor. 
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. 
Modifications made to the study conduct as a result of the major disruption involving Ukraine and
neighboring countries/territories should be summarized in the clinical study report.
!
Certain protocol-mandated visits to the study site may not be possible during the major 
disruption involving Ukraine and neighboring countries/territories. Therefore, temporary 
measures may be implemented if considered appropriate by the sponsor and investigator to 
maintain continuity of patient 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:
NCT04882098

Guidance on Study Conduct During Major Disruption
CNTO1959 (guselkumab)
Clinical Protocol CNTO1959PSA3004
CONFIDENTIAL – FOIA Exemptions Apply in U.S.
3
Status: Approved,  Date: 04 May 2022
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remote (eg, by phone / telemedicine) or in-person, off-site (eg, in-home) interactions 
between site staff (or designees) and patients for study procedures (eg, those related to 
safety monitoring / efficacy evaluation / study intervention storage and administration 
[including training where pertinent])
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procurement of study intervention by patients (or designee) from the study site or 
shipment of study intervention from the study site directly to patients for at-home 
administration
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laboratory assessments using a suitably accredited local laboratory; for selected measures 
(eg, urine pregnancy), home testing may be employed
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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 in the eCRF. 
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other relevant study data elements impacted by the major disruption involving Ukraine 
and neighboring countries/territories should also be documented in eCRFs 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. 
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The sponsor will evaluate the totality of impact of the major disruption involving Ukraine and 
neighboring countries/territories on collection of key study data and additional data analyses 
will be outlined in study SAP(s).  
NCT04882098