A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects 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:01 May 2020
Janssen Research & Development *
Clinical Protocol
COVID-19 Appendix
Protocol Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating
the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects with
Active Psoriatic Arthritis
Discover2
ProtocolCNTO1959PSA3002; Phase 3
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 toJanssen Biotech, Inc.; Janssen Products, LP; Janssen Biologics, 
BV; Janssen-Cilag International NV; Janssen, Inc; Janssen Pharmaceutica NV; Janssen SciencesIreland
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).]
Status:
Approved  
Date:
01 May2020
Prepared by: Janssen Research & Development, LLC  
EDMS number:
EDMS-RIM-46730version 1.0
THIS APPENDIX APPLIES TO ALL CURRENT APPROVED VERSIONS OF PROTOCOL
CNTO1959PSA3002
GCP Compliance: This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory 
requirements. 
Confidentiality Statement
NCT03158285
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.

COVID-19 Appendix
CNTO 1959 (guselkumab)
Clinical ProtocolCNTO1959PSA3002
CONFIDENTIAL –FOIA Exemptions Apply in U.S.
2
Status: Approved,  Date:01 May 2020
COVID-19 APPENDIX
GUIDANCE ON STUDY CONDUCT DURING THECOVID-19 PANDEMIC
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on 
the conduct of this clinical study due to, for example, self-isolation/quarantine by subjectsand 
study-site personnel; travel restrictions/limited access to public places, including hospitals; study 
site personnel being reassigned to critical tasks.
In alignment with recent health authority guidance, the sponsor is providing options for 
study-related subjectmanagement in the event of disruptionto the conduct of the study. This 
guidance does not supersede any local or government guidelines or requirements or the clinical 
judgement of the investigator to protect the health and well-being of subjectsand site staff. If, at 
any time, a subject’ssafety is considered to be at unacceptable risk, study agentwill be 
discontinued, and study follow-up will be conducted.
Scheduled visits that cannot be conducted in person at the study site will be performed to the extent 
possible remotely/virtually or delayed until such time that on-site visits can be resumed. At each 
contact, subjectswill be interviewed to collect safety data. Key efficacy endpoint assessments 
should be performed if required and as feasible. Subjectswill 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 subjectson study 
agent, including follow up. Modifications to protocol-required assessments may be permitted via 
COVID-19 Appendix after consultation between the subjectand investigator, and with the 
agreement of the sponsor (see below).
The sponsor will continue to monitor the conduct and progress of the clinical study, and any 
changes will be communicated to the sites and to the health authorities according to local guidance. 
If a subjecthas tested positive for COVID-19, theinvestigator should contact the sponsor’s 
responsible medical officer to discuss plans for study agentand follow-up. Modifications made to 
the study conduct as a result of the COVID-19 pandemic should be summarized in the clinical 
study report.

COVID-19 Appendix
CNTO 1959 (guselkumab)
Clinical ProtocolCNTO1959PSA3002
CONFIDENTIAL –FOIA Exemptions Apply in U.S.
3
Status: Approved,  Date:01 May 2020
ADDITIONAL ELEMENTS, WHERE APPLICABLE:
Certain protocol-mandated visits to the study site may not be possible during the COVID-19 
outbreak. Therefore, temporary measures may be implemented if considered appropriate by 
the sponsor and investigator to maintain continuity of subjectcare and studyintegrity. Certain 
measures, such as those listed below, may be necessary and should be instituted in accordance 
with applicable (including local) laws, regulations, guidelines, and procedures:
o remote (eg, by phone / telemedicine) or in-person, off-site (eg, in-home) interactions 
between site staff (or designees) and subjectsfor study procedures e.g. those related to 
safety monitoring / efficacy evaluation / study agentstorage and administration 
(including training where pertinent)
o procurement of study agentby subjects(or designee) or shipment of study agentfrom 
the study site directly to subjectsfor at home administration (including the potential for 
self-administration of study agent)
o laboratory assessments using a suitably accredited local laboratory; for selected 
measures (eg,urine pregnancy), home testing may be employed
o other procedures, eg, imaging, may be conducted at an appropriate facility
Missed assessments/visits will be captured in the clinical trial management system for 
protocol deviations.  Discontinuations of study agents and withdrawal fromthe study 
should be documented with the prefix “COVID-19-related” in the case report form (CRF).  
o other relevant study data elements impacted by the pandemic should also be 
documented / labeled as“COVID-19-related” in CRFs and / or other study systems, 
as directed by detailed sponsor guidance. These may include missed / delayed / 
modified study visits / assessments / dosing, and instances where temporary 
measures such as those above are implemented.  
The sponsor will evaluate the totality of impact of COVID-19 on collection of key study 
data and additional data analyses will be outlined in study SAP(s). 
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 during participation in the study. 

COVID-19 Appendix
CNTO 1959 (guselkumab)
Clinical ProtocolCNTO1959PSA3002
CONFIDENTIAL –FOIA Exemptions Apply in U.S.
4
Status: Approved,  Date:01 May 2020
INVESTIGATOR AGREEMENT

1
Status: Approved,  Date: 23 January 2018
Janssen Research & Development *
Clinical Protocol
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating 
the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects with 
Active Psoriatic Arthritis
Discover 2
ProtocolCNTO1959PSA3002; Phase 3
AMENDMENT 1
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 SciencesIrelandUC; 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.
This study will be conducted under US Food & Drug Administration INDregulations (21 CFR 
Part 312)
EudraCT NUMBER:
2016-001224-63
Status:
Approved
Date:
23 January 2018
Prepared by: Janssen Research & Development, LLC  
EDMS number: EDMS-ERI-125132842:  3.0
GCP Compliance: This study will beconducted in compliance with Good Clinical Practice, and applicable regulatory 
requirements. 
Confidentiality Statement
NCT03158285
The information in this document contains trade secrets and commercial information that are privileged or confidential and may 
not be disclosed unless such disclosure is required by applicable law or regulations. In any event, persons to whom the 
information is disclosed must be informed that the information is privileged or confidential and may not be further disclosedby 
them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as privileged or 
confidential.

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
2
Approved, Date: 23 January 2018
TABLE OF CONTENTS
TABLE OF CONTENTS...............................................................................................................................2
LIST OF ATTACHMENTS............................................................................................................................5
LIST OF IN-TEXT TABLES AND FIGURES................................................................................................5
PROTOCOL AMENDMENTS.......................................................................................................................7
SYNOPSIS..................................................................................................................................................18
TIME AND EVENTS SCHEDULE..............................................................................................................29
ABBREVIATIONS......................................................................................................................................40
1.
INTRODUCTION................................................................................................................................43
1.1.
Background....................................................................................................................................43
1.1.1.
Disease Background...................................................................................................................43
1.1.2.
Treatment Options......................................................................................................................43
1.1.3.
Clinical Studies...........................................................................................................................44
1.1.3.1.
Phase 2 Study in Psoriatic Arthritis (CNTO1959PSA2001)....................................................45
1.1.3.2.
Phase 2 Study in Psoriasis (CNTO1959PSO2001, X-PLORE)..............................................47
1.1.3.3.
Phase 3 Studies in Psoriasis (CNTO1959PSO3001, CNTO1959PSO3002, and 
CNTO1959PSO3003)..............................................................................................................49
1.1.3.3.1.
Efficacy.................................................................................................................................49
1.1.3.3.2.
Safety...................................................................................................................................49
1.1.3.4.
Phase 2 Study in Rheumatoid Arthritis (CNTO1275ARA2001)..............................................49
1.2.
Overall Rationale for the Study......................................................................................................50
1.2.1.
Role of Interleukin-23 and TH17 Pathways in the Treatment of Psoriatic Arthritis....................50
1.2.2.
Study Rationale..........................................................................................................................51
1.2.3.
Dose Rationale...........................................................................................................................51
1.2.3.1.
Rationale for Guselkumab 100 mg at Weeks 0 and 4 then Every 8Weeks Dose 
Regimen..................................................................................................................................51
1.2.3.2.
Rationale for Guselkumab 100 mg Every 4 Weeks Dose Regimen........................................52
2.
OBJECTIVES, ENDPOINTS, AND HYPOTHESIS...........................................................................53
2.1.
Objectives and Endpoints..............................................................................................................53
2.1.1.
Objectives...................................................................................................................................53
2.1.2.
Endpoints....................................................................................................................................53
2.2.
Hypothesis.....................................................................................................................................58
3.
STUDY DESIGN AND RATIONALE.................................................................................................58
3.1.
Overview of Study Design..............................................................................................................58
3.2.
Study Design Rationale..................................................................................................................60
3.2.1.
Study Population.........................................................................................................................60
3.2.2.
Study Control, Randomization, and Blinding..............................................................................60
3.2.3.
Study Phases and Duration of Treatment..................................................................................61
3.2.4.
Study Evaluations.......................................................................................................................61
4.
SUBJECT POPULATION..................................................................................................................62
4.1.
Inclusion Criteria............................................................................................................................62
4.2.
Exclusion Criteria...........................................................................................................................67
4.3.
Prohibitions and Restrictions.........................................................................................................70
5.
TREATMENT ALLOCATIONAND BLINDING.................................................................................
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CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
3
Approved, Date: 23 January 2018
6.
DOSAGE AND ADMINISTRATION..................................................................................................72
7.
TREATMENT COMPLIANCE............................................................................................................73
8.
PRESTUDY AND CONCOMITANT THERAPY................................................................................74
8.1.
Non-biologic DMARDs...................................................................................................................75
8.1.1.
Permitted Non-biologic DMARDs...............................................................................................75
8.1.2.
Prohibited Non-biologic DMARDs and Apremilast.....................................................................78
8.1.3.
Systemic Immunosuppressive Drugs.........................................................................................78
8.2.
Corticosteroids...............................................................................................................................78
8.2.1.
Oral Corticosteroids....................................................................................................................78
8.2.2.
Corticosteroids –Intravenous,Intramuscular, or Epidural Administration.................................78
8.2.3.
Corticosteroids –Intra-articular Injection....................................................................................79
8.2.4.
Corticosteroids –Other Routes of Administration......................................................................79
8.3.
Nonsteroidal Anti-inflammatory Drugs and Other Analgesics........................................................79
8.4.
Biologic Agents, Cytotoxic Drugs, JAK Inhibitors, or Investigational Agents.................................79
8.5.
Complementary Therapies.............................................................................................................80
8.6.
Topical Therapy and Ultraviolet B Light.........................................................................................80
8.7.
Systemic Therapy for Psoriasis.....................................................................................................80
9.
STUDY EVALUATIONS....................................................................................................................80
9.1.
Study Procedures...........................................................................................................................80
9.1.1.
Overview.....................................................................................................................................80
9.1.2.
Blood Sample Collection.............................................................................................................81
9.1.3.
Screening Phase........................................................................................................................81
9.1.4.
Treatment Phase........................................................................................................................84
9.1.5.
Post Treatment Phase (Follow-Up)............................................................................................85
9.2.
Efficacy Evaluations.......................................................................................................................86
9.2.1.
Psoriatic Arthritis Response Evaluations....................................................................................86
9.2.1.1.
Joint Assessment....................................................................................................................86
9.2.1.2.
Nonevaluable Joints................................................................................................................87
9.2.1.3.
American College of Rheumatology Response.......................................................................87
9.2.1.4.
Dactylitis Assessment..............................................................................................................88
9.2.1.5.
Enthesitis Assessment............................................................................................................88
9.2.1.6.
Imaging Evaluation..................................................................................................................88
9.2.1.7.
Disability Index of the Health Assessment Questionnaire.......................................................89
9.2.1.8.
Minimal Disease Activity..........................................................................................................90
9.2.1.9.
Psoriatic Arthritis Disease Activity Score.................................................................................90
9.2.1.10.
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAppa) 
Composite Score (GRACE).....................................................................................................90
9.2.1.11.
Disease Activity Index Score 28..............................................................................................91
9.2.1.12.
Modified Composite Psoriatic Disease Activity Index.............................................................92
9.2.1.13.
Disease Activity Index for Psoriatic Arthritis............................................................................92
9.2.1.14.
Modified Psoriatic Arthritis Responder Criteria........................................................................92
9.2.1.15.
Bath Anky
losing Spondylitis Disease Activity Index................................................................92
9.2.2.
Psoriasis Response Evaluations................................................................................................93
9.2.2.1.
Investigator’s Global Assessment of Psoriasis........................................................................93
9.2.2.2.
Psoriasis Area and Severity Index..........................................................................................93
9.2.2.3.
Dermatology Life Quality Index...............................................................................................93
9.2.3.
Other Patient Reported Outcomes.............................................................................................94
9.2.3.1.
36-Item Short-form Health Survey...........................................................................................94
9.2.3.2.
EQ-5D Questionnaire..............................................................................................................94
9.2.3.3.
Functional Assessment of Chronic Illness Therapy -Fatigue.................................................95
9.3.
Health Economics..........................................................................................................................95
9.4.
Pharmacokinetics and Immunogenicity.........................................................................................95
9.4.1.
Serum Collection and Handling..................................................................................................
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CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
4
Approved, Date: 23 January 2018
9.4.2.
Analytical Procedures.................................................................................................................96
9.4.3.
Pharmacokinetic Parameters.....................................................................................................96
9.4.4.
Immunogenicity Assessments....................................................................................................96
9.5.
Biomarkers.....................................................................................................................................96
9.6.
Pharmacogenomics (DNA) Evaluations.........................................................................................97
9.7.
Safety Evaluations.........................................................................................................................97
9.7.1.
Evaluations of Safety and Tolerability........................................................................................97
9.7.2.
Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)..............................................100
9.7.3.
Anticipated Events....................................................................................................................102
9.8.
Sample Collection and Handling..................................................................................................103
10. SUBJECT COMPLETION/DISCONTINUATION OF STUDY TREATMENT/WITHDRAWAL 
FROM THE STUDY.........................................................................................................................103
10.1.
Completion...................................................................................................................................103
10.2.
Discontinuation of Study Treatment.............................................................................................103
10.3.
Withdrawal From the Study..........................................................................................................105
10.4.
Withdrawal From the Use of Research Samples.........................................................................106
11. STATISTICAL METHODS...............................................................................................................106
11.1.
Subject Information......................................................................................................................107
11.2.
Sample Size Determination.........................................................................................................107
11.3.
Efficacy Analyses.........................................................................................................................109
11.3.1.
Primary Endpoint Analyses......................................................................................................109
11.3.2.
Major Secondary Analyses.......................................................................................................111
11.3.3.
Other Planned Secondary Analyses.........................................................................................111
11.4.
Pharmacokinetic Analyses...........................................................................................................111
11.5.
Immunogenicity Analyses............................................................................................................111
11.6.
Biomarkers Analyses...................................................................................................................111
11.7.
Pharmacokinetic/Pharmacodynamic Analyses............................................................................111
11.8.
Pharmacogenomic Analyses.......................................................................................................112
11.9.
Health Economics Analysis..........................................................................................................112
11.10. Safety Analyses...........................................................................................................................112
11.11. Interim Analysis............................................................................................................................112
11.12. Data Monitoring Committee.........................................................................................................112
12. ADVERSE EVENT REPORTING....................................................................................................113
12.1.
Definitions....................................................................................................................................113
12.1.1.
Adverse Event Definitions and Classifications.........................................................................113
12.1.2.
Attribution Definitions................................................................................................................115
12.1.3.
Severity Criteria........................................................................................................................115
12.2.
Special Reporting Situations........................................................................................................116
12.3.
Procedures...................................................................................................................................116
12.3.1.
All Adverse Events....................................................................................................................116
12.3.2.
Serious Adverse Events...........................................................................................................117
12.3.3.
Pregnancy.................................................................................................................................118
12.3.4.
Events of Special Interest.........................................................................................................118
12.4.
Contacting Sponsor Regarding Safety.........................................................................................118
13. PRODUCT QUALITY COMPLAINT HANDLING............................................................................118
13.1.
Procedures...................................................................................................................................119
13.2.
Contacting Sponsor Regarding Product Quality..........................................................................119
14. STUDY AGENT INFORMATION.....................................................................................................119
14.1.
Physical Description of Study Agents..........................................................................................119
14.2.
Packaging....................................................................................................................................119
14.3.
Labeling........................................................................................................................................120
14.4.
Preparation, Handling, and Storage.............................................................................................
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CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
5
Approved, Date: 23 January 2018
14.5.
Drug Accountability......................................................................................................................120
15. STUDY-SPECIFIC MATERIALS.....................................................................................................121
16. ETHICAL ASPECTS.......................................................................................................................121
16.1.
Study-Specific Design Considerations.........................................................................................121
16.2.
Regulatory Ethics Compliance.....................................................................................................122
16.2.1.
Investigator Responsibilities.....................................................................................................122
16.2.2.
Independent Ethics Committee or Institutional Review Board.................................................122
16.2.3.
Informed Consent.....................................................................................................................123
16.2.4.
Privacy of Personal Data..........................................................................................................124
16.2.5.
Long-Term Retention of Samples for Additional Future Research..........................................125
16.2.6.
Country Selection.....................................................................................................................125
17. ADMINISTRATIVE REQUIREMENTS............................................................................................126
17.1.
Protocol Amendments..................................................................................................................126
17.2.
Regulatory Documentation..........................................................................................................126
17.2.1.
Regulatory Approval/Notification..............................................................................................126
17.2.2.
Required Prestudy Documentation...........................................................................................126
17.3.
Subject Identification, Enrollment, and Screening Logs..............................................................127
17.4.
Source Documentation.................................................................................................................127
17.5.
Case Report Form Completion....................................................................................................128
17.6.
Data Quality Assurance/Quality Control......................................................................................129
17.7.
Record Retention.........................................................................................................................129
17.8.
Monitoring....................................................................................................................................130
17.9.
Study Completion/Termination.....................................................................................................131
17.9.1.
Study Completion/End of Study................................................................................................131
17.9.2.
Study Termination.....................................................................................................................131
17.10. On-Site Audits..............................................................................................................................131
17.11. Use of Information and Publication..............................................................................................131
REFERENCES..........................................................................................................................................134
INVESTIGATOR AGREEMENT...............................................................................................................143
LIST OF ATTACHMENTS
Attachment 1:
The CASPAR Criteria...............................................................................................137
Attachment 2:
QuantiFERON® TB Gold Testing.............................................................................138
Attachment 3:
Tuberculin Skin Testing............................................................................................140
Attachment 4:
Hepatitis B Virus (HBV) Screening with HBV DNA..................................................141
Attachment 5:
Anticipated Events....................................................................................................142
LIST OF IN-TEXT TABLES AND FIGURES
TABLES
Table 1:
TIME AND EVENTS SCHEDULE FROM SCREENING THROUGH WEEK 24......................29
Table 2:
TIME AND EVENTS SCHEDULE FROM WEEK 28 THROUGH WEEK 112..........................35
Table 3:
Summary of Efficacy Results at Week 24 (CNTO1959PSA2001)...........................................46
Table4:
Permitted Concomitant Medications for PsA and the Maximum Allowed Doses During 
the Study...................................................................................................................................75
Table5:
Protocol Requirements of the Permitted Non-biologic DMARDs.............................................77
Table 6:
DAS Response.........................................................................................................................91
Table 7:
Statistical Power for Treatment Difference in ACR 20 Response at Week 24.......................108
Table 8:
Statistical Power for Treatment Difference in vdH-S Change from Baseline at Week 24......
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CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
6
Approved, Date: 23 January 2018
FIGURES
Figure 1: Schematic Overview of the Study Through End of Study.........................................................
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CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
7
Approved, Date: 23 January 2018
PROTOCOL AMENDMENTS
Protocol Version
Issue Date
Original Protocol
16 March 2017
Amendment 1
23January 2018
Amendments below are listed beginning with the most recent amendment.
Amendment 1(23January 2018)
This amendment is considered to be substantialbased on the criteria set forth in Article 10(a) of Directive 
2001/20/EC of the European Parliament and the Council ofthe European Union.  
The overall reason for the amendment:The overall reason for the amendment is due to FDAfeedbackand 
correction of errors.
Applicable Section(s) Description of Change(s)
Rationale:Toupdate the footnotes in Table 1 tocorrect minor errorsand provide clarification.
Table 1, Time and 
Events Schedule from 
screening through 
Week 24
Footnote ‘b’ was modified to have a visitwindow of ±4 days instead of 7 and text was 
clarified: Through Week 24, study visitswill have a visit window of ±4days.
Footnote ‘p’ language was revised for clarification(deleted text is striked-through):“All 
patient questionnaires should be completed before any other tests, procedures, or 
evaluations on the day of the visit for baseline and post-baseline visits.  The questionnaires 
and site assessments will be completed/recordedon the tablet.”
Footnotes‘q’ and ‘r’: “will/must” was changed to “should”.
Footnote ‘v’ was citedto the following rows: Hepatitis B and C Serologies, HIV Antibody 
Test, C-reactive Protein, Rheumatoid factor, and Follicle Stimulating Hormone.
Rationale:To update the footnotes in Table 1 to provide clarification.
Table 1, Time and 
Events Schedule from 
screening through 
Week 24
Footnote ‘x’ was modified as follows:
Original text:
Prior to randomization, FSH is required for selected female subjects to determine 
childbearing potential.  This test is only required for a female subject of any age with 
amenorrhea for at least 6 months. This test should NOT be done for any female subject of 
childbearing potential or female subjects >45 years of age with amenorrhea for at least 12 
months. Refer to Inclusion Criterion 10 for details.
Modified text (deleted text is striked-through and new text in bold and underlined): 
Prior to randomization, FSH isonlyrequired for selected female subjects with 
amenorrhea for less than 12 monthsto determine childbearing potential.  This test is only 
required for a female subject of any age with amenorrhea for at least 6 months.Two FSH 
measurements are needed to confirm amenorrhea in these subjects. This test should 
NOT be done for any female subject of childbearing potential or female subjects >45 years 
of agewith amenorrhea for at least 12 months. Refer to Inclusion Criterion 10 for details.
Rationale:To updateTable 1 footnote and study procedures to state that the eC-SSRS will be completed at 
screening after the Independent Joint Assessor has completed the Joint Count assessment so that the site user can 
determine subject’s eligibility prior to the subject completing the PRO assessment.  Also, to clarify that the 
eC-SSRS will be performed firstof the PRO assessmentsat baseline and all post-baseline visits.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
8
Approved, Date: 23 January 2018
Applicable Section(s) Description of Change(s)
Table 1, Time and 
Events Schedule from 
screening through 
Week 24, footnote i;
Sections9.1.3 
Screening Phase; and 
9.7.2 eC-SSRS
Original text:
The eC-SSRS will be performed first at the screening visit (after signing informed consent)
if the screening visit is a single visit. If the screening visit is divided into more than 1 visit, 
the eC-SSRS will be performed first at the second screening visit (after the subject is 
determined to be eligible by the central laboratory test results).  The eC-SSRS will be 
performed first at Week 0/baseline, before study agent administration. At all post baseline 
visits, the eC-SSRS will be the first assessment/questionnaire that the subject must 
complete.
Modified text (deleted text is striked-through and newtext in bold and underlined): 
The eC-SSRS shouldwillbe performed firstafter the joint assessmentat the screening 
visit (after signing informed consent)if the screening visit is a single visit. If the screening 
visit is divided into more than 1 visit, the eC-SSRS will be performed first at the second 
screening visit (after the subject is determined to be eligible by the central laboratory test 
results).  At Week 0/baseline and at all post-baseline visits, the eC-SSRS willshouldbe 
the first assessment/questionnaire that the subject mustcompletesprior to study agent 
administration (see Section 9.7.2 for details).
Rationale:To correct minor errors.
Table 1,footnotes l 
and u; Table 2,
footnote j; Exclusion 
criterion 30; and 
Section 9.1.3 
Screening phase
Reference to Inclusion Criterion 13 was changed to Criterion 14.
Rationale:To update the footnotesin Table 2 to correct minor errors.
Table 2, Time and 
Events Schedulefrom 
Week 28 through 
Week 112
Footnote ‘a’ was clarified and now reads (new text in bold and underlined): Through 
Week 100, study visits will have a visit window of ±7 days; Week 112 visit or thefinal
safety visit (12 weeks after the last dosein subjects who discontinued study 
treatment)will have a visit window of ±14 days.
Footnote ‘n’ language was clarified and now reads(deleted text is striked-through):All 
patient questionnaires should be performed before any other tests, procedures, or
evaluations on the day of the visit.  The patient questionnaires and site assessments will be 
completed/recorded on the tablet.
Footnote ‘o’:the word“must” was changed to “should”.
Footnote ‘q’ was added to C-reactive Protein.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
9
Approved, Date: 23 January 2018
Applicable Section(s) Description of Change(s)
Rationale:To delete redundancies.
Section 1.2.3.2 
Rationale for 
Guselkumab 100mg 
Every 4weeks Dose 
Regimen
Deleted text: 
Although subjects who had higher systemic exposure of guselkumab (serum guselkumab 
concentrations at the fourth quartile level) had 12-13% higher rates of infections when 
compared with subjects who had serum guselkumab concentrations in the lower 3 
quartiles, a pattern of increasing rates of these events with higher exposure was not present 
across the first, second, and third quartile levels. Moreover, the clinical relevance of this 
finding appears to be limited, given that the vast majority of infections were non-serious 
and mild to moderate in intensity and that the frequency of the infections requiring 
treatment was generally similar across all 4 exposure quartiles.
Rationale:To correct error noted in hemoglobin level.
Section 4.1 
Inclusion criteria 
Original text in inclusion criterion 17 from:
a. Hemoglobin
≥8.5 g/dL
(SI: ≥100 g/L)
Modified text (deleted text is striked-through and newtext in bold and underlined): 
a. Hemoglobin
≥8.5 g/dL
(SI: ≥85100g/L)
Rationale: To correct error noted in visit windows.
Section 7 Treatment 
Compliance 
Original text:
All post-baseline visits will have a visit window of ±7 days counting from Week 0 as 
Day1. The safety follow-up visit at 12 weeks after the last dose will have a visit window 
of ±14 days.  
Modified text (deleted text is striked-through and new text in bold and underlined): 
All post-baseline visitsthrough Week 100up to and including Week 24will have a visit 
window of ±74days counting from Week 0 as Day 1. After Week 24, all visits will have 
a visit window of ±7 days.The Week 112 visit orthefinalsafetyfollow-upvisit at (12 
weeks after the last dose in subjects who discontinued study treatment) will have a visit 
window of ±14 days.    
Rationale: To revise for clarification.
Sections4.2 
Exclusion Criteria
#13; 9.1.3 Screening 
Phase; 9.1.4 
Treatment Phase; 
9.7.2 eC-SSRS; 10.2 
Discontinuation of 
Study Treatment
The eC-SSRS ideation level language was revised for better clarity.
The Baseline/Screeningversion name was changed to Lifetimeversion.
The Since Last Visitversion was changed to Since Last Contactversion
Clarified that the eC-SSRS measures five possible levels of suicidal ideation and four 
possible suicidal behaviors.
Rationale:To allow for a reduction in steroid dose after Week 24,as it may be medically appropriate.
Section 8.2.1 Oral 
Corticosteroids
The following text regarding reduction of steroid dose after Week 24 has been added: 
After Week 24 and through Week 52, a one-time dose decrease in oral corticosteroids
is allowed.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
10
Approved, Date: 23 January 2018
Applicable Section(s) Description of Change(s)
Rationale: To clarify requirements for hand and footradiographs at screening.
Sections9.1.1 
Overview; 9.1.3 
Screening; 9.2.1.6 
Imaging Evaluation
The requirement for hand and footradiographs at screening was changed to: 
All eligible subjects should have radiographs taken approximately 2 weeks but not greater 
than 4 weeks prior to randomization.  
The word “will” was changed to “should”.
For posterior-anterior view chest radiograph, the text “as per country regulations where 
applicable” was deleted.
Rationale: To revise for clarification.
Section 9.1.3
Screening Phase
Original text:
The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) (Baseline/Screening 
version) will be the first assessment performed at the screening visit (after signing 
informed consent) if the screening visit is a single visit. If the screening visit is divided 
into more than 1 visit, the eC-SSRS will be performed as the first assessment at the visit 
that occurs after the subject is determined to be eligible by the central laboratory test 
results.  
Modified text (deleted text is striked-through and new text in bold and underlined): 
If the screening is a single visit, tThe electronic Columbia-Suicide Severity Rating Scale 
(eC SSRS) (LifetimeBaseline/Screening version) shouldwillbe performedafter the 
joint assessment the first assessment performed at the screening visit(after signing 
informed consent) if the screening visit is a single visit. If the screening visit is divided 
into more than 1 visit, the eC-SSRS shouldwillbe performed after the joint assessment 
andas the first assessment at the visit that occurs afterthe subject is determined to be 
eligible by the central laboratory test results.  
Rationale:To revise for clarification.
Section 9.2.1.10 
Group for Research 
and Assessment of 
Psoriasis and 
Psoriatic Arthritis 
(GRAPPA) 
Composite Score 
(GRACE)
Original text:
9.2.1.10. Arithmetic Mean of the Desirability Function and Group for Research and 
Assessment of Psoriasis and Psoriatic Arthritis (GRAppa) Composite Score 
(GRACE) Index
The Arithmetic Mean of the Desirability Function is calculated by transforming the 
following variables, using predefinedalgorithms and expressing the total score as a mean 
with a score range of 0–1, where 1 indicates a better state than 0:23,22
• Tender joint count (0-68)
• Swollen joint count (0-66)
• HAQ (0-3)
• Patient’s global assessment of disease activity by VAS (arthritis and psoriasis, 0-
100mm)
• Patient’s assessment of skin disease activity by VAS (0-100 mm)
• Patient’s global assessment of disease activity (arthritis) by VAS (0-100 mm)
• PASI (0-72)
• Psoriatic arthritis Quality of Life Index (PsAQoL) which is determined from a 
transformation algorithm in which:
      - PsAQoL = 25.355 + (2.367 × HAQ) –(0.234 × PCS) –(0.244 × MCS)
     - GRACE index = (1-AMDF) ×1024
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
11
Approved, Date: 23 January 2018
Applicable Section(s) Description of Change(s)
Modified text (deleted text is striked-through and new text in bold and underlined): 
9.2.1.10. Arithmetic Mean of the Desirability Function and Group for Research and 
Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Composite Score 
(GRACE) Index
The GRAPPA Composite score (GRACE) is a composite score of Group for Research 
and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), derived as GRACE 
Index = (1 -AMDF) x 10, where, AMDF is the Arithmetic Mean of the Desirability 
Function (AMDF).22-24
The Arithmetic Mean of the Desirability Function AMDFis calculated by transforming 
the following variables, using predefined algorithms and expressing the total score as a 
mean with a score range of 0–1, where 1 indicates a better state than 0:22, 23
• Tender joint count (0-68)
• Swollen joint count (0-66)
• HAQ-DI score(0-3)
• Patient’s global assessment of disease activity by VAS (arthritis and psoriasis, 0-
100mmVAS)
• Patient’s assessment of skin disease activity by VAS(0-100 mmVAS)
• Patient’s global assessment of disease activity (arthritis) by VAS (0-100 mm)
• PASI score(0-72)
• Psoriatic arthritis Quality of Life Index (PsAQoL)which is derived as follows:which 
is determined from a transformation algorithm in which:
      - PsAQoL = 25.355+ (2.367 × HAQ-DI) –(0.234 × SF-PCS) –(0.244 × SF-MCS), 
where,
o
HAQ-DI: HAQ-DI score (0-3)
o
SF-PCS: PCS score of SF-36 Health Survey
o SF-MCS: MCS score of SF-36 Health Survey
     - GRACE index = (1-AMDF) ×1024
Rationale:To revise for clarification.
Section 9.7.1 
Evaluation of Safety
Original text:
• FSH is optional.  It is only needed for determining childbearing potential of a female 
subject of any age with amenorrhea for at least 6 months.A female subject of any age with 
amenorrhea for at least 6 months who also has FSH >40 IU/L is considered not of 
childbearing potential. FSH is not needed for female subjects >45 years of age with 
amenorrhea for at least 12 months or any female subject of childbearing potential. Refer to 
Inclusion Criterion 10 fordetail.
Modified text (deleted text is striked-through and new text in bold and underlined): 
• FSH is optional.  It is only needed for determining childbearing potential of a female 
subject of any age with amenorrhea for at least 6 monthsless than 12 months..In the 
absence of 12 months of amenorrhea, 2 FSH measurements are needed. A female 
subject of any age with amenorrhea for at least 6 months who also has FSH >40 IU/L is 
considered not of childbearing potential.FSH is not needed for female subjects>45 years 
of agewith amenorrhea for at least 12 months or any female subject of childbearing 
potential. Refer to Inclusion Criterion 10 for detail.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
12
Approved, Date: 23 January 2018
Applicable Section(s) Description of Change(s)
Rationale:To revise to allow for telephone system.
Section 9.7.2 
eC-SSRS
Original text:
Subjects will complete the eC-SSRS questionnaire using the Sponsor-provided electronic 
tablets. Study site personnel will train the subjects on how to use the electronic device. The 
eC-SSRS will be provided in the local languages in accordance with local guidelines.
TheeC-SSRS will be performed during each evaluation visit according to the Time and 
Events schedule. During a visit, subjects will be directed to a private, quiet place with the 
electronic device to complete the assessment. 
Modified text (deleted text is striked-through and new text in bold and underlined): 
Subjects will complete the eC-SSRS questionnaire using the Sponsor-provided electronic 
tablets (or through an Interactive Voice Response System [IVRS], if available ). Study 
site personnel will train the subjects on how to use the electronic device and/or a 
telephone system. 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 Time and 
Events schedule. During a visit, subjects will be directed to a private, quiet place with the 
electronic device and/or a telephoneto complete the assessment. 
Rationale:Treatment failure criteria was amended to include study termination for any reason.  Treatment failure 
criteria amended to remove early escape criteria met at Week 16 and initiated or increased the dose of one of the 
permitted concomitant medications.Additional sensitivity/supplemental analyses as well as tipping point analysis 
will be defined in the SAP.
Synopsis; 
Section11.3.1 
Primary Endpoint 
Analyses
Original text:
The primary endpoint to be analyzed for the primary analysis is proportion of subjects who 
achieved an ACR 20 response at Week 24 and who had not met the following treatment 
failure criteria prior to Week 24.  Subjects who met the following treatment failure prior to 
Week 24 will be considered as ACR 20 non-responder at Week 24 regardless of the 
observed ACR 20 response status.   Subjects who meet the following treatment failure 
criteria include subjects who:
1. Discontinued study agent injections due to lack of efficacy.
2. Initiated or increased the dose of non-biologic DMARDs (MTX, SSZ, HCQ, LEF) or 
oral corticosteroids over baseline for PsA.
3. Initiated protocol prohibitedmedications/therapies for PsA.
4. Met early escape criteria at Week 16 and initiated or increased the dose of one of the 
permitted concomitant medications.
The treatment effect of each guselkumab group versus placebo will be tested using a CMH 
test stratified by baseline non-biologic DMARD (MTX, SSZ, HCQ, LEF) use (yes/no) and 
the most recent available CRP value prior to randomization (<2.0 mg/dL or ≥2.0 mg/dL).  
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.
In the primary efficacy analysis, data from all randomized subjects who received at least 1 
administration of study treatment (full analysis set) will be analyzed according to their 
assigned treatment group regardless of their actual treatment received. In general, subjects 
with missing data for ACR 20 at Week 24 will be considered non-responders at Week 24. 
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
13
Approved, Date: 23 January 2018
Applicable Section(s) Description of Change(s)
[…]
Sensitivity Analysis
To evaluate the robustness of the primary analysis results, sensitivity analyses will be 
performed., including, but not limited to, the following: 
1. A similar analysis, however, if subjects meet treatment failure rules, ACR 20 response 
will be assumed tobe missing. Subjects with missing ACR 20 response will be imputed by 
Multiple-Imputation (MI) method under the assumption of Missing At-Random. 
2. A similar analysis, however, ACR 20 response using all observed data regardless of 
meeting treatment failure criteria.  Subjects with missing ACR 20 response will be 
imputed by Multiple-Imputation (MI) method under the assumption of Missing At-
Random.  And 2-dimensional tipping point analyses based on MI will be included to assess 
the robustness of the assumption regarding the missing data mechanism.
Additional sensitivity analyses may be specified in the SAP to further address the 
robustness of the primary analysis. 
Modified text (deleted text is striked-through and new text in bold and underlined): 
The primary endpoint to be analyzed for the primary analysis is proportion of subjects who 
achieved an ACR 20 response at Week 24 and who had not met the following treatment 
failure criteria prior to Week 24.  Subjects who met the following treatment failure prior to 
Week 24 will be considered as ACR 20 non-responder at Week 24 regardless of the 
observed ACR 20 response status.   Note that the intercurrent event of Treatment 
Failure prior to Week 24 (defined below) will be treated as non-response for the 
primary analysis, regardless of the observed ACR 20 response status.
Treatment Failure Criteria
Subjects who meet the following treatment failure criteria include subjects who:
1. Discontinued study agent injections due to lack of efficacy.
2. Terminate study participation for any reason.
3.2.  Initiated or increased the dose of non-biologic DMARDs (MTX, SSZ, HCQ, LEF) or 
oral corticosteroids over baseline for PsA.
4.3.
Initiated protocol prohibited medications/therapies for PsA.
4. Met early escape criteria at Week 16 and initiated or increased the dose of one of the 
permitted concomitant medications.
Subjects with missing data at Week 24 will be considered non-responders.
The treatment effect of each guselkumab group versus placebo will be tested usinga CMH 
test stratified by baseline non-biologic DMARD (MTX, SSZ, HCQ, LEF) use (yes/no) and 
the most recent available CRP value prior to randomization (<2.0 mg/dL or ≥2.0 mg/dL).  
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.
In the primary efficacy analysis, data from all randomized subjects who received at least 1 
administration of study treatment (fullanalysis set) will be analyzed according to their 
assigned treatment group regardless of their actual treatment received. In general, subjects 
with missing data for ACR 20 at Week 24 will be considered non-responders at Week 24. 
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
14
Approved, Date: 23 January 2018
Applicable Section(s) Description of Change(s)
[…]
Sensitivity Analysis
To evaluate the robustness of the primary endpoint analysis results, the exhaustive 
scenario tipping pointsensitivity analyses will be performedby varying the amount of 
non-responder imputation for missing data. including, but not limited to, the following:
Additional supplemental estimand and sensitivity analyses which vary how 
intercurrent events (eg, treatment failures) are handled, how observed data are used, 
and how missing data are treatedwill be specified in the SAP to further address the 
robustness of treatment effect of ACR20 at Week 24for the primary and alternative 
estimands (which will also be defined in the SAP).
Rationale:Subjects must sign the ICF independently and be able toread and write to participate in this study.
Sections 16.2.3 
Informed Consent; 
16.2.4 Privacy of 
Personal Data
Original text:
Each subject (or a legally acceptable representative) must give written consent according 
to local requirements after the natureof 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 and by the reviewing IEC/IRB and be in a 
language that the subject can readand 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 subjects or their legally acceptable representatives the 
aims, methods, reasonably anticipated benefits, and potential hazards of the study, and any 
discomfort participation in the study may entail. Subjects 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 subject 
will receive for the treatment of his or her disease. Subjects will be told that alternative 
treatments are available if they refuse to take part and that such refusal will not prejudice 
future treatment. Finally, they will be told that the investigator will maintain a subject 
identification register for the purposes of long-term follow up if needed and that their 
records may be accessed by health authorities and authorized Sponsor personnel without 
violating the confidentiality of the subject, to the extent permitted by the applicable law(s) 
or regulations. By signing the ICF the subject or legally acceptable representative is 
authorizing such access. 
The subject or legally acceptable representative 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 either the subject
's or his or 
her legally acceptable representative
's personally dated signature. After having obtained 
the consent, a copy of the ICF must be given to the subject.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
15
Approved, Date: 23 January 2018
Applicable Section(s) Description of Change(s)
Subjects 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 
subject or his or her legally acceptable representative 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 subject.
If the subject or legally acceptable representative is unable to read or write, an impartial 
witness should be present for the entire informed consent process (which includes reading 
and explaining all written information) and should personally date and sign the ICF after 
the oral consent of the subject or legally acceptable representative is obtained.
A limited number of study sites may be asked by the Sponsor to obtain informed consent 
usinga validated electronic system instead of a paper-based process. If both parties 
(Sponsor and the study site) agree, and if participation is allowed by local regulations and 
IEC/IRB requirements, the means to facilitate such a process will be provided to the sites 
by Sponsor. The actual mechanism of consenting will be facilitated by the use of an 
eTablet device (eg, iPad®), but overall the consent process will remain the same, as 
described in this section. At these study sites, subjects will still be required to review the 
entire informed consent as a written document on the eTablet and then to apply their 
handwritten signature electronically by the use of a stylus directly onto the eTablet. 
Modified text (deleted text is striked-through, new text in boldand underlined):
Each subject (or a legally acceptable representative)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 and by the reviewing IEC/IRB and be in a 
language that the subject 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 subjects or their legally acceptable representativesthe 
aims, methods, reasonably anticipated benefits, and potential hazards of the study, and any 
discomfort participation in the study may entail. Subjects will be informed that their 
participation is voluntary and that they maywithdraw consent to participate at any time. 
They will be informed that choosing not to participate will not affect the care the subject 
will receive for the treatment of his or her disease. Subjects will be told that alternative 
treatments are available if they refuse to take part and that such refusal will not prejudice 
future treatment. Finally, they will be told that the investigator will maintain a subject 
identification register for the purposes of long-term follow up if needed and that their 
recordsmay be accessed by health authorities and authorized Sponsor personnel without 
violating the confidentiality of the subject, to the extent permitted by the applicable law(s) 
or regulations. By signing the ICF the subject or legally acceptable representative is 
authorizing such access.
The subject or legally acceptable representativewill 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 eitherthe subject
's or his or 
her legally acceptable representative
'spersonally dated signature. After having obtained 
the consent, a copy of the ICF must be given to the subject.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
16
Approved, Date: 23 January 2018
Applicable Section(s) Description of Change(s)
Subjects 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 
subject or his or her legally acceptable representativewill 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 subject.
If the subject or legally acceptable representative is unable to read or write, an impartial 
witness should be present for the entire informed consent process (which includes reading 
and explaining all written information) and should personally date and sign the ICF after 
the oral consent of the subject or legally acceptable representative is obtained
The subject must be able to read and write and should personally sign the ICF. An 
impartial witness or legally acceptable representative should not sign the ICF on the 
subject’s behalf. 
A limited number of study sites may be asked by the Sponsor to obtain informed consent 
using a validated electronic system instead of a paper-based process. If both parties 
(Sponsor and the study site) agree, and if participation is allowed by local regulations and 
IEC/IRB requirements, the means to facilitate such a process will be provided to the sites 
by Sponsor. The actual mechanism of consenting will be facilitated by the use of an 
eTablet device (eg, iPad®), but overall the consent process will remainthe same, as 
described in this section. At these study sites, subjects will still be required to review the 
entire informed consent as a written document on the eTablet and then to apply their 
handwritten signature electronically by the use of a stylus directly onto the eTablet. 
Alternately, the site will also have the option to print the electronic version of the ICF 
and apply a handwritten signature .
Section 16.2.4
Original text:
The informed consent obtained from the subject (or his or her legally acceptable 
representative) 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.
Modified text (deleted text is striked-through, new text in bold and underlined):
The informed consent obtained from the subject (or his or her legally acceptable 
representative) 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.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
17
Approved, Date: 23 January 2018
Applicable Section(s) Description of Change(s)
Rationale: To clarify the sample storage period.
Section 16.2.5 Long-
Term Retention of 
Samples
Original text:
Samples collected in this study may be stored for up to 15 years.
Modified text (deleted text is striked-through, new text in bold and underlined):
Samples collected in this study may be stored for up to 15 years, starting from last 
patient, last visit.
Rationale: To revise for clarification.
Section 17.4 Source 
Documentation
Revised language to clarify eC-SSRS questionnaires can be completed through IVRS as an 
alternative method.
Clarified that the at-home administrations occur at Weeks 56, 60, 64, 72, 80, 88, 92, and 
96.  
Rationale:Minor errors were noted.
Throughout the 
protocol
Minor grammatical, formatting, or spelling changes were made.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
18
Approved, Date: 23 January 2018
SYNOPSIS
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the 
Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects with Active Psoriatic 
Arthritis
CNTO 1959 (guselkumab) is a fully human immunoglobulin G1 lambda monoclonal antibody that binds 
to the p19 protein subunit of human interleukin 23 (IL‑23) with high specificity and affinity.  The binding 
of guselkumab to the IL-23p19 subunit blocks the binding of extracellular IL-23 to the cell surface IL-23 
receptor, inhibiting IL-23 specific intracellular signaling and subsequent activation and cytokine 
production. In this manner, guselkumab inhibits the biological activity of IL-23 in all in vitro assays 
examined.
EudraCT NUMBER: 2016-001224-63
OBJECTIVES, ENDPOINTS, AND HYPOTHESIS
Primary Objective
The primary objective of this study is to evaluate the efficacy of guselkumab treatment in subjects with 
active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Secondary Objectives
The secondary objectives are to assess the following for guselkumab treatment:

Efficacy in improving psoriatic skin lesions

Improvement in physical function 

Inhibition of progression of structural damage

Efficacy in improving general and disease specific health-related quality of life and patient-reported 
health outcomes 

Safety 

Pharmacokinetics, pharmacodynamics, and immunogenicity 
Primary Endpoint
The primary endpoint is the proportion of subjects who achieve an American College of Rheumatology 
(ACR)20 response at Week 24. 
Major Secondary Endpoints
NCT03158285
1. Change from baseline inDisability Index of the Health Assessment Questionnaire(HAQ-DI)score 
at Week 24.
2. Proportion of subjects who achieve an ACR 50 response at Week 24.
3. Proportion of subjects with a psoriasis response of an Investigator’sGlobal Assessment (IGA) (ie, an 
IGA psoriasis score of 0 [cleared] or 1 [minimal] AND ≥2-grade reduction from baseline) at 
Week 24 among the subjects with ≥3% body surface area (BSA) psoriatic involvement and an IGA 
score of ≥2 (mild) at baseline.
4. Proportion of subjects who achieve an ACR 20 response at Week 16.

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
19
Approved, Date: 23 January 2018
5. Change from baseline in modified van der Heijde-Sharp (vdH-S) score at Week24.
6. Proportion of subjects withresolution of enthesitis at Week 24 among the subjects with enthesitis at 
baseline.
7. Proportion of subjects with resolution of dactylitis at Week 24 among the subjects with dactylitis at 
baseline.
8. Change from baseline in enthesitis score (based on Leeds Enthesitis Index [LEI]) at Week 24 among 
the subjects with enthesitis at baseline. 
9. Change from baseline in dactylitis scoreat Week 24 among the subjects with dactylitis at baseline. 
10. Change from baseline in 36-item Short Form Health Survey Physical Component Summary (SF-36 
PCS)at Week 24.
11. Change from baseline in Disease Activity Score 28 (DAS28) C-reactive protein (CRP) at Week 24.
12. Change from baseline in SF-36 Mental Component Summary (MCS)at Week 24. 
13. Proportion of subjects who achieve anACR 50 response at Week 16.
14. Proportion of subjects who achieve an ACR 70 response at Week 24.
Other Secondary Endpoints
Endpoints Related to Reduction of Signs and Symptoms and Physical Function
NCT03158285
1. Proportions of subjects who achieve an ACR 20, ACR 50, and ACR 70 responses by visit over time 
through Week 100.
2. Percent change from baseline in ACR components by visit over time through Week 100.
3. Change from baseline in HAQ-DI score by visit over time through Week 100.  
4. Proportion of subjects who achieve a clinically meaningful improvement (a ≥0.35 improvement 
from baseline) in HAQ-DI score by visit over time through Week 100 among those subjects with 
HAQ-DI score ≥ 0.35 at baseline.  
5. Proportion of subjects who achieve a DAS28 (CRP) response by visit over time through Week100.
6. Proportion of subjects who achieve a DAS28 (CRP) remission by visit over time through Week100.
7. Change from baseline in DAS28 (CRP) by visit over time through Week 100.
8. Proportion of subjects who achieve a response based on modified Psoriatic ArthritisResponse 
Criteria (PsARC) by visit over time through Week 100.
9. Proportion of subjects with resolution of enthesitis by visit by visit over time through Week 100 
among the subjects with enthesitis at baseline.
10. Proportion of subjects with resolution of dactylitis by visit by visit over time through Week 100 
among the subjects with dactylitis at baseline.
11. Change from baseline in enthesitis score (based on LEI) by visit over time through Week 100 among 
the subjectswith enthesitis at baseline.

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
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Approved, Date: 23 January 2018
12. Change from baseline in dactylitis score by visit over time through Week 100 among the subjects 
with dactylitis at baseline.
13. Change from baseline in Psoriatic ArthritiS Disease Activity Score (PASDAS) by visit over time 
through Week 100.
14. Change from baseline in Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 
GRAppa Composite ScoreIndex by visit over time through Week 100.
15. Change from baseline in Work Productivity and Activity Impairment Questionnairescores by visit 
over time through Week 100.
16. Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score by 
visit over time through Week 100.
17. Change from baseline in Disease Activity Index for Psoriatic Arthritis score by visit over time 
through Week 100.
18. Proportion of subjects who maintain an ACR 20 response at Week 52 and Week 100 among the 
subjects who achieved an ACR 20 response at Week 24.  
19. Proportion of subjects who maintain an ACR 50 response at Week 52 and Week 100 among the 
subjects who achieved an ACR 50 response at Week 24.  
20. Proportion of subjects who maintain an ACR 70 response at Week 52 and Week 100 among the 
subjects who achieved an ACR 70 response at Week 24.  
21. Proportion of subjects who maintainaHAQ-DI response (ie, ≥0.35 improvement from baseline in 
HAQ-DI score) at Week 52 and Week 100 among the subjects who achieved a HAQ-DI response at 
Week 24.  
22. Proportion of subjects who achieve minimal disease activity by visit over time through Week 100.
23. Proportions of subjects who achieve a ≥20%, ≥50%, ≥70%, and ≥90% improvement from baseline in 
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by visit over time through 
Week 100 among the subjects with spondylitis and peripheral joint involvement as their primary 
arthritic presentation of PsA.
Endpoints Related to Skin Disease
NCT03158285
1. Proportions of subjects who achieve ≥ 75%, ≥ 90%, and 100% improvement in Psoriatic Area and 
Severity Index (PASI) score from baseline by visit over time through Week 100 among the subjects 
with ≥3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
2. Proportion of subjects withanIGA score of 0 (cleared) by visit over time through Week 100 among 
the subjects with ≥3% BSA psoriatic involvement and anIGA score of ≥2 (mild) at baseline.
3. Change from baseline in PASI score by visit over time through Week 100 among the subjects with 
≥3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
4. Proportion of subjects who achieve a Dermatology Life Quality Index (DLQI) score of 0 or 1 by 
visit over time through Week 100 among the subjects with baseline DLQI score >1 and with ≥ 3% 
BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
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Approved, Date: 23 January 2018
5. Proportion of subjects who achieve ≥ 5-point improvement from baseline in DLQI score by visit 
over time through Week 100 among the subjects with baseline DLQI score ≥ 5 and with ≥ 3% BSA 
psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
6. Change from baseline in DLQI score by visit over time through Week 100 among the subjects with 
≥ 3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
7. Proportion of subjects who achieve both PASI 75 and ACR 20 responses by visit over time through 
Week 100 among the subjects with ≥3% BSA psoriatic involvement and an IGA score of ≥2 (mild) 
at baseline.
8. Proportion of subjects who achieve both PASI 75 and modified PsARC response by visit over time 
through Week 100 among the subjects with ≥3% BSA psoriatic involvement and an IGA score of ≥2 
(mild) at baseline.
Endpoints Related to Joint Structural Damage
NCT03158285
1. Change from baseline in modified vdH-S score by visit over time through Week 100. 
2. Change in total modified vdH-S score from Week 24 to Week 52, from Week 24 to Week 100, and 
from Week 52 to Week 100.
3. Change from baseline in modified vdH-S erosion score by visit over time through Week 100.
4. Change in modified vdH-S erosion score from Week 24 to Week 52, from Week 24 to Week 100, 
and from Week 52 to Week 100.
5. Change from baseline in modified vdH-Sjoint space narrowing (JSN) score by visit over time 
through Week 100.
6. Change in modified vdH-S JSN score from Week 24 to Week 52, from Week 24 to Week 100, and 
from Week 52 to Week 100.
7. 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 100.
8. Proportion of subjects with a change of ≤0 from baseline and proportion of subjects with a change of 
≤ 0.5 from baseline in modified vdH-S score by visit over time through Week 100.
9. Proportion of subjects with a change of ≤0 from baseline and proportion of subjects with a change of 
≤ 0.5 from baseline in modified vdH-S erosion score at by visit over time through Week 100.  
10. Proportion of subjects with achange of ≤0 from baseline and proportion of subjects with a change of 
≤ 0.5 from baseline in modified vdH-S JSN score by visit over time through Week 100.  
11. Proportion of subjects with radiographic progression (based on the smallest detectable change 
[SDC]) from baseline by visit over time through Week 100.
12. Proportion of subjects with radiographic joint erosion progression (based on SDC) from baseline by 
visit over time through Week 100.
13. Proportion of subjects with radiographic JSN progression (based on the SDC) from baseline by visit 
over time through Week 100.
14. Proportion of subjects with pencil in cup or gross osteolysis deformities by visit over time through 
Week 100.

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
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Approved, Date: 23 January 2018
Endpoints Related to Health Related Quality of Life
1. Change from baseline in PCS score of the SF-36 by visit over time through Week 100.
2. Change from baseline in MCS score of the SF-36 by visit over time through Week 100.
3. Change from baseline in domain scales scores of SF-36 by visit over time through Week 100.
4. Proportion of subjects who achieve ≥ 5-point improvement from baseline in SF-36 MCS score by 
visit over time through Week 100.
5. Proportion of subjects who achieve ≥ 5-point improvement from baseline in SF-36 PCS score by 
visit over time through Week 100.
6. Change from baseline in Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-
Fatigue)by visit over time through Week 100.
7. Proportion of subjects who achieve ≥ 4-point improvement from baseline in FACIT-Fatigue score 
improvement by visit over time through Week 100.
8. Change from baseline in EuroQol five-dimension questionnaire (EQ-5D) Visual Analogue Scale and 
in EQ-5D index scores by visit over time through Week 100.
Hypothesis
The primary hypothesis is the guselkumab 100 mg every 4 weeks (q4w)treatment group is superior to
placebo as assessed by the proportion of subjects achieving an ACR 20 response at Week24.
OVERVIEW OF STUDY DESIGN
This is a Phase 3randomized, double-blind, placebo-controlled, multicenter, 3-arm study of guselkumab 
in subjects with active PsA who are biologic naïve* and have had inadequate response to standard 
therapies (eg, non-biologic disease-modifying antirheumatic drugs[DMARDs], apremilast, nonsteroidal 
anti inflammatory drugs [NSAIDs]).
*
Subjects may not have previously received any biologic treatment including, but not limited to, 
guselkumab, ustekinumab, secukinumab (AIN457), anti-tumor necrosis factor alpha (TNFα)agents 
(such as adalimumab, etanercept, infliximab, golimumab subcutaneous [SC]or intravenous [IV], 
certolizumab pegol, or their respective biosimilars), tildrakizumab (MK3222), ixekizumab 
(LY2439821), brodalumab (AMG827), risankizumab (BI-655066), or other investigative biologic 
treatment for PsA or psoriasis.
Stable doses (as defined below) of concomitant NSAIDs, oral corticosteroids, and selected non-biologic 
DMARDs(limited to methotrexate[MTX], sulfasalazine[SSZ], hydroxychloroquine[HCQ], leflunomide
LEF) will be allowed but are not required:

NSAIDsand other analgesics:  the marketed dose approved in the country where the study is being 
conducted 

Oral Corticosteroids:
equivalent to ≤10 mg/day of prednisone

Selected Non-biologic DMARDs:

MTX:≤25 mg/week

NCT03158285
SSZ: ≤3 g/day

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
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Approved, Date: 23 January 2018

HCQ:≤400 mg/day

LEF:≤20 mg/day
The study will include approximately 684 subjects.  
Subjects who satisfy all inclusion and exclusion criteria will be randomly assigned to one of the following 
3 treatment groups in a 1:1:1 ratio using permuted block randomization stratified by baseline non-biologic 
DMARD (MTX, SSZ, HCQ, LEF) use (yes/no) and the most recent available CRP value prior to 
randomization (<2.0mg/dL vs ≥2.0 mg/dL):

Group I(n=228):  Subjects will receive SC guselkumab 100 mg q4w from Week 0 through 
Week 100.

Group II(n=228):  Subjects will receive SC guselkumab 100 mg at Weeks 0and 4then every 
8weeks (q8w) (Weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, and 100) and placebo injections at 
other visits (Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, and 96) to maintain the blind.

Group III(n=228):  Subjects will receive SC placebo q4w from Week 0 to Week 20and will cross 
over at Week 24 to receive SC guselkumab 100 mg q4w from Week 24 through Week 100.
At Week 16, all subjects in Groups I, II and III with <5% improvement from baseline in both tender and 
swollen joint counts will be considered as meeting early escape criteria. These subjects will remain on the 
dosing regimen they were to randomized at Week 0. At Week 16, subjects who meet early escape 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 above, as selected by the investigator.  Titration to a stable dose of 
the medication should be completed for subjects qualifying for early escape by the Week 24 visit.
At Week 24, all subjects in the placebo group (Group III) will cross over to receive guselkumab 100 mg 
SC q4w through Week 100; this will allow for collection of additional safety data for the 100 mg SC q4w 
dose.  Subjects in the guselkumab groups (Groups I and II) will remain on the dosing regimen they were 
randomized to at Week 0, through Week100.
Subjects will be followed for adverse events and serious adverse events up to 12 weeks following the last 
study agent administration.  The end of the study is defined as the time the last subject completes the last 
study visit. For subjects who complete the Week 100 visit, the last study visit is the Week 112 visit.  For 
subjects who discontinue study agent prior toWeek 100, the last study visit is the final safety visit.
An independent Data Monitoring Committeewill be established to monitor unblinded data on an ongoing 
basis through at least the Week 24 DBL to ensure the continuing safety of the subjects enrolled in this 
study.
Samples for the analysis of pharmacodynamic biomarkers will be collected from all subjects. 
A pharmacogenomic blood sample will be collected from subjects who consent separately to this 
component of the study where local regulations permit.  Subject participation in pharmacogenomic 
research is optional.
Three DBLs are scheduledat Weeks 24, 52, and 112.
SUBJECT POPULATION
NCT03158285
The target study population is subjects with active PsA who are biologic naïve (see above) and have had 
inadequate response to standard therapies (eg, non-biologic DMARDs, apremilast, and/or NSAIDs). This 
population is considered appropriate to provide relevant efficacy and safety information for the intended 
use of guselkumab in PsA.   Additionally, a biologic naïve population with a CRP ≥0.6 mg/dL is required 

CNTO 1959  (guselkumab)
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Approved, Date: 23 January 2018
to enrich the population for radiographic progression and increase the power for detection of treatment 
effect on radiographic endpoints.
Subjects must also meet all inclusion and exclusion criteria.
DOSAGE AND ADMINISTRATION
Guselkumab 100 mg and matching liquid placebo for guselkumab will be provided in a single-use 
prefilled syringe (PFS) assembled with the UltraSafe PLUS
TMPassive Needle Guard (PFS-U).
Study agent will be administered at the site by a health care professional until the subject (or caregiver) is 
trained for self-administration. Study agent will be administered by site personnel at Weeks 0 and 
4. Beginning at Week 8, at the discretion of the investigator and subject, and after appropriate and 
documented training, subjects will self-administer study agent at the investigative site under the 
supervision of a health care professional.  The option to begin self-administration of study agent at home 
will begin afterWeek 52.Subjects unable to have injection(s)administered away from study site will be 
required to return to the site for administration of study agent injection(s) by a health care professional.  
After Week 52, subjects will have study visits and assessments at Weeks 68, 76, 84, 100, and 112.
Safety and efficacy assessments, including blood samples for clinical laboratory and 
pharmacokinetics/immunogenicity, should be performed before study agent administration.
The three dose groups(Groups I, II, and III) are described above.
EFFICACY EVALUATIONS
Psoriatic Arthritis Response Evaluations

Joint Assessment

Nonevaluable Joints

American College of Rheumatology Response(ACR)

Dactylitis Assessment

Enthesitis Assessment

Imaging Evaluation

Disability Index of the Health Assessment Questionnaire

Minimal Disease Activity

PsoriaticArthritis Disease Activity Score

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis Composite Score(GRACE)

DiseaseActivity Index Score 28

ModifiedComposite Psoriatic Disease Activity Index

DiseaseActivity Index for Psoriatic Arthritis

ModifiedPsoriatic Arthritis Responder Criteria

NCT03158285
BathAnkylosing Spondylitis Disease Activity Index

CNTO 1959  (guselkumab)
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Approved, Date: 23 January 2018
Psoriasis Response Evaluations

Investigator’sGlobal Assessment of Psoriasis

PsoriasisArea and Severity Index

DermatologyLife Quality Index
Other Patient Reported Outcomes

36-Item Short-form Health Survey

EQ-5D Questionnaire

Functional Assessment of Chronic Illness Therapy –Fatigue(FACIT)
HEALTH ECONOMICS EVALUATIONS
The Work Productivity and Activity Impairment Questionnaire - Specific Health Problem 
(WPAI-SHP):PsAwill be used to study the impact of PsA on work and other daily activities during the 
past 7 days.
PHARMACOKINETIC AND IMMUNOGENICITYEVALUATIONS
Serum samples will be used to evaluate the PK of guselkumab as well as the immunogenicity of 
guselkumab.  Serum collected for PK and immunogenicity analyses may additionally be used to evaluate 
safety or efficacy aspects that address concerns arising during or after the study period.
BIOMARKERS

Samples for the analysis of pharmacodynamic biomarkers will be collected from all subjects. The 
samples will be used to better understand the biology of PsA, to provide a biological assessment of 
the response of patients to treatment with guselkumab, to analyze differences between responders 
and non-responders, and to determine if the markers can be used to classify patients as potential
responders prior to treatment.
RNA from whole blood samples will be used for gene expression analysis to determine the 
molecular profile of PsA and to assess changes in gene expression post guselkumab treatment.

Pharmacogenomics testing is optional.  For subjects who provide consent, awhole blood sample will 
be utilized for pharmacogenomics evaluation.  The analysis may include complete genome-wide 
testing and/or targeted sequencing.  The testing will be done to search for links of specific genes to 
disease or response to drug.
SAFETY EVALUATIONS
The safety and tolerability of study agent(guselkumab and placebo) will be monitored by collecting 
information on adverse events (including injection site and allergic reactions), clinical laboratory tests, 
physical examinations, vital signs, suicidal ideation or behavior (usingthe electronic Columbia-Suicide 
NCT03158285
Severity Rating Scale questionnaires), concomitant medication review, and early detection of 
tuberculosis.
Serum and/or plasma samples collected for pharmacokinetic or pharmacodynamicanalyses may also be 
used to evaluate safety concerns that may arise during or after the study period.
Safety will be monitored through Week 112.

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Protocol CNTO1959PSA3002Amendment 1
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Approved, Date: 23 January 2018
STATISTICAL METHODS
Simple descriptive summary statistics, such as n, mean, standard deviation, median, inter quantile range, 
minimum, and maximum for continuous variables, and counts and percentages for discrete variables will 
be used to summarize most data.
Sample Size Determination
The sample size selection was determined based on the primary endpoint of proportion of subjects who 
achieve ACR 20 response at Week 24 and the major secondary endpointof change from baseline in 
vdH-S score at Week 24.
The table below provides the statistical power under various assumptions using a 2-sided chi-square test.  
For this study, the sample size was also evaluated based on the following assumptions:  

20% to 25% ACR 20 response rates at Week 24 in subjects treated with placebo 

40% to 50% ACR 20 response rates at Week 24 in subjects treated with guselkumab 
Statistical Power for Treatment Difference in ACR 20 Response at Week 24
Sample size per arm
ACR 20 Response Rate
Power
Placebo Group
Guselkumab Group
Difference (Δ) 
228
20%
40%
20%
>99%
228
20%
45%
25%
>99%
228
25%
45%
20%
99%
228
25%
50%
25%
>99%
228
30%
50%
20%
99%
The table below provides the statistical power under various assumptions.  The statistical power was 
estimated based on 10000simulations with treatment comparison performed at each simulation using an 
ANOVA test on the van der Waerden normal score.  
For this study, the sample size was determined based on the following assumptions:

The overall mean difference in change from baseline in vdH-S score at Week 24 between the 
placebo group and a guselkumab group ranges from 0.6 to 0.8.

40% –50% subjects in eachtreatment group have a change score of 0 from baseline in vdH-S 
score at Week 24 (ie, the subpopulation with a change score of 0). 

NCT03158285
For the other subjects (those from the normal distributions), the SD of the normal distributions 
is 2.5 for all treatment groups and the mean of the normal distribution is 1.80 for the placebo 
group. 
If the SD of the normal distributions is 3.0, the power will go down to as low as approximately 80%. 

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
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Approved, Date: 23 January 2018
Statistical Power for Treatment Difference in vdH-S Change from Baseline atWeek 24
Placebo Group
Guselkumab Group
Overall
Mean 
Difference 
Power
%subjects 
without change
Rest of 
subjects
Overall
mean
%subjects
without change
Rest of 
subjects
Overall
mean
Mean
SD
Mean
SD
45%
1.80
2.5
1.00
45%
0.71
2.5
0.40 
0.60
89.0%
45%
1.80
2.5
1.00
45%
0.35
2.5
0.20 
0.80
98.9%
50%
1.80
2.5
0.90
50%
0.60
2.5
0.30 
0.60
91.7%
50%
1.80
2.5
0.90
50%
0.20
2.5
0.10 
0.80
99.4%
50%
1.80
2.5
0.90
45%
0.55
2.5
0.30 
0.60 
91.1%
50%
1.80
2.5
0.90
45%
0.18
2.5
0.10 
0.80
99.2%
Primary Endpoint Analysis
The primary endpoint to be analyzed for the primary analysis is the proportion of subjects who achieved 
an ACR 20 response at Week 24.  Note that the intercurrent event of Treatment Failure prior to Week 24 
(defined below) will be treated as non-response for the primary analysis, regardless of the observed 
ACR20 response status.
Treatment Failure Criteria
NCT03158285
Subjects who meet the followingtreatment failure criteria include subjects who:
1. Discontinued study agent injections due to lack of efficacy.
2. Terminate study participation for any reason
3. Initiated or increased the dose of non-biologic DMARDs (MTX, SSZ, HCQ, LEF) or oral 
corticosteroids over baseline for PsA.
4. Initiated protocol prohibited medications/therapies for PsA. 
Subjects with missing data at Week 24 will be considered non-responders.
The treatment effect of each guselkumab group versus placebo will be tested using a Cochran-Mantel-
Haenszel test stratified by baseline non-biologic DMARD (MTX, SSZ, HCQ, LEF) use (yes/no) and the 
most recent available CRP value prior to randomization (<2.0 mg/dL or ≥2.0mg/dL).  The magnitude of 
the effect will be estimated by the difference in ACR 20 response rates betweenthe guselkumab and 
placebo groups with the 95% confidence interval calculated based on Wald statistics.
In order to control the overall Type 1 error rate, the primary analysis will be tested in a fixed sequence.
1. Guselkumab 100 mg q4w versus placebo in ACR 20 response at Week 24
2. Guselkumab 100 mg at Weeks 0, 4, and then q8w versus placebo in ACR 20 response at Week 24
With the above specified order, each of the hypotheses will be tested at a 2-sided α-level of 0.05 provided 
that significance is achieved for the preceding hypothesis in the specified order. If a given comparison is 
not significant at the 2-sided α-level of 0.05, the remaining treatment group comparisons will be 
considered as supportive analysis.

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Major Secondary Analyses
The major secondary endpoints are listed above.  The methods of analysis and the approach to control the 
TypeI error for multiplicity, as well as the data-handling rules for the major secondary endpoints will be 
specified in the Statistical Analysis Plan.  
Safety Analysis
Routine safety evaluations will be performed.  Adverse events, serious adverse events, and infectionswill 
be summarized by treatment group.  The following analyses will also be usedto assessthe safety of 
subjects in the study:  incidence and type of adverse events, incidence and type ofserious adverse events, 
incidence and type of infections, and incidence and type of injection site reactions.
Laboratory parameters, change from baseline in selected laboratory parameters(hematologyand 
chemistry) and incidence of laboratory parameters that meet the criteria for Common Terminology 
Criteria for Adverse Events Grade 3 or Grade 4 will be summarized by treatment group.
All safety analyses will be based on the population of subjects who received at least 1 injection of study 
agent.  Subjects will be summarized by the treatment they actually received
Interim Analysis
NCT03158285
No interim analysis is planned for this study.

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TIMEAND EVENTS SCHEDULE 
Table 1:
TIME AND EVENTS SCHEDULE FROM SCREENING THROUGH WEEK 24
Phase
Screeninga
Placebo-controlled Treatment
b
Week
0c
2
4
8
12 
16 
20 
24
Study Proceduresd
Screening/Administrative
Informed Consent(ICF/eICF
e)
X
Pharmacogenomics (DNA) (optional)
f
ICF/eICF
e
X
Review of Inclusion/Exclusion Criteria
X
X
Demography/Medical History 
X
Pre-planned Surgery/Procedure(s)
X
Pre-study Therapy Review for Eligibility
X
X
Study Agent Administrationg
Randomization
X
Study Agent Administration
X
X 
X
X
X
X 
X
Early Escape
Early Escape 
Xh
Safety Assessments
Physical Examination (including skin)
X
X
eC-SSRSi
X
X 
X 
X 
X
X
X
X 
X
Vital Signs
j
X
X 
X 
X 
X
X
X
X 
X
Height
X
Weight
X
X
Local 12-lead ECG
Xk
Tuberculosis Evaluationl
X
X 
X 
X 
X
X
X
X 
X
Chest Radiograph
m
X
Pregnancy Test
n
X
X
X 
X
X
X
X 
X
Injection Site Reaction Evaluation
X
X 
X
X
X
X 
X
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
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Approved, Date: 23 January 2018
Table 1:
TIME AND EVENTS SCHEDULE FROM SCREENING THROUGH WEEK 24
Phase
Screeninga
Placebo-controlled Treatment
b
Week
0c
2
4
8
12 
16 
20 
24
Efficacy Assessments
PsA Evaluations for Arthritis
o
X
X 
X 
X 
X
X
X
X 
X
HAQ-DIp
X 
X 
X 
X
X
X
X 
X
Patient’s Global Assessment of Disease 
Activity (Arthritis and Psoriasis)
p
X
X
X
X
Patient’s Assessment of Skin Disease 
Activity (Skin VAS)p
X
X
X
X
Dactylitis assessments
X 
X 
X 
X
X
X
Enthesitis assessments (LEI)
X 
X 
X 
X
X
X
Radiographs of Hands and Feetq,r
X
X
BASDAIp,s
X
X
X
X
Pelvicx-ray
t
X
SF-36p
X
X
X
X
DLQIp
X
X
X
X
FACIT-fatigue
p
X
X
X
X
WPAI:PsAp
X
X
X
EQ-5Dp
X
X
X
BSA %Involvement of Psoriasis
X
IGA-Psoriasis
X
X
X
PASI
X
X
X
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
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Approved, Date: 23 January 2018
Table 1:
TIME AND EVENTS SCHEDULE FROM SCREENING THROUGH WEEK 24
Phase
Screeninga
Placebo-controlled Treatment
b
Week
0c
2
4
8
12 
16 
20 
24
Clinical Laboratory Assessments
QuantiFERON-TB testu
X
Hepatitis B and C Serologiesv
X
HIV Antibody Test
v
X
Hematology
v
X
X
X 
X
X
X
X 
X
Chemistryv
X
X
X 
X
X
X
X 
X
Lipid Panel
v
X
C-reactive Protein
v
X
X 
X 
X 
X
X
X
X 
X
Rheumatoid Factor
v,w
X
Follicle Stimulating Hormonev,x
X
Pharmacokinetics/Immunogenicityy
Serum GuselkumabConcentration
X 
X 
X 
X
X
X
X 
X
Population PK
Xz
Antibodies to Study Agent
X
X
X
X
Pharmacogenomics (DNA)
DNA Collection (Whole Blood in EDTA)
f
X
X
X
Other Biomarkers
Serum Biomarkers
X
X
X
Whole Blood (RNA)
X
X
X
Ongoing Subject Review
Concomitant Therapy
X--------------------------------------------------------------------------------------------------------------------------------------------------X
Adverse Events
X--------------------------------------------------------------------------------------------------------------------------------------------------X
NCT03158285

CNTO 1959  (guselkumab)
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Approved, Date: 23 January 2018
Table 1:
TIME AND EVENTS SCHEDULE FROM SCREENING THROUGH WEEK 24
a:The screening visit is to occur within 6 weeks before administration of study agent 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 subject may then return 
for theremainder of the screening procedures only if the subject is eligible for the study as determined by the central laboratory test results. 
b: Through Week 24,study visits will have a visit window of ±4days.
c:Subjects must fast (ie, no food or beverages [except water]) for at least 8 hours before blood is drawn forthelipid panel(Week 0). All other visits can be nonfasting.
d:If a subject permanently discontinues study agent administration at Week 24, the final efficacy visitshould occur at the time of discontinuation or as soon as possible and 
all assessments under the Week 100/final efficacyshould be performed, including radiographs of hands and feet(see footnote “r” below), with the exception of study 
agent administration.  Fasting is not required for the final efficacy visit. The subject should also return for a final safety visit approximately 12 weeks after the last study 
agent administration.   
e:An eICF will be used at a limited number of sites to obtain informed consentto participate in the study, and to obtain informed consent to participate in the optional 
DNA research component of the study, asapplicable.
f:To participate in the optional DNA research component of this study, subjects must sign the DNA research ICF (or eICF) indicating willingness to participate.  Blood 
samples for pharmacogenomic and epigenetic research will be collected only from subjects who give informed consent for DNA research. 
g:Study agent will be administered SC at the site by a health care professional during visits to the site until the subject (or caregiver) is trained for 
self-administration.Study agent will be administered bysite personnel at Weeks 0 and 4.Beginning at Week 8, at the discretion of the investigator and subject, and
after appropriate and documented training, subjects mayself-administer study agent at the investigative site under the supervision of a health care professional.  A 
caregiver may also be trained to administer study agent. Safety and efficacy assessments, including blood samples for clinical laboratory and 
pharmacokinetics/immunogenicity, should be performed before study agent administration.  
h: 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 Table4, at the discretion of the investigator.  Titration to a stable 
dose of themedicationshould be completed for subjects qualifying for early escape by the Week 24 visit.
i:The eC-SSRS shouldbe performed after the joint assessmentat the screening visit (after signing informed consent). At Week 0/baseline and at all post-baseline visits,
the eC-SSRS shouldbe the first assessment/questionnaire that the subject completesprior to study agent administration(see Section 9.7.2for details). 
j:Vital signs include blood pressure and heart rate.
k:12-lead ECG mustbe done prior to administration of study agent.
l:Subjects (as outlined inInclusion Criterion14) must undergo testing for TB (Attachment 2or Attachment 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.  
m:The chest radiograph may be taken within 3 months prior to the first administration of study agent.
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 agent.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
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Approved, Date: 23 January 2018
Table 1:
TIME AND EVENTS SCHEDULE FROM SCREENING THROUGH WEEK 24
o: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 agent administration at each visit, as 
applicable.
p:All patient questionnairesshould be completed before any other tests, procedures, or evaluations on the day of the visit for baseline and post-baseline visits.
q: To minimize unnecessary x-rays, it is recommended that subjects have the baseline radiographs of hands and feet taken after the inclusion and exclusioncriteria have 
been checked and the subject appears eligible to enter the study.  All eligible subjects shouldhave radiographs taken approximately 2 weeks but not greater than 4 weeks 
prior to randomization.
r: Week 24 radiographs shouldbe taken within ±2 weeks of the Week 24 visit.  For subjects who discontinue study agent prior to Week 24, radiographs ofthe hands and 
feet should be performed at the time of study agent discontinuation. If discontinuation occurs prior toor atWeek 16, the subject should also have radiographs performed 
at the Week 24 visit. If discontinuation occursafter Week 16, the radiographs do not need to be repeated at Week 24.  For subjects who also discontinue study 
participationat any time during the study, radiographs should be performed at the time of study discontinuationunlessanother set of radiographshas been obtained 
within the past 6 weeks.
s:The BASDAI will be completed only in subjects with spondylitis with peripheral arthritis as their primary arthritic presentation of PsA.
t:For patients with spondylitis, confirmation of sacroiliitis should be performed at the screening visit byalocally performedpelvic x-ray (single anterior-posterior view) 
unless a pelvic or SI joint x-ray or pelvic MRIhas been previously performed.  Results must be documented.    
u:A tuberculin skin test is additionally required if the QuantiFERON®-TB Gold test is not approved/registered in the country in which this study is being conducted, with 
the exception noted in Inclusion Criterion14.
v:Laboratory tests are listed in Section 9.7.1.
w:This test is optional.  It can be done if needed to confirm whether CASPAR criteria are met. 
x:Prior to randomization, FSH is only required for female subjects with amenorrhea for less than 12 months. Two FSH measurements are needed to confirm amenorrhea in 
these subjects. This testshould NOT be done for any female subject of childbearing potential or female subjects with amenorrhea for at least 12 months. Refer to 
Inclusion Criterion 10for details.
y:All blood samples must be collected before study agent administration at visitswhen a study agent 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. Details will be 
provided in the Laboratory Manual.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
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Approved, Date: 23 January 2018
Table 1:
TIME AND EVENTS SCHEDULE FROM SCREENING THROUGH WEEK 24
z:An additional study visit, at which a venous blood sample (approximately 4 mL) for population PK analysis will be collected from all subjects, must occur on a random 
day between Week 4 to Week 12, but not on the same days of the scheduled Weeks 4, 8 or 12 visits. Additionally, this blood sample must be collected at least 24 hours 
prior to or after the actual time of study agent administration at Weeks 4, 8, or 12 (ie, itcannot be collected within 24 hours before or after study agent administration).  
The serum sample for population PK will be split into 2 aliquots (1 aliquot for serum guselkumab concentration and 1 aliquot as a back-up sample).
Abbreviations: BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; BSA = body surface area; CASPAR = ClASsification criteria for Psoriatic Arthritis;
DLQI = Dermatology Life Quality Index; DNA = deoxyribonucleic acid; ECG = electrocardiogram;eC-SSRS= electronic Columbia-Suicide Severity 
Rating Scale; EDTA = ethylenediaminetetraacetic acid; eICF=electronic informed consent form; EQ-5D = EuroQol five dimensions questionnaire; 
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; MRI = magnetic resonance imaging; PASI= Psoriatic Area and Severity Index; PsA = psoriatic arthritis; RNA = ribonucleic acid; SF-36 = 36-item 
Short Form Health Survey; SI =TB = tuberculosis;VAS = visual analog scale; WPAI = Work Productivity and Activity Impairment Questionnaire.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
35
Approved, Date: 23 January 2018
Table 2:
TIME AND EVENTS SCHEDULE FROM WEEK 28 THROUGH WEEK 112
Phase
Active Treatmenta
Safety 
Follow-up
Weekb
28 
32 
36 
40 
44 
48 
52 
56 
60 
64 
68 
72 
76 
80 
84 
88 
92 
96
Final 
Efficacy
Visit
c/ 
100
Final 
Safety 
Visita/112
Study Proceduresd
Study Agent Administratione
Study Agent 
Administration
X 
X 
X 
X 
X 
X 
X 
Xf
Xf
Xf
Xg
Xf
Xg
Xf
Xg
Xf
Xf
Xf
X
Safety Assessments
Physical 
Examination 
(including skin)
X
X
eC-SSRSh
X 
X 
X 
X 
X 
X 
X
X
X
X
X 
X
Vital Signsi
X
X
X 
X
X 
X
Weight
X
X
X
Tuberculosis 
Evaluationj
X 
X 
X 
X 
X 
X 
X
X
X
X
X 
X
Pregnancy Testk
X 
X 
X 
X 
X 
X 
X
Xl
Xl
Xl
X 
X
Injection Site 
Reaction 
Evaluation
X 
X 
X 
X 
X 
X 
X
Xl
Xl
Xl
X
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
36
Approved, Date: 23 January 2018
Table 2:
TIME AND EVENTS SCHEDULE FROM WEEK 28 THROUGH WEEK 112
Phase
Active Treatmenta
Safety 
Follow-up
Weekb
28 
32 
36 
40 
44 
48 
52 
56 
60 
64 
68 
72 
76 
80 
84 
88 
92 
96
Final 
Efficacy
Visit
c/ 
100
Final 
Safety 
Visita/112
Efficacy Assessments
PsA Evaluations 
for Arthritism
X
X
X
X
X
X
X
X
HAQ-DIn
X
X
X
X
X
X
X
X
Patient’s Global 
Assessment of 
Disease Activity
(arthritis and 
psoriasis)n
X
X
X
Patient’s 
Assessment of 
Skin Disease 
Activity (Skin 
VAS)n
X
X
X
Dactylitis 
Assessments
X
X
X
Enthesitis 
Assessments 
(LEI)
X
X
X
Radiographs of 
Hands and Feet
o
X
X
BASDAIn,p
X
X
X
SF-36n
X
X
X
DLQIn
X
X
X
FACIT-fatigue
n
X
X
X
WPAI:PSAn
X
X
X
EQ-5Dn
X
X
X
IGA-Psoriasis
X
X
X
PASI
X
X
X
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
37
Approved, Date: 23 January 2018
Table 2:
TIME AND EVENTS SCHEDULE FROM WEEK 28 THROUGH WEEK 112
Phase
Active Treatmenta
Safety 
Follow-up
Weekb
28 
32 
36 
40 
44 
48 
52 
56 
60 
64 
68 
72 
76 
80 
84 
88 
92 
96
Final 
Efficacy
Visit
c/ 
100
Final 
Safety 
Visita/112
Clinical Laboratory Assessments
Hematologyq
X 
X 
X
X
X
X
X
X
X 
X
Chemistryq
X 
X 
X
X
X
X
X
X
X 
X
CRPq
X
X
X
X
X
X
X
X
Pharmacokinetics/Immunogenicityr
Serum 
Guselkumab 
Concentration
X
X
X
X
X
X 
X
Antibodies to 
Study Agent
X
X
X
X 
X
Pharmacogenomics (DNA)
DNA Collection 
(Whole Blood in 
EDTA)s
X
X
Biomarkers
Serum 
Biomarkers
X
X
Whole Blood 
(RNA)
X
X
Ongoing Subject Review
Concomitant 
Therapy
X-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------X
Adverse Events
X-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------X
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
38
Approved, Date: 23 January 2018
Table 2:
TIME AND EVENTS SCHEDULE FROM WEEK 28 THROUGH WEEK 112
a:Through Week 100, study visits willhave a visit window of ±7 days; Week 112 visit or the final safety visit (12 weeks after the last dosein subjects who discontinued study 
treatment) will have a visit window of ±14 days.
b:All visits can be nonfasting.
c:With the exception of study agent administration, all assessments performed at Week 100 will also be performed at the final efficacy visit.
d:If a subject discontinues study agent at or after Week 24, the final efficacy visitassessments should occur at the time of discontinuation or as soon as possible and all assessments 
under the final efficacy/Week 100 visit should be performed, including radiographs of hands and feet, with the exception of study agent administration.  Thesubject should also 
return for a final safety visit approximately 12 weeks after the last study agent administration.   
e: At the discretion of the investigator and subject, and after appropriate and documented training, subjects will continue to self-administer study agent at the investigative site under the 
supervision of a health care professional.  Safety and efficacy assessments, including blood samples for clinical laboratory and pharmacokinetics/immunogenicity, should be 
performed before study agent administration.
f:The option to begin self-administration of study agent at home will begin at Week 56; subjects will record study agent administration on a diary card.  Subjects who self-administer 
are not required to visit the study site at Weeks 56,60, 64, 72, 80, 88, 92, and 96.  Subjects unable to have injection(s)administered away from the study site will be required to 
return to the site at these study weeks for administration of study agent injection(s). An injection site evaluation and AE review will be done at the study site at the time of injection.
g:Dosing for all clinic visits (ie, Weeks 28, 32, 36, 40, 44, 48, 52, 68, 76, 84, and 100)should occur after all procedures at the clinic visit.
h:At all post-baseline visits, the eC-SSRS willbe the first assessment/questionnaire that the subject must complete.
i:Vital signs include blood pressure and heart rate.
j:Subjects (as outlined in Inclusion Criterion14) must undergo testing for TB (Attachment 2or Attachment 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.  
k:Females of childbearing potential who are dosed at the clinicmust have a negative urine pregnancy test at all dosing visits prior to administration of study agent.  For subjects not 
dosed at the clinic (see footnote “f”above), a urine pregnancy test is not required prior to administration of study agent.
l:Only performed for subjects who are dosed at the site.
m: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 assessments should be performed prior to study agent administration at each visit, as applicable.
n:All patient questionnaires should be performed before any other tests, procedures, or evaluations on the day of the visit.
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
39
Approved, Date: 23 January 2018
Table 2:
TIME AND EVENTS SCHEDULE FROM WEEK 28 THROUGH WEEK 112
o:Single radiographs ofthe hands (posteroanterior) and feet (anteroposterior) shouldbe performedwithin ±2 weeks of the Week 52 and Week 100 visits.  For subjects who 
permanently discontinue study agent after Week 24 but prior to Week 100, radiographs of hands and feet should be performed atthe time of discontinuation of study agent or as soon 
as possible unless another set of radiographs has been obtained within the past 6 weeks.
p:The BASDAI will be completed only in subjects with spondylitiswith peripheral arthritis as their primary arthritic presentation of PsA.  
q:Laboratory tests are listed in Section 9.7.1.
r:All blood samples must be collected before study agent administration at visits when a study agent 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. Details will be provided in the 
Laboratory Manual.
s:Blood samples for pharmacogenomic and epigenetic research will be collected only from subjects who give informed consent for DNA research. 
Abbreviations:
BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; CRP =C-reactive protein; DLQI = Dermatology Life Quality Index; DNA = deoxyribonucleic acid; 
eC-SSRS = electronic Columbia-Suicide Severity Rating Scale; EDTA = ethylenediaminetetraacetic acid; EQ-5D = EuroQol five dimensions questionnaire; 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; PASI = Psoriatic Area and Severity Index; PsA = psoriatic arthritis; RNA = ribonucleic acid; SF-36 = 36-item Short Form Health Survey; 
VAS = visual analog scale; WPAI = Work Productivity and Activity Impairment Questionnaire
NCT03158285

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
40
Approved, Date: 23 January 2018
ABBREVIATIONS
ACR
American College of Rheumatology
AMDF
Arithmetic Mean of the Desirability Function
AE
adverse event
ALT
alanine aminotransferase
ANOVA
analysis of variance
ARC
Anticipated Event Review Committee
AST
aspartate aminotransferase
BASDAI
Bath Ankylosing Spondylitis Disease Activity Index
BCG
bacillusCalmette-Guérin
BQL
below the lowest quantifiable sample concentration of the assay
BSA
body surface area
CASPAR
ClASsification criteria for Psoriatic Arthritis
CRF
case report form(s) (paper or electronic as appropriate for this study)
CRP
C-reactive protein
DAS28
Disease Activity Score 28 
DBL
database lock
DLQI
Dermatology Life Quality Index
DMARDs
disease-modifying antirheumatic drugs
DMC
Data Monitoring Committee
DNA
deoxyribonucleic acid
ECG
electrocardiogram
eC-SSRS
electronic Columbia-Suicide Severity Rating Scale
eDC
electronic data capture
EDTA
ethylenediaminetetraacetic acid
NCT03158285
EQ-5D
EuroQol five dimensions questionnaire
FACIT
Functional Assessment of Chronic Illness Therapy
FAS
Full Analysis Set
FSH
follicle stimulating hormone
GCP
Good Clinical Practice
GRACE 
GRAppa Composite score
GRAppa
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
HAQ
Health Assessment Questionnaire
HAQ-DI
Disability Index of the Health Assessment Questionnaire
HBV
hepatitis B virus
HCP
healthcare professional
HCQ
Hydroxychloroquine

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
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Approved, Date: 23 January 2018
HCV
hepatitis C virus
HIV
human immunodeficiency virus
ICF
informed consent form
ICH
International Conference on Harmonisation
IEC
Independent Ethics Committee
IGA
Investigator’s Global Assessment
IJA
independent joint assessor
IL
interleukin
IRB
Institutional Review Board
IV
intravenous
IWRS
interactive web response system
JAK
Janus kinase
JSN
joint space narrowing
LEF
leflunomide
LEI
Leeds Enthesitis Index
mAb
monoclonal antibody
MCP
metacarpophalangeal 
mCPDAI
modified Composite Psoriatic Disease Activity Index
MCS
Mental Component Summary
MDA
minimal disease activity
MI
multiple imputation
MRI
magnetic resonance imaging
MTX
methotrexate
NAb
neutralizing antibody
NSAID
nonsteroidal anti-inflammatory drug
PASDAS
Psoriatic ArthritiS Disease Activity Score
PASI
Psoriatic Area and Severity Index
PCS
Physical Component Summary
PD
pharmacodynamic(s)
PFS
prefilled syringe
PFS-U
prefilled syringe with an UltraSafe PLUS
TM
NCT03158285
PassiveNeedle Guard
PGA
Physician’s Global Assessment
PIP
proximal interphalangeal
PK
pharmacokinetic(s)
PQC
Product Quality Complaint
PRO
patient-reported outcome(s) (paper or electronic as appropriate for this study)
PsA
psoriatic arthritis
PsARC
Psoriatic ArthritisResponse Criteria

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
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NCT03158285
Approved, Date: 23 January 2018
q4w
every 4weeks
q8w
every 8 weeks
RA
rheumatoid arthritis
RNA
ribonucleic acid
SAE
serious adverse event
SAP
Statistical Analysis Plan
SC
subcutaneous
SD
standard deviation
SDC
smallest detectable change
SF-36
36-item Short Form Health Survey
SSZ
sulfasalazine
SUSAR
suspected unexpected serious adverse reaction
TB
tuberculosis
Th17
T helper 17
TNFα
tumor necrosis factor alpha
UV
ultraviolet
VAS
Visual Analogue Scale
vdH-S
van der Heijde-Sharp (score)
WPAI
Work Productivity and Activity Impairment Questionnaire

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
43
Approved, Date: 23 January 2018
1.
INTRODUCTION
CNTO 1959 (guselkumab) is a fully human immunoglobulin G1 lambda monoclonal antibody 
(mAb) that binds to the p19 protein subunit of human interleukin 23 (IL‑23) with high 
specificity and affinity.  The binding of guselkumab to the IL-23p19 subunit blocks the binding 
of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular 
signaling and subsequent activation and cytokine production. In this manner, guselkumab 
inhibits the biological activity of IL-23 in all in vitro assays examined.
Guselkumab has been extensively studied in 3 large Phase 3 studies in psoriasis. For the most
comprehensive nonclinical and clinical information regarding guselkumab, refer to the latest 
version of the Investigator
's Brochurefor guselkumab.
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.
1.1.
Background
1.1.1.
Disease Background
Psoriaticarthritis (PsA) is a chronic inflammatory arthropathy of the peripheral and axial joints 
associated with psoriasis.46The estimated prevalence of PsA in the general population varies 
from 0.02% to 1.0% across the world.15,46  In patients with psoriasis, the prevalence of PsA 
ranges from 6% to 42%.15  Psoriatic arthritis is a multi-faceted disease that impacts the joints, soft 
tissues, and skin, all of which affect quality of life.18,45  The burden of disease can be severe, with 
some patients developing destructive arthritis leading to bony erosion and loss of joint 
architecture; some patients even require surgical intervention to alleviate pain and restore 
function of severely damaged joints.
57  Psoriatic arthritis not only results in functional disability 
and impaired quality of life, but patients with this disease have increased mortality.
16,47,49,56
1.1.2.
Treatment Options
NCT03158285
Current treatment options for PsA include conventional therapies such as nonsteroidal 
anti-inflammatory drugs (NSAIDs), intra-articular corticosteroid injections, low-dose systemic 
steroids, oral disease-modifying antirheumatic drugs (DMARDs; eg, methotrexate [MTX], 
sulfasalazine [SSZ], and leflunomide [LEF]), and immunosuppressive drugs (eg, cyclosporine A, 
tacrolimus).  The addition of biologic treatments for PsA, including tumor necrosis factor alpha 
(TNFα) inhibitors (etanercept, infliximab, adalimumab, golimumab, certolizumab), ustekinumab, 
an IL-12/IL-23 inhibitor, and secukinumab (an IL-17inhibitor) significantly improved skin and 
joint responses in patients when used on top of conventional DMARDS or alone.  Apremilast, a 
new oral phosphodiesterase 4 inhibitor, is also available for the treatment of PsA; however, its 
use is associated with less degree of skin and joint improvements compared with biologic 
treatments.

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
44
Approved, Date: 23 January 2018
Despite these recent advances in treatment options for PsA, there remains an unmet medicalneed 
for novel therapeutic agents that address the heterogeneous clinical manifestations of PsA and 
offer an improved benefit/risk profile for the individual patient. 
1.1.3.
Clinical Studies
Guselkumab is being developed as a potential treatment for psoriasis, PsA, and other 
immune-mediated diseases.  As of 31 August 2016, 15clinical studies with guselkumab have 
been completed or are ongoing.
Seven clinical studies have been completed:

CNTO1959PSO1001, a Phase 1 study with 2 parts; Part 1 enrolled healthy subjects and 
Part2 enrolled subjects with moderate to severe plaque psoriasis.
CNTO1959PSO1002, a Phase 1 study of guselkumab in Japanese subjects with moderate to 
severe plaque psoriasis.
CNTO1959PSO2001, a Phase 2, randomized, placebo-and active-comparator-controlled, 
parallel group, multicenter, dose-ranging study of guselkumab in subjects with moderate to 
severe plaque psoriasis.

CNTO1275ARA2001, a Phase 2 study of guselkumab and ustekinumab (STELARA®) in 
subjects with activerheumatoid arthritis (RA)despite concomitant MTX therapy. Further 
development of guselkumab in the RA indication hasbeen discontinued by the Sponsor.
CNTO1959PPP2001, a Phase 2 study to assess the efficacy, safety, and tolerability of 
guselkumab following subcutaneous (SC) administration in Japanese subjects with 
palmoplantar pustulosis.

CNTO1959NAP1001, a Phase 1 study to assess pharmacokinetic (PK)comparability of 2 
formulations and to evaluate the PK comparability of guselkumab delivered by 2 different 
devices in healthy subjects.
CNTO1959NAP1002, a Phase 1 study to characterize the elimination of guselkumab 
glycoform variants in healthy subjects.
Eight studies are ongoing:
CNTO1959PSO1003, a Phase 1 study to assess the drug-drug interaction potential of 
guselkumab treatment in subjects with moderate to severe plaque psoriasis.
CNTO1959PSA2001, a Phase 2 study to evaluate the efficacy and safety of guselkumab in 
subjects with active PsA.
CNTO1959PSO3001, a Phase 3 study to evaluate the efficacy and safety of guselkumab in 
subjects with moderate to severe plaque psoriasis.

NCT03158285
CNTO1959PSO3002, a Phase 3 study to evaluate the efficacy and safety of guselkumab in 
subjects with moderate to severe plaque psoriasis with randomized withdrawal and 
retreatment.

CNTO 1959  (guselkumab)
Protocol CNTO1959PSA3002Amendment 1
45
Approved, Date: 23 January 2018
CNTO1959PSO3003, a Phase 3 study to evaluate the efficacy and safety of guselkumab in 
subjects with moderate to severe plaque psoriasis and an inadequate response to 
ustekinumab.
CNTO1959PSO3004, a Phase 3 study to evaluate the efficacy and safety of guselkumab in 
subjects with moderate to severe plaque psoriasis in Japan. 
CNTO1959PSO3005, a Phase 3 study to evaluate the efficacy and safety of guselkumab in 
subjects with generalized pustular psoriasis or erythrodermic psoriasis in Japan.
CNTO1959PPP3001, a Phase 3 study to evaluate the efficacy and safety of guselkumab in 
subjects with palmoplantar pustulosis in Japan.
Preliminary efficacy and safety results for the ongoing Phase 2 PsA study (CNTO1959PSA2001)
arepresented in Section 1.1.3.1.  Preliminary efficacy and safety results for the 5 ongoing studies 
in psoriasis are presented in Section 1.1.3.2(Phase 2 study) and Section 1.1.3.3(Phase 3 studies).
In RA, 1 Phase 2 dose-ranging study has been completed; see Section 1.1.3.4.
Further detailsare provided in the guselkumab Investigator’s Brochure.
1.1.3.1. 
Phase 2 Study in Psoriatic Arthritis (CNTO1959PSA2001)
Study Design
CNTO1959PSA2001 isa Phase 2a, multicenter, randomized, double-blind, placebo-controlled, 
study evaluating the efficacy and safety of guselkumab in subjects with active PsAand ≥3% 
body surface area (BSA) of plaque psoriasis despite current or previous treatment with 
standard-of-care therapies, including those previously exposed to anti-TNFαagents. In this 
study, 149 subjects with active PsA were randomized in a 1:2 ratio to receive either placebo or 
guselkumab 100 mg SC at Weeks 0, 4,then every 8 weeks (q8w) through Week 44. At 
Week 16,subjects in both treatment groups who had<5% improvement from baseline in both 
tender and swollen joint countsqualifiedfor early escape andswitched to open-label therapy 
with ustekinumab.  At Week 24, subjects remaining in the placebo group crossedover to receive
guselkumab 100 mg at Week 24, 28, then q8w through Week 44. All subjects will have a final 
safety visit at Week 56.
Preliminary efficacy, safety and PK results through Week 24 are summarized below:
EfficacyResults
The study met its primary and all secondary endpoints. The primary endpoint was the proportion 
of subjects who achieved an American College of Rheumatology (ACR)20 response at 
Week 24, and was significantly higher in the guselkumab group (58.0%) compared with the 
placebo group (18.4%, p<0.001).
In addition, significantly more guselkumab subjects achieved ACR 50 and ACR 70 responses, 
and PASI 50, PASI 75, and PASI 90 responses at Week 24 compared with the placebo group 
(Table 3
NCT03158285
).Significant treatment effect on ACR 20 response was observed as early as Week 4 
(21% vs 0, p<0.001), and the effect increased over time reaching the maximum by Week 16 

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(60.0% vs. 16.3%, p<0.001) vs. placebo. Other secondary efficacy endpoints are summarized in 
Table 3.These results demonstrated that treatment with guselkumab significantly improved joint 
symptoms, physical function, psoriasis, enthesitis, dactylitis,and quality of life in this 
population.
Table 3:
Summary of Efficacy Results at Week 24 (CNTO1959PSA2001)
Efficacy Endpoints
Placebo
Guselkumab
p-value
ACR 20
18.4%
58.0%
p<0.001
ACR 50
10.2%
34.0%
P=0.002
ACR 70
2.0%
14.0%
p=0.023
(post hoc)
PASI 75
12.5%
78.6%
p<0.001
PASI 90
6.3%
66.3%
p<0.001
PASI 100
6.3%
39.8%
P<0.001
Mean (SD) change from baseline in HAQ-DI score
-0.06 (0.530)
-0.42 (0.512)
p<0.001
Median percent change from baseline in Leeds 
EnthesitisIndex (LEI)
a
-33.33%
-100.00%
p=0.009
% of patients with unresolved enthesitisa
71.0%
43.4%
p=0.012
Median percent change from baseline in dactylitisb
-33.33%
-100.00%
p<0.001
% of patients with unresolved dactylitisb
82.6%
44.8%
p=0.001
Mean (SD) change from baseline in SF-36 physical 
component summary (PCS) score
0.46 (6.51) 
6.59 (7.47)
p<0.001
Mean (SD) change from baseline in SF-36 mental 
component summary (MCS) score
0.42(6.74)
4.95 (9.06)
p=0.002
% of patients achieving Minimal Disease Activity 
(MDA)
2.0%
23.0%
p=0.001
a Among the patients with enthesitis at baseline (Placebo: N=31; Guselkumab: N=76)
b Among the patients with dactylitis at baseline (Placebo: N=23; Guselkumab: N=58)
ACR = American College of Rheumatology; HAQ-DI = Disability Index of the Health Assessment 
Questionnaire; PASI = Psoriatic Area and Severity Index; SD = standard deviation
Safety Results
NCT03158285
Treatment with guselkumab was generally well-tolerated through Week 24. 
Through Week 24, the proportions of subjects with 1 or more adverse events (AEs)were 
comparable between placebo (32.7%) and guselkumab (36.0%) groups. The proportions of 
subjects with 1 or more AEs were similar in subjects with or without MTX at baseline. The most 
common AE in both treatment groups was nasopharyngitis, which wasreported in 5 (10.2%) 
subjects in the placebo groupand 6 (6.0%) subjects in the guselkumab group. No injection site 
reactions were reported in the guselkumab group. Two serious adverse events (SAEs)were 

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reported, one (2.0%) in the placebo group (joint injury) and one (1.0%) in guselkumab group 
(myocardial infarction). One (1.0%) subject in guselkumab group had AEs of leukopenia and 
neutropenia (both of mild severity) that subsequently resulted in discontinuation of study agent 
administration after the Week 24visit. No deaths, malignancies, anaphylactic or serum sickness-
like reactions were reported in the study through Week 24.
Infections (as assessed by the investigators) were comparable between the placebo (20.4%) and 
guselkumab (16.0%) groups. Infections reported by >1 subject in the guselkumab group included 
nasopharyngitis (6 [6.0%]), gingivitis (2 [2.0%]) and urinary tract infection (2 [2.0%]). No 
serious infections, tuberculosis (TB) or opportunistic infections were reported through Week 24. 
The proportions of subjects with 1 or more infections requiringoral or parenteral antimicrobial 
treatment were similar between the placebo (14.3%) and guselkumab (10.0%) groups.
Overall, there were no clinically important findings for hematology or chemistry laboratory 
parameters.    
Pharmacokinetics and Immunogenicity Results
Steady state of serum guselkumab concentration was achieved by approximately Week 20 
followingSC administrations of 100 mg guselkumab at Week 0 and 4, and q8w thereafter. The 
median steady-state trough serum guselkumab concentration at Week 20 was 0.93 µg/mL, which 
is similar to those observed in Phase 3 studies in subjects with psoriasis.Only one subject (1%, 
1/100) was positive for antibodies to guselkumab through Week 24 with low antibody titers 
(1:20).
Conclusions
In subjects with active PsA who had ≥3% BSA involvement of psoriasis, guselkumab 
demonstratedrobust efficacy across all efficacy endpoints on joint signs and symptoms, physical 
function, skin disease, enthesitis, dactylitis, andhealth-related quality of life.
Efficacy was generally demonstrated both in subjects receiving MTX and in subjects not 
receivingMTX.  Similarly, guselkumab 100 mg was well tolerated in the PsA population 
through Week 24 with no unexpected safety findings.  
1.1.3.2. 
Phase 2 Study in Psoriasis (CNTO1959PSO2001, X-PLORE)
Study Design
In the X-PLORE study, 293 subjects with moderate to severe plaque-type psoriasis were 
randomized to receive 1 of 5 guselkumab SCdose regimens (5 mg at Weeks 0, 4, and then every 
12 weeks [q12w], 15 mg q8w, 50 mg at Weeks 0, 4, and then q12w, 100 mg q8w, or 200 mg at 
Weeks 0, 4, and then q12w), placebo, or adalimumab (HUMIRA®
NCT03158285
) 80 mg at Week 0, 40 mg at 
Week 1, and then 40 mg every 2 weeks (q2w). 

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Efficacy Results
The proportions of subjects who achieved a Physician’s Global Assessment (PGA) score of 
cleared (0) or minimal (1) were significantly higher at Week 16 in all guselkumab treatment 
groups compared with the placebo group. In addition, higher proportions of subjects in the 
guselkumab 50 mg q12w, 100 mg q8w, and 200 mg q12w groups achieved a PGA score of 
cleared (0) or minimal (1) compared with the adalimumab group at Week 16. A dose-response in 
efficacy was observed up to 100 mg q8w; the proportions of subjects who achieved aPGA of 0 
or 1 were similar in the 100 mg q8w and 200 mg q12w dose groups. Results for improvements in 
Psoriasis Area and Severity Index (PASI) scores were generally similar to those observed for 
PGA.
Safety Results
Treatment with guselkumab was generally well-tolerated through Week 52. The proportions of 
subjects with 1 or more AEs were comparable across the combined guselkumab, placebo, and the 
adalimumab groups through Week 16, with no evidence of a dose-response in the occurrence of 
AEs across the guselkumab groups. Through Week 16, the proportion of subjects with 1 or more 
SAEs was low across all treatment groups. Two serious infections (appendicitis and lung abscess 
in the guselkumab 50 mg group), no malignancies, and no major cardiovascular events were 
reported.  Similar patterns of AEs were observed through Week 52. Events of interest through 
Week 52 included the 2 serious infections noted through Week 16, 1malignancy (cervical 
dysplasia, including carcinoma in situ) in the 200 mg q12w group, and 3 major cardiovascular 
events (1 fatal myocardial infarction in the 5 mg q12w group and 1 nonfatal myocardial 
infarction and 1 stroke, each in the 100 mg q8w group).
Pharmacokinetics and Immunogenicity Results
NCT03158285
Approximate dose-proportionality in serum guselkumab concentrations through Week 52 was 
observed after multiple SC administrations at dose levels ranging from 15 mg to 200 mg. Steady 
state serum guselkumab concentrations were achieved by approximately Week 16 for both the 
q8w and q12w regimens. In each treatment group, mean or median trough serum guselkumab 
concentrations were maintained at steady state through Week 40 (q8w groups) or Week 52 
(q12w groups). There was no evidence of accumulation in serum guselkumab concentrations 
over time with SC q8w or q12w administrations. Serum guselkumab concentrations appeared to 
be affected by subject body weight; higher-weight subjects (>90 kg) had lower mean steady-state 
trough serum guselkumab concentrations compared with lower-weight subjects (≤90 kg).
The overall incidence of antibodies to guselkumab across all guselkumab treatment groups 
through Week 52 was 3.8%, with generally low titers. None of the subjects who were positive 
for antibodies to guselkumab had antibodies that were able to neutralize the bioactivity of 
guselkumab in vitro. No consistent impact of antibodies to guselkumab on serum guselkumab 
concentrations was observed across the guselkumab treatment groups.

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Conclusions
Treatment with guselkumabwas well tolerated across a wide range of doses andled to 
substantial, clinically meaningful improvements in psoriasis, with several dose regimens yielding 
superior outcomes to those observed with adalimumab.
1.1.3.3.
Phase 3 Studies in Psoriasis (CNTO1959PSO3001, 
CNTO1959PSO3002, and CNTO1959PSO3003)
1.1.3.3.1.
Efficacy
A large global Phase 3 program consisting of 3 studies (CNTO1959PSO3001, 
CNTO1959PSO3002, and CNTO1959PSO3003) is ongoing to investigate the efficacy and safety 
of SC guselkumab in subjects with moderate to severe plaque psoriasis. Guselkumab treatment 
was compared with adalimumab treatment in both CNTO1959PSO3001 and 
CNTO1959PSO3002. Study CNTOPSO3003 was conducted in subjects with an inadequate 
response to ustekinumab.
Guselkumab administered as a 100 mg SC injection at Weeks 0and 4then q8w:  

Provided a rapid, substantial, and clinically meaningful improvement in skin disease as well 
as difficult to treat regional psoriasis resulting in improvements in patient-reported outcomes 
compared with placebo over 16 weeks and adalimumab up to 48 weeks. The superior 
efficacy of guselkumab was evident across all endpoints and thresholds assessed including 
measures of complete clearance of psoriasis as defined by an Investigator’s Global 
Assessment (IGA)0 or a PASI 100 response.
Continuous q8w guselkumab maintenance treatment was significantly more effective at 
maintaining a high level skin response than withdrawal of treatment in study PSO3002.

Guselkumab therapy provided a high level clinical response and treatment benefits among 
adalimumab PASI 90 non-responders in study PSO3002 and ustekinumab inadequate 
responders (IGA≥2) in study PSO3003.
1.1.3.3.2.
Safety
In the Phase 3 pooled safety analysis set (subjects from CNTO1959PSO3002 and 
CNTO1959PSO3003), guselkumab at the dose regimen of 100 mg, administered SC at Weeks 0, 
4 and then q8w, demonstrated a favorable safety profile consistent with that seen in the overall 
population from studies CNTO1959PSO3001 and CNTO1959PSO3002 and was well tolerated 
in adult patients with moderate to severe plaque psoriasis.
1.1.3.4. 
Phase 2 Study in Rheumatoid Arthritis (CNTO1275ARA2001)
Study Design
NCT03158285
CNTO1275ARA2001 was a randomized, double-blind, multicenter, placebo-controlled, 
parallel-group study to evaluate the efficacy and safety of ustekinumab and guselkumab 
administered SC in subjects with active RA despite MTX treatment. In this study, 274 subjects 
with active RA who were on a stable dose of MTX were randomized to receive 1 of 5 treatments: 

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Approved, Date: 23 January 2018
placebo, ustekinumab 90 mg q8w, ustekinumab 90 mg q12w, guselkumab 50mg q8w, or 
guselkumab 200 mg q8w through Week 28 with induction doses at Weeks 0 and 4. After the last 
study agentadministration at Week 28, subjects were followed for safety through Week48.
Conclusions
The primary efficacy endpoint (ACR 20 response at Week 28) was not met in the guselkumab
groupsand no significant improvements were observed in any of the major secondary endpoints 
for the combined guselkumab group. Further development of guselkumab for this indication has 
been discontinued.
Guselkumab was generally well tolerated.
1.2.
Overall Rationale for the Study
1.2.1.
Role of Interleukin-23 and TH17 Pathways in the Treatment of
Psoriatic Arthritis
Interleukin (IL)-23 is a member of the IL-12 family of heterodimeric cytokines. IL-23 shares the 
p40 subunit with IL-12. However, in contrast to IL-12, which is formed from p40/p35 
heterodimers, the p40 subunit is paired with a p19 subunit to form IL-23.
39  IL-23, alone or in 
combination with other cytokines (transforming growth factor-β and IL-6 or IL-1β), drives the 
expansion and/or maintenance of mouse and human CD4+ IL-17 producing T helper 17 (Th17) 
cells. Th17 cells produce downstreampro-inflammatory cytokines, IL-17A, IL-17F, IL-22, IL-6, 
and TNFα.
5,29,50
Inhibition of upstream signaling by IL-23 blockade is expected to interrupt Th17 pathways that 
contribute to the chronic inflammationunderlying the pathophysiology of many immune 
mediated diseases41,48including PsA, psoriasis, multiple sclerosis, inflammatory bowel disease, 
and axial spondyloarthritis.  In addition, susceptibility to psoriasis, PsA, and inflammatory bowel 
disease has been shown to be associated with genetic polymorphisms in IL-23/IL-23R receptor 
(R) components.
2,7,30,38,40
In addition to the robust efficacy demonstrated in the treatment of psoriasis, biologic treatments 
targeting Th17 pathways, including ustekinumab, secukinumab, and ixekizumab, have been 
shownto induce rapid and significant improvement of arthritis and psoriasis in subjects with 
active PsA. The efficacy and safety of ustekinumab, a fully human IgG1κ mAb that binds with 
high affinity and specificity to the shared p40 subunit of both human IL-12 and IL-23, in subjects 
with active PsA have been demonstrated in 3 adequate, placebo-controlled studies (1Phase2 
study, C0743T1020; and 2 Phase 3 studies, CNTO1275PSA3001 [PSUMMIT1]26,31 and 
CNTO1275PSA3002 [PSUMMIT2]
44).  In the Phase 3 PsA studies FUTURE 1,
32  FUTURE 2,36
and SPIRIT-P1,
33 both secukinumab and ixekizumab, the 2 anti-IL17 agents, demonstrated 
significant reduction on signs and symptoms of PsA, improvement of physical function and 
inhibition of structural damage.  The robust efficacy of the treatments targeting Th17 pathways
observed in both psoriasis and PsA, including that demonstrated by guselkumab across all 
efficacy endpointsin the Phase 2 PsA study (CNTO1959PSA2001)(see Section 1.1.3.1
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), 

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highlightsthe central role that IL-23/IL-17 axis has in the pathogenesis of both psoriasis and 
PsA.  
1.2.2.
Study Rationale
Psoriatic arthritisis a multi-faceted disease that impacts the joints, soft tissues, and skin, all of 
which affect quality of life. Up to 42% of patients with moderate to severe psoriasis have PsA. 
There is often a medical need to have a single therapeutic agent to control both skin and joint 
psoriatic symptoms, as well as to control enthesitis, dactylitis, and to prevent joint damage.
Investigation of guselkumab in the current Phase 3 PsA clinical study is supported by the 
following:

Robust efficacy results and a favorable safety profile from a Phase 2 study of guselkumab in 
PsA (Section 1.1.3.1), in whichthe primary and all secondary endpoints were met.
Efficacyand safety results of guselkumab observed in Phase 2 and Phase 3 studies in 
psoriasis (Sections1.1.3.2and 1.1.3.3, respectively).
The purpose of this study is to further define the clinical efficacy of guselkumabin the reduction
of signs and symptoms, and structural damage inhibition and to evaluate the safety profile of 
guselkumab in the treatment of PsA.
1.2.3.
Dose Rationale
Based upon guselkumabclinical efficacy, safety, pharmacokinetics data,and exposure-response 
modeling analysis using data from the Phase 2 study (CNTO1959PSA2001) in subjects with 
PsA, 2dose regimens have been chosen for evaluation in the guselkumab Phase 3 PsA program: 
100mg at Weeks0and 4then every 8 weeks (q8w)
100mg every 4 weeks (q4w)
The rationalefor these dose regimens of guselkumab is presented below in Section 1.2.3.1
(100mg at Weeks 0 and 4 then q8w) and Section 1.2.3.2(100 mg q4w).
1.2.3.1.
Rationale forGuselkumab 100 mg at Weeks 0 and 4 then Every 
8Weeks Dose Regimen
This dose regimenwas evaluated in the Phase 2 PsA study (CNTO1959PSA2001) and in the
3 global Phase 3 studies in psoriasis. In the CNTO1959PSA2001study, robust efficacy and 
clinically meaningful improvement was observed with this dose regimen in all important 
domains of PsA including jointsigns and symptoms, physical function, psoriasis, enthesitis, 
dactylitis, and quality of life in patients with active PsA and ≥3% BSA of psoriasis 
(Section1.1.3.1). Additionally, significant benefit was also observed with this dose regimen 
on plaquepsoriasis in patients with moderate-to-severe psoriasis in the Phase 3 psoriasis
studies (Section 1.1.3.3
NCT03158285
).  

CNTO 1959  (guselkumab)
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PsA is a chronic inflammatory arthropathy which can result in irreversible structural damage 
of joints, therefore, rapid control of the disease is desired.  An additional dose is being 
included at Week 4 to ensure that trough guselkumab levels do not fall below those obtained 
at steady-state levels.  This additional Week 4 dose results in a slightly higher Cmax and 
Ctroughin the first 12 weeks than those at steady state (~21% and ~18%, respectively) and 
may result in a more rapid onset of response. However, this dosing regimen is not expected 
to result in substantially higher levels of efficacy at Week 24 than would be achieved by 
q8w dosing during maintenance, ie, from Week 24 and onwards.
The safety of this dosing regimen has been established in a large psoriasis development 
program.Furthermore, the safety profile in the Phase 2 studies in patients with PsA and RA 
is consistent with that seen in the psoriasis program.  

In summary, the efficacy and safety data in both the PsA and psoriasisstudies support 
further evaluation of this dose regimen in the Phase 3 PsA studies, including evaluation of 
its effect on the inhibition ofstructural damage.
1.2.3.2.
Rationale for Guselkumab 100 mg Every4 WeeksDose Regimen
A dose regimen of 100 mg q4w is being included in this study in order to determine ifmore 
frequent dosing may achieve higher efficacy in PsA, including the inhibition of structural 
damage.
Modeling analyses based on data from CNTO1959PSA2001 suggest that a higher or more 
frequent dose regimen may achieve better efficacy in PsA:

Based on population pharmacokinetic modelingand simulation, the 100mg q4w dose 
regimen was predicted to result in an approximately 4-fold higher median steady-state 
trough concentration (3.95 µg/mL) compared to 100 mg q8w (0.99 µg/mL), and higher 
trough concentrations, may provide an opportunity to maximize efficacy, including 
inhibition of structural damage, in PsA.
An exposure-response modeling and simulation analysis based on the data from 
CNTO1959PSA2001 predicted that the 100 mg q4w dose regimen could achieve higher 
efficacy (ie, ACR responses) in PsA patients at Week 16 compared with the q8w dose 
regimen. Conversely, this analysis showed that a lower dose regimen (50 mg q8w) 
could result in lower efficacy (ie, ACR responses).
Treatment with the 100 mg q4w dose regimen is expected to result in acceptable safety 
based on the exposure-safetyanalysis in thePhase 3psoriasisprogram:
No consistent pattern suggesting an association between systemic guselkumab exposure 
quartiles and the rates of occurrence of SAEs or AEs leading to discontinuation was 
evident, with a possible exception of non-serious infections. Moreover, the clinical 
relevance of this finding appears to be limited, given that the vast majority of these 
non-serious infections were mild to moderate in intensity and that the frequency of the 
infections requiring treatment was generally similar across all 4 exposure quartiles.

NCT03158285
Guselkumab has been shown to have an acceptable safety profile in multiple patient 
populations, including with a higher dose regimen thatwas studied in a Phase 2 RA study 
(200mg q8w).  Therefore, guselkumab 100 mg q4w is expectedto be well tolerated in the 
Phase 3 PsA population. 

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Approved, Date: 23 January 2018
Overall, the two dose regimens of guselkumab (100 mg Weeks 0 and 4 then q8wand 100 mg 
q4w) selected for the Phase 3PsAprogramwill allow for an adequate assessment of theoptimal 
benefit/risk profile of guselkumabin PsA.
2.
OBJECTIVES, ENDPOINTS, AND HYPOTHESIS
2.1.
Objectivesand Endpoints
2.1.1.
Objectives
PrimaryObjective
The primary objective of this study is to evaluate the efficacy of guselkumab treatment in 
subjects with active PsA by assessing the reduction in signs and symptoms of PsA.
Secondary Objectives
The secondary objectives are to assess the following for guselkumab treatment:
Efficacy in improving psoriatic skin lesions

Improvement in physical function
Inhibition of progression of structural damage
Efficacy in improving general and disease specific health-related quality of life and patient-
reported health outcomes 

Safety 
Pharmacokinetics, pharmacodynamics (PD), and immunogenicity 
2.1.2.
Endpoints
Note:  Refer to Section 9for evaluations related to endpoints.
Primary Endpoint
The primary endpoint is proportion of subjects who achieve an ACR 20 response at Week 24. 
Major Secondary Endpoints
NCT03158285
1. Change from baseline in HAQ-DI score at Week 24.
2. Proportion of subjects who achieve an ACR 50 response at Week 24.
3. Proportion of subjects with a psoriasis response of an IGA(ie, an IGA psoriasis score of 0 
[cleared] or 1 [minimal] AND ≥2-grade reduction from baseline) at Week 24 among the 
subjects with ≥3% BSApsoriatic involvement and an IGA score of ≥2 (mild) at baseline.
4. Proportion of subjects who achieve an ACR 20 response at Week 16.
5. Change from baseline in modified van der Heijde-Sharp (vdH-S) score at Week24.

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6. Proportion of subjects with resolution of enthesitis at Week 24 among the subjects with 
enthesitis at baseline.
7. Proportion of subjects with resolution of dactylitis at Week 24 among the subjects with 
dactylitis at baseline.
8. Change from baseline in enthesitis score (based on Leeds Enthesitis Index [LEI]) at 
Week 24 among the subjects with enthesitis at baseline. 
9. Change from baseline in dactylitis score at Week 24 among the subjects with dactylitis at 
baseline. 
10.Change from baseline in 36-item Short Form Health Survey(SF-36) Physical Component 
Summary (PCS)at Week 24.
11.Change from baseline in Disease Activity Score 28 (DAS28) C-reactive protein(CRP) at 
Week 24.
12. Change from baseline in SF-36 Mental Component Summary (MCS)at Week 24. 
13.Proportion of subjects who achieve an ACR 50 response at Week 16.
14.Proportion of subjects who achieve an ACR 70 response at Week 24.
Other SecondaryEndpoints
Endpoints Related to Reduction of Signs and Symptoms and Physical Function
NCT03158285
1. Proportions of subjects who achieve an ACR 20, ACR 50, and ACR 70 responses by visit 
over time through Week 100.
2. Percent change from baseline in ACR components by visit over time through Week 100.
3. Change from baseline in HAQ-DI score by visit over time through Week 100.  
4. Proportion of subjects who achieve a clinically meaningful improvement (a ≥0.35 
improvement from baseline) in HAQ-DI score by visit over time through Week 100 among 
those subjects with HAQ-DI score ≥ 0.35 at baseline.  
5. Proportion of subjects who achieve a DAS28 (CRP) response by visit over time through 
Week 100.
6. Proportion of subjects who achieve a DAS28 (CRP) remission by visit over time through 
Week 100.
7. Change from baseline in DAS28 (CRP) by visit over time through Week 100.
8. Proportion of subjects who achieve a response based on modified Psoriatic 
ArthritisResponse Criteria (PsARC) by visit over time through Week 100.

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NCT03158285
9. Proportion of subjects with resolution of enthesitis by visit by visit over time through 
Week 100 among the subjects with enthesitis at baseline.
10.Proportion of subjects with resolution of dactylitis by visit by visit over time through 
Week 100 among the subjects withdactylitis at baseline.
11.Change from baseline in enthesitis score (based on LEI) by visit over time through 
Week 100 among the subjects with enthesitis at baseline.
12.Change from baseline in dactylitis score by visit over time through Week 100 among the 
subjects with dactylitis at baseline.
13.Change from baseline in Psoriatic ArthritiS Disease Activity Score (PASDAS) by visit over 
time through Week 100.
14.Change from baseline in Group for Research and Assessment of Psoriasis and Psoriatic 
Arthritis(GRAppa) Composite score (GRACE) Index by visit over time through Week 100.
15.Change from baseline in Work Productivity and Activity Impairment Questionnaire(WPAI) 
scores by visit over time through Week 100.
16.Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) 
score by visit over time through Week 100.
17.Change from baseline in Disease Activity Index for Psoriatic Arthritis score by visit over 
time through Week 100.
18.Proportion of subjects who maintainan ACR 20 response at Week 52 and Week 100 among 
the subjects who achieved an ACR 20 response at Week 24.  
19.Proportion of subjects who maintainan ACR 50 response at Week 52 and Week 100 among 
the subjects who achieved an ACR 50 response at Week 24.  
20.Proportion of subjects who maintainanACR 70 response at Week 52 and Week 100 among 
the subjects who achieved an ACR 70 response at Week 24.  
21.Proportion of subjects who maintain aHAQ-DI response (ie, ≥0.35 improvement from 
baseline in HAQ-DI score) at Week 52 and Week 100 among the subjectswho achieved a 
HAQ-DI response at Week 24.  
22.Proportion of subjects who achieve minimal disease activity (MDA) by visit over time 
through Week 100.
23.Proportions of subjects who achieve a ≥20%, ≥50%, ≥70%, and ≥90% improvement from 
baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by visit 
over time through Week 100 among the subjects with spondylitis and peripheral joint 
involvement as their primary arthritic presentation of PsA.

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Endpoints Related to Skin Disease
1. Proportions of subjects who achieve ≥75%, ≥90%, and 100% improvement in Psoriatic Area 
and Severity Index (PASI) score from baseline by visit over time through Week 100 among 
the subjects with ≥3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
2. Proportion of subjects with an IGA scoreof 0 (cleared) by visit over time through Week 100 
among the subjects with ≥3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at 
baseline.
3. Change from baseline in PASI score by visit over time through Week 100 among the 
subjects with ≥3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
4. Proportion of subjects who achieve a Dermatology Life Quality Index (DLQI) score of 0 or 
1 by visit over time through Week 100 among the subjects with baseline DLQI score >1 and 
with ≥ 3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
5. Proportion of subjects who achieve ≥ 5-point improvement from baseline in DLQI score by 
visit over time through Week 100 among the subjects with baseline DLQI score ≥ 5 and 
with ≥ 3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
6. Change from baseline in DLQI score by visit over time through Week 100 among the 
subjects with ≥ 3% BSA psoriatic involvement and an IGA score of ≥2 (mild) at baseline.
7. Proportion of subjects who achieve both PASI 75 and ACR 20 responses by visit over time 
through Week 100 among the subjects with ≥3% BSA psoriatic involvement and an IGA 
score of ≥2 (mild) at baseline.
8. Proportion of subjects who achieve both PASI 75 and modified PsARC response by visit 
over time through Week 100 among the subjects with ≥3% BSA psoriatic involvement and 
an IGA score of ≥2 (mild) at baseline.
Endpoints Related to Joint Structural Damage
NCT03158285
1. Change from baseline in modified vdH-S score by visit over time through Week 100. 
2. Change in total modified vdH-S score from Week 24 to Week 52, from Week 24 to 
Week 100, and from Week 52 to Week 100.
3. Change from baseline in modified vdH-S erosion score by visit over time through 
Week 100.
4. Change in modified vdH-S erosion score from Week 24 to Week 52, from Week 24 to 
Week 100, and from Week 52 to Week 100.
5. Change from baseline in modified vdH-S joint space narrowing (JSN) score by visit over 
time through Week 100.

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6. Change in modified vdH-S JSN score from Week 24 to Week 52, from Week 24 to 
Week 100, and from Week 52 to Week 100.
7. 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 100.
8. Proportion of subjects with a change of ≤0 from baseline and proportion of subjects with a 
change of ≤ 0.5 from baseline in modified vdH-S score by visit over time through 
Week 100.
9. Proportion of subjects with a change of ≤0 from baseline and proportion of subjects with a 
change of ≤ 0.5 from baseline in modified vdH-S erosion score at by visit over time through 
Week 100.  
10.Proportion of subjects with a change of ≤0 from baseline and proportion of subjects with a 
change of ≤ 0.5 from baseline in modified vdH-S JSN score by visit over time through 
Week 100.  
11.Proportion of subjects with radiographic progression (based on the smallest detectable 
change [SDC]) from baseline by visit over time through Week 100.
12.Proportionof subjects with radiographic joint erosion progression (based on SDC) from 
baseline by visit over time through Week 100.
13.Proportion of subjects with radiographic JSN progression (based on the SDC) from baseline 
by visit over time through Week 100.
14.Proportion of subjects with pencil in cup or gross osteolysis deformities by visit over time 
through Week 100.
Endpoints Related to Health Related Quality of Life
NCT03158285
1. Change from baseline in PCSscore of the SF-36by visit over time through Week 100.
2. Change from baseline in MCS score of the SF-36by visit over time through Week 100.
3. Change from baseline in domain scales scores of SF-36 by visit over time through 
Week 100.
4. Proportion of subjects who achieve ≥ 5-point improvement from baseline in SF-36 MCS 
score by visit over time through Week 100.
5. Proportion of subjects who achieve ≥ 5-point improvement from baseline in SF-36 PCS 
score by visit over time through Week 100.
6. Change from baseline in Functional Assessment of Chronic Illness Therapy-fatigue 
(FACIT-Fatigue) by visit over time through Week 100.

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7. Proportion of subjects who achieve ≥ 4-point improvement from baseline in FACIT-Fatigue 
score improvement by visit over time through Week 100.
8. Change from baseline in EuroQol five-dimension questionnaire (EQ-5D) Visual Analogue 
Scale (VAS) and in EQ-5D index scores by visit over time through Week 100.
2.2.
Hypothesis
The primary hypothesis is that the guselkumab 100 mg q4w treatment groupis superior to 
placeboas assessed by the proportion of subjects achieving an ACR 20 response at Week 24.
3.
STUDY DESIGN AND RATIONALE
3.1.
Overview of Study Design
This is a Phase 3randomized, double-blind, placebo-controlled, multicenter, 3-arm study of 
guselkumab in subjects with active PsA who are biologic naïveand have had inadequate 
responseto standard therapies (eg, non-biologic DMARDs, apremilast, NSAIDs).  The study will 
include approximately 684 subjects.  Stable dosesof concomitant NSAIDs, oral corticosteroids, 
and selected non-biologic DMARDs (limited to MTX, SSZ, hydroxychloroquine[HCQ], LEF) 
will be allowed (see Table4) but arenot required.
The study consists ofthe following phases:
a screening phase of up to 6 weeks
a blinded treatment phase of approximately 2 years (ie, 100 weeks), including a 
placebo-controlled period from Week 0 to Week 24 and an active treatmentperiodfrom 
Week 24 to Week 100
a safety follow-up phase of 12 weeks after the last administration of study agent.
An overview of the study design is provided in Figure 1. 
At Week 0, approximately 684subjects who satisfy all inclusion and exclusion criteria will be 
randomly assigned to one of the following 3 treatment groups in a 1:1:1ratio using permuted 
block randomization stratified by baseline non-biologic DMARD(MTX, SSZ, HCQ, LEF) use
(yes/no) and the most recent available CRP value prior to randomization(<2.0 mg/dL vs 
≥2.0mg/dL):
Group I(n=228): Subjects will receive SC guselkumab 100 mg q4w from Week 0 through 
Week 100.

Group II(n=228): Subjects will receive SC guselkumab 100 mg at Weeks 0 and 4 then q8w 
(Weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, and 100)and placebo injections at other 
visits (Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, and 96) to maintain the blind.

Group III
NCT03158285
(n=228): Subjects will receive SC placebo q4w from Week 0 to Week 20and 
will cross over at Week 24 to receive SC guselkumab 100 mg q4w from Week 24 through 
Week 100.

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At Week 16, all subjects in Groups I, II and III with <5% improvement from baseline in both 
tender and swollen joint countswill be considered as meeting early escape criteria. These 
subjectswillremainon the dosing regimen they were to randomizedat Week 0.AtWeek 16, 
subjects who meet early escape criteria will be allowedto initiate or increase the dose of one of 
the permitted concomitant medications up to the maximum allowed dose as specified in Table4, 
as selected by the investigator.  Titration to a stable dose of the medicationshould be completed 
for subjects qualifying for early escape by the Week 24 visit.
At Week 24, all subjects in the placebo group (Group III) will cross over to receive guselkumab 
100 mg SC q4w through Week 100; this will allow for collection of additional safetydata for the 
100 mg SC q4w dose.  Subjects in the guselkumab groups (Groups I andII) will remain on the 
dosingregimenthey were randomized to at Week 0, through Week100.
Subjects will be followed for AEs and SAEs up to 12 weeks following the last study agent 
administration.  The end of the study is defined as the time the last subject completes the last 
studyvisit. For subjects who complete the Week 100 visit, the last study visit is the Week 112 
visit.  For subjects who discontinuestudy agentprior to Week 100, the last study visit is the final 
safety visit.
Database locks (DBLs) are scheduled at Weeks 24, 52, and End of Study(Week 112).  The first 
DBL will occur when all randomized subjects have either completed the Week24 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 subjects have either completed the Week 52 
assessments or terminated study participation prior to the Week 52 visit (referred to as Week 52 
DBL).  The third DBL will occur when all randomized subjects have either completed their final 
safety visitor have terminated study participation(referred to as Final DBL).
An independent Data Monitoring Committee (DMC) will be established to monitor unblinded 
data on an ongoing basis through at leastthe Week 24 DBLto ensurethe continuing safety of the 
subjects enrolled in this study.  Refer to Section 11.12for further detail.
Samples for the analysis of pharmacodynamic biomarkers will be collected from all subjects. 
A pharmacogenomic blood sample will be collected from subjects who consent separately to this 
component of the study where local regulations permit.  Subject participation in 
pharmacogenomic research is optional.
A diagram of the study design is provided in Figure 1
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Figure 1:
Schematic Overview of the StudyThroughEnd of Study
3.2.
Study Design Rationale
3.2.1.
Study Population
The target study population is subjects with active PsA who are biologic naïve and have had 
inadequate response to standard therapies (eg, non-biologic DMARDs, apremilast, and/or 
NSAIDs). This population is considered appropriate to provide relevant efficacy and safety 
information for the intended use of guselkumab in PsA.  Additionally, a biologic naïve 
population with a CRP ≥0.6 mg/dL is required to enrich the population for radiographic
progression and increase the power for detection of treatment effect on radiographic endpoints.
3.2.2.
Study Control, Randomization, and Blinding 
A placebo control will be used to establish the frequency and magnitude of changes in endpoints 
that may occur in the absence of active treatment.
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Randomization will be used to minimize bias in the assignment of subjects to treatment groups, 
to increase the likelihood that known and unknown subject attributes (eg,demographic and 
baseline characteristics) are evenly balanced across treatment groups, and to enhance the validity 
of statistical comparisons across treatment groups.
Blinded treatment will be used to reduce potential bias during data collection and evaluation of 
clinical endpoints.
3.2.3.
Study Phases and Duration of Treatment
There will be 4phases in this study: Screening, double-blind placebo-controlled, active 
treatment, 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 ofthe study will be the double-blind, placebo-controlled phase from 
Week 0 to Week 24.The primary endpoint is evaluated at Week 24 as guselkumab is 
expected to achieve maximal efficacy between Weeks20 and 24 of treatment basedon the 
findings in the guselkumab Phase 2 study (CNTO1959PSA2001)in PsA. 
The third phase of the study will be the double-blind, active treatment phase from Week 24 
through Week 100. This duration will provide adequate time to evaluate the maintenance of
the efficacy and long-term safety of guselkumab in PsA over a 2-year exposure period.

The fourth phase of the study will be the safety follow-up phase and will be 12weeks from 
the last administration of study agent to the final safety visit. The safety follow-up allows for 
monitoring of the subjectsfor a period equivalent to approximately 5times the half-life of 
guselkumab.  
The placebo-controlled period is limited to 24 weeks.  An early escape option is included in the 
study design to provide additional treatment options for subjects who have <5% improvement in 
swollen and tender joint counts at Week 16. 
3.2.4.
Study Evaluations
Efficacy evaluations chosen for this study were established in previous studiesof 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 United States/European Union regulatory 
guidance documents.
Subjects will be monitored closely for safety with visits at the clinical site as described in the 
Time and Events Schedule(Table 1and Table 2)while on therapy. Safety monitoring will 
include collecting information on AEs, review of concomitant medications, vital signs, 
laboratory assessments, physical exams, and early detection of TB as described in Section 9.7
NCT03158285
. 
Safety data will be reviewed by the Sponsor’s Medical Monitor on an ongoing basis. An 
independent DMCcomposed of clinicians and statisticians not associated with the conduct of the 
study will review unblinded study data for safety purposes on a periodic basisthroughat leastthe 
Week 24 DBL.

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Serum samples will be collected to evaluate the PK of guselkumab, as well as the 
immunogenicity of guselkumab (antibodies to guselkumab) as described in the Timeand Events 
Schedule(Table 1and Table 2).
DNA and Biomarker Collection
It is recognized that genetic variation can be an important contributory factor to interindividual 
differences in drug 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 a drug. The goal of the pharmacogenomic component is to collect deoxyribonucleic 
acid(DNA)to allow the identification of genetic factors that may influence efficacyof
guselkumaband to identify genetic factors associated with PsA.
Biomarker samples will be collected to better understand the biology of PsA, to provide a 
biological assessment of the response of patients to treatment with guselkumab, to analyze 
differences between responders and non-responders, and to determine if the markers can be used 
to classify patients as potential responders prior to treatment.  The goal of the biomarker analyses 
is to evaluatethe pharmacodynamicsof guselkumaband aid in evaluating the drug-clinical 
response relationship.
DNA andbiomarkersamples may be used to help address emerging issues and to enable the 
development of safer, more effective, and ultimately individualizedtherapies.
4.
SUBJECT POPULATION
Adult subjects age 18 and older with active PsA are eligible for the study.
Screening for eligible subjects will be performed within6 weeksbefore the first administration
of the study agent.
The inclusion and exclusion criteria for enrolling subjects in this study are described in the 
following2 subsections. If there is a question about the inclusion or exclusion criteria below, the 
investigator mustconsult with the appropriate Sponsor representativeor delegate and resolve any 
issues before enrolling a subject in the study.  Waivers are not allowed. 
For a discussionof the statistical considerations of subject selection, refer to Section11.2.
4.1.
Inclusion Criteria
Each potentialsubject must satisfy all of the following criteria to be enrolled in the study:
1. Be a man or a woman at least 18 years of age (or the legal age of consent in the jurisdiction 
in which the study is taking place).
2. Have a diagnosis of PsA for at least 6 months before the first administration of study agent 
and meet ClASsification criteria for Psoriatic ARthritis (CASPAR) at screening
(Attachment1
NCT03158285
).

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3. Have active PsA as defined by:
a. At least 5swollen joints and at least 5tenderjoints at screening and at baseline
-AND-
b. CRP≥0.6 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 subject eligible if the test result is within 
acceptable range on repeat testing in the central laboratory.
4. Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular 
arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral 
arthritis, or spondylitis with peripheral arthritis(confirmation of sacroiliitis shouldbe 
performed at the screeningvisit by a locally performed pelvic x-ray [single anterior-
posterior view] unless a pelvic or SI joint x-ray or pelvic magnetic resonance imaging(MRI)
has been previously performed.  Results must be documented).
5. Have active plaque psoriasis, with at least one psoriatic plaque of ≥2cmdiameter or nail 
changes consistent with psoriasis or documented history of plaque psoriasis.
6. Have active PsA despiteprevious non-biologic DMARD,apremilast, and/or NSAID 
therapy.

Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 
3months or evidence of intolerance.
Apremilast therapy is defined as taking apremilast at the marketed dose approved in the 
country where the study is being conductedfor at least 4 months or evidence of 
intolerance.

NCT03158285
NSAID therapy is defined as taking an NSAID for at least 4weeks or evidence of 
intolerance.  
7. If currently using non-biologic DMARDs (limited to MTX, SSZ, HCQ, or LEF), subjects 
should have started treatment at least 3 monthsand the dose must be stable for at least 
4weeksbefore first administration of study agent 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 agent. If 
currently not using LEF, must not have received for at least 12 weeks before first 
administration of study agent.  
a.
If usingMTX, theroute of administration and dose must bestable and the dose must 
be ≤25mg/week.
b.
If receiving SSZ,the dose must be ≤3g/day. 
c.
If receiving HCQ,the dose must be ≤400 mg/day. 
d.
If receiving LEF, the dose must be ≤20 mg/day.
8. If currently using NSAIDs or other analgesics for PsA,subjects must be on a stable dose for 
at least 2 weeks before first administration of study agent. If currently not using NSAIDs or 
other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 
2weeks before first administration of study agent.

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9. If currently using oral corticosteroidsfor PsA,subjects must be on a stable dose equivalent 
to ≤10 mg of prednisone/day for at least 2 weeks before first administration of study agent. 
Ifcurrently not using oral corticosteroids, the subject must not have received oral 
corticosteroids within 2weeks before first administration of study agent.
10.Contraceptive use by men or women should be consistent with local regulations regarding 
the use of contraceptive methods for subject participating in clinical studies.
Before randomization, a woman must be either:
Not of childbearing potential defined as:

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, however in the absence of 12 months of amenorrhea, a single 
FSH measurement is insufficient.

Permanently sterile: Permanent sterilization methods include hysterectomy, 
bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral 
oophorectomy.
Of childbearing potential and practicing a highly effective method of contraception 
(failure rate of <1% per year when used consistently and correctly). Examples of highly 
effective contraceptives include:

User-independent methods: implantableprogestogen-only hormone contraception 
associated with inhibition of ovulation; intrauterine device (IUD); intrauterine 
hormone-releasing system (IUS); vasectomized partner; 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 drug. 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 subject).

User-dependent methods: combined (estrogen- and progestogen-containing) 
hormonal contraception associated with inhibition of ovulation: oral, intravaginal, 
and transdermal; progestogen-only hormone contraception associated with 
inhibition of ovulation: oral and injectable.
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 subjects participating in clinical studies.

NCT03158285
Agree to remain on a highly effective method throughout the study and for at least 
12 weeks after the last dose of study agent.

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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.
11.A woman of childbearing potential must have a negative serum pregnancy test at screening 
and a negative urine pregnancy test at Week 0.
12.A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted 
reproductionfrom first administration of study agent through at least 12 weeks after 
receiving the last administration of study agent.
13.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 condom [with 
spermicidal foam/gel/film/cream/suppository if available in their locale] or a partner with an 
occlusive 
cap 
[diaphragm 
or 
cervical/vault 
caps] 
plus 
spermicidal 
foam/gel/film/cream/suppository if availablein their locale), during the study and for at least 
12 weeks after receiving the last administration of guselkumab. All men must also agree to 
not donate spermduring the study and for at least 12 weeks after receiving the last 
administration of guselkumab.
14.Are considered eligible according to the following TB screening criteria:
Have no history of latent or active TB prior to screening. An exception is made for 
subjects who have a history of latent TB and are currently receiving treatment for latent 
TB, will initiate treatment for latent TB prior to first administration of study agent, or 
have documentation of having completed appropriate treatment for latent TB within 
5years prior tothe first administration of study agent. It is the responsibility of the 
investigator to verify the adequacy of previous anti-TB treatment and provide 
appropriate documentation.
Have no signs or symptoms suggestive of active TB upon medical history and/or 
physical examination.
Have had no recent close contact with a person with active TB 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 prior tothe 
first administration of study agent.
Within 8weeks prior tothe first administration of study agent, have a negative 
QuantiFERON®-TB Gold test result(Attachment 2), or have a newly identified positive 
QuantiFERON®-TB Gold test result in which active TB has been ruled out and for 
which appropriate treatment for latent TB (Section 9.1.3) has been initiated prior tothe 
first administration of study agent. Within 8weeks prior tothe first administration of 
study agent, a negative tuberculin skin test (Attachment 3), or a newly identified 
positive tuberculin skin test in which active TB has been ruled out and for which 
appropriate treatment for latent TB (Section 9.1.3) has been initiated prior to the first 
administration of study agent, is additionally required if the QuantiFERON®
NCT03158285
-TB Gold 
test is not approved/registered in that country* or the tuberculin skin test is mandated by 
local health authorities.

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Indeterminate results should be handled as outlined in Section 9.1.3.  Subjects with 
persistently indeterminate QuantiFERON®-TB Gold test results 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 subject has no 
additional risk factors for TB as determined by the investigator. This determination 
must be promptly reported to the Sponsor’s medical monitor and recorded in the 
subject
's source documents and initialed by the investigator.
NOTE: The QuantiFERON®-TB Gold test and the tuberculin skin test (is/are)not 
required to be performed at screening for subjects with a history of latent TB and 
ongoing treatment for latent TB or documentation of having completed adequate 
treatment as described above; subjects with documentation of having completed 
adequate treatment as described above are not required to initiate additional treatment 
for latent TB.

Have a chest radiograph (posterior-anterior view)taken within 3 months prior to the 
first administration of study agent and read by a qualified radiologist, with no evidence 
of current, active TB or old, inactive TB.
15.Agree not to receive a live virus or live bacterial vaccination during the study, or within 
12weeks after the last administration of study agent. 
16.Agree not to receive a bacillus Calmette-Guérin (BCG) vaccination during the study, and 
within 12 months after the last administration of studyagent.
17.Have screening laboratory test results within the following parameters:
a. Hemoglobin
≥8.5 g/dL
(SI: ≥85g/L) 
b. White blood cells
≥3.5 x 103/μL
(SI: ≥3.5 GI/L)
c. Neutrophils
≥1.5 x 103/μL
(SI: ≥1.5GI/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 ≤1.5times the upper limit of normal range for the central 
laboratory conducting the test.
NOTE:
NCT03158285
A one-time repeat of these screening laboratory tests is allowed during the 6-week 
screening phase and the Investigator may consider the subject eligible if the previously 
abnormal laboratory test result is within acceptable the range on repeat testing in the central 
laboratory.
18.Agree to avoid prolonged sun exposure and agree not to use tanning booths or other 
ultraviolet (UV) light sources from the first administration of study agent through 12 weeks 
after the final dose of study agent(for patients with skin lesions or with documented history 
of psoriasis).

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19.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 2weeks before the first study agent administration and through 
Week 52.
20.Be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
21.Sign an informed consent form (ICF) indicating that he or she understands the purpose of 
and procedures required for the study and is willing to participate in the study.
22.Sign a separate ICF if he or she 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 subject from study participation.
4.2.
Exclusion Criteria
Any potential subject who meets any of the following criteria will be excluded from participating 
in the study:
1. Has other inflammatory diseases that might confound the evaluations orbenefit of 
guselkumab therapy, including but not limited to RA, axial spondyloarthritis(this does not
include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or 
Lyme disease.
2. Has previously received any biologic treatment including, but not limited to, guselkumab, 
ustekinumab, secukinumab (AIN457), anti-TNFα agents (such as adalimumab, etanercept, 
infliximab, golimumab SC orintravenous [IV], certolizumab pegol, or their respective 
biosimilars), tildrakizumab (MK3222), ixekizumab (LY2439821), brodalumab (AMG827), 
risankizumab (BI-655066), or other investigative biologictreatment for PsA or psoriasis.
3. Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K),decernotinib 
(VX-509), or any other Janus kinase (JAK) inhibitor.    
4. Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 
6thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus)within
4weeks of the first administration of study agent.
5. Is currently receiving 2 or more non-biologic DMARDs specified in Table4. 
6. Has received non-biologic DMARDs (other than MTX, SSZ, HCQ, LEF)including, but not 
limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first 
administration of study agent.
7. Has received apremilast within 4 weeksprior to the first administration of study agent.
8. Has received phototherapyor 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 Table4
NCT03158285
) 
within 4 weeks of the first administration of study agent. 
9. 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 agent. 

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10.Has received epidural,intra-articular, intramuscular, or IV corticosteroids, including 
adrenocorticotropic hormone during the 4 weeks before first administration of study agent.
11.Has received lithium within 4 weeks of the first administration of any study agent. 
12.Has received an experimental antibody or biologic therapywithin 6 months prior to the first 
administration of study agent, or received any other experimental therapy, including an 
investigational medical device, or new investigational agent within 90days or 5 half-lives 
(whichever is longer) prior to the first administration of study agent or is currently enrolled 
in another study using an investigational agent or procedure. 
13.Has unstable suicidal ideation or suicidal behaviorin the last 6 months, that may be defined 
as an eC-SSRS rating at screening of: 
Ideation level 4: Some intent to act, no plan;OR

Ideation level 5: Specific plan and intent;OR

NCT03158285
Any ofthe following suicidal behaviors:
– actualsuicide attempts
– interrupted attempts
– abortedattempts
–
preparatory actions
ANDis confirmed to be at risk by the investigator based on an evaluation by a mental health 
professional. The final decision on excluding a subject will be made at the judgment of the 
investigator.
14.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. 
15.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. 
16.Currently has a malignancy or has a history of malignancy within 5 years before screening 
(with the exception of a nonmelanoma skin cancer that has been adequately treated with no 
evidence of recurrence for at least 3 months before the first study agent administration or 
cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 
3months before the first study agent administration). 
17.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. 
18.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 nonremitting cystitis), fungal infection (eg, 
mucocutaneous candidiasis), or open, draining, or infectedskin wounds or ulcers. 
19.Has a transplanted organ (with exception of a corneal transplant >3 months before the first 
administration of study agent). 

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20.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. 
21.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 before screening.
22.Has or has had a herpes zoster infection within 2 months before screening.
23.Iscurrentlypregnant, breastfeeding, or planning a pregnancy (both men and women) within
12 weeks after receiving the last administration of study agent. 
24.Has a nonplaque form ofpsoriasis (eg, erythrodermic, guttate, or pustular). 
25.Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of 
psoriasis from beta blockers, calcium channel blockers, or lithium). 
26.Has received, or is expected to receive, anylive virus or bacterial vaccination within 3 
months before the first administration of study agent.
27.Has had a BCG vaccination within 12 months of screening.
28.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. 
29.Subject has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients 
(refer to Investigator’s Brochure). 
30.Has a history of active granulomatous infection, including histoplasmosis or 
coccidioidomycosis, before screening. Refer to Inclusion Criterion 14for information 
regarding eligibility with a history of latent TB. 
31.Has a chest radiograph within 3 months prior to the first administration of study agent that 
shows an abnormality suggestive of a malignancy, significant cardiovascular or pulmonary 
disease or current active infection, including TB. 
32.Has ever had a nontuberculous mycobacterial infection or opportunistic infection (eg, 
cytomegalovirus, pneumocystosis, aspergillosis). 
33.Is infected with human immunodeficiency virus (HIV, a confirmed positive serology for 
HIV antibody). 
34. Tests positive for hepatitis B virus (HBV) infection (Attachment 4)at screening.
35.Is seropositivefor antibodies to hepatitisC virus (HCV)at screening, unless thesubjecthad 
2 negative HCV ribonucleic acid(RNA)test results at least 6 months apartprior to 
screeningandhavea third negative HCV RNA test result at screening.
NCT03158285
36.Has had major surgery (eg, requiring general anesthesia and hospitalization) within 8 weeks 
before screening, or will not have fully recovered from such surgery, or has such major 
surgery planned during the time the subject is expected to participate in the study 
(112weeks).
Note: Subjects with planned surgical procedures to be conductedunder local anesthesia 
may participate.
37.Is known to have had a substance abuse (drug or alcohol) problem within the previous 
12months prior to the first administration of study agent. 

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38.Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack 
of easy access to veins. 
39.Lives in an institution on court or authority order. 
40.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 subject or that could prevent, limit, 
or confound the protocol-specified assessments. 
41.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. 
42.Is an employee of the Sponsor.
NOTE:
Investigators should ensure that all study enrollment criteria have been met at 
screening and at baseline before randomization. If a subject
's status changes 
(including laboratory results or receipt of additional medical records) before 
randomization such that he or she no longer meets all eligibility criteria, then the 
subject should be excluded from participation in the study. Section 17.4describesthe 
required documentation to support meeting the enrollment criteria.  
4.3.
Prohibitions and Restrictions
Potential subjects must be willing and able to adhere to the following prohibitions and 
restrictions during the course of the study to be eligible for participation:
1. A woman of childbearing potential who is heterosexually active must remain on a highly 
effective method of birth control (Inclusion Criterion10) from the first administration of 
study agent throughat least 12weeks after receiving the last administration of study agent.
2. A woman must not currently be pregnant or breastfeeding and shouldagree to plan to not 
become pregnant.
3. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted 
reproduction from the first administration of study agent through at least 12 weeks after 
receiving the last administration of study agent.
4. A man who is sexually active with a woman of childbearing potential and has not had a 
vasectomy must agree to use a barrier method of birth control (ie, male condom, female 
diaphragm or cervical cap, or condom, Inclusion Criterion13) from the first administration 
of study agent throughat least 12 weeks after receiving the last administration of study 
agent.  Additionally, he should agree to not plan a pregnancy. 
5. All men must agree to not donate sperm from the first administration of study agent through
at least 12 weeks after receiving the last administration of study agent.
6. Subjects must not receive a live virus or bacterial vaccination during the study and for 
12weeks after the last administration of study agent, with the exception of a BCG 
vaccination, which is prohibited for 12 months after the last administration of study agent; 
see Prohibition 7
NCT03158285
.
7. Subjects must not receive a BCG vaccination during the study and for 12 months after the 
last administration of study agent.

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8. Subjects must comply with restrictions on concomitantmedications and therapies during the 
study as specified in Section 8.
9. Subjects must avoid prolonged sun exposure and not to use tanning booths or other UV light 
sources during the study (for patients with skin lesions or with documented history of 
psoriasis).
5.
TREATMENT ALLOCATIONAND BLINDING
Treatment Allocation
Central randomization will be implemented in this study.  At Week 0, subjects will be randomly 
assigned (1:1:1) to 1 of 3treatment groups (guselkumab 100 mg q4w, guselkumab 100 mg at 
Weeks 0 and 4 then q8w, or placebo) based on a computer-generated randomization schedule 
prepared before the study by or under the supervision of the Sponsor.  Permuted block 
randomization with stratification bythe most recentavailable CRP value prior to randomization
(<2.0 mg/dL vs ≥2.0 mg/dL)and baseline non-biologic DMARD (MTX, SSZ, HCQ, or LEF) use
(yes/no) will be used.  The interactiveweb response system (IWRS) will assign a unique 
treatment code, whichwill dictate the treatment assignment and matching study agent kit for the 
subject. The requestor must use his or her own user identification and personal identification 
number when contacting theIWRSand will then give the relevant subject details to uniquely 
identify the subject.
Blinding
NCT03158285
To maintain the study blind, the study agentcontainer will have a multipart label containing the 
appropriate regulatory requirements for clinical supplies.  Each unit will be uniquely identifiable 
through a medication number. A tear-off label is designed to be torn off, separated from the 
study agentcontainer, and attached to the subject
's source documents. The label will not identify 
the study agentin the container. However, if it is necessary for a subject
's safety, the study blind 
may be broken and the identity of the study agentascertained. The study agentnumber will be 
entered in the case report form (CRF) when the study agentis administered. The study agents
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 subject.  In general, randomization codes will be disclosed fully only if the study is 
completed and the clinical database is closed.
Under normal circumstances, the blind should not be broken for individual subjects until the End 
of StudyDBLof the study.  Otherwise, the blind should be broken only ifspecific emergency 
treatment/course of action would be dictated by knowing the treatment status of the subject.  In
the event of an emergency, the investigator may determine the identity of the treatment from 
IWRS. 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 

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be documented by site personnel in theappropriate section of theCRF and in the source 
document.  The investigator is also advised not to reveal the study treatment assignment to the 
study site or Sponsor personnel.
Subjects who have had their treatment assignment unblinded are expected to continue to return 
for scheduled evaluations.  Further study agent administrations should be discussed with the 
study responsible physician.  At the Week 24 DBL, the data will be unblinded for analysis to 
someSponsor personnel while subjects are still participating in the study.  Identification of 
Sponsor personnel who will have access to the unblinded subject-level data will be documented 
prior to unblinding.  Investigative study sites and subjects will remain blinded to initial treatment 
assignment until afterthe final database islocked.
Data that may potentially unblind the treatment assignment (ie, study agent serum 
concentrations, antibodies to study agent, treatment allocation) will be handled with special care 
so that, prior to unblinding, such data will only be available to data management staff for 
purposes of data cleaning and, if applicable, clinical pharmacology representatives for the 
purposes of performing PKand antibodies to guselkumab analyses and quality assurance 
representatives for the purposes of conducting independent drug audits.
A given subject’s treatment assignment may be unblinded to the Sponsor,Institutional Review 
Board/Independent Ethics Committee (IRB/IEC), and site personnel to fulfill regulatory 
reporting requirements.
6.
DOSAGE AND ADMINISTRATION
Guselkumab 100 mg and matching liquid placebo for guselkumab will be provided in a 
single-use prefilled syringe (PFS)assembled with the UltraSafe PLUSTM
NCT03158285
Passive Needle Guard 
(PFS-U).
Study agent will be administered at the site by a health care professional(HCP)until the subject 
(or caregiver) is trained for self-administration. Study agent will be administered by site 
personnel at Week 0 and Week 4.Beginning at Week 8, at the discretion of the investigator and 
subject, and after appropriate and documented training, subjects mayself-administer study agent 
at the investigative site under the supervision of an HCP. A caregiver may also be trained to 
administer study agent. Subjects unable or unwilling to self-administer will continue to have 
study agent injections performed by anHCP. 
The option to begin self-administration of study agent at home will begin after Week 52.After 
Week 52, subjects (or a caregiver) who are able to self-administer will be supplied study agent 
for self-administration away from the site (ie, at home).Subjects will be instructed to contact the 
investigator promptly in the event of any signs of an allergic reaction, infection, or 
bleeding.Subjects unable to have injection(s)administered away from the site will be required 
to return to the site for administration of study agent injection(s)by a health care
professional.After Week 52, subjects will have study visits and assessments at Weeks 68, 76, 
84, 100, and 112.

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Through Week 24, study agent administration at the site should be ± 4 days from the scheduled 
day of study agent administration; afterWeek 24, alladministrations should be ± 7 days from 
scheduled study agent administration day.Study agent administrations must always be at least 
14days apart.
The dose regimens are as follows:
Group I(n=228): Subjects will receive SC guselkumab 100 mg q4w from Week 0 through 
Week 100;
Group II(n=228): Subjects will receive SC guselkumab 100 mg at Weeks 0 and 4 then q8w
(Weeks 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92, and 100) and placebo injections at other 
visits (Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, and 96)to maintain the blind.
Group III(n=228): Subjects will receive SC placebo q4w from Week 0 to Week 20, and 
will cross over at Week 24 to receive SC guselkumab 100 mg q4w from Week 24 through 
Week 100.
At Week 16, all subjects in Groups I, II and III with <5% improvement from baseline in both 
tender and swollen joint counts will be considered as meeting early escape criteria. These 
subjects will remain on the dosing regimen they were randomized to at Week 0.  At Week 16, 
subjects who meet early escape criteria will be allowed to initiate or increase the dose of one of 
the permitted concomitant medications up to the maximum allowed dose asspecified in Table4, 
as selected by the investigator. Titration to a stable dose of the medicationshould be completed 
for subjects qualifying for early escape by the Week 24 visit.
7.
TREATMENT COMPLIANCE
NCT03158285
Study agent will be administered at the investigational site through Week 52and study personnel
will maintain a log of all study agent administrations.Study agent supplies for each subject will 
be inventoried and accounted for.All ongoing therapies administered at the time of screening 
must be recorded.
Subjects will receive instructions on compliance with study treatment when they begin 
self-administration of study agent at home. When subjects begin selfadministration at home, the 
investigator or designated study personnel will maintain a log of all study agentdispensed and 
returned.
When study agent is selfadministered by subjects at home, subjects will record all study drug 
administrationson a diary card.
During the course of the study, the investigator or designated study research personnel will be 
responsiblefor providing additional instruction to reeducate any subject who is not compliant 
with taking the study agent.
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 subject 
cannot receive a dose of study agent at the scheduled visit, the subject must make every effort to 

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still come in for the scheduled assessmentsfor that visit.  The dose should be administered 
within 2weeks of that scheduled visit.  The subject should then resume the normal study 
schedule relative to the baseline visit (Week0).  In the case when a subject does not come in to 
the investigational site for a scheduled visit, the site will follow-up with that subject.  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 drug dispensed and will compare the amount of 
study drug dispensed with the amount returned.  Additional details may be provided in the Site 
Investigational Product Manual that is provided separately and noted in Section 15.
All post-baseline visits up to and including Week 24 will have a visit window of ±4days 
counting from Week 0 as Day 1. After Week 24, all visits will have a visit window of ±7 days. 
The Week 112 visitorthe final safety visit (12 weeks after the last dosein subjects 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 subject should resume his 
or her normal dose schedule.
Information regarding study agentadministrations that are administered outside of the scheduled 
windows or missed will be recorded. Subject charts and worksheets may be reviewedand 
compared with the data entrieson the CRFs to ensure accuracy.
8.
PRESTUDY ANDCONCOMITANT THERAPY
The Sponsor 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 subjects’ concomitant medications for PsA stable through 
Week 24or 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 subject’s medical record.
Subjects may not be receiving more than one non-biologic DMARD from baseline (see 
Exclusion Criterion 5) through Week 52.  After Week 52 and through the end of the study, 
subjects may receive another non-biologic DMARD.
Permitted concomitant medications for PsA andthe maximum allowed doses during the study as 
specified in the following sections are summarized in Table4
NCT03158285
.  

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Table4:
Permitted Concomitant Medications for PsA and the Maximum Allowed Doses During the 
Study 
Permitted Concomitant Medications
for PsA
a,b
Maximum Allowed Dose
NSAIDs and other analgesics
Marketed dose approved in in the countrywhere 
the study is being conducted
Oral corticosteroids
Equivalent to 10 mg/day of prednisone
Non-biologic DMARDs:
Methotrexate (MTX)c
25 mg/week
Sulfasalazine (SSZ)
3 g/day
Hydroxychloroquine (HCQ)
400mg/day
Leflunomide (LEF)
20 mg/day
a Permitted concomitant medications are not supplied by the Sponsor.
b Subjects may not be receiving more than one non-biologic DMARD frombaseline(see Exclusion 
Criterion 5) through Week 52.  After Week 52 and through the end of the study, subjects may receive 
another non-biologic DMARD.
c It is recommended that all subjects 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.
Subjects should not initiate any new treatment for PsA through Week 52, except at Week 16 for 
those subjects who have < 5% improvement from baseline in both tender and swollen joint 
counts (early escape criteria).  Subjects who meet early escape criteriawill be allowed to initiate 
or increase the dose of one of the permitted concomitant medications up to the maximum 
alloweddose as specified inTable4, as selected by the investigator.  Titration to a stable dose of 
the medication should be completed for subjects qualifying for early escape by the Week 24 
visit.
Beginning at Week 52, the treatment options in Table4are allowed to be initiated or dose 
increased up to the maximum allowed dose specified in Table4forsubjects with ongoing PsA 
disease activity at the investigator’s judgment; the rationale should be clearly documented in the 
subject’s medical record.
Concomitant medication review will occur at study visits identified in the Time and Events 
Schedule.
8.1.
Non-biologicDMARDs
8.1.1.
Permitted Non-biologic DMARDs
Subjects are permittedto enterthe study on a stable dose ofone non-biologic DMARD(limited 
to MTX, SSZ, HCQ, or LEF)up to the maximum allowed dose specified in Table4
NCT03158285
.  Only 1 of
thesenon-biologic DMARDs is allowedfrom baseline through Week 52; subjects receiving 2 or 

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more non-biologic DMARDs at baseline are excluded from study participation.  After Week 52 
and through the end of the study, subjects may receive another non-biologic DMARD.
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 Table5
NCT03158285
for protocol requirements of the permitted non-biologic DMARDs.

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Table5:
Protocol Requirements of the Permitted Non-biologic DMARDs
Permitted Non-
biologic DMARDs
Baseline 
Usage
Prior to Week 0
Week 0 through 
Week 52
Week 52 through Week 
112
Methotrexate (MTX)
Used 
Treatment should have 
started at least 3 
months prior to the 
first administration of 
study agent. MTX 
routes of 
administration and 
doses should be stable 
for at least 4 weeks 
prior to the first 
administration of the 
study agentand must 
be ≤ 25mg/week.
Stable dose and route 
of administration 
(oral, intramuscular, 
or SC permitted) 
required unless early 
escape or 
unacceptable side 
effects
Dose changes allowed up 
to the maximum dose 
specified in Table4or 
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 
agent
Not allowed unless 
early escape(see 
Section 6)
Allowed up to the 
maximum dose specified 
in Table4at 
investigator’s discretion
Sulfasalazine (SSZ) 
or 
Hydroxychloroquine 
(HCQ)
Used 
Treatment should have 
started at least 3 
months prior to the 
first administration of 
study agent. Dose 
should be stable for at 
least 4 weeks prior to 
the first administration 
of the study agentand 
must be ≤ 3 g/day
(SSZ) or ≤ 400mg/day 
(HCQ).
Stable dose required 
unless early escape or 
unacceptable side 
effects
Dose changes allowedup 
to the maximum dose 
specified in Table4, at the 
investigator’s discretion
Not Used
Discontinued at least 4 
weeks prior to the first 
administration of study
agent
Not allowed unless 
early escape (see 
Section 6)
Allowed up to the 
maximum dose specified 
in Table4at 
investigator’s discretion
Leflunomide (LEF)
Used 
Treatment should have 
started at least 3 
months prior to the 
first administration of 
study agent. Dose 
should be stable for at 
least 4 weeks prior to 
the first administration 
of the study agentand 
must be ≤ 20mg/day.
Stable dose required 
unless early escape or 
unacceptable side 
effects
Dose changes allowed up 
to the maximum dose 
specified in Table4at the 
investigator’s discretion
Not Used
Discontinued at least 
12weeks prior to the 
first administrationof 
study agent. 
Not allowed unless 
early escape (see 
Section 6)
Allowed up to the 
maximum dose specified 
in Table4at 
investigator’s discretion
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8.1.2.
Prohibited Non-biologic DMARDsand Apremilast
All other non-biologic DMARDs (including, but not limited to chloroquine, gold preparations, 
penicillamine) and apremilastmust be discontinued at least 4 weeks prior to the first 
administration of study agent and remain prohibited through Week 112.
8.1.3.
Systemic Immunosuppressive Drugs
Systemic immunosuppressants (including, but not limited to azathioprine, cyclosporine, 
6thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, or tacrolimus) must be 
discontinued at least 4 weeks prior to the first administration of study agent and remain 
prohibited through Week 112.  If any of these systemic immunosuppressants is initiated during 
the study, study agent must be permanently discontinued.
Systemic immunosuppressants do not refer to corticosteroids; see Section 8.2for restrictions 
regarding the use of corticosteroids.
8.2.
Corticosteroids
8.2.1.
Oral Corticosteroids
Subjects using oral corticosteroids at baseline for PsAmust be on a stable dose equivalent to 
≤10mgprednisone per day for at least 2 weeks prior to the first administration of study agent 
and continue on this dose through Week 52 unless early escape atWeek 16 (see Section 3).  
After Week 24 and through Week 52, a one-time dose decrease in oral corticosteroids is allowed.
Starting at Week 52, the dose and type of oral corticosteroid may be adjusted, at the discretion of
the investigator, for subjects 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 subject develops unacceptable side effects. 
Subjects not using oral corticosteroids at baseline for PsA must have discontinued oral 
corticosteroidsat least 2weeks prior to the first administration of study agent and must not 
receive oral corticosteroids through Week 52 of the study for PsA. An exception is made for 
subjects who qualify for early escape at Week 16 (see Section 3).
8.2.2.
Corticosteroids –Intravenous, Intramuscular, or Epidural 
Administration 
NCT03158285
Intravenous, intramuscular, or epidural administration of corticosteroids for the treatment of PsA 
arenot allowed through Week 112.  
Long-term, (>2 weeks), oral or IV corticosteroid use for indications other than PsA or psoriasis 
isnot allowed through Week 112.  Short-term (≤2 weeks) oral, IV, intramuscular, 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.

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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, subjects 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 subject be evaluated for infection prior to receiving an intra-articular 
corticosteroid injection.
8.2.4.
Corticosteroids –Other Routes of Administration
Inhaled, otic, ophthalmic, intranasal, and other routes of mucosal delivery of corticosteroids for 
indicationsother than PsA and psoriasis are allowed throughout the course of the study.
8.3.
Nonsteroidal Anti-inflammatory Drugs and Other Analgesics
For subjects receiving NSAIDs, including aspirin and selective cyclooxygenase 2 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 agent and 
continue through Week 52 unless early escape at Week 16 (see Section 3).  The dose 
administered should be the usual marketed dose approved in the country where the study is being 
conducted. 
The useof topical analgesics including capsaicin and diclofenac is allowedand should be 
recorded in the CRF. For topical and analgesic patches, the dose should be stable through 
Week 52 and may be changed only if the subject develops unacceptable side effects.
Subjects 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 agent and 
must not receive NSAIDs or other analgesics for PsA through Week 52 of the study.  An 
exception is made for subjects who qualify for early escape at Week 16 (see Section 3).
Starting at Week 52, subjects 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.
8.4.
Biologic Agents, Cytotoxic Drugs, JAK Inhibitors, or Investigational 
Agents
NCT03158285
The concomitant use of biologic agents, cytotoxic agents, JAK inhibitors, and investigational 
drugs is not allowed.  Biologic agents include, but are not limited to golimumab, anakinra, 
etanercept, adalimumab, infliximab, ustekinumab, alefacept, efalizumab, rituximab, natalizumab, 

CNTO 1959  (guselkumab)
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certolizumab pegol, tildrakizumab (MK3222), secukinumab (AIN457), ixekizumab 
(LY2439821), brodalumab (AMG827), 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 limitedto tofacitinib, baricitinib, 
filgotinib, peficitinib (ASP015K),and decernotinib (VX-509).  If any of these medications are 
used,study agent must be permanently discontinued.
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 agent through Week 52.  
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 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 112. 
Phototherapy including UVB or tanning beds are not permitted during the study through 
Week 112.  Subjects shouldbe encouraged to avoid prolonged sun exposure during the study.  
8.7.
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 Table4) must be 
discontinued at least 4 weeks prior to the first administration of study agent and is not permitted 
through Week 112; if a systemic antipsoriatic treatment (except those in Table4) is initiated 
during the study, study agent must be permanently discontinued.
9.
STUDY EVALUATIONS
9.1.
Study Procedures
9.1.1.
Overview
The Time and Events Schedule (Table 1and Table 2
NCT03158285
) summarizes the frequency and timing of 
efficacy, PK, immunogenicity, biomarker, and safety measurements applicable to this study.

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For women of childbearing potential only, additional serum or urine pregnancy tests may be
performed, as determined necessary by the investigator or required by local regulation, to 
establish the absence of pregnancy at any time during the subject
's participation in the study. 
Also additional TB tests may be performed as determined necessary bythe investigator or 
required by local regulation.
Except at the screening visit, all PRO assessments should be conducted/completedbefore any 
tests, procedures, or other consultations at all other visits as specified in the Time and Events 
Schedule to prevent influencing subject perceptions.  For additional detailsand the order for 
which that are to be performed, refer to the PRO user manuals.
To minimize unnecessary x-rays, it is recommended that subjects have the baseline radiographs 
of hands and feet taken after the inclusion and exclusion criteria have been checked and the 
subject appears eligible to enter the study.  All eligible subjects shouldhave radiographs taken 
approximately 2 weeks but not greater than 4 weeks prior to randomization.
During screening, each subject will be provided with an electronic device to enter study-related 
dataas applicable. Study-site personnel will train the subjects on how to use the electronic
device, including instructions to capture the data according to the study design.
9.1.2.
Blood SampleCollection
Blood samples should be collected at the visits indicated in the Time and Events Schedule. The 
date and time of collection will be recorded. When blood samples are to be collected for safety, 
PK, efficacy, biomarkers, and pharmacogenomics/epigenetic evaluations at the same time point, 
the order of blood draws will be samples for: CRP, chemistry/lipids, hematology, 
PK/Immunogenicity, serum biomarkers, pharmacogenomics, epigenetics, and RNA expression.
The total blood volume tobe collected in this study from each subject will be approximately 
313.5mL.  Subjects who consent to participate in the optional pharmacogenomics will have an 
additional blood volume collected of approximately 50 mL, for a total of approximately
363.5mL.  
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the 
samples.
9.1.3.
ScreeningPhase
NCT03158285
Screening procedures will be performed as indicated in the Time and Events Schedule.
After written informed consent has been obtained and within a period of 6 weeks before 
randomization, all screening evaluations will be performed. The screening visit may be 
completed in a single visit or may be divided into more than 1 visit. 
It is recommended thatafter obtaining informed consent, the investigator complete all laboratory 
tests at the first visit. The subject may then return for the remainder of the screening procedures 
only if the subject is eligible for the study as determined by the central laboratory test results. 

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Subjects who meet all of the inclusion and none of the exclusion criteria will be enrolled in the 
study.  Subjects who chose to participatein the optional pharmacogenomicsresearch component 
of the study must provideconsenton a separateICF.
The recording of AEs and concomitant medications will start after the signing of the informed 
consent and will continue until the last study-related procedure has been completed.
If the screening is a single visit, the electronic Columbia-Suicide Severity Rating Scale
(eC-SSRS) (Lifetimeversion) shouldbeperformed after the joint assessment(after signing 
informed consent). If the screening visit is divided into more than 1 visit, the eC-SSRS shouldbe 
performed after the joint assessment andafter the subject is determined to be eligible by the 
central laboratory test results.  
Females of childbearing potential must have a negative serum pregnancy testprior to 
randomization and a negative urine pregnancy test at all dosing visits prior to administration of 
study agent. Femalesof childbearing potential and males capable of fathering a child must 
consent to use a highly effective method of contraception and continue to use contraception for 
theduration of the study and for at least 12weeks after receiving the last administration of 
blinded study agent. The method(s) ofcontraception used by each subject must be documented. 
For details, see Section4.1.
A 12-lead electrocardiogram (ECG) will be performed locally at baseline prior to administration 
of study agent to ensure that,should the subject require an ECG during the study for any reason,
an ECG before first study agentadministration is available for comparison to detect changes.
A chest radiograph (posterior-anterior view) will be performed at screening to ensure that the 
subject does not have any abnormality suggestive current, active TB or old, inactive TB. Chest 
radiographs taken up to 3 months before the first administration of study agentmay be used.  
The BASDAI will be completed only in subjects with spondylitis with peripheral arthritis as their 
primary arthritic presentation of PsA(confirmation of sacroiliitis shouldbe performed at the 
screeningvisit by a locally performed pelvic x-ray [single anterior-posterior view] unless a
pelvic or SI joint x-ray or pelvic MRI has been previously performed.  Results must be 
documented).       
Subjects as outlined inInclusion Criterion14must undergo testing for TB (Attachment 2or 
Attachment 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 subject 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 Gold 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 in order to evaluate a 
subject who has high risk of having latent TB.  If either the QuantiFERON®
NCT03158285
-TB Gold test or the 
tuberculin skin test is positive, the subject is considered to have latent TB infection for the 
purposes of eligibility for this study.

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Subjects with a negative QuantiFERON®-TB Gold test result (and a negative tuberculin skin test 
result in countries in which the QuantiFERON®-TB Gold test is not approved/registered*orthe 
tuberculin skin test is mandated by local health authorities) are eligible to continue with 
prerandomization procedures. Subjects with a newly identified positive QuantiFERON®-TB 
Gold or tuberculin skin 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, United Statesguidelines must be followed, or the subject 
will be excluded from the study.
* Exceptions are made for those countries where the tuberculin skin test is not feasible due to 
various reasons (eg, shortage of test reagents) with the permission of respective health 
authorities, as applicable.
A subject whose first QuantiFERON®-TB Gold test result is indeterminate should have the test 
repeated.  In the event that the second QuantiFERON®-TB Gold test result is also indeterminate, 
the subject 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 subject 
has no additional risk factors for TB as determined by the investigator.  This determination must 
be promptly reported to the Sponsor’s medical monitor and recorded in the subject
's source 
documents and initialed by the investigator.
Subjects will undergo screening for HBV (Attachment 4) and antibodies to HCV and HIV.
The baseline radiographs of the hands and feet must be taken prior to randomization. To 
minimize unnecessary x-rays, it is recommended that subjects have the baseline radiographs of 
hands and feet taken after the inclusion and exclusion criteria have been checked and the subject 
appears eligible to enter the study.  All eligible subjects shouldhave radiographs taken 
approximately 2 weeks but not greater than 4 weeks prior to randomization.
Retesting
The re-testing of abnormal screeninglaboratory blood tests and CRP levels,which are 
exclusionary,is allowed only once using an unscheduled visit during the screening period (to 
reassess eligibility).
Repeat Screening
NCT03158285
If a subject was a screen failure in the past but currently the subject is expected to be able to meet 
the subject eligibility criteria, the subject 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 subject will be assigned a new subject number, and must undergo the 
informed consent process and all other screening procedures again as in the Time and Events 
Schedule.

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Chest x-raysand radiographs of hands and feet, if done within the specified allowed time, are not 
required to be repeated.
If the QuantiFERON®-TB Gold test and/or the tuberculin skin test was positive in the first 
screening, these tests should not be repeated.  Also, if the QuantiFERON®-TB Gold test and 
tuberculin skin test were done within the specified allowed time, they should not be repeated.
9.1.4.
Treatment Phase
The treatment phase includes the placebo-controlled and active treatment phases. At Week 0, 
eligible subjects will be randomly assigned to receive 1 of 3treatments:  guselkumab SC 100 mg 
q4w, guselkumab SC 100 mg at Weeks 0 and 4 then q8w, or placebo SC. For additional details, 
see Section 6. Safety and efficacy assessments must be performed before study agent
administration as noted in the Time and Events Schedule.
Early Detection of Active Tuberculosis
To aid in the early detection of TB reactivation or new TB infection during study participation, 
subjects must be evaluated for signsand symptoms of active TB at scheduled visits (refer to 
Time and Events Schedule) or by telephone contact approximately every 8 to 12 weeks if a 
subject misses scheduled visits.  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 subject may have TB reactivation or new TB infection, 
an immediate and thorough investigation should be undertaken, including, where possible, 
consultationwith a physician specializing in TB.
Investigators should be aware that TB reactivation in immunocompromised subjects may present 
as disseminated disease or with extrapulmonary features.Subjects with evidence of active TB 
should be referred for appropriate treatment.
Subjects 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 Goldtest, a repeat 
tuberculin skin test in countries in which the QuantiFERON®
NCT03158285
-TB Gold 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 subject’s risk of developing 

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active TB and whether treatment for latent TB is warranted.  If the QuantiFERON
®-TB Gold test 
result is indeterminate, the test should be repeated as outlined in Section 9.1.3.  
Subjects should be encouraged to return for all subsequent scheduled study visits according to 
the protocol.
Columbia-Suicide Severity Rating Scale
At all visitsexcept during screening, the eC-SSRS (Since Last Contactversion) shouldbe the 
first assessment/questionnaire that the subject must complete.
9.1.5.
PostTreatment Phase (Follow-Up)
All subjects who complete the Week 100 visit assessments will be asked to return for a final 
safety visitat Week 112.
Subjects Who Discontinue Study Agent
Prior to Week 24
If a subject discontinues study agent before the Week 24 visit, the subject should return for all 
visitsthrough Week 24. The final safety visit assessments will be conducted atthenext 
scheduled visit that occurs approximately 12 weeks after the last administration of studyagent.  
If a subject discontinues before the Week 24 visit and after the Week 12study agent 
administration, the subject should return for the Week 24 visit and also 12 weeks after the last 
administration of study agent for a final safety visit(refer to the Week 112 visit in Table 1and 
Table 2).   
For subjects who discontinue study agent prior to Week 24, radiographs of the hands and feet 
should be performed at the time of study agent discontinuation. If the discontinuation occurs 
prior toor at Week 16, the subject should also have radiographs performed at the Week 24 visit. 
If the discontinuation occurs after Week 16, the radiographs do not need to be repeated at 
Week 24.
At or After Week 24 andPrior to Week 100
If a subject discontinues study agent at or after Week 24 and before the Week 100 visit, the final 
efficacy visit (refer to the Week 100 visit in Table 2) should be performed as soon as possible. 
The subject should return 12 weeks after their last dose for their final safety visit(refer to the 
Week 112 visit in Table 2
NCT03158285
).  
Forsubjects who permanently discontinue study agent after Week 24 but prior to Week 100, 
radiographs of hands and feet should be performed at the time of discontinuation of study agent
or as soon as possible unless another set of radiographs has been obtained within the past 
6weeks.

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Subjects Who Discontinue Study Participation
For subjects who discontinue study participation at any time during the study,radiographs of the 
handsand feet should be performed at the time of study discontinuation unless another set of 
radiographs has been obtained within the past 6 weeks.
No proceduresand evaluations should be conducted after a subject withdraws consent.
9.2.
EfficacyEvaluations
Efficacy assessments will be performed at the site by applicablesite personnel trained by the 
Sponsor asindicated in the Time and Events Schedule.
9.2.1.
Psoriatic Arthritis Response Evaluations
9.2.1.1.
Joint Assessment
NCT03158285
Each of 68 joints will be evaluated for tenderness, and each of 66 joints will be evaluated for 
swelling (hips are excluded for swelling).
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 ofexperience 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 
subject should also perform the joint assessments for that subject at every subsequent visit 
through Week 52. 
Through Week 112, the IJA should have no other contact with the subject once the subject is 
randomized, should not be the treating physician, should not discuss the subject’s clinical status 
with the subject or other site personnel during the joint assessment, and will not be permitted to 
review the subject’s medical records or the CRFs, or any of the previous joint assessments. The 
IJA should maintain a neutral attitude during joint assessment and should limit interactions with 
the subject only to activities associated with performing joint assessmentor enthesitis or 
dactylitis assessments.
The IJA will perform only joint assessmentsand enthesitis and dactylitis assessments; this
individual will not perform or assist in any other assessments in this study such as but not limited 
to administering patient and/or physician global assessments or administering study agent.
The Sponsor will provide training for each site’s designated IJA prior to the screening of the first 
subject at each site. A back-up IJA must complete training before performing a joint assessment 
for a subject’s study visit.  

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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 should 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.
9.2.1.2.
Nonevaluable Joints
While it may be reasonable in clinical practice to identify as nonevaluable any joint which in the 
past or during study participation has been surgically altered (ie, prosthesis placement) or 
medically treated (ie, intra-articular injection), the designation of nonevaluable joints for the 
purposes of this study is slightly different.
Joints should only be designated as “non-evaluable” by the IJA if it is physically impossible to 
assess the joint (ie, joint inaccessible due to a cast, joint not present due to an amputation, or a 
recent wound near or at the joint so as to make it impossible to assess).  In all other cases, the 
IJA should assess each joint for tenderness and swelling (hips are excluded for swelling).  This 
should be completed regardless of any visual indications of prior surgeries (eg, scars) or 
knowledge they may have of a subject’s prior joint procedures/injections (eg, if the subject was 
the IJA’s patient prior to study participation).
9.2.1.3.
American College of Rheumatology Response
American College of Rheumatology responses are presented as the numerical measurement of 
improvementin multiple disease assessment criteria. For example, an ACR 20 response
10is 
defined as:
1. ≥20% improvement from baseline in both swollen joint count (66 joints) and tender joint 
count (68 joints),
AND
2. ≥20% improvement from baseline in 3 of the following 5 assessments:
Patient’s assessment of pain (VAS)
Patient’s Global Assessment of Disease Activity (arthritis, VAS)
Physician’s Global Assessment of Disease Activity (VAS)
Patient’s assessment of physical function as measured by HAQ-DI

NCT03158285
CRP
ACR 50 and ACR 70similarly defined except improvement threshold from baseline is 50%and 
70%, respectively.

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9.2.1.4.
Dactylitis Assessment
Presence and severity of dactylitis will be assessedby theIJA in both hands and feet using a 
scoring systemfrom 0 to 3 (0 –no dactylitis, 1 –mild dactylitis, 2 –moderate dactylitis, and 3 –
severe dactylitis)
17,19. 
The Sponsor will provide dactylitis assessment training.  Documentation of this training will be 
maintained in the study site’s training files. Previous dactylitis assessment 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 dactylitis 
assessmentsfor a subject should also perform the dactylitis assessments for that subject at every 
subsequent visit through Week 100.
9.2.1.5.
Enthesitis Assessment
Enthesitis will be assessed by the IJA using the LEI.
21  The LEI was developedto assess 
enthesitis in subjects with PsA, and evaluates the presence or absence of pain by applying local 
pressure to the following entheses:
Lateral epicondylehumerus, left and right

Medial femoral condyle, left and right

Achilles tendon insertion, left and right
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 subject should also perform the enthesitis assessments for that subject at every 
subsequent visit through Week 100.
9.2.1.6.
Imaging Evaluation
NCT03158285
Single radiographs of the hands (posteroanterior) and feet (anteroposterior) will be performed at 
visits as specified in the Time and Events Schedule.  To minimize unnecessary x-rays, it is 
recommended that subjects have the baseline radiographs of hands and feet taken after the 
inclusion and exclusion criteria have been checked and the subject appears eligible to enter the 
study.  All eligible subjects shouldhave radiographs taken approximately 2 weeks but not greater 
than 4 weeks prior to randomization; and at Week 24, Week 52,and Week 100 within ±2weeks 
of the scheduled visit.

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Subjects Who Discontinue Study Agent
For subjects who discontinue study agent prior to Week 24, radiographs of the hands and feet 
should be performed at the time of study agent discontinuation. If the discontinuation occurs
prior to or at Week 16, thesubjectshould also have radiographs performed at the Week 24visit. 
If the discontinuation occurs after Week 16, the radiographs donot need to be repeated at 
Week24.
Forsubjects who permanently discontinue study agent after Week 24 but prior to Week 100, 
radiographs of hands and feet should be performed at the time of discontinuation of study agent 
or as soon as possible unless another set of radiographs hasbeen obtained within the past 
6weeks.
Subjects Who Discontinue Study Participation
For subjects who discontinue study participationat any time duringthe studyradiographs 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. Totalmodified vdH-Sis an original vdH-S score
51,modified for the purpose of 
PsA radiological damage assessment, by addition of distal interphalangeal jointsof 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 JSNscore.The joint erosion score is a summary of 
erosion severity in 40 joints of the hands and 12 joints in thefeet. 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.  TheJSN 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.
9.2.1.7.
Disability Index of the Health Assessment Questionnaire
The functional status of the subject will be assessed by the HAQ-DI.
13 This 20-question 
instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional 
areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily 
living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, 
indicating inability to perform a task in that area (ie, lower scores are indicative of better 
functioning). Properties of the assessment have been evaluated and its validity in PsA has been 
determined.25  It has also been shown to be responsive to changes in a subject’s disease.
34  In 
PsA, a decrease in score of 0.35has been determined to indicate a meaningful improvement.
NCT03158285
35

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9.2.1.8.
Minimal Disease Activity
The PsA MDA criteria are a composite of 7 outcome measures used in PsA. Subjects are 
classified as achieving MDA if they fulfilled 5 of 7 outcome measures: tender joint count ≤1; 
swollen joint count ≤1; psoriasis activity and severity index ≤1; patient pain VAS score of ≤15; 
patient global disease activity VAS (arthritis and psoriasis) score of ≤20; Health Assessment 
Questionnaire (HAQ) score ≤0.5; and tender entheseal points ≤1.
6
9.2.1.9.
Psoriatic Arthritis Disease Activity Score
The PASDAS is calculated using the following variables: patient global VAS (arthritis and 
psoriasis, to 0–100), physician global VAS (range0–100), swollen joint count(0-66), tender 
joint count(0-68), CRP level (mg/L), enthesitis (measured by the LEI), tender dactylitis count 
(scoring each digit from 0–3 and recoding to 0–1, where any score >0 equaled 1), and, finally, 
the PCS scale of the SF-36 health survey.
24,23
PASDAS= {[(0.18 × √Physician global VAS) + (0.159 × √Patient global VAS) –(0.253 × 
√SF36 –PCS) + (0.101 × LN (Swollen joint count + 1)) + (0.048 × LN (Tender joint count + 1)) 
+ (0.23 × LN (Leeds Enthesitis Count + 1)) + (0.377 × LN (Dactylitis count + 1)) + (0.102 × LN 
(CRP + 1))] +2} ×1.5
The cutoffs for disease activity are 3.2 (low) to 5.4 (high).
22
9.2.1.10.
Group for Research and Assessment of Psoriasis and Psoriatic 
Arthritis (GRAppa) CompositeScore (GRACE)
The GRAPPAComposite score(GRACE) is a composite score of Group for Research and 
Assessment 
of 
Psoriasis 
and 
Psoriatic 
Arthritis 
(GRAPPA), derived 
as 
GRACEIndex=(1 -AMDF) x 10, where, AMDF is the Arithmetic Mean of the Desirability 
Function (AMDF).
22-24
The AMDF is calculated by transforming the followingvariables, using predefined algorithms 
and expressing the total score as amean with a score range of 0–1, where 1 indicates a better 
state than0:22, 23
Tender joint count (0-68)
Swollen joint count (0-66)
HAQ-DI score(0-3)
Patient’s global assessment of disease activity (arthritis and psoriasis, 0-100VAS)
Patient’s assessment of skin disease activity (0-100 VAS)
Patient’s global assessment of disease activity (arthritis) (0-100 VAS)

NCT03158285
PASIscore(0-72)

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Psoriatic arthritis Quality of Life Index (PsAQoL) which is derived as follows:
PsAQoL = 25.355 + (2.367 × HAQ-DI) –(0.234 × SF-PCS) –(0.244 × SF-MCS), 
where,
o HAQ-DI: HAQ-DI score (0-3)
o SF-PCS: PCS score of SF-36 Health Survey
o SF-MCS: MCS score of SF-36 Health Survey.
9.2.1.11.
Disease Activity Index Score 28
The DAS28 using CRP is a statistically derived index combining tender joints (28 joints), 
swollen joints (28 joints), CRP, and Patient’s Global Assessment of Disease Activity (GH).
52  
The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist,
metacarpophalangeal (MCP) 1, MCP2, MCP3, MCP4, MCP5, proximal interphalangeal (PIP1), 
PIP2, PIP3, PIP4, PIP5 joints of both the upper right extremity and the upper left extremity as 
well as the knee joints of lower right and lower left extremities.  The DAS28 using CRP is a
continuous parameter and is defined as follows:
DAS28(CRP) = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 
0.014 × GH + 0.96;where:

TEN28 is 28 joint count for tenderness

SW28 is 28 joint count for swelling

Ln (CRP+1) is natural logarithm of (CRP value [mg/L] + 1)
SQRT(TEN28) is square root of TEN28
SQRT(SW28) is square root of SW28
GH is Patient’s Global Assessment of Disease Activity (arthritis).
DAS Response
To be classified as a DAS28 responder, subjects should have a good or moderate response.  The 
DAS28 response criteria are defined in Table 6.
53
Table 6:
DAS Response
Improvement in DAS28 score
Present DAS28 score
> 1.2
> 0.6 to 1.2
0.6
3.2
Good response
Moderate response
No response
> 3.2 to 5.1
Moderate response 
Moderate response
No response
> 5.1
Moderate response
No response
No response
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9.2.1.12.
Modified Composite Psoriatic DiseaseActivity Index
The mCPDAIassesses 4 domains (joints, skin, entheses, and dactylitis). The mCPDAI scores are 
calculated using the following assessments: joints (66 swollen and 68 tender joint counts), 
HAQ-DI score, PASI, dactylitis, and enthesitis. Within each domain a score (range 0–3) is 
assigned according to predefined cutoffs
23, as below. The scores for each domain are then added 
together to givea final score range of 0 to 12.
9.2.1.13.
Disease Activity Index for Psoriatic Arthritis
Disease Activity Index for Psoriatic Arthritis is calculated as the sum of the following 
components: tender joint count (0–68), swollen joint count (0–66), CRP level (mg/dL), patient 
assessment of painfor pain (0–10VAS), and patient globalassessment ofdisease activity 
(arthritis, 0 –10VAS).
23  The cutoffs for disease activity are 18.5 (low) to 45.1 (high).
22
9.2.1.14.
Modified Psoriatic Arthritis Responder Criteria
Subjects will be assessed using the modified PsARC.  A subject is considered a responder if they 
have improvement in at least 2 of the following criteria, including at least one of the joint criteria 
and with no deterioration in the other criteria
42:
≥ 30% decrease in the swollen joint count(66joints);

≥ 30% decrease in the tender joint count(68joints);

≥ 20% improvement in the patient
's overall assessmentof disease(arthritis) on a VAS; 
and
≥ 20% improvement in the physician’s overall assessment of disease on a VAS. 
9.2.1.15.
Bath Ankylosing Spondylitis Disease Activity Index
The BASDAI was developed as a subject self-assessment for ankylosing spondylitisthat consists 
of 6 questions relating to the 5 major symptoms of ankylosing spondylitis.
14  Only subjects with 
spondylitis with peripheral arthritis as their primary arthritic presentation of PsA will complete 
the BASDAI using a 10-unit VASto indicate the degree of their symptoms overthe past week 
on the following criteria:
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A. Fatigue
B. Spinal pain
C. Joint pain
D. Enthesitis
E. Qualitative morning stiffness
F. Quantitative morning stiffness
The BASDAI score = 0.2 (A + B + C + D + 0.5[E + F]).  Higher scores indicate greater disease 
severity and a score decrease of 50% or 2 points is considered clinically meaningful(49).
58
9.2.2.
Psoriasis Response Evaluations
9.2.2.1.
Investigator’s Global Assessment of Psoriasis
The IGA documents the investigator’s assessment of the subject’s psoriasis at a given time point. 
Overall lesions are graded for induration, erythema, and scalingusing 0 (no evidence), 
1(minimal), 2 (mild), 3 (moderate) and 4 (severe) scale. The IGA score of psoriasis isbased 
upon theaverageof induration, erythema and scaling scores.The patient’spsoriasis is assessed 
as cleared(0), minimal(1), mild (2), moderate (3), or severe (4).
Every effort should be made to ensure that the physician or designee who performed the IGA
evaluations for a subject at baseline should also perform the IGAevaluations for the subject at all 
subsequent visits through Week 52. The Sponsor will provide IGAtraining. Documentation of 
this training will be maintained in the site’s training files. Previous IGAtraining 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.
9.2.2.2.
Psoriasis Area and Severity Index
The PASI is a system used for assessing and grading the severity of psoriatic lesions and their 
response to therapy.
12  The PASI produces a numeric score that can range from 0 to 72. A
PASI75 response is defined as ≥75% improvement in PASI score from baseline; PASI 90 and 
PASI 100 are similarly defined.
Every effort should be made to ensure that the physician or designee who performed the PASI 
evaluations for a subject at baseline should also perform the PASI evaluations for the subject at 
all subsequent visits through Week 52. The Sponsor will provide PASI training. 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.
9.2.2.3.
Dermatology Life Quality Index
The DLQI questionnaire is frequently used to assess the patient’s perspective on the impact of 
skin disorders on daily living.  The development of the instrument included a wide variety of 
dermatologic conditions.
11  The content validity and other psychometric properties were further 
assessed in a subsequent study in patients with psoriasis9and other conditions
1
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.  The DLQI, a 

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10item instrument, has 4 item response options, and has a recall period of 1 week.  The total 
score of DLQI range from 0-30 with lower scores indicating lesser impact of psoriasis on the 
patients’ daily lives. In dermatologic disease, a change of 5 points has been determined to be 
meaningful.
27
9.2.3.
Other Patient Reported Outcomes
9.2.3.1.
36-Item Short-form Health Survey
The SF-36questionnaire was developed as part of the Rand Health Insurance Experiment and 
consists of 8 multi-item domain scales:
Limitations in physical functioning due to health problems;

Limitations in usual role activities due to physical health problems;
Bodily pain;
General mental health (psychological distress and well-being);
Limitations in usual role activities due to personal or emotional problems;
Limitations in social functioning due to physical or mental health problems;
Vitality (energy and fatigue);

General health perception.
These scales are scored from 0 to 100 with higher scores indicating better health. Another 
algorithm yields 2 summary scores, the PCS and the MCS. These summary scores are also scaled
with higher scores indicating better health but are scored using a norm-based system where linear 
transformations are performed to transform scores to a mean of 50 and standard deviations of 10, 
based upon generalUSpopulation norms.
54  It has been demonstrated in a study of patients with 
RAthat a change of 4.4 in PCS and 4.7 in MCS was the minimally important change.
28There is 
no specific cut-off for a clinically meaningful change in patients with PsA and a conservative 
threshold of ≥5 points change in both PCSand MCS have been used in the clinical studiesto 
define clinically meaningful improvement for various diseases.  The concepts measured by the 
SF-36 are not specific to any age, disease, or treatment group, allowing comparisonof relative 
burden of different diseases and the relative benefit of different treatments.
55
9.2.3.2.
EQ-5D Questionnaire
The EQ-5D is a standardized measure of health status developed by the EuroQoL Group to 
provide a simple, generic measure of health for clinical and economic appraisal.
8
NCT03158285
  TheEQ-5D is 
applicable to a wide range of health conditions and treatments.  EQ-5D essentially consists of 2 
elements:  The EQ-5D descriptive system and the EQ VAS.  The EQ-5D descriptive system 
comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and 
anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate 
problems, severe problems, and extreme problems.  The respondent is asked to indicate his/her 
health state by ticking (or placing a cross) in the box against the most appropriate statement in 
each of the 5 dimensions.  This decision results in a 1-digit number expressing the level selected 

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for that dimension.  The digits for 5 dimensions can be combined in a 5-digit number describing 
therespondent’s health state,which can be converted into a single summary index (EQ-5D 
index) by applying a formula that attaches values (also called weights) to each of the levels in 
each dimension.  The EQ VAS records the respondent’s self-rated health ona vertical line, VAS 
where the endpoints are labeled ‘Best imaginable health state’ and ‘Worst imaginable health 
state’.  The EQ VAS can be used as a quantitative measure of health outcome as judged by the 
individual respondents.
9.2.3.3.
Functional Assessment of Chronic Illness Therapy -Fatigue
Fatigue has been identified as an important symptom and a unique concept in addition to the core 
disease measures of patients with PsA.
4 The FACIT-Fatigue questionnaire consists of 13 
questions that assess a subject’s level of fatigue and tiredness over the last 7 days.  Each question 
is graded on a 5-point scale (0 = not at all; 1=a little bit; 2 = somewhat; 3 = quite a bit; 4 = very 
much); accordingly, scores can range from 0 to 52.  Lower scores reflect more severe fatigue.  
Although not developed for PsA, FACIT-Fatiguehas demonstrated strong internal consistency 
and test-test reliability.  It distinguishes between healthy and PsA patients and is correlated with 
swollen joint count and actively inflamed joint count.  In rheumatology, a change of 4points is 
considered meaningful and has been used in the PsA population.
3
9.3.
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 
(http://www.reillyassociates.net/WPAI_General.html).  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 AS 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.
9.4.
Pharmacokinetics and Immunogenicity
Serum samples will be used to evaluate the PK of guselkumabas well as the immunogenicity of 
guselkumab (antibodies to guselkumab). Serum collected for PK and 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. 
Subject confidentiality will be maintained.
9.4.1.
Serum Collection and Handling
NCT03158285
Venous blood samples will be collected at the time points shown in the Time and Events 
Schedule for the determination of serum guselkumab concentrations and antibodies to 

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guselkumab. Serum samples will also be collected at the final visit from subjects who terminate 
study participation early. 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 agent, and 1 aliquot as a 
back-up). Samples must be collected before study agent administration at visits when a study 
agent administration is scheduled. The exact dates and times of blood sample collection must be
recorded in the laboratory requisition form.
A random venous blood sample for population PK analysis will be collected from all subjects on 
any day between Weeks 4 to 12, except on the days of the scheduled study visit at Weeks 4, 8, 
and 12.  Additionally, this blood sample must be collected at least 24 hours prior to or after the 
actual time of study agent administration at Weeks 4, 8, or 12 (ie, it cannot be collected within 
24 hours before or after study agent administration).  Each population PK serum sample will be 
split into 2 aliquots (1 aliquot for serum guselkumab concentration and 1 aliquot as a back-up 
sample).  
Additional information about the collection, handling, and shipment of biological samples can be 
found in the Laboratory Manual.
9.4.2.
Analytical Procedures
Serum samples will be analyzed to determine serum guselkumab concentrations using a 
validated, specific, and sensitive immunoassay method bytheSponsor’s bioanalytical facility or 
under the supervision of the Sponsor. The Sponsor, or its designee, under conditions in which the 
subjects’ identity remains blinded, will assay these samples.  
9.4.3.
Pharmacokinetic Parameters
If feasible, the apparent total systemic clearance and apparent volume of distribution of 
guselkumab will be estimated using a nonlinear mixed-effects modeling approach.
9.4.4.
Immunogenicity Assessments
Antibodies to guselkumab will be detected using a validated immunoassay method in serum 
samples collected from all subjects according to the Time and Events Schedule. Serum samples 
that test positive for antibodies to guselkumab will be further characterized to determine if 
antibodies to guselkumab could neutralize the biological effects of guselkumab in vitro (ie, 
neutralizing antibodies [NAbs] to guselkumab). All samples will be tested by the Sponsor or 
Sponsor
's designee.
9.5.
Biomarkers
NCT03158285
Samples for serum biomarkers will be collected for all subjects as indicated in the Time and 
Events Schedule.
Samples for the analysis of pharmacodynamic biomarkers will be collected from all subjects. 
The samples will be used to better understand the biology of PsA, to provide a biological 
assessment of the response of patients to treatment with guselkumab, to analyze differences 

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between responders and non-responders, and to determine if the markers can be used to classify 
patients as potential responders prior to treatment. They may also be used to develop tests/assays 
related to guselkumab and PsA. Serum samples will be used to analyze inflammation and 
spondyloarthropathy related proteins. Markers related to the biology of PsA, including (but not 
limited to) Th17, IL-17A, IL-17F, IL-21, IL-22 and IL-23, metabolomics and bone homeostasis 
pathways will also be measured. Ribonucleic acidfrom whole blood samples will be used for 
gene expression analysis to determine the molecular profile of PsA and to assess changes in gene 
expression post guselkumab treatment.
9.6.
Pharmacogenomics (DNA) Evaluations
A whole blood sample will be utilized for pharmacogenomics evaluation.  The analysis may 
includecompletegenome-wide testing and/or targeted sequencing.  The testing will be done to 
search for links of specific genes to disease or response to drug. Genes of interestmay include 
(but are not limited to) HLA-B27 and HLAcw6.  DNA methylation testing may also be
performed. Only DNA research related to guselkumab or to the diseases for which this drug is 
developed will be performed. Pharmacogenetics testing as well as methylation testing will be 
undertaken in this study in consenting subjects.   Subjects participating in this portion of the 
study must sign a separate informed consent. Further, a subject may withdraw such consent at 
any time without affecting their overall participation in the study.
9.7.
Safety Evaluations
Safety assessments will be collected for all subjects as indicated in the Time and Events 
Schedule.
The safety and tolerability of study agent (guselkumab and placebo) will be monitored by 
collectinginformation on AEs(including injection site and allergic reactions), clinical laboratory 
tests, physical examinations, vital signs, suicidalideation or behavior (using the eC-SSRS 
questionnaires), concomitant medication review,and early detection of TB, as specified in the 
Time and Events Schedule. Serum and/or plasma samples collected for PK or PD analyses may 
also be used to evaluate safety concerns that may arise during or after the study period.
Detailsregarding the independent DMC are provided in the DMC Charter.
Safety will be monitored through Week 112. Any clinically relevant changes occurring during
the study must be recorded on the AE section of the CRF.
Clinicallyimportant abnormalities persisting at the end of the study/early withdrawal may be 
followed by the investigator until resolution or until a clinically stable endpoint is reached.
9.7.1.
Evaluations of Safety and Tolerability
NCT03158285
The study will include the following evaluations of safety and tolerability according to the time 
pointsprovided in the Time and Events Schedule: 

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Adverse Events
Adverse events will be reported by the subject for the duration of the study. Adverse events will 
be followed by the investigator.
At each of the visits, subjects will be questioned about the occurrence of new AEs since the 
previous visit, or the outcome of any AEs reported at previous visits.
Allergic Reactions
The Sponsor will proactively monitor reported AEs and query the study site, if necessary, to 
capture anaphylactic reaction/serum sickness events in the CRFs.
Injection-Site Reactions
An injection site reaction is any unfavorable or unintended sign that occurs at the study agent 
injection site. Any adverse reaction (eg, pain, erythema, and/or induration) should be noted on 
the AE page of the CRF.
Through Week 52, all subjects will be carefully observed at the study site for at least 30 minutes 
after the SC injection of study agentfor symptoms of an injection-site reaction. If an injection 
site reaction is observed, the subject should be treated at the investigator’s discretion. Subjects 
self-administering study agentaway from the study site will be trained in the recognition and 
documentation of injection site reactions.
Clinical Laboratory Tests
Blood samples for serum chemistry and hematology will be collected. The investigator must 
review the laboratory report, document this review, and record any clinically relevant changes 
occurring during the study in the AE section of the CRF. The laboratory reports must be filed 
with the source documents.
All abnormal laboratory values will be evaluated for clinical significance by the investigator. If 
clinically significant abnormal laboratory values (in the opinion of the investigator) are detected, 
the test(s) should be repeated as necessary and in discussion with the study responsible 
physician.
Instructions for the collection, handling, and shipping of blood samples are provided in the 
Laboratory Manual.
The following tests will be performed by the central laboratory:

NCT03158285
Hematology Panel
-hemoglobin
-neutrophils
-hematocrit
-bands
-red blood cell count
-eosinophils
-white blood cell count
-basophils

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-lymphocytes
-platelets
-monocytes
Serum Chemistry Panel
-sodium
-calcium
-potassium
-albumin
-chloride
-total protein
-alkaline phosphatase
-ALT
-blood urea nitrogen (BUN)
-bicarbonate
-creatinine
-total bilirubin, with fractionation if 
hyperbilirubinemia
-glucose
-uric acid
-AST

Lipid Panel
-total cholesterol
-high density lipoprotein cholesterol
-low density lipoprotein cholesterol
-triglycerides
Serology:HBV, including HBV serology and HBV DNA (when indicated),antibodyto 
HCV and HCV RNA (when indicated), and antibody to HIV.
Rheumatoid Factor test (optional, if needed for checking CASPAR criteria at screening)
High sensitivity CRP
FSHis optional. It is only needed for determining childbearing potential of a female subject 
of any age with amenorrhea for less than 12 months. In the absence of 12 months of 
amenorrhea, 2 FSH measurements are needed.FSH is not needed for female subjects with 
amenorrhea for at least 12 months or any female subject of childbearing potential. Refer to 
Inclusion Criterion 10for detail.
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 agent administration 
visit. Pregnancy tests must be completed and the result must be negative before the 
administration of any agent for that visit. All pregnancy test results must be recorded in study 
source documents.
Electrocardiogram
NCT03158285
(ECG)
A supine 12-lead ECG will be performed locally at Week 0prior to administration of study 
agent, asspecified in the Time and Events Schedule. A full 12-lead ECG will be recorded and

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the ECG data,including a copy of tracing as well as interpretation,should be stored in the 
subject
's source document.
PhysicalExamination
Physical examinations will be performed by the investigator or designated physician as specified 
in the Time and Events Schedule. Any abnormalities or changes in severity noted during the 
review of body systems should be documented in the source document.
Height and Weight 
Height and weight will be measured as specified in the Time and Events Schedule.  
Vital Signs
Blood pressure and heart rate measurements will be assessed at the time points specified in the 
Time and Events Schedule.
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.
9.7.2.
Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)
No signal of suicidal ideation and behavior has been observed in the clinicaltrials of guselkumab 
to date.
However, in lightof the recent reports concerning suicidal ideation and behavior in patients with 
plaquepsoriasis treated with an IL-17R antagonist (brodalumab), the eC-SSRS will be used as a 
screening tool to prospectivelyevaluate the potential of guselkumab to induce suicidal ideation 
and behavior.The eC-SSRS measures five possible levels of suicidal ideation and four possible 
suicidal behaviors, as well as non-suicidal self-injurious behavior. The assessment is a fully-
structured, subject self-report eC-SSRS questionnaire, including standardized questions, follow-
up prompts, error handling routines, and scoring conventions.
37,43Two versions of the eC-SSRS 
will be used in this study, the Lifetimeversion and the Since Last Contactversion. TheLifetime
version will be conducted during the screening visit and the Since Last Contact
NCT03158285
version will be 
conductedat all other visits through Week 112.
Subjects will complete the eC-SSRS questionnaire using the Sponsor-provided electronic tablets
(or throughanInteractive Voice Response System [IVRS], if available). Studysite personnel 
will train the subjects on how to use the electronic deviceand/or a telephone system. The 
eCSSRS 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 Time and Events
schedule. During a visit, subjects will be directed to a private, quiet place with the electronic 
deviceand/or a telephoneto complete the assessment. Subjects who do not have suicidal 
behavior or ideation will answer a limited number of questions and will usually complete the 
assessment in about 3minutes. Subjects with significant suicidal ideation and behavior may 
require up to 10 minutes to answer all relevant questions. The eC-SSRS should be performed 

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after the joint assessment at the screening visit (after signing informed consent). At Week 
0/baselineand at all post-baseline visits,the eC-SSRS will be the first assessment/questionnaire 
that the subject completesprior to study agent administration.
At the conclusion of each assessment, the site will receive an eC-SSRS Findings Report. At 
screening (In the last 6 months”) and Week 0, subjects with anIdeation level (1-5)or any 
suicidal behaviors or with a response of “YES” for non-suicidal,self-injurious behaviormust be 
determined to be not at risk by the investigator based on an evaluation by a mental health 
professional in order to be randomized. Subjects with anIdeation level (1-5)on the eC-SSRS or 
any suicidal behaviors or with a response of “YES” for non-suicidal,self-injurious behavior at 
any post-baseline visit will also be referred to an appropriate mental health professional for 
evaluation. If a subject’s psychiatric disorder can be adequately treatedwith psychotherapy 
and/or pharmacotherapy then the subject, at the discretion of the investigator, should be 
continued with treatment. Ultimately, the determination of suicidality and risk is up to the 
investigator’s clinical judgment following evaluationby a mental health professional (eg, 
psychiatrist, psychologist, or appropriately trained social worker or nurse).
Positivereports are generated from the eC-SSRS vendor for ANY of the following findings:
Ideation level 4: Some intent to act, no plan
Ideation level 5: Specific plan and intent

Behaviors: Actualsuicide attempts
Behaviors: Interrupted attempts
Behaviors: Aborted attempts
Behaviors: Preparatory actions.
Negativesuicidality indication reports are generated from the eC-SSRS vendor when there are 
NO indications of the above.
The subject should not be released from the site until the eC-SSRS Findings Report (both for 
negative and positive reports) is reviewed by theinvestigator and the subject’s risk has been 
assessed and follow-up determined, as appropriate.
Foreach Ideation Level and Behavior, the following actions and associated alerts will be 
generated, if applicable:
No ideation with No Behaviors: No further action is needed. 
Ideation Levels (1-5) or suicidal behavior: Subject risk assessed and referral to a mental 
health professional.

NCT03158285
Ideation Level of a 1, 2, or 3with No Behaviors: Negative findings report will be 
generated.

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Ideation Level of a 4 or 5 or any suicidal behavior: Positive findings report will be 
generated. When the system reports that the subject has a positive suicidal indication 
(including for an incomplete-positiveassessment), the site will be immediately notified 
by fax/email and a telephone call from the eC-SSRS vendor.
Non-suicidal, self-injurious behavior = YES: Subject risk assessed and referral to a mental 
health professional. Negative findings report will be generated.
Interruption or the discontinuation of study treatment should be considered for any subject who 
reports suicidal IdeationLevel 4(someintentto act, no plan), Ideation Level 5 (specific plan and 
intent), or anysuicidal behavior(actual suicide attempts, interrupted attempts, aborted attempts, 
or preparatory actions) on a post-baseline(after Week 0)eC-SSRS assessment and who is 
deemed to be at risk by the investigator based upon evaluation by a mentalhealth professional. 
Discussion of such subjects with the medical monitor or designee is required (See Section 10.2). 
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 arenew or considered to be a 
worsening and clinically significant, should be reported on the AE eCRF (see Section 12).
9.7.3.
Anticipated Events
Anticipatedevents will be recorded and reported in this study. 
An anticipated event is an AE (serious or non-serious) that commonly occurs as a consequence 
of the underlying disease or condition under investigation (disease related) or background 
regimen.
For thepurposes of this study the following events will be considered anticipated events:
Worsening of psoriasis
Worsening of PsA
These events will be captured on the CRF and in the database, and will be reported to the 
Sponsor as described in All Adverse Events(Section 12.3.1
NCT03158285
). Any event thatmeets SAE criteria
will be reported to the Sponsor within the appropriate timeline as described in Serious Adverse 
Events. These anticipated events are exempt from expedited reporting as individual single cases 
to Health Authorities. However, if based on an aggregate review, it is determined that an 
anticipated event is possibly related to study agent, the Sponsor will report these events in an 
expedited manner.
An Anticipated Event Review Committee (ARC) will be established to perform reviews of 
pre-specified anticipated events at an aggregate level. The ARC is a safety committee within the 
Sponsor’s organization that is independent of the Sponsor’s study team. The ARCwill meet to 
aid in the recommendation to the Sponsor’s study team as to whether there is a reasonable 
possibility that an anticipated event is related to the study agent.

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Details of statistical analysis of anticipated events, including the frequency of review and 
threshold to trigger an aggregate analysis of anticipated events will be provided in a separate 
Anticipated Events Safety Monitoring Plan.
9.8.
Sample Collection and Handling
The actual dates and times of sample collection must be recorded in thelaboratory requisition 
form. Refer to the Time and Events Schedule for the timing and frequency of all sample
collections.
Instructionsfor 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.
10.
SUBJECT COMPLETION/DISCONTINUATION OF STUDY 
TREATMENT/WITHDRAWALFROM THE STUDY
10.1. Completion
A subject will be considered to have completed the study if he or she has completed assessments 
at Week 112 of the study. Subjects who prematurely discontinue study treatment for any reason 
before completion of the final safety visit at Week 112will not be consideredto have completed 
the study.
10.2. Discontinuation of Study Treatment
A subject will not be automatically withdrawn from the study if he or shehasto discontinue
treatment before the end of the treatment regimen.
A subject
'sstudy treatment mustbe discontinued if:
The investigator believes that for safety reasonsor tolerability reasons(eg,AE) it is in the 
best interest of the subject to discontinue studytreatment.
Thesubject becomes pregnantor plans to become pregnant.

The subject is diagnosed with a malignancy, with the exception of no more than 2localized 
basal cell skin cancers that are treated with no evidence of recurrence or residual disease.

The subject is deemed ineligible according to the following TB screening criteria: 
A diagnosis of active TB is made.
A subject 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 subject undergoing evaluation has a chest radiograph with evidence of current active 
TB and/or a positive QuantiFERON®-TB Gold test result (or a positive tuberculin skin 
test result in countries in which the QuantiFERON®
NCT03158285
-TB Gold test is not 
approved/registeredor the tuberculin skin test is mandated by local health authorities), 

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unless active TB can be ruled out and appropriate treatment for latent TBcan be 
initiated before the next administration of study agentand continued to completion. 
Indeterminate QuantiFERON®-TB Gold test results should be handled as described in 
Section 9.1.3.  Subjects with persistently indeterminate QuantiFERON®-TB Gold 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 subject has no additional risk factors for TB as determined by the investigator. 
This determination must be promptly reported to the Sponsor’s medical monitor and 
recorded in the subject
's source documents and initialed by the investigator.
A subject receiving treatment for latent TB discontinues this treatment prematurely or is 
noncompliantwith the therapy.
The subject initiates the following protocol-prohibited medications:  apremilast,systemic 
immunosuppressive drugs (Section 8.1.3), biologic agents, cytotoxic drugs, JAK inhibitors, 
or investigational agents (Section 8.4), and systemic therapy for psoriasis (Section8.7).
The subject withdraws consent for administration of study agent.
The subject is unable to adhere to the study visit schedule or comply with protocol 
requirements.

The subject develops an allergic reaction such as bronchospasm with wheezing and/or 
dyspnea requiring ventilatory support, or symptomatic hypotension that occurs following a 
study agentadministration.

NCT03158285
The subject 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 agent.  
These may be accompanied by other events including pruritus, facial, hand, or lip edema, 
dysphagia, urticaria, sore throat, and/or headache.
Discontinuation of study treatment should be considered for subjects who report suicidal Ideation 
Level 4 (some intent to act, no plan), Ideation Level 5 (specific plan and intent), or anysuicidal 
behavior(actual suicide attempts, interrupted attempts, aborted attempts, or preparatory actions)
on a post-baseline(after Week 0)eC-SSRS assessment. Discussion of such subjects with the 
medical monitor or designee is required.
Discontinuationof study agentshould be considered and discussed with the studyresponsible 
physician or designee for subjects who develop a serious or opportunistic infection.
Subjectswho decide to discontinue study agentadministration must be interviewed by the 
investigator to determine if a specific reason for discontinuing study agentcan be identified. 
Subjects should be explicitly asked about the contribution of possible AEs or lack of efficacy to 
their decision to discontinue study agent; investigators should confirm that any AE information 
elicited or lack of efficacy has been documented. If a subject elects to discontinue study agent
due to an AE or lack of efficacy, the event or lack of efficacy should be recorded as the reason 
for study agentdiscontinuation, even if the investigator
's assessment is that the AE or the 
patient’s PsA condition would not require study agentdiscontinuation. The reason for study 

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agentdiscontinuation must be documented in the CRF and in source documents. Study agent
assigned to a subject who discontinues may not be assigned to another subject.
If a subject discontinues study agent administrations before the Week 100 visit, he/she should be 
encouraged toreturnfor all visits as outlined in the Time and Events Schedule (see 
Section9.1.5).
If a subject permanently discontinues study agent at orafter Week 24, the final efficacy visit 
should occur at the time of discontinuationor as soon as possibleand all assessments under the 
final efficacy/Week 100visitshould be performed, including radiograph of hands andfeet, with 
the exception of study agent administration.  The subject should also return for a final safety visit
approximately 12 weeksafter the last study agentadministration.
10.3. Withdrawal From the Study
A subjectwill be withdrawn from the study for any of the following reasons:
Lost to follow-up
Withdrawal of consent

NCT03158285
Death
To ensure access for subject follow-up, study sites should try to obtain both primary and 
secondary telephone contact numbers from subjects (eg, home, work, and mobile phones), as 
well as other contact information such as email addresses, and emphasize the importance of 
follow-up information to the subject, before randomization.
If a subject fails to return for study visits, study site personnel must make all reasonable efforts to 
contact the subject to determine the subject’s reason for discontinuation/withdrawal before 
considering the subject to be lost to follow-up. Due diligence should include repeated telephone 
calls, certified letters, and email requests. Measures taken to obtain follow-up information must 
be documented.
Withdrawal of consent should be a very unusual occurrence in a clinicaltrial; the investigator 
should make every effort to maintain good subject relationships to avoid withdrawals of consent. 
For subjects who truly request withdrawal of consent, it is recommended that the subject 
withdraw consent in writing and provide a reason, if possible; if the subject or the subject’s 
representative refuses to do so or is physically unavailable, the study site should document the 
reason for the subject’s failure to withdraw consent in writing, sign the documentation, and 
maintain it withthe subject’s source records.
When a subject withdraws before completing the study, the reason for withdrawal is to be 
documented in the CRF and in the source document. Study agentassigned to the withdrawn 
subject may not be assigned to another subject. Subjects who withdraw from the study will not 
be replaced.

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10.4. Withdrawal From the Use of Research Samples
A subject who withdraws from the study will have the following options regarding the optional 
researchsample(s):

The collected sample(s) will be retained and used in accordance with the subject
's original 
separate informed consent for optional research samples.

The subject may withdraw consent for optional research sample(s), in which case the 
sample(s) 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 receivewritten confirmation from the 
Sponsor that the sample(s) have been destroyed.
Withdrawal From theOptional Research Samples While Remaining in the Main Study
The subjectmay withdraw consent for optional research samples while remaining in the study. In 
such a case, the optional research sample(s) will be destroyed. The sample destruction process 
will proceed as described above.
Withdrawal From the Use of Samplesin Future Research
The subject may withdraw consent for use of samples for future research (refer to 
Section16.2.5).  Insuch a case, samples will be destroyed after they are no longer needed for the 
clinical study. Details of the sample retention for future research are presented in the main ICF 
and in the separate ICF for optional research samples.
11.
STATISTICAL METHODS
NCT03158285
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 subject information and efficacy and 
safety data is outlined below. Specific details will be provided in the Statistical Analysis Plan 
(SAP).
In general, efficacy and subject information analyses will be based on Full Analysis Set (FAS) 
and include all randomized subjects who received at least 1 dose (complete or partial) of study 
treatment and will be analyzed based on the randomized treatment groups, regardless of the 
treatment they actuallyreceived. 
Safety analyses will include all subjects who received at least 1 dose (complete or partial) of 
study treatment and subjects will be analyzed based on the treatment groups theyactually 
received, regardless of the treatment groups they were assigned to.
Pharmacokinetics (PK) analysis for guselkumab will include subjects who receive at least one 
completedose of guselkumab and have at least one post-dose sample collection. Antibodies to 
guselkumab will be analyzed for subjects who receive at least one dose of guselkumaband have 
at least one post-dose sample collection.

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Simple descriptive summary statistics, such as n, mean, standard deviation (SD), median, inter 
quantile (IQ) range, minimum, and maximum for continuous variables, and counts and 
percentages for discrete variables will be used to summarize most data.  
In general, for response efficacy endpoints, treatment comparisons will be performed using a 
Cochran-Mantel-Haenszel (CMH) test stratified by baseline non-biologicDMARD (MTX, SSZ, 
HCQ, LEF) use (yes/no) andthe most recentavailable CRP value prior to randomization 
(<2.0mg/dL or≥2.0mg/dL).  
In general, for continuous endpoints of efficacy data, treatment comparisons will be performed 
using either a Mixed-Effect Model Repeated Measure model or an analysis of covariance model.  
All the models will have treatment group, the baseline non-biologic DMARD (MTX, SSZ, HCQ, 
LEF)use (yes/no), the most recentavailable CRP value prior to randomization(<2.0 mg/dL or 
≥2.0mg/dL), and baseline valueas explanatory factors  
In general, for continuous endpoints of radiographic data, treatment comparisons will be 
performedusing an ANOVA test on the van der Waerden normal score.
In general, all statistical tests will be performed at a 2-sided significance level of α=0.05.
In addition, graphical data displays (eg, line plots) and subject listings may also be used to 
summarize/present the data. 
11.1. Subject Information
Descriptive statistics by the randomized treatment group will be provided for demographics, 
baseline disease characteristics, and prior and concomitant medications.
11.2. Sample Size Determination
The sample size selection was determined based onthe primary endpoint of proportion of 
subjects who achieve ACR 20 response at Week 24 and the major secondary endpoint of change 
frombaseline invdH-S score at Week 24.
Primary Endpoint –ACR 20 Response at Week 24
In the Phase 3 CNTO1275PSA3001 study with ustekinumab, the ACR 20 response rates at 
Week 24 were22.8%, 42.4% and 49.5%, respectively, for the placebo, ustekinumab 45 mg, and 
ustekinumab 90 mg treatment groups. In the Phase 2 CNTO1959PSA2001 study with 
guselkumab, the ACR 20 response rates at Week 24 were 18.4% and 58.0%, respectively, for the 
placebo and guselkumab 100 mg treatment groups.  
Assuminga 45% ACR 20 response rate in the guselkumab group and a 25% ACR 20 response 
rate in the placebo group, a sample size of 228 subjects per treatment group (684 in total) will 
provide a power of approximately 99% to detect a significant treatment difference at a 2-sided 
significance level of 0.05.  Table 7
NCT03158285
provides the statistical power under various assumptions 
using a 2-sided chi-square test.  

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For this study, the sample size was also evaluatedbased on the following assumptions:  

20% to25% ACR 20 response rates at Week 24 in subjects treated with placebo 
40% to 50% ACR 20 response rates at Week 24 in subjects treated with guselkumab
Table 7:
Statistical Power for Treatment Difference in ACR 20 Response at Week 24
Sample size per arm
ACR 20 Response Rate
Power
Placebo Group
Guselkumab Group
Difference (Δ) 
228
20%
40%
20%
>99%
228
20%
45%
25%
>99%
228
25%
45%
20%
99%
228
25%
50%
25%
>99%
228
30%
50%
20%
99%
Major Secondary Endpoint –Change from Baseline in vdH-S Score at Week 24
For change from baseline in vdH-S score, subjects in each treatment group can be considered a 
mixture of 2 subpopulations: 1 subpopulation with a change score of 0 and 1 subpopulation with 
a change score sampled from a normal distribution.  Therefore, the distributionof the vdH-S 
change scores is determined by 3parameters: the probability that a subject has a change score of 
0, mean of the normal distribution, and 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 subjects (including both subpopulations 1 and 2) in that treatment group.
In the Phase3 CNTO1275PSA3001 study with ustekinumab, the following statistics were 
observed on change from baseline in vdH-S score at Week 24:
The overall mean (SD) of change from baseline in vdH-S score at Week 24 (after excluding 
one extreme outlier, eg, the subject with a change score of 58) was 0.92 (2.15), 0.28 (1.94), 
and 0.17 (1.45) in the placebo, ustekinumab 45 mg and 90 mg treatment groups, 
respectively. 
Approximately 49%, 47%, and 46% subjects had a change score of 0 in the placebo, 
ustekinumab 45 mg and 90 mg treatment groups, respectively.
Approximately 40% of 0’s in each group was true 0’s (that is, the difference in the 
reader-level vdH-S score between the 2 readers selected was ≤ 2 and the average of the 
reader-level vdH-S score between the 2 readers selected was 0).

NCT03158285
Excluding the above subjects with a true 0 change score, the mean (SD) change score 
(after one excluding extreme outlier) was 1.59 (2.60), 0.47 (2.50), and 0.32 (1.96) in the 
placebo, ustekinumab 45 mg and 90 mg treatment groups, respectively. Excluding all 
0’s, the mean (SD) change score for the 3 groups was 1.82 (2.75), 0.52 (2.64), and 0.32 
(1.96).

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Assuming an overall mean change of 0.9 from baseline in vdH-S score in the placebo group, and 
an overall mean change of 0.3in the guselkumab group, and an SDof 2.5 for each treatment 
group, a sample size of 228 subjects per treatment group (684 in total) will provide a power of 
approximately 90% to detect a significant treatment difference at a 2-sided significance level of 
0.05.  Table 8provides the statistical power under various assumptions.  The statistical power 
was estimated based on 10000simulations with treatment comparison performed at each 
simulation using an ANOVA test on the van der Waerden normal score.  
For this study, the sample size was determined based on the following assumptions:

The overall mean difference in change from baseline in vdH-S score at Week 24 between 
the placebo group and a guselkumab group ranges from 0.6 to 0.8.
40% –50% subjects in each treatment group have a change score of 0 from baseline in 
vdH-S score at Week 24 (ie, the subpopulation with a change score of 0). 

For the other subjects (those from the normal distributions), the SD of the normal 
distributions is 2.5 for all treatment groups and the mean of the normal distribution is 
1.80 for the placebo group. 
If the SD of the normal distributionsis 3.0, the power will go down to as low as approximately
80%. 
Table 8:
Statistical Power for Treatment Difference in vdH-S Change from Baseline at Week 24 
Placebo Group
Guselkumab Group
Overall
Mean 
Difference 
Power
%subjects 
without change
Rest of 
subjects
Overall
mean
%subjects
without change
Rest of 
subjects
Overall
mean
Mean
SD
Mean
SD
45%
1.80
2.5
1.00
45%
0.71
2.5
0.40 
0.60
89.0%
45%
1.80
2.5
1.00
45%
0.35
2.5
0.20 
0.80
98.9%
50%
1.80
2.5
0.90
50%
0.60
2.5
0.30 
0.60
91.7%
50%
1.80
2.5
0.90
50%
0.20
2.5
0.10 
0.80
99.4%
50%
1.80
2.5
0.90
45%
0.55
2.5
0.30 
0.60
91.1%
50%
1.80
2.5
0.90
45%
0.18
2.5
0.10 
0.80
99.2%
11.3. Efficacy Analyses
11.3.1.
Primary Endpoint Analyses
NCT03158285
The primary endpoint to be analyzed for the primary analysis is proportion of subjects who 
achieved an ACR 20 response at Week 24.Note that the intercurrent event of Treatment Failure 
prior to Week 24 (defined below) will be treated as non-response for the primary analysis, 
regardless of the observed ACR 20 response status.

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Subjects who meet the following treatment failure criteria includesubjects who:
1. Discontinued study agent injections due to lack of efficacy.
2. Terminate study participation for any reason.
3. Initiated or increased the dose of non-biologic DMARDs (MTX, SSZ, HCQ, LEF) or 
oral corticosteroids over baseline for PsA.
4. Initiated protocol prohibited medications/therapies for PsA. 
Subjects with missing data at Week 24 will be considered non-responders. 
The treatment effect of each guselkumab group versus placebo will be tested usinga CMHtest 
stratified by baseline non-biologic DMARD (MTX, SSZ, HCQ, LEF)use(yes/no) and the most 
recentavailable CRP value prior to randomization(<2.0 mg/dL or ≥2.0mg/dL). The magnitude 
of the effect will be estimated by the difference in ACR 20 response rates betweenthe 
guselkumab and placebo groups with the 95% confidence interval calculated based on Wald 
statistics.
In order to control the overall Type 1 error rate, the primary analysis will be tested in a fixed 
sequence.
1. Guselkumab 100 mg q4w versus placebo in ACR 20 response at Week 24
2. Guselkumab 100 mg at Weeks0, 4, and then q8w versus placebo in ACR 20 response at 
Week 24
With the above specified order, each of the hypotheses will be tested at a 2-sided α-level of 0.05 
provided that significance isachieved for the preceding hypothesis in the specified order. If a 
given comparison is not significant at the 2-sided α-level of 0.05, the remaining treatment group 
comparisons will be considered as supportive analysis.
To evaluate the robustness of the primaryendpointanalysis results,the exhaustive scenario 
tipping pointsensitivity analyses will be performedby varying the amount of non-responder 
imputation for missing data.
Additional sensitivity/supplemental analyses which vary how intercurrent events (eg, treatment 
failures) 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 
for the primary and alternative estimands (which will also be defined in the SAP).
Subgroup Analyses
NCT03158285
Subgroup analysis will be performed to evaluate consistency in the primary efficacyendpointby 
demographic characteristics, baseline disease characteristics, and baseline medications. 
Interaction testbetween the subgroups and treatment group will also be provided ifappropriate.

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11.3.2.
Major Secondary Analyses
The major secondary endpointsare provided in Section 2.1.2.
The methods of analysis and the approach to control the Type I error for multiplicity, as well as 
the data-handling rules for the major secondary endpoints will be specified in the SAP.  
11.3.3.
Other Planned Secondary Analyses
In addition to the primaryanalyses andmajor secondary analyses, all other secondary endpoints 
(Section 2.1.2) will be descriptively summarized over time by treatment groups. Treatment 
comparisons will be performed by visit through Week24.  The methods of analysis and the data-
handling rules will be provided in the SAP.
11.4. 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.
If feasible, a population PK analysis using a nonlinear mixed effects modeling approach will be 
used to characterize the disposition characteristics of guselkumab. 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.
11.5. Immunogenicity Analyses
The incidence and titers of antibodies to guselkumab will be summarized for all subjects who 
receive at least 1 dose of guselkumab and have appropriate samples for detection of antibodies to 
guselkumab (ie, subjects with at least 1 sample obtained after their first dose of guselkumab). 
The incidence of NAbs to guselkumab will be summarized for subjects who are positive for 
antibodies to guselkumab and have samples evaluable for NAbs.
11.6. Biomarkers Analyses
Results will be presented in a separate biomarker technical report.
11.7.
Pharmacokinetic/Pharmacodynamic Analyses
NCT03158285
If data permit, the relationships between serum guselkumab concentration and efficacy may be 
analyzed graphically.  If a relationship is observed, a suitable PK/PD model may be developed to 
describe the exposure-response relationship and will be presented in a separate technical report.

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11.8. Pharmacogenomic Analyses
Results will be presented in a separate pharmacogenomics technical report.
11.9. Health Economics Analysis
The change from baseline in impact of disease on work productivity and daily activity via 
WPAI:PsAwill be descriptively summarized by treatment group over time and compared 
between treatment groups at Week 24.
11.10. Safety Analyses
Routine safety evaluations will be performed.  Adverse events, serious AEs (SAEs), and 
infections will be summarized by treatment group.
The following analyses will also be used to assess the safety of subjects in the study:

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.
The laboratory parameters and change from baseline in selected laboratory parameters 
(hematology and chemistry).

The incidence of Common Terminology Criteria for Adverse Events Grade 3 or 
Grade4 abnormal laboratory parameters (hematology and chemistry).
Listings of serious infections and anaphylactic reaction/serum sickness reactions will also be 
provided.  All safety analyses will be based on the population of subjects who received at least 1 
injection of study agent; subjects will be summarized by the treatment they actually received. 
11.11. Interim Analysis
No interim analysis is planned for this study.
11.12. Data Monitoring Committee
NCT03158285
An independent DMC will be established to monitor unblinded data on an ongoing basis through 
at least the Week 24 database lock (DBL)to ensure the continuing safety of the subjects enrolled 
in the study.
The DMC will have 3 to 6 members who are independent of the Sponsor.  None of the members 
will be participating in the current study. The DMC will consist of at least 1 medical expert in 
the relevant therapeutic area and at least 1 statistician. The members of the committee will be 
specified prior to study initiation. The major function of this committee will be to monitor the 
safety of the study agent and to provide recommendations for placing the study on hold or 
stopping the study in the event that any unanticipated serious events occur.

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The committee will meet periodically to review interim data. After the review, the DMC will 
make recommendations regarding the continuation of the study. 
SAE reports will be provided to the DMC members on an ongoing monthly basis.  Periodic 
safety reviewswill occur every 4months.  The DMC may change the frequency or number of 
reviews based on interim safety findings and may request additional data.  The safety reviews 
will focus on particular AEs, SAEs, and mortality.  
In addition, during the study, theSponsor
's study responsible physician (or designee) will 
regularly review blinded safety data from the sites and notify the DMC and appropriate Sponsor 
personnel of any issues.  
The content of the safety summaries, the DMC role and responsibilities and the general 
procedures (including communications) and their recommendations on the study conduct will be 
defined and documented in the DMC charter prior to the first DMC review.
12.
ADVERSE EVENT REPORTING
Timely, accurate, and complete reporting and analysisof safety information from clinical studies 
are crucial for the protection of subjects, 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 affiliateswill be conducted in 
accordance with those procedures.
Method of Detecting AdverseEvents and Serious Adverse Events
Care will be taken not to introduce bias when detecting AEs or SAEs. Open-ended and 
nonleadingverbal questioning of the subject is the preferred method to inquire about AE 
occurrence. 
SolicitedAdverse Events
SolicitedAEs are predefined local andsystemic events for which the subject is specifically 
questioned(see Section 9.1.1).
UnsolicitedAdverse Events
UnsolicitedAEs are allAEsfor which the subject isspecifically not questioned.
12.1. Definitions
12.1.1.
Adverse Event Definitions and Classifications
Adverse Event
NCT03158285
An AEis any untoward medical occurrence in a clinical study subject administered a medicinal 
(investigational or non-investigational) product. An AE does not necessarily have a causal
relationship with the treatment. An AE can therefore be any unfavorable and unintended sign 
(including an abnormal finding), symptom, or disease temporally associated with the use of a 

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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 includesany 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 Section12.3.1for 
time of last AErecording).
Serious Adverse Event
An SAE based on ICH and European UnionGuidelines on Pharmacovigilance for Medicinal 
Productsfor Human Use is any untoward medical occurrence that at any dose:
Results in death
Is life-threatening
(The subject 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*
*
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 subject or may require intervention to prevent one of the other outcomes 
listed in the definition above. These should usually be considered serious.
If a serious and unexpected AE occurs for which there is evidence suggesting a causal 
relationship between the study agentand the event (eg, death from anaphylaxis), the event must 
be reported as a serious and unexpected suspected adverse reaction even if it is a component of 
the study endpoint (eg, all-cause mortality).
Unlisted (Unexpected) Adverse Event/ReferenceSafety Information
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An AE is considered unlisted if the nature or severity is not consistent with the applicable 
product referencesafety information. For guselkumab, the expectedness of an AE will be 
determined by whether or not it is listed in the Investigator
's Brochure.

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Adverse Event Associated With theUse of the Drug
An AEis considered associated with the use of the drug if the attribution is possible, probable, or 
very likely (Section12.1.2).
12.1.2.
Attribution Definitions
Not Related
An AEthat is notrelated to the use of the drug.
Doubtful
An AEfor which analternative explanation is more likely, eg,concomitant drug(s), concomitant 
disease(s), or the relationship in time suggests that a causal relationship is unlikely.
Possible
An AEthat might be due to the use of the drug. An alternative explanation, eg,concomitant 
drug(s), concomitant disease(s), is inconclusive. The relationship in time is reasonable; therefore, 
the causal relationship cannot be excluded.
Probable
An AE that might be due to the use of the drug. The relationship in time is suggestive 
(eg,confirmed by dechallenge). An alternative explanation is less likely, eg,concomitant 
drug(s), concomitantdisease(s).
Very Likely
An AEthat is listed as a possible adverse reaction and cannot be reasonably explained by an 
alternative explanation, eg,concomitant drug(s), concomitant disease(s). The relationship in time 
is verysuggestive (eg,it is confirmed by dechallenge and rechallenge).
12.1.3.
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
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:
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 subject (eg,laboratory abnormalities).

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12.2. Special Reporting Situations
Safety events of interest on a Sponsor study agentthat may require expedited reporting or safety 
evaluation include, but are not limited to:
Overdoseof a Sponsorstudy agent
Suspected abuse/misuse of a Sponsorstudy agent
Accidentalor occupationalexposure to a Sponsorstudy agent
Medication error involving a Sponsorproduct (with or without subject/patient exposure to 
the Sponsorstudy agent, eg, name confusion)
Exposure to a Sponsorstudy agentfrom breastfeeding
Special reporting situations should be recorded in the CRF. Any special reporting situation that 
meets the criteria of an SAE should be recorded on the SAEpage of the CRF.
12.3. Procedures
12.3.1.
All Adverse Events
All AEs and special reporting situations, whether serious or non-serious, will be reported from 
the time a signed and dated ICFis obtained until completion of the subject
's last study-related 
procedure,which may include contact for follow-up of safety.  Serious AEs, including those 
spontaneously reported to the investigator within12 weeks after the last dose of study agent, 
mustbe reported using the Serious Adverse Event Form. The Sponsor will evaluate any safety 
information that is spontaneously reported by an investigator beyond the time frame specified in 
the protocol.
All events that meet the definition of an SAE will be reported as SAEs, regardless of whether 
they are protocol-specific assessments.  Anticipated events will be recorded and reported as 
described in Attachment 5
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.
All AEs, regardless of seriousness, severity, or presumed relationship to study agent, must be 
recorded using medical terminology in the source document and the CRF. 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 CRF their opinion concerning the relationship of the 
AEto study therapy. All measures required for AEmanagement must be recorded in the source 
document and reported according to Sponsorinstructions.
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 IEC/IRBthat 
approved the protocol unless otherwise required and documented by the IEC/IRB.A SUSAR 

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will be reported to regulatory authorities unblinded. Participating investigators and IEC/IRB will 
receive a blinded SUSAR summary, unless otherwise specified.
For all studies with an outpatient phase, including open-label studies, the subject 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:
Studynumber

Statement, in the local language(s), that the subject is participating in a clinical study

Investigator
's name and 24-hour contact telephone number
Local Sponsor
's name and 24-hour contact telephone number(for medical staff only)
Sitenumber
Subject number
Any other information that is required to do an emergency breaking of the blind
12.3.2.
Serious Adverse Events
All SAEsoccurring during thestudymust be reported to the appropriate Sponsor contact person 
bystudy-site personnelwithin 24hoursof theirknowledge of the event.
Information regarding SAEs will be transmitted to the Sponsor using the Serious Adverse Event 
Form, which must be completed and signed by a physician fromthe study site, and transmitted to 
the Sponsor within 24 hours. The initial and follow-up reports of an SAE should be made by 
facsimile (fax).
All SAEs that have not resolved by the end of the study, or that have not resolved upon 
discontinuation of the subject
's participation in the study, must be followed until any of the 
following occurs:
Theevent resolves
Theevent stabilizes
The event returns to baseline, if a baseline value/status is available
The event can be attributed to agents other than the study agentor to factors unrelated to 
study conduct

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It becomes unlikely thatany additional information can be obtained (subject 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 an SAE. 
Any event requiring hospitalization (or prolongation of hospitalization) that occurs during the 
course of a subject
's participation in a study must be reported as an SAE, except hospitalizations 
for the following:

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Hospitalizations not intended to treat an acute illness or AE (eg, social reasons such as 
pending placement in long-term care facility).
Surgery or procedureplanned before entry into the study (must be documented in theCRF).
Note:
Hospitalizations thatwere 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 AEthat results in a prolongation of the originally 
planned hospitalization is to be reported as a new SAE.
For convenience the investigator may choose to hospitalize the subject for the duration of 
the treatmentperiod.
The cause of death of a subject in a studywithin12 weeks after the last doseof study agent,
whether or not the event is expected or associated with the study agent, is considered an SAE.
12.3.3. 
Pregnancy
All initial reports of pregnancy in female subjects or partners of male subjects must be reported 
to the Sponsor by the study-site personnelwithin 24 hours of their knowledge of the event using 
the appropriate pregnancy notification form. Abnormal pregnancy outcomes (eg, spontaneous 
abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy) are considered SAEs 
and must be reported using the Serious Adverse Event Form.  Any subject who becomes 
pregnant during the study must be promptly withdrawn from the studyanddiscontinue further 
study treatment.
Because the effect of the study agenton sperm is unknown,pregnancies in partners of male 
subjects included in the study will be reported as noted above.
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the 
infant will be required.
12.3.4.
Events of Special Interest
Any newly identified malignancy or case of active TB occurring after the first administration of 
study agent in subjects participating in this clinical study must be reported by the investigator 
according to the procedures in Section12.2.  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.
12.4. Contacting Sponsor Regarding Safety
The names (and corresponding telephone numbers) of the individuals who should be contacted 
regarding safety issues or questions regarding the study are listed in the Contact Information 
page(s), which will be provided as a separate document.
13.
PRODUCT QUALITY COMPLAINT HANDLING
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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, or reliability of a product, including its labeling or package integrity. A PQC may 

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have an impact on the safety and efficacy of the product. Timely, accurate, and complete 
reporting and analysis of PQC information from studies are crucial for the protection of subjects, 
investigators, and the Sponsor, and are mandated by regulatory agencies worldwide. The 
Sponsor has established procedures in conformity with regulatory requirements worldwide to 
ensure appropriate reporting of PQC information; all studies conducted by the Sponsor or its 
affiliates will be conducted in accordance with those procedures.
13.1. 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.
If the defect is combined with an SAE, the study-site personnelmust report the PQC to the 
Sponsor according to the SAEreporting timelines (refer to Section12.3.2, Serious Adverse 
Events). A sample of the suspected product should be maintained for further investigation if 
requested by the Sponsor.
13.2. Contacting Sponsor Regarding Product Quality
The names (and corresponding telephone numbers) of the individuals who should be contacted 
regarding product quality issues are listed in the Contact Information page(s), which will be 
provided as a separate document.
14.
STUDY AGENTINFORMATION
14.1. Physical Description of Study Agents
The guselkumab supplied for this study is a sterile liquid for SC injection in a single-use PFS 
assembledin aPFS-U.  Each single-use PFS-U contains 100 mg (1 mL fill of liquid) in a 1 mL 
glass syringe with a 27 gauge, 1/2 inch fixed needle and a latex-free rigid needle shield. No 
preservatives are present. The guselkumab solution should be essentially free of visible 
particulate matter. The PFS-U is a passive safety needle guard that is permanently assembled on 
the syringe and incorporates a spring driven shield that automatically extends beyond the PFS 
needle following complete injection of the guselkumab PFS contents. Guselkumab will be 
manufactured and provided under the responsibility of the Sponsor. Refer to the Investigator
's 
Brochure for a list of excipients.
Placebo for guselkumabis supplied as a sterile liquid for SC injection at a nominal volumeof 
1.0mL in a single-use PFS assembled with the PFS-U. 
Concomitantmedications, including those in Table4, will not be supplied by the Sponsor but 
rather must be acquired from a commercial pharmacy.
14.2. Packaging
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The investigational supplies will be uniquely packaged to assure that they are appropriately 
managed throughout the supply chain process.

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14.3. Labeling
Study agentlabels will contain information to meet the applicable regulatory requirements.
14.4. Preparation, Handling, and Storage 
All study agentmust be stored at controlled temperatures ranging from 36°F to 46°F (2°C to 
8°C) and protected from light. Vigorous shaking of the product should be avoided. The sterile 
product does not contain preservatives and is designed for single use only. Protection from light 
is not required during administration. 
After Week 52, subjects who are able and who have been appropriately trained in the self-
administration of study agent may self-administer study agent at home, as per the Time and 
Events Schedule.Study personnel will instruct subjects on how to transport, store, and 
administer study agent for at-home use as indicated for thisprotocol.
Further details regarding the storage of guselkumab and placebo will be provided in the Site 
Investigational Product Manual.
14.5. Drug Accountability
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The investigator is responsible for ensuring that all study agentreceived at the site is inventoried 
and accounted for throughout the study. The study agentadministered to the subject must be 
documented on the drug accountability form. All study agentwill be stored and disposed of 
according to the Sponsor
's instructions. Study-site personnel must not combine contents of the 
study agentcontainers.
Study agentsmust 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 agent(including guselkumab and placebo,) must be 
available for verification by the Sponsor
's study site monitor during on-site monitoring visits.
The return to the Sponsor of unused study agents(including guselkumab and placebo) will be 
documented on the drug return form. When the study site is an authorized destruction unit and 
study agentsupplies are destroyed on-site, this must also be documented on the drug return form.
Potentially hazardous materials such as used ampules, needles, syringes and vials containing 
hazardousliquidsshould be disposed of immediately in a safe manner and therefore will not be 
retained for drug accountability purposes. The immediate destruction of these drug supplies 
should be documented in the drug accountability records on site.
Study agentsshould be dispensed under the supervision of the investigator or a qualified member 
of the study-site personnel, or by a hospital/clinic pharmacist. Study agentswill be supplied only 
to subjects participating in the study. Study agentsmay not be relabeled or reassigned for use by 
other subjects.The investigator agrees neither to dispense the study agentfrom, nor store it at, 
any site other than the study sites agreed upon with the Sponsor.

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Subjects whowill be self-administering study agent at home will receive detailed instructions for 
study drug storage and disposal of used syringes and handling of unused study material. These 
subjects will receive a sharps containerto dispose of used syringesand will be instructed to 
return the sharps container and/or unused cartons with syringes. Subjects who self administer at 
home will record study drugadministrations with time and date information on a diary card.
15.
STUDY-SPECIFIC MATERIALS
The investigator will be provided with the following supplies:

Investigator
'sBrochure 
Study site investigational product and procedures manual
Laboratory manual and laboratory supplies
ePRO device and user manual
Interactive voice response system/IWRS manual 

Electronic data capture (eDC)manual
Sample ICF
Imaging manual
iPad
®and site user guide, if the study site is participating in electronic informed consent
16.
ETHICAL ASPECTS
16.1. Study-Specific Design Considerations
NCT03158285
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects 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 subjects who are fully able to understand the risks, 
benefits, and potential AEs ofthe study, and provide their consent voluntarily will be enrolled.
The primary ethical concern isthat subjects with active disease may receive placebo for 
24weeks. However, the placebo controlis 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 subject will be closely monitored during the study and early escape 
has been incorporated in the study design to allow subjects receive additional concomitant 
medications for PsA at the investigator’s discretion if the early escape criterion is met. The
duration of the placebo exposure is limited to 24 weeks and is considered acceptable byICH
(http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E
10_Guideline.pdf).
The total blood volume to be collected is considered to be an acceptable amount of blood to be 
collected over this time period from the population in this study based upon the standard of the 
American Red Cross for blood donation.

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Subjects will be exposed to radiation during radiography of hands/feet collected at Weeks 0, 24, 
52, and100. A total of 0.012 mSV radiation exposure is expected from these procedures, which 
is comparable to ~3 days of exposure to natural background radiation. Additionally 1 Chest X-
ray may be performed at screening if the subject does not have a chest X-ray within 12 weeks 
prior to the first administration of study agent. The exposure from 1 standard chest X-ray is 
0.1mSV,comparable to 10 days of exposure to natural background radiation. 
16.2. Regulatory Ethics Compliance
16.2.1.
Investigator Responsibilities
The investigator is responsible for ensuring that the study is performed in accordance with the 
protocol, current 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 subjects. 
Compliance with this standard provides public assurance that the rights, safety, and well-being of 
study subjects are protected, consistent with the principles that originated in the Declaration of 
Helsinki, and that the study data are credible.
16.2.2.
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 subjects)

Investigator
's Brochure (or equivalent information)and amendments/addenda
Sponsor-approved subject recruiting materials
Information on compensation for study-related injuries or payment to subjects 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 subjects

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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 subjects, data or study conduct, unless required locally), the ICF, applicable 
recruiting materials, and subject compensation programs, and the Sponsor 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.

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Approvalfor 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 subjects, data or study conduct)
Revision(s) to ICF and any other written materials to be provided to subjects

If applicable, new or revised subject recruiting materials approved by the Sponsor
Revisions to compensation for study-related injuries or payment to subjects for participation 
in the study, if applicable
New edition(s) of the Investigator
's Brochure 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 agent

New information that may adversely affect the safety of the subjects or the conduct of the 
study
Deviations from or changes to the protocol to eliminate immediate hazards to the subjects
Report of deaths of subjectsunder 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
For all protocol amendments (excluding theones that are purely administrative, with no 
consequences for subjects, 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). 
16.2.3.
Informed Consent
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Each subjectmust 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 and by the 

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reviewing IEC/IRB and be in a language that the subject 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 Sponsorpolicy.
Before enrollment in the study, the investigator or an authorized member of the study-site 
personnel must explain to potential subjects the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study,and any discomfort participation in the study may entail. 
Subjects 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 
affectthe care the subject will receive for the treatment of his or her disease. Subjects will be 
told that alternative treatments are available if they refuse to take part and that such refusal will 
not prejudice future treatment. Finally, they will be told that the investigator will maintain a 
subject identification register for the purposes of long-term follow up if needed and that their 
records may be accessed by health authorities and authorized Sponsor personnel without 
violating the confidentiality of thesubject, to the extent permitted by the applicable law(s) or 
regulations. By signing the ICF the subject is authorizing such access. 
The subject 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 subject
's personally dated signature. After having obtained the consent, a copy 
of the ICF must be given to the subject.
Subjects 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 subject 
will be asked to sign and personally date a separate ICF indicating agreement to participate in the 
optional researchcomponent. 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 subject.
The subject must be able to read and write and should personally sign the ICF. An impartial 
witness or legally acceptable representative should not sign the ICF on the subject’s behalf.
A limited number of study sites may be asked by the Sponsorto obtain informed consent using a 
validated electronic system instead of a paper-based process.If both parties (Sponsorand the 
study site) agree, and if participation is allowed by local regulations and IEC/IRB requirements, 
the means to facilitate such a process will be provided to the sites by Sponsor. The actual 
mechanism of consenting will be facilitated by the use of an eTablet device (eg, iPad®), but 
overall the consent process will remain the same, as described in this section. At these study 
sites, subjects will still be required to review the entire informed consent as a written document 
on the eTablet and then to apply their handwritten signature electronically by the use of a stylus 
directly onto the eTablet.Alternately, the site will also have the option to print the electronic 
version of the ICF and apply a handwritten signature.
16.2.4.
Privacy of Personal Data
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The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to fulfill the objectives of the study.

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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 subjects confidential.
The informed consent obtained from the subject 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 subject has the right to request through the investigator access to his or her personal data and 
the right to request rectification of any data that are not correct or complete. Reasonable steps 
will be taken to respond to such a request, taking into consideration the nature of the request, the 
conditions of the study, and the applicable laws and regulations.
Exploratory DNA, PD, PK, and immunogenicity research is not conducted under standards 
appropriate for the return of data to subjects. 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 subjects 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.
16.2.5.
Long-Term Retentionof Samples for Additional Future Research
Samples collected in this study may be stored for up to 15 years, starting from last patient, last 
visit(or according to localregulations) for additional research. Samples will only be used to 
understand guselkumab, to understand PsA, to understand differential drug responders, and to 
develop tests/assays related to guselkumaband PsA.  The research may begin at any time during 
the study or the post-studystorage period. 
Stored samples will be coded throughout the sample storage and analysis process and will not be 
labeled with personal identifiers. Subjects may withdraw their consent for their samples to be 
stored for research (refer to Section 10.3).
16.2.6.
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 productif the need for the product persists, unless explicitly 
addressed as a specific ethical consideration in Section16.1
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17.
ADMINISTRATIVE REQUIREMENTS
17.1. 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 subjects, 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. When the change(s) involves 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 must be made as soon as 
possible to discuss the situation and agree on an appropriate course of action. The data recorded 
in the CRF and source documents will reflect any departure from the protocol, and the source
documents will describe this departure and the circumstances requiring it.
17.2. Regulatory Documentation
17.2.1.
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.
17.2.2.
Required Prestudy Documentation
The following documents must be provided to the Sponsor before shipment of study agentto the 
study site:
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, subject compensation programs. This approvalmust 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.

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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 

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obtained to state that this person did not participate in the deliberations or in the 
vote/opinion of the study.
Regulatory authority approvalor 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 followingdocuments must be provided to the Sponsor before enrollment of the first subject:
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
17.3. Subject Identification, Enrollment, and Screening Logs
The investigator agrees to complete a subject identification and enrollment log to permit easy 
identification of each subject during and after the study. This document will be reviewed by the 
Sponsor study-site contact for completeness.
The subject identification and enrollment log will be treated as confidential and will be filed by 
the investigator in the study file. To ensure subject confidentiality, no copy will be made. All 
reports and communications relating to the study will identify subjects by subject identification 
and date of birth if permitted by the local authorities. In cases where the subject is not 
randomized into the study, the date seen and date of birth (as appropriate) will be used.
The investigator must also complete a subject screening log, which reports on all subjects who 
were seen to determine eligibility for inclusion in the study.
17.4. Source Documentation
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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: 
subject 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;prior andconcomitant medication; drug 
receipt/dispensing/return records; study agentadministration information; and date of study 

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completion and reason for early discontinuation of study agentor withdrawal from the study, if 
applicable.
The author of an entry in the source documents should be identifiable.
Specific details required as source data for the study and source data collection methods will be 
reviewed with the investigator before the study and will be described in the monitoring 
guidelines (or other equivalent document).
The following subject-and investigator-completed PsAscales and assessments designated by the 
Sponsorwill be recorded directly into an electronic device and will be considered source data:  
Joint Assessment, Subject’s Assessment of Pain, Subject’s Global Assessment of Disease 
Activity, Physician’s Global Assessment of Disease Activity, Dactylitis and Enthesitis 
Assessments, HAQ-DI, SF-36, FACIT-Fatigue, BASDAI, PASI, DLQI, BSA, EQ-5D, eC-SSRS.
If available,subjects may also use the telephone as an alternative method to complete the 
eC-SSRS assessment.
The minimum source documentation requirements for Section 4.1and Section 4.2that 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 subject interview or other protocol required assessment (eg, physical examination, 
laboratory assessment) and documented in the source documents.
An electronic source system may be utilized, which contains data traditionally maintained in a 
hospital or clinic record to document medical care (eg,electronic source documents) as well as 
the clinical study-specific data fields as determined by the protocol. This data is electronically 
extracted for use by the Sponsor. If the electronic source system is utilized, references made to 
the CRF inthe protocol include the electronic source system but information collected through 
the electronic source system may not be limited to that found in the CRF. Data in this system 
may be considered source documentation.
Duringat-home administration (Weeks56, 60, 64, 72, 80, 88, 92, and 96), subjects will enter
information on their study agent administration on a patient diary.
17.5. Case Report Form Completion
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Case report forms are prepared and provided by the Sponsor for each subject in electronic 
format. All CRF 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 CRF are 
accurate and correct.

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The study data will be transcribed by study-site personnel from the source documents onto an 
electronic CRF, 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 CRF. Any 
such worksheets will become part of the subject
's source documents.  Data must be entered into 
CRF in English. The CRF must be completed as soon as possible after a subject visit and the 
forms should be available for review at the next scheduled monitoring visit.
All subjective 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 CRF are needed after 
the initial entry into the CRF, 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 delegate can generate a query for resolution by the investigator and 
study-site personnel.
17.6. 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,direct 
transmission of clinical laboratory data from a central laboratoryto the Sponsor’s clinical 
database, and electronic transmission of ePRO data to the ePRO vendor database then to the 
Sponsor’s clinical database. Written instructions will be provided for collection, handling, 
storage, and shipment of samples. 
Guidelines for CRF completion will be provided and reviewed with study-site personnel before 
the start of the study 
The Sponsor will review CRF 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.
17.7. Record Retention
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In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all CRF 
and all source documents that support the data collected from each subject, as well as all study 
documents as specified in ICH/GCP Section8, 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 2years 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 2years have elapsed since the formal 
discontinuation of clinical development of the investigationalproduct. 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.
17.8. Monitoring
NCT03158285
The Sponsor will use a combination of monitoring techniques(central, remote, on-site 
monitoring)to monitor this study.
The Sponsor 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 visits, the 
monitor will compare data entered into the CRF with the source documents (eg, 
hospital/clinic/physician’s officemedical records); a sample may be reviewed. The nature and 
location of all source documents will be identified to ensure that all sources of original data 
required to complete the CRF are known to the Sponsor 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 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 as requiring central review.

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17.9. Study Completion/Termination
17.9.1.
Study Completion/End of Study
The study is considered completed with the last visit forthe last subject participating in the 
study. The final data from the study site will be sent to the Sponsor (or designee) after 
completion of the final subject visit at that study site, in the time frame specified in the Clinical 
Trial Agreement.
17.9.2.
Study Termination
The Sponsor reserves the right to close the study site or terminate the study at any time for any 
reasonat 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 subjects bythe investigator
Discontinuation of further study agentdevelopment
17.10. On-Site Audits
Representatives of the Sponsor
'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. Subject 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 auditvisits 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 if he or she has 
been contacted by a regulatory agency concerning an upcoming inspection.
17.11. Use of Information and Publication
NCT03158285
All information, including but not limited to information regarding guselkumabor 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 

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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 inthe 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 Sponsorwith all data obtained in the study.
The results of the study will be reported in a ClinicalStudy Report generated by the Sponsor and 
will contain data from all study sites that participated in the study as per protocol. Recruitment 
performance or specific expertise related to the nature and the key assessment parameters of the 
study will be used to determine a coordinating investigator. Results of pharmacogenomic or 
biomarker analyses performed after the Clinical Study Report has been issued will be reported in 
a separate report and will not require a revision of the Clinical Study Report. Study subject 
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 ofMedical Journal 
Editors guidelines,the Sponsor shall have the right to publish such primary (multicenter) data 
and information without approval from the investigator. The investigator has the right to publish 
study site-specific data after the primary data are published. If an investigator wishes to publish 
information from the study, a copy of the manuscript must be provided to the Sponsor for review 
at least 60days 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 60days to allow 
for filing of a patent application. In the event that issues arise regarding scientific integrity or 
regulatory compliance, the Sponsor will review these issues with the investigator. The Sponsor 
will not mandate modifications to scientific content and does not have the right to suppress 
information. For multicenter study designs and substudy approaches, secondary results generally 
should not be published before the primary endpoints of a study have been published. Similarly, 
investigators will recognize the integrity of a multicenter study by not submitting for publication 
data derived from the individual study site until the combined results from the completed study 
have been submitted for publication, within 12months of the availability of the final data (tables, 
listings, graphs), 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 Uniform Requirements for Manuscripts Submitted to 
Biomedical Journals, which state that the named authors must have made a significant 
contribution to the design of the study or analysis and interpretation of the data, provided critical 
review of the paper, and given final approval of the final version.

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Registration of Clinical Studies and Disclosureof Results
NCT03158285
The Sponsor will register and disclose the existence of and the results of clinical studies as 
required by law.

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Attachment 1:The CASPAR Criteria
To meet the CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria, a patient must have inflammatory 
articular disease (joint, spine, or entheseal) with ≥3 points from the following 5 categories:
1. Evidence of current psoriasis, a personal history of psoriasis, or a family history of psoriasis.

Current psoriasis is defined as psoriatic skin or scalp disease present today as judged by a 
rheumatologist or dermatologist.†

A personal history of psoriasis is defined as a history of psoriasis that may be obtained from a patient, 
family physician, dermatologist, rheumatologist, or other qualified health care provider.

A family history of psoriasis is defined as a history of psoriasis in a first-or second-degree relative 
according to patient report.
2. Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis observed on current physical 
examination.
3. A negative test result for the presence of rheumatoid factor by any method except latex but preferably by enzyme-
linked immunosorbent assay or nephelometry, according to the local laboratory reference range.
4. Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded by a 
rheumatologist.
5. Radiographic evidence of juxtaarticular new bone formation, appearing as ill-defined ossification near joint 
margins (but excluding osteophyte formation) on plain radiographs of the hand or foot.
†Current psoriasis is assigned a score of 2; all other features are assigned a score of 1.
Reference
NCT03158285
Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H; CASPAR Study Group. Classification 
criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis & Rheumatism. 
2006;54(8):2665-2673.

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Attachment 2:QuantiFERON® TB Gold Testing
The QuantiFERON®-TB Gold test is one of the interferon-(IFN-) based blood assays for TB screening (Cellestis, 
2009).  It utilizes the recently identified M.tuberculosis-specific antigens ESAT-6 and CFP-10 in the standard 
format, as well as TB7.7 (p4) in the In-Tube format, to detect in vitro cell-mediated immune responses in infected 
individuals.  The QuantiFERON®-TB Gold assay measures the amount of IFN-produced by sensitized T-cells 
when stimulated with the synthetic M. tuberculosis-specific antigens.  In M. tuberculosis-infected persons, sensitized 
Tlymphocytes will secrete IFN-in response to stimulation with the M. tuberculosis-specific antigens and,thus, the 
QuantiFERON®-TB Gold test should be positive.  Because the antigens used in the test are specific to M. 
tuberculosisand not found in BCG, the test is not confounded by BCG vaccination, unlike the tuberculin skin test.  
However, there is some cross-reactivity with the 3 Mycobacterium species, M. kansasii, M. marinum, and 
M.szulgai.  Thus, a positive test could be the result of infection with one of these 3species of Mycobacterium, in 
the absence of M. tuberculosisinfection.
In a study of the QuantiFERON®-TB Gold test (standard format) in subjects with active TB, sensitivity has been 
shown to be approximately 89% (Moriet al, 2004).  Specificity of the test in healthy BCG-vaccinated individuals 
has been demonstrated to be more than 98%.  In contrast, the sensitivity and specificity of the tuberculin skin test 
was noted to be only about 66% and 35% in a study of Japanesepatients with active TB and healthy BCG-
vaccinated young adults, respectively.  However, sensitivity and specificity of the tuberculin skin test depend on the 
population being studied, and the tuberculin skin test performs best in healthy young adults whohave not been 
BCG-vaccinated.
Data from a limited number of published studies examining the performance of the QuantiFERON®-TB Gold assay 
in immunosuppressed populations suggest that the sensitivity of the QuantiFERON®-TB Gold test is better than the 
tuberculin skin test even in immunosuppressed patients (Ferrara et al, 2005; Kobashi et al, 2007; Matulis et al, 
2008).  The ability of IFN--based tests to detect latent infection has been more difficult to study due to the lack of a 
gold standard diagnostic test; however, several TB outbreak studies have demonstrated that the tests correlated 
better than the tuberculin skin test with the degree of exposure that contacts had to the index TB case (Brock et al, 
2004; Ewer et al, 2003).  In addition, TB contact tracing studies have shown that patients who had a positive 
QuantiFERON®-TB Gold test result and were not treated for latent TB infection were much more likely to develop 
active TB during longitudinal follow-up than those who had a positive tuberculin skin test and a negative 
QuantiFERON®-TB Gold test result (Higuchi et al, 2007; Diel et al, 2008).
Although the performance of the new IFN--based blood tests for active or latent M.tuberculosisinfection have not 
been well validated in the immunosuppressed population, experts believe these new tests will be at least as, if not 
more, sensitive, and definitely more specific, than the tuberculin skin test (Barnes, 2004; personal communication, 
April, 2008 TB Advisory Board).
Performing the QuantiFERON®-TB Gold Test
The QuantiFERON®-TB Gold test In-Tube format will be provided for this study.  The In-Tube format contains 1 
additional M. tuberculosis-specific antigen, TB7.7 (p4), which is thought to increase the specificity of the test.  
To perform the test using the In-Tube format, blood is drawn through standard venipuncture into supplied tubes that 
already contain the M. tuberculosis-specific antigens.  Approximately 3 tubes will be needed per subject, each 
requiring 1mL of blood.  One tube contains the M. tuberculosis-specific antigens, while the remaining tubes contain 
positive and negative control reagents.  Thorough mixing of the blood with the antigens is necessary prior to 
incubation.  The blood is then incubated for 16 to 24 hours at 37C, after which tubes are centrifuged for 
approximately 15 minutes at 2000 to 3000g.  Following centrifugation, plasma is harvested from each tube, frozen, 
and shipped on dry ice to the central laboratory.  The central laboratory will perform an ELISA to quantify the 
amount of IFN-
NCT03158285
present in the plasma using spectrophotometry and computer software analysis.
The central laboratory will analyze and report results for each subject, and sites will be informed of the results.  
Subjects who have an indeterminate result should have the test repeated.
In the rare instance that the site isnot able to perform the QuantiFERON®-TB Gold test handling process prior to  
sending to Covance, this test may be performed locally by another laboratory, as approved by the Sponsor.

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Adherence toLocal Guidelines
Local country guidelines for immunocompromised patientsshould be consulted for acceptable antituberculous 
treatment regimens for latent TB.  If no local country guidelines for immunocompromised patients exist, US 
guidelines must be followed. 
In countries in which the QuantiFERON®-TB Gold test is not considered approved/registered, a tuberculin skin test 
is additionally required.
References
Barnes PF. Diagnosing latent tuberculosis infection: Turning glitter to gold [editorial]. Amer J Respir Crit Care 
Med.2004;170:5-6.
Brock I, Weldingh K, Lillebaek T, et al. Comparison of tuberculin skin test and new specific blood test in 
tuberculosis contacts. Am J Respir Crit Care Med.2004;170:65-69.
Cellestis.  QuantiFERON-TB Gold clinicians guide and QuantiFERON-TB Gold In-Tube Method package insert.  
Downloaded from www.cellestis.com, February 2009.
Diel R, Loddenkemper R, Meywald-Walter K, Niemann S, Nienhaus A. Predictive value of a whole blood IFN-
assay for the development of active tuberculosis disease after recent infection with mycobacterium tuberculosis. Am 
J Respir Crit Care Med. 2008;177:1164-1170.
Ewer K, Deeks J, Alvarez L, et al. Comparison of T-cell-based assay with tuberculin skin test for diagnosis of 
Mycobacterium tuberculosisinfection in a school tuberculosis outbreak. Lancet.2003;361:1168-73.
Ferrara G, Losi M, Meacci M, et al. Routine hospital use of a new commercial whole blood interferon-assay for 
the diagnosis of tuberculosis infection. Am J Respir Crit Care Med. 2005; 172:631-635.
Higuchi K, Nobuyuki H, Mori T, Sekiya Y. Use of QuantiFERON-TB Gold to investigate tuberculosis contacts in a 
high school.  Respirology.  007;12:88-92.
Kobashi Y, Mouri K, Obase Y, et al. Clinical evaluation of QuantiFERON TB-2G test for immunocompromised 
patients. Eur Respir J. 2007; 30:945-950.
Matulis G, Jüni P, Villiger PM, Gadola SD. Detection of latent tuberculosis in immunosuppressed patients with 
autoimmune diseases: performance of a Mycobacterium tuberculosis antigen-specific interferon assay. Ann 
Rheum Dis. 2008;67:84-90
Mori T, Sakatani M, Yamagishi F, et al. Specific detection of tuberculosis infection:  An interferon-
NCT03158285
-based assay 
using new antigens. Am J Respir Crit Care Med.2004;170:59-64.

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Attachment 3:Tuberculin Skin Testing
Administering the Mantoux Tuberculin Skin Test
The Mantoux tuberculin skin test (CDC, 2000) is the standard method of identifying persons infected with 
Mycobacterium tuberculosis.  Multiple puncture tests (Tine and Heaf) should not be used to determine whether a 
person is infected because the amount of tuberculin injected intradermally cannot be precisely controlled.  
Tuberculin skin testing is both safe and reliable throughout the course of pregnancy.  The Mantoux tuberculin test is 
performed by placing an intradermal injection of 0.1mL 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 5tuberculin units (TU) of standard 
purified protein derivative (PPD)-S or 2TU of PPD-RT23, Statens Seruminstitut, as recommended by the World 
Health Organization.  PPD strengths of 1TU or 250TU are not acceptable (Menzies, 2000).  Using a disposable 
tuberculin syringe with the needle bevel facing upward, the injection should be made just beneath the surface of the 
skin.  This should produce a discrete, pale elevation of the skin (a wheal) 6mm to 10mm 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.  Subjects should never be allowed to read 
their own tuberculin skin testresults.  If a subject fails to show up for the scheduled reading, a positive reaction may 
still be measurable up to 1week after testing.  However, if a subject 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 subjects may not be immunocompromised at baseline. 
In the US and Canada, an induration of 5mm 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. 
Treatment of Latent Tuberculosis
Local country guidelinesfor immunocompromised patientsshould be consulted for acceptable antituberculous 
treatment regimens for latent TB.  If no local country guidelines for immunocompromised patients exist, US 
guidelines must be followed.
References
NCT03158285
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; Divisionof 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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Attachment 4:Hepatitis B Virus (HBV) Screening with HBV DNA
Subjects must undergo screening for hepatitis B virus (HBV). At a minimum, this includes testing for HBsAg (HBV 
surface antigen), anti-HBs (HBV surface antibody), and anti-HBc total (HBV core antibody total): 

Subjects who test negative for all HBV screening tests (ie, HBsAg-, anti-HBc-, and anti-HBs-) are eligible
for this study.

Subjects who test negativefor surface antigen (HBsAg-) and test positive for core antibody (anti-HBc+) 
andsurface antibody (anti-HBs+) are eligiblefor this study.

Subjects who test positive onlyfor surface antibody(anti-HBs+) are eligiblefor this study.

Subjects who test positivefor surface antigen (HBsAg+) are NOTeligiblefor this study, regardless of the 
results of other hepatitis B tests.

Subjects who test positive only for core antibody (anti-HBc+) must undergo further testing for the 
presence of hepatitis B virus deoxyribonucleic acid (HBV DNA test). If the HBV DNA test is positive, the 
subject is NOT eligiblefor this study. If the HBV DNA test is negative, the subject is eligiblefor this 
study. In the event the HBV DNA test cannot be performed, the subject is NOT eligiblefor this study. 
For subjects who are not eligible for this study due to HBV test results, consultation with a physician with 
expertise in the treatment of hepatitis B virus infection is recommended.  
Eligibility based on hepatitis B virus test results
Hepatitis B test result
Action
Hepatitis B surface 
antigen
(HBsAg)
Hepatitis B surface
antibody
(anti-HBs)
Hepatitis B core 
antibody
(anti-HBc total)
Include
—
—
—
—
+
—
—
+
+
Exclude
+
— or+
— or+
Require testing for presence 
HBV DNA*
—
—
+
* If HBV DNA is detectable, exclude from the  clinical study. If HBV DNA testing cannot be performed, 
or there is evidence of chronic liver disease, exclude from the clinical study.  
NCT03158285

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Attachment5:Anticipated Events
Anticipated Event
Anticipated events will be recorded and reported in this study. 
An anticipated event is an AE(serious or non-serious) that commonly occurs as a consequence of the 
underlying disease or condition under investigation (disease related) or background regimen.
For the purposes of this study the following events will be considered anticipated events:
Worsening of psoriasis
Worsening of PsA
Reporting of Anticipated Events
These events will be captured on the CRF and in the database, and will be reported to the Sponsor as 
described in All Adverse Events. Any event that meets SAEcriteria will be reported to the Sponsor within 
the appropriate timeline as described in Serious Adverse Events(Section 12.3.2). These anticipated events 
are exempt from expedited reporting as individual single cases to Health Authorities. However, if based 
on an aggregate review, it is determined that an anticipatedevent is possibly related to study agent, the 
Sponsor will report these events in an expedited manner.
Anticipated Event Review Committee (ARC)
An Anticipated Event Review Committee (ARC) will be established to perform reviews of pre-specified 
anticipatedevents at an aggregate level. The ARC is a safety committee within the Sponsor’s organization 
that is independent of the Sponsor’s study team. The ARC will meet to aid in the recommendation to the 
Sponsor’s study team as to whether there is a reasonable possibility that an anticipated event is related to 
the study agent.
Statistical Analysis
NCT03158285
Details of statistical analysis of anticipated events, including the frequency of review and threshold to 
trigger an aggregate analysis of anticipated events will be provided in a separate Anticipated Events 
Safety Monitoring Plan.

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INVESTIGATOR AGREEMENT
NCT03158285