Conditions: Spondylitis, Ankylosing Arthritis, Psoriatic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 100
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety of subcutaneous (SC) golimumab in participants with active Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) over 24 weeks.

Detailed description:
This post-marketing study will evaluate safety and efficacy profile of golimumab (a fully human anti-Tumour Necrosis Factor alpha \[TNF-alpha\] monoclonal antibodies \[mAb\], administered subcutaneously) in a real-world in Indian participants with active spondyloarthropathy of ankylosing spondylitis (AS) or psoriatic arthritis (PsA). AS is a chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, axial skeleton, entheses, and peripheral joints. PsA is a chronic, inflammatory, usually rheumatoid factor negative arthritis that is associated with psoriasis. Golimumab binds with high affinity to human TNF-alpha and inhibits TNF-alpha bioactivity, TNF-alpha-mediated cell cytotoxicity and TNF-alpha mediated endothelial cell activation. Golimumab also induces activation of complement-mediated cell lysis and reduces the development of arthritis. Study evaluation includes efficacy (efficacy parameters for AS and PsA) and safety. Participant's safety will be monitored throughout the study. The total duration of study will be approximately 24 weeks.

Arms:
arm 1: Participants will receive golimumab 50 milligram (mg) subcutaneous (SC) injection at Week 0 and every 4 weeks (q4w) thereafter through Week 24. Concomitant medications may be allowed on a case by case basis as per the physician's judgement.

Interventions: intervention 1: Golimumab
Intervention descriptions: intervention 1: Participants will receive golimumab 50 mg SC injections at Week 0 and q4w thereafter through Week 24.

Protocol document:
Prot_000.pdf: 
 
 
 
Johnson & Johnson Private Limited 
 
Clinical Protocol 
 
A Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and 
Efficacy of Golimumab (a Fully Human Anti-TNFα Monoclonal Antibody, Administered 
Subcutaneously) in the Treatment of Indian Patients with Active Spondyloarthropathy of 
Ankylosing Spondylitis or Psoriatic Arthritis 
 
Protocol CNTO148SPD4001; Phase 4 
 
AMENDMENT 1 
SIMPONI (Golimumab)  
 
 
This compound is approved for marketing in India for the following indications in adults: 
• Moderately to severely active rheumatoid arthritis in combination with methotrexate 
• Active psoriatic arthritis alone 
• Active ankylosing spondylitis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Status: 
Approved 
Date: 
2 July 2018 
Prepared by:   Johnson & Johnson Private Limited 
EDMS number: EDMS-ERI-155893782; 3.0 
 
GCP Compliance:  This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory 
requirements.  
Confidentiality Statement 
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 disclosed 
by them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as 
privileged or confidential. 
NCT03733925


SIMPONI (Golimumab) 
Clinical Protocol CNTO148SPD4001 
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Approved, Date: 2 July 2018 
TABLE OF CONTENTS 
TABLE OF CONTENTS ............................................................................................................................... 2 
LIST OF IN-TEXT TABLES AND FIGURES ............................................................................................... 4 
PROTOCOL AMMENDMENTS ................................................................................................................... 5 
STUDY SYNOPSIS........................................................................................................................................ 6 
ABBREVIATIONS ...................................................................................................................................... 13 
1.
INTRODUCTION .............................................................................................................................. 15 
1.1. 
Background ...................................................................................................................................... 15 
1.1.1. 
Ankylosing spondylitis .................................................................................................................. 15 
1.1.2. 
Psoriatic Arthritis .......................................................................................................................... 16 
1.1.3. 
Rationale for Golimumab in Ankylosing Spondylitis and Psoriatic Arthritis ....................................... 17 
1.2. 
Overall Rationale for the Study .......................................................................................................... 17 
2.
OBJECTIVES, ENDPOINTS, AND HYPOTHESIS ........................................................................... 18 
2.1. 
Objectives ........................................................................................................................................ 18 
2.2. 
Endpoints ......................................................................................................................................... 18 
2.3. 
Hypothesis ....................................................................................................................................... 18 
3.
STUDY DESIGN AND RATIONALE ................................................................................................. 19 
3.1. 
Overview of Study Design ................................................................................................................. 19 
3.2. 
Study Design Rationale ..................................................................................................................... 20 
4.
SUBJECT POPULATION .................................................................................................................. 21 
4.1. 
Inclusion Criteria .............................................................................................................................. 21 
4.2. 
Exclusion Criteria ............................................................................................................................. 22 
4.3. 
Prohibitions and Restrictions ............................................................................................................. 24 
5.
TREATMENT ALLOCATION AND BLINDING .............................................................................. 24 
6.
DOSAGE AND ADMINISTRATION ................................................................................................. 24 
7.
TREATMENT COMPLIANCE .......................................................................................................... 25 
8.
PRESTUDY AND CONCOMITANT THERAPY ............................................................................... 25 
9.
STUDY EVALUATIONS.................................................................................................................... 25 
9.1. 
Study Procedures .............................................................................................................................. 25 
9.1.1. 
Overview ...................................................................................................................................... 25 
9.1.2. 
Screening Visit: Visit 1 / Day (-7 to -1) ........................................................................................... 26 
9.1.3. 
Treatment and Assessment Visits .................................................................................................... 27 
9.2. 
Safety Evaluations ............................................................................................................................ 30 
9.3. 
Efficacy Evaluations for Ankylosing Spondylitis ................................................................................. 31 
9.4. 
Efficacy Evaluations for PsA ............................................................................................................. 32 
10.
SUBJECT COMPLETION/DISCONTINUATION OF STUDY TREATMENT/
WITHDRAWAL FROM THE STUDY ............................................................................................... 33 
10.1. 
Completion ...................................................................................................................................... 33 
10.2. 
Discontinuation of Treatment............................................................................................................. 33 
10.3. 
Withdrawal from the Study ................................................................................................................ 34 
11.
STATISTICAL METHODS................................................................................................................ 34 
11.1. 
Analysis Population .......................................................................................................................... 35 
11.1.1. 
Safety Population .......................................................................................................................... 35 
11.1.2. 
Intent-to-Treat Population .............................................................................................................. 35 


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11.2. 
Sample Size Determination ................................................................................................................ 35 
11.3. 
Endpoints: ........................................................................................................................................ 35 
11.4. 
Safety Analyses ................................................................................................................................ 36 
11.5. 
Efficacy Analyses ............................................................................................................................. 36 
11.6. 
Interim Analysis ............................................................................................................................... 36 
12. 
ADVERSE EVENT REPORTING ...................................................................................................... 36 
12.1. 
Definitions ....................................................................................................................................... 36 
12.1.1. 
Adverse Event Definitions and Classifications ................................................................................. 36 
12.1.2. 
Attribution Definitions ................................................................................................................... 37 
12.1.3. 
Severity Criteria ............................................................................................................................ 38 
12.2. 
Special Reporting Situations .............................................................................................................. 38 
12.3. 
Procedures ....................................................................................................................................... 39 
12.3.1. 
All Adverse Events ........................................................................................................................ 39 
12.3.2. 
Serious Adverse Events ................................................................................................................. 40 
12.3.3. 
Pregnancy ..................................................................................................................................... 41 
12.4. 
Contacting Sponsor Regarding Safety ................................................................................................. 42 
13. 
PRODUCT QUALITY COMPLAINT HANDLING ........................................................................... 42 
13.1. 
Procedures ....................................................................................................................................... 42 
13.2. 
Contacting Sponsor Regarding Product Quality ................................................................................... 42 
14. 
STUDY DRUG INFORMATION ........................................................................................................ 42 
14.1. 
Physical Description of Study Drug(s) ................................................................................................ 42 
14.2. 
Packaging ........................................................................................................................................ 42 
14.3. 
Labelling.......................................................................................................................................... 43 
14.4. 
Preparation, Handling, and Storage .................................................................................................... 43 
14.5. 
Drug Accountability.......................................................................................................................... 43 
15. 
STUDY-SPECIFIC MATERIALS ...................................................................................................... 43 
16. 
ETHICAL ASPECTS ......................................................................................................................... 44 
16.1. 
Study-Specific Design Considerations ................................................................................................ 44 
16.2. 
Regulatory Ethics Compliance ........................................................................................................... 44 
16.2.1. 
Investigator Responsibilities ........................................................................................................... 44 
16.2.2. 
Independent Ethics Committee or Institutional Review Board ........................................................... 44 
16.2.3. 
Informed Consent .......................................................................................................................... 45 
16.2.4. 
Privacy of Personal Data ................................................................................................................ 46 
17. 
ADMINISTRATIVE REQUIREMENTS ............................................................................................ 47 
17.1. 
Protocol Amendments ....................................................................................................................... 47 
17.2. 
Regulatory Documentation ................................................................................................................ 47 
17.2.1. 
Regulatory Approval/Notification ................................................................................................... 47 
17.2.2. 
Required Prestudy Documentation .................................................................................................. 47 
17.3. 
Patient Identification, Enrolment, and Screening Logs ......................................................................... 48 
17.4. 
Source Documentation ...................................................................................................................... 48 
17.5. 
Case Report Form Completion ........................................................................................................... 49 
17.6. 
Data Quality Assurance/Quality Control ............................................................................................. 50 
17.7. 
Record Retention .............................................................................................................................. 50 
17.8. 
Monitoring ....................................................................................................................................... 51 
17.9. 
Study Completion/Termination .......................................................................................................... 51 
17.9.1. 
Study Completion/End of Study ..................................................................................................... 51 
17.9.2. 
Study Termination ......................................................................................................................... 51 
17.10. 
On-Site Audits .................................................................................................................................. 52 
17.11. 
Use of Information and Publication .................................................................................................... 52 
REFERENCES ............................................................................................................................................ 54 
APPENDIX A: 
EVALUATION OF ANKYLOSING SPONDYLITIS ...................................................... 56 


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APPENDIX B: 
PATIENT GLOBAL ASSESSMENT (PGA) - NRS: ....................................................... 57 
APPENDIX C: TOTAL AND NIGHT SPINAL PAIN - NRS: ...................................................................... 58 
APPENDIX D: 
BATH ANKYLOSING SPONDYLITIS FUNCTIONAL INDEX (BASFI) 
ASSESSMENT ................................................................................................................................... 59 
APPENDIX E: 
THE BATH ANKYLOSING SPONDYLITIS DISEASE ACTIVITY INDEX 
(BASDAI) SCALE: ............................................................................................................................. 60 
APPENDIX F: 
THE CLASSIFICATION CRITERIA FOR PSORIATIC ARTHRITIS 
[CASPAR] CLASSIFICATION CRITERIA FOR PSORIATIC ARTHRITIS .................................... 61 
APPENDIX G: 
AMERICAN COLLEGE OF RHEUMATOLOGY PRELIMINARY 
DEFINITION OF IMPROVEMENT IN RHEUMATOID ARTHRITIS* (ACR20) ............................. 62 
1. 
TENDER JOINT COUNT ASSESSMENT (28 JOINT COUNT) ........................................................ 63 
2. 
SWOLLEN JOINT COUNT ASSESSMENT (28 JOINT COUNT) ..................................................... 63 
3. 
PATIENT’S ASSESSMENT OF PAIN ............................................................................................... 63 
4. 
PATIENT’S GLOBAL ASSESSMENT OF DISEASE ACTIVITY – VAS .......................................... 64 
5. 
PHYSICIAN’S GLOBAL ASSESSMENT OF DISEASE ACTIVITY – VAS ...................................... 64 
6. 
HEALTH ASSESSMENT QUESTIONNAIRE (HAQ-DI)© ................................................................ 65 
7. 
ACUTE-PHASE REACTANT VALUE............................................................................................... 67 
APPENDIX H: 
TUBERCULIN SKIN TESTING .................................................................................... 68 
APPENDIX I: 
QUANTIFERON-TB GOLD TESTING ......................................................................... 69 
INVESTIGATOR AGREEMENT ................................................................................................................ 71 
 
LIST OF IN-TEXT TABLES AND FIGURES 
TABLES 
Table 1: 
TIME AND EVENTS SCHEDULE ..................................................................................................... 10 
 
FIGURES 
Figure 1: 
Schematic Overview of the Phase IV clinical study for a single subject ........................................... 20 
 
 
 


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PROTOCOL AMMENDMENTS 
 
Protocol Version  
Issue Date 
Original Protocol 
17-Jan-2018 
Amendment 1 
02-Jul-2018 
 
Amendment_1 (02-Jul-2018)  
The overall reason for the amendment: the overall reason for this amendment was to provide clarification to the 
existing inclusion criteria with definition of Inadequate response, dose, duration of partial responder and time period 
of assessment for patients with Ankylosing Spondylitis and Psoriatic Arthritis as suggested by DCGI. 
Applicable Section(s) 
Description of Change(s) 
Rationale: As requested by the DCGI, definition of inadequate response, dose, duration of partial responder 
and time period of assessment for patients with Ankylosing Spondylitis was provided as a clarification to 
the existing inclusion criteria for Ankylosing Spondylitis. 
Synopsis; 
4.1 Inclusion Criteria 
Patients with Ankylosing Spondylitis, having an Inadequate response (defined as 
BASDAI ≥4) to current or past therapies (including biologics naïve patients). Patients 
who were receiving NSAIDs or DMARDs had to have received continuous therapy 
for 3 months at the highest recommended doses or had to have been unable to receive 
a full 3-month course of full-dose NSAID or DMARD therapy because of intolerance, 
toxicity, or contraindications. Maximum recommended dosages for DMARDs if used, 
would be: methotrexate 25 mg/week, oral corticosteroids (≤10 mg/day of prednisone 
or equivalent) or sulfasalazine 3 g/day. 
Rationale: As requested by the DCGI, definition of inadequate response, dose, duration of partial responder and 
time period of assessment for patients with Psoriatic Arthritis was provided as a clarification to the existing 
inclusion criteria for Psoriatic Arthritis. 
Synopsis; 
4.1 Inclusion Criteria 
Patients with Psoriatic Arthritis, having an inadequate response (defined by presence 
of active arthritis [presence of any swollen or any tender joint]) despite current or 
previous therapies (including biologics naïve patients). Patients who were receiving 
NSAIDs or DMARDs had to have received continuous therapy for 3 months at the 
highest recommended doses or had to have been unable to receive a full 3-month 
course of full-dose NSAID or DMARD therapy because of intolerance, toxicity, or 
contraindications. Maximum recommended dosages for DMARDs, if used would be: 
methotrexate 25 mg/week, oral corticosteroids (≤10 mg/day of prednisone or 
equivalent), sulfasalazine 3 g/day or leflunomide 20 mg/day. 
 
 
 


SIMPONI (Golimumab) 
 
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STUDY SYNOPSIS 
A Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and Efficacy of 
Golimumab (a Fully Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously) in the 
Treatment of Indian Patients with Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic 
Arthritis  
The term "sponsor" used throughout this document refers to the entities listed in the Contact Information 
page(s), which will be provided separately. 
Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive 
forms of human tumour necrosis factor α (TNFα, a cytokine protein). This interaction prevents the binding 
of TNFα to its receptors, thereby inhibiting the biological activity of TNFα. Golimumab antibody does not 
bind to other TNF superfamily ligands, including human lymphotoxin. Golimumab does not lyse human 
monocytes expressing transmembrane TNF in the presence of complement or effector cells. Elevated TNFα 
levels in the blood, synovium, and joints have been implicated in the pathophysiology of several chronic 
inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis (PsA), and ankylosing spondylitis 
(AS). 
Post-marketing Phase IV clinical trial is useful in identifying new safety issues and trends, which were not 
observed in previously conducted controlled clinical studies. The data obtained from the present study will 
help to understand the safety and efficacy profile of golimumab in a real-world Indian scenario compared 
with that obtained in a controlled clinical environment.  
The objective of the present study is to address the mandatory regulatory requirement of Indian Health 
Regulatory Authority (Drugs Controller General of India [DCGI]) regarding conduct of study in Indian 
population to monitor the adverse events (AEs) with SIMPONI® (golimumab 50 mg) in patients of AS or 
PsA with active disease. The study will assess the safety of SIMPONI® prescribed as per locally approved 
prescribing information in Indian patients with active AS or PsA. 
OBJECTIVES 
Primary Objective 
• 
To assess the safety of subcutaneous (SC) golimumab in patients with active AS or PsA over 24 weeks. 
Secondary Objectives 
• 
To assess the efficacy of SC golimumab in patients with active AS or PsA as measured by reduction 
in signs and symptoms of arthritis in active AS or PsA at Week 14. 
• 
To assess achievement of sustained arthritis response in patients with active AS or PsA at Week 24. 
HYPOTHESIS 
No formal hypothesis testing will be conducted.  
OVERVIEW OF STUDY DESIGN 
This is an open-label, multicentre, interventional, noncomparative, single-arm, Phase IV study to assess the 
safety and efficacy of golimumab in Indian patients with active spondyloarthropathy of AS or PsA. 
Approximately, 100 patients (50 patients of AS and 50 patients of PsA) selected by investigators and 
determined to be eligible for golimumab treatment per protocol eligibility criteria will be enrolled in the 
study, after obtaining written informed consent. Patients will be monitored for AEs during 24 weeks of 
treatment with golimumab and till end of study (EOS) visit (8 weeks after the last dose of golimumab). 
Participating investigator will be trained on the locally approved prescribing information of golimumab by 
the sponsor designee before the enrolment of first patient. Commercial stocks of SIMPONI® will be used 


SIMPONI (Golimumab) 
 
Clinical Protocol CNTO148SPD4001 
7 
Approved, Date: 2 July 2018  
for the patients enrolled in the study with appropriate labelling and will be provided free of cost to the 
patient enrolled for 24 weeks treatment. Patients will procure SIMPONI® from the existing distribution 
channel (regular supply chain) as obtained by routine patients but the drug will be free of cost for clinical 
trial patients as per the mentioned duration in the study protocol. Study drug will be administered at the 
investigator study site by the investigator or an appropriately licensed and authorized health professional 
(under the supervision of the investigator). 
Screening Visit (Visit 1 / Day [-7 to -1]): 
After obtaining the signed informed consent, data will be collected at this visit including demographics, 
medical history, disease-related history, concomitant medications, and laboratory investigations.  
Treatment Visits: 
Patients who qualify will be enrolled in the study and will receive the study drug on confirmation of their 
enrolment status. Patients will receive golimumab 50 mg SC injections at Week 0 and every 4 weeks 
thereafter through Week 24 (ie Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24).   
Assessment Visit:  
This visit will be an additional visit conducted at Week 14. In this visit, all the assessments will be 
performed for evaluating efficacy endpoints at Week 14. 
End of treatment (EOT) Visit: 
The EOT visit will be conducted after the completion of 24 weeks SIMPONI® treatment (at Week 24) or 
on the day at which the patient discontinues the SIMPONI® treatment or study.  
End of Study (EOS) Visit:  
End of study visit (in-person or telephonic as per convenience of the patient) will be conducted 8 weeks 
after the EOT visit or after the last dose of golimumab (whichever is earlier), to inquire about any AEs 
experienced by the patient. Any clinically significant abnormalities persisting at the EOS/early withdrawal 
will be followed by the investigator until resolution or until a clinically stable endpoint is reached.  
All the study-related activities or procedures of each and every visit of this Phase IV clinical trial are 
summarized in the TIME AND EVENTS SCHEDULEError! Reference source not found., presented 
after the synopsis. 
SUBJECT POPULATION 
Patients eligible for the study will be men or women (excluding pregnant or nursing women; men and 
women planning a pregnancy) aged 18 years or older who have had a definite diagnosis of AS or PsA prior 
to first study drug administration. 
Key criteria for AS patients:  
Adult patients who have definite diagnosis of AS (according to the Modified New York Criteria) and either 
have an inadequate response (defined as BASDAI ≥4) to current or past therapies (including biologics naïve 
patients). Patients who were receiving NSAIDs or DMARDs had to have received continuous therapy for 
3 months at the highest recommended doses or had to have been unable to receive a full 3-month course of 
full-dose NSAID or DMARD therapy because of intolerance, toxicity, or contraindications. Maximum 


SIMPONI (Golimumab) 
 
Clinical Protocol CNTO148SPD4001 
8 
Approved, Date: 2 July 2018  
recommended dosages for DMARDs if used, would be: methotrexate 25 mg/week, oral corticosteroids (≤10 
mg/day of prednisone or equivalent) or sulfasalazine 3 g/day. 
Key criteria for PsA patients: 
Patients who have definite diagnosis of active PsA (according to the ClASsification criteria for Psoriatic 
ARthritis [CASPAR]) prior to the first administration of study drug and have at least 1 of the PsA subsets: 
distal interphalangeal joint arthritis, polyarticular arthritis with the absence of rheumatoid nodules, arthritis 
mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis; patients who are negative 
for rheumatoid factors according to the reference range of the local laboratory conducting the test and have 
inadequate response (defined by presence of active arthritis [presence of any swollen or any tender joint]) 
despite current or previous therapies (including biologics naïve patients). Patients who were receiving 
NSAIDs or DMARDs had to have received continuous therapy for 3 months at the highest recommended 
doses or had to have been unable to receive a full 3-month course of full-dose NSAID or DMARD therapy 
because of intolerance, toxicity, or contraindications. Maximum recommended dosages for DMARDs, if 
used would be: methotrexate 25 mg/week, oral corticosteroids (≤10 mg/day of prednisone or equivalent), 
sulfasalazine 3 g/day or leflunomide 20 mg/day. 
Further screening as per inclusion and exclusion criteria will apply. 
DOSAGE AND ADMINISTRATION 
Golimumab will be prescribed to the patients as per locally approved prescribing information. The 
recommended dose of SIMPONI® is 50 mg administered by SC injection once a month for both AS and 
PsA. 
ENDPOINTS: 
Safety Endpoint 
• 
Occurrence of an AE/ serious adverse event (SAE) (clinical or laboratory safety event). 
Efficacy Endpoints 
• 
Proportion of AS patients achieving at least 20% improvement in the Assessment of Spondyloarthritis 
International Society criteria (ASAS20) at Week 14. 
• 
Proportion of PsA patients meeting the American College of Rheumatology 20% improvement criteria 
(ACR20) at Week 14. 
• 
Proportion of AS patients achieving ASAS20 criteria at Week 24. 
• 
Proportion of PsA patients meeting the ACR20 criteria at Week 24. 
SAFETY EVALUATIONS 
Routine safety evaluations will be performed for AEs and SAEs and will be summarized. Safety will be 
assessed by evaluating the incidence and type of AEs, including SAEs, causality, or clinically significant 
AEs (as per principal investigator’s discretion), and discontinuations due to AEs and routine clinical 
laboratory values. Frequency of serious infections, including tuberculosis, demyelinating disorders, new 
onset of autoimmune diseases, and malignancies will be summarized. The incidence of study drug injection-
site reactions will be noted. The laboratory (haematology and chemistry) parameters and change from 
baseline in laboratory parameters will be assessed. The incidence of markedly abnormal laboratory 
(haematology and chemistry) parameters will also be evaluated. 
STATISTICAL METHODS 
Sample Size Determination: 




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Table 1: 
TIME AND EVENTS SCHEDULE 
 
Schedule of events 
 
Screening 
Week 0 
Week 4 
Week 8 
Week 12 
Week 
14 
Week 16 
Week 20 
Week 24 
Week 32k 
Visit 
Day 
Visit 1 
Day (-7 to -
1) 
(±4 days) 
Visit 2 
Day 1 
(±4 days) 
Visit 3 
Day 28 
(±4 days) 
Visit 4 
Day 56 
(±4 days) 
Visit 5 
Day 84 
(±4 days) 
Visit 6 
Day 98 
(±4 
days) 
Visit 7 
Day 112 
(±4 days) 
Visit 8 
Day 140 
(±4 days) 
Visit 9 
Day 168 
(±4 days) 
Visit 10 
Day 224 
(±4 days) 
 
 
Approximatel
y start of 
Month 1 
Approximatel
y start of 
Month 2 
Approximatel
y start of 
Month 3 
Approximatel
y start of 
Month 4 
 
Approximatel
y start of 
Month 5 
Approximatel
y start of 
Month 6 
Approximatel
y end of 
Month 6 
Approxim
ately end 
of Month 8 
Assessment/Study 
Procedurea 
 
 
 
 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
 
Physical 
Examination 
X 
 
 
 
 
 
 
 
 
 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Height and 
Weight 
X 
 
 
 
 
 
 
 
 
 
Chest X-rayb 
X 
 
 
 
 
 
 
 
 
 
Serum Pregnancy 
Test 
X 
 
 
 
 
 
 
 
 
 
Urine Pregnancy 
Test 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
HLA B-27 Statusc 
X 
 
 
 
 
 
 
 
 
 
HIV, HBV and 
HCV testd 
X 
 
 
 
 
 
 
 
 
 
ECG 
X 
 
 
 
 
 
 
 
 
 
TB Suspicion & 
Evaluatione 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
QuantiFeron - TB 
Gold Test 
X 
 
 
 
 
 
 
 
 
 
Tuberculin Skin 
Test  
X 
 
 
 
 
 
 
 
 
 
Review of 
Eligibility Criteria 
X 
X 
 
 
 
 
 
 
 
 
Study Drug 
Injection 
 
X 
X 
X 
X 
 
X 
X 
X 
 


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Study Drug 
Injection-site 
Evaluationf 
 
X 
X 
X 
X 
 
X 
X 
X 
 
ASAS20 Response 
Evaluationg 
 
X 
X 
 
 
X 
 
 
X 
 
BASDAI 
Evaluation (NRS) 
X 
X 
X 
 
 
X 
 
 
X 
 
BASFI Evaluation 
(NRS) 
 
X 
X 
 
 
X 
 
 
X 
 
Total and Night 
Spinal Pain 
Assessment (NRS) 
X 
X 
X 
 
 
X 
 
 
X 
 
Patient Global 
Assessment (NRS) 
 
X 
X 
 
 
X 
 
 
X 
 
ACR20 Response 
Evaluationh 
 
X 
X 
 
 
X 
 
 
X 
 
HAQ 
 
X 
X 
 
 
X 
 
 
X 
 
CRP (quantitative 
mg/L) 
X 
X 
X 
 
 
X 
 
 
X 
 
ESR 
X 
X 
X 
 
 
X 
 
 
X 
 
Routine 
Laboratory 
Analysesi 
X 
 
 
 
 
 
 
 
X 
 
Concomitant 
Medication 
Review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
AE/SAE Reviewj 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
a. All assessments are to be completed prior to study drug injection, except at Week 14 (no study drug injection), unless otherwise specified. 
 
b. May be taken within 3 months prior to Week 0. 
 
c. This test should be performed if previous results are not available (for AS subjects). 
 
d. ELISA test for HIV, HBsAg test for HBV, and Anti-HCV test for HCV will be performed. 
 
e. If TB is suspected at any time during the study, a chest x-ray, QuantiFERON-TB Gold test, and tuberculin skin test should be performed. 
 
f. Subjects should be monitored for the occurrence of AEs for 30 minutes after study drug administration. 
 
g. For AS subjects, evaluations include BASDAI, BASFI, patient’s global assessment, total back pain, and night back pain assessments. 
 
h. For PsA subjects, evaluations include tender and swollen joint count assessment, Patient’s assessment of pain, Patient’s global assessment of disease activity, 
Physician’s global assessment of disease activity, HAQ and Acute-phase reactant (ESR and CRP). 
 
i. Routine Labs: Samples for routine laboratory analyses (haemoglobin, haematocrit, platelet count, total and differential white blood cell count, blood urea 
nitrogen, creatinine, total bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, sodium, potassium, blood glucose, albumin and 
total protein) will be collected. 
j. If there is any ongoing AE at last visit, it will be followed up till resolution or considered stable as per investigator 


SIMPONI (Golimumab) 
 
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k. End of study (EOS) visit (in-person or telephonic as per convenience of the patient) will be conducted 8 weeks after the EOT Visit or after the last dose of 
golimumab (whichever is earlier), to inquire about any AEs experienced by the patient. 
 
 
Abbreviations: ACR20=American College of Rheumatology 20% improvement criteria; AE=Adverse event; ASAS20=Assessment in SpondyloArthritis 
International Society 20% improvement criteria; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=The Bath Ankylosing Spondylitis 
Functional Index; CRP=C-reactive protein; ECG=electrocardiogram; ESR=erythrocyte sedimentation rate; HAQ=Health Assessment Questionnaire; 
HBV=hepatitis B virus; HCV=hepatitis C virus; HIV=human immunodeficiency virus; HLA-B27=human leukocyte antigen-B27; NRS=numerical rating scale; 
SAE=Serious Adverse Event; TB=Tuberculosis 


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ABBREVIATIONS 
ACR20 
American College of Rheumatology 20% Improvement Criteria 
AE(s) 
Adverse Event(s) 
ALT 
Alanine Aminotransferase 
AS 
Ankylosing Spondylitis  
ASAS20 
Assessment in SpondyloArthritis International Society 20% Improvement 
Criteria 
AST 
Aspartate Aminotransferase 
BASDAI 
Bath AS Disease Activity Index  
BASFI 
Bath AS Functional Index 
BCG 
Bacille Calmette-Guérin 
BUN 
Blood Urea Nitrogen 
CASPAR 
The ClASsification criteria for Psoriatic ARthritis  
CHF 
Congestive Heart Failure 
CRP 
C-reactive Protein 
DCGI 
Drugs Controller General of India 
DIP 
Distal Interphalangeal  
DMARD 
Disease Modifying Antirheumatic Drugs 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form(s) 
eDC 
Electronic Data Capture 
EOS 
End of study  
EOT 
End of treatment 
ESR 
Erythrocyte Sedimentation Rate 
GCP 
Good Clinical Practice 
HAQ 
Health Assessment Questionnaire 
HBV 
Hepatitis B Virus  
HCV 
Hepatitis C Virus  
HIV 
Human Immunodeficiency Virus 
HLA-B27 
Human Leukocyte Antigen-B27 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
ITT 
Intention-to-Treat 
IV 
Intravenous 
LAR 
Legally Acceptable Representative  
mAb 
Monoclonal Antibodies 
MCP 
Metacarpophalangeal  
MTX 
Methotrexate 
NCI-CTCAE 
National Cancer Institute Common Terminology Criteria for Adverse Events 
NRS 
Numerical Rating Scale 
PGA 
Patient Global Assessment 
PIP 
Proximal Interphalangeal  
PQC 
Product Quality Complaint 
PsA 
Psoriatic Arthritis 
RA 
Rheumatoid Arthritis  


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SAE(s) 
Serious Adverse Event(s) 
SC 
Subcutaneous 
SD 
Standard Deviation 
SSZ 
Sulfasalazine 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TB 
Tuberculosis 
TNF 
Tumour Necrosis Factor 
VAS 
Visual Analogue Scale (Score) 
WBC 
White Blood Cell 
 
 
 


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1. 
INTRODUCTION 
Golimumab is a human monoclonal antibody (mAb) that binds to both the soluble and 
transmembrane bioactive forms of human tumour necrosis factor α (TNFα, a cytokine protein). This 
interaction prevents the binding of TNFα to its receptors, thereby inhibiting the biological activity 
of TNFα. Golimumab antibody does not bind to other TNF superfamily ligands, including human 
lymphotoxin. Golimumab does not lyse human monocytes expressing transmembrane TNF in the 
presence of complement or effector cells. Elevated TNFα levels in the blood, synovium, and joints 
have been implicated in the pathophysiology of several chronic inflammatory diseases such as 
rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). TNFα is an 
important mediator of the articular inflammation that is characteristic of these diseases. Treatment 
with golimumab has been shown to decrease the levels of C-reactive protein (CRP), interleukin 6, 
matrix metalloproteinase 3, intercellular adhesion molecule 1 and vascular endothelial growth factor 
in patients with RA, PsA, and AS.1 
Golimumab is indicated for the treatment of adult patients with active PsA. It is also indicated for 
the treatment of adult patients with active AS.1 
For the most comprehensive nonclinical and clinical information regarding golimumab, refer to the 
latest version of the prescribing information of SIMPONI®.1 
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. 
Ankylosing spondylitis 
Ankylosing spondylitis is a chronic inflammatory disease of unknown etiology that involves the 
sacroiliac joints, axial skeleton, entheses, and peripheral joints. Chronic inflammation of entheses 
leads to new bone formation, syndesmophytes, and ankylosis of joints, primarily in the axial 
skeleton, that may lead to dramatic loss of range of motion and to disability. The disease may also 
have nonskeletal manifestations, including uveitis, carditis, pulmonary fibrosis, bowel 
inflammation, 
and 
cardiac 
conduction 
abnormalities. 
Considered 
a 
subset 
of 
the 
spondyloarthropathies, AS is strongly associated with the presence of the human leukocyte antigen-
B27 (HLA-B27).2 
The mean AS prevalence per 10,000 (from 36 eligible studies) was 23.8 in Europe, 16.7 in Asia, 
31.9 in North America, 10.2 in Latin America and 7.4 in Africa. The prevalence of AS is generally 
believed to be between 0.1% and 1.4% globally.3 AS is traditionally considered as a predominantly 
male disease, with a commonly reported male:female ratio around 3:1. Moreover, a slower 
progression rate for spinal ankylosis was found in female patients, although they reported 
significantly more pain and need for drug therapy.4 
Although patients may experience a variety of musculoskeletal symptoms (proximal arthralgias, 
chest pain, and tenderness around peripheral joints from enthesitis), the most common presenting 
symptom is chronic low-back pain. The low-back pain usually begins before the age of 40 years, is 


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insidious in onset, associated with morning stiffness, and eventually, is symmetrical. These 
musculoskeletal symptoms may be associated with constitutional symptoms, such as fatigue, fever, 
and weight loss.5 
Until recently, treatment has been limited to nonsteroidal anti-inflammatory drugs and 
physiotherapy, but the development of cytokine inhibitors that inhibit the activity of TNFα has been 
an important advance in treatment.6 The current management approach to AS requires a 
combination of nonpharmacologic and pharmacologic treatment modalities. Appropriate and timely 
use of TNFα antagonists is an additional option for patients with active AS who are inadequately 
controlled with conventional treatment. TNF-α inhibitor therapies have demonstrated rapid and 
consistent effectiveness in reducing the axial and peripheral symptoms of AS, and improving patient 
function and quality of life.  
1.1.2. 
Psoriatic Arthritis 
Psoriatic arthritis is a chronic, inflammatory, usually rheumatoid factor negative arthritis that is 
associated with psoriasis. Psoriasis affects 2% to 3% of the population. Psoriatic arthritis develops 
in approximately 30% of psoriatics. The reported prevalence of PsA varies from 7% to 42%.7 The 
prevalence of psoriasis in the general Caucasian population is approximately 2%. Psoriatic arthritis 
affects men and women equally and peaks between the ages of 30 and 55 years.8  
Psoriatic arthritis involves peripheral joints, axial skeleton, sacroiliac joints, nails, and entheses, and 
is associated with psoriatic skin lesions.8,9 The presentation of PsA can be categorized into 5 
overlapping clinical patterns, which include oligoarthritis in approximately 22% to 37% of patients; 
polyarthritis in 36% to 41% of patients; arthritis of distal interphalangeal (DIP) joints in up to 20% 
of patients; spondylitis affecting approximately 7% to 23% of patients; and arthritis mutilans in 
approximately 4% of patients.9,10 Over one-third of patients with PsA also develop dactylitis and 
enthesitis.9,11 More than one-half of the patients with PsA may have evidence of erosions on x-rays, 
and up to 40% of the patients develop severe, erosive arthropathy.9,10 Psoriatic arthritis leads to 
functional impairment, reduced quality of life, and increased mortality.10,11,12,13 
Most of the treatments currently used for PsA were adapted from experience in the RA patient 
population. Despite the progressive and potentially disabling nature of PsA, and in contrast with 
RA, only a few, randomized, controlled trials have examined the role of traditional disease 
modifying antirheumatic drugs (DMARDs) in the treatment of PsA.14,15,16,17 In these studies, 
methotrexate (MTX), cyclosporine, sulfasalazine (SSZ), and leflunomide demonstrated efficacy in 
the treatment of this condition, although the treatments were associated with a time lag of several 
weeks between treatment initiation and a clinically significant response in either arthritis or 
psoriasis (MTX, cyclosporine), or only had modest efficacy on the skin (SSZ, leflunomide). 
Corticosteroids are rarely used to treat PsA since they are known to cause severe psoriasis flares 
upon withdrawal.  
Until recently the main classification criteria for psoriatic arthritis were those of Moll and Wright. 
These are not suitable to diagnose early PsA (sensitivity 80 to 85%). Now ClASsification criteria 
for Psoriatic ARthritis [CASPAR] with high sensitivity and specificity have been developed.7 


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New biologic treatments targeting TNF, including the recombinant soluble TNF receptor etanercept 
and the monoclonal anti-TNFα antibodies infliximab and adalimumab, were recently shown to 
induce rapid and significant improvement of arthritis and psoriasis in subjects with active PsA while 
maintaining an acceptable safety profile.18,19,20 
Etanercept and adalimumab are administered either twice weekly, weekly, or every 2 weeks by 
subcutaneous (SC) injection, while infliximab is administered as an intravenous (IV) infusion in an 
office based setting at Week 0, 2, 6, and every 8 weeks thereafter. Golimumab, a fully human 
monoclonal anti-TNFα antibody, administered every 4 weeks by SC injection, may optimize 
convenience of use and provide efficacy comparable to infliximab.  
1.1.3. 
Rationale for Golimumab in Ankylosing Spondylitis and Psoriatic Arthritis 
The safety and efficacy profile of anti-TNFα therapy for a variety of rheumatological indications, 
including AS & PsA, has been well characterized. Although therapy with anti-TNFα agents has 
been used successfully in the treatment of AS, anti-TNFα agents have limitations with respect to 
safety, dosing regimen, cost, and immunogenicity. To address some of these limitations, the sponsor 
has developed a fully human anti-TNFα mAb, designated golimumab (also known as CNTO 148 
and rTNV148B). Like REMICADE® (infliximab), a human/murine chimeric anti-TNFα mAb, 
golimumab binds with high affinity to human TNFα and inhibits TNFα bioactivity. The constant 
regions of both the heavy and light chains of golimumab have amino acid sequences identical to the 
corresponding constant regions of infliximab. Golimumab contains human variable regions (fully 
human mAb), whereas infliximab contains mouse variable regions (mouse/human chimeric mA). 
Preclinical in vitro studies have demonstrated that golimumab has high affinity for soluble TNFα 
and inhibits TNFα binding to the TNFα receptor with a 2- to 4-fold greater potency than infliximab. 
In addition, golimumab inhibits TNFα-mediated cell cytotoxicity and TNFα mediated endothelial 
cell activation. Golimumab also induces activation of complement-mediated cell lysis and reduces 
the development of arthritis in mice that over-express human TNFα. 
SIMPONI® (golimumab) was approved in USA and Europe for treatment of active AS and PsA 
since 2009. Refer to the latest prescribing information of SIMPONI® for updated information 
regarding premarketing safety and efficacy of golimumab in AS and PsA. 
1.2. 
Overall Rationale for the Study 
Post-marketing Phase IV clinical trial is useful in identifying new safety issues and trends, which 
were not observed in previously conducted controlled clinical studies. The data obtained from the 
present study will help to understand the safety and efficacy profile of golimumab in a real-world 
Indian scenario compared with that obtained in a controlled clinical environment. The objective of 
the present study is to address the mandatory regulatory requirement of Indian Health Regulatory 
Authority (Drugs Controller General of India [DCGI]) regarding conduct of study in Indian 
population to monitor the adverse events (AEs) with SIMPONI® (golimumab 50 mg) in patients of 
AS or PsA with active disease. The study will assess the safety of SIMPONI® prescribed as per 
locally approved prescribing information in Indian patients with active AS or PsA. 


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2. 
OBJECTIVES, ENDPOINTS, AND HYPOTHESIS 
2.1. 
Objectives 
Primary Objective 
• 
To assess the safety of SC golimumab in patients with active AS or PsA over 24 weeks. 
Secondary Objectives 
• 
To assess the efficacy of SC golimumab in patients with active AS or PsA as measured by 
reduction in signs and symptoms of arthritis in active AS or PsA at Week 14. 
• 
To assess achievement of sustained arthritis response in patients with active AS or PsA at Week 
24. 
2.2. 
Endpoints 
Safety Endpoint 
• 
Occurrence of an AE/SAE (clinical or laboratory safety event). 
Efficacy Endpoints 
• 
Proportion of AS patients achieving at least 20% improvement in the Assessment of 
Spondyloarthritis International Society criteria (ASAS20) at Week 14. 
• 
Proportion of PsA patients meeting the American College of Rheumatology 20% Improvement 
Criteria (ACR20) criteria at Week 14. 
• 
Proportion of AS patients achieving ASAS20 criteria at Week 24. 
• 
Proportion of PsA patients meeting the ACR20 criteria at Week 24. 
Refer to Section 9, Study Evaluations for evaluations related to endpoints. 
2.3. 
Hypothesis 
No formal hypothesis testing will be conducted. 
 
 


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3. 
STUDY DESIGN AND RATIONALE 
3.1. 
Overview of Study Design 
This is an open-label, multicentre, interventional, noncomparative, single-arm, Phase IV study to 
evaluate safety and efficacy of golimumab (a fully human anti-TNFα mAb, administered 
subcutaneously) in the treatment of Indian patients with active spondyloarthropathy of AS or PsA. 
A total of 100 patients will be enrolled in this study. Approximately, 50% patients would be enrolled 
for each indication. Enrollment of participants with the diagnosis of AS and PsA will start 
simultaneously. After enrollment of all 50 participants with one of the disease condition (AS or 
PsA) the recruitment of participants for that particular disease condition should be stopped, while 
recruitment for the other disease condition should continue until 50 participants are recruited. 
Patients will receive golimumab 50 mg SC injections at Week 0 and every 4 weeks thereafter 
through Week 24. The end of treatment (EOT) visit is defined as the time the last subject completes 
the Week 24 visit. End of study (EOS) visit (in-person or telephonic as per convenience of the 
patient) will be conducted 8 weeks after the EOT Visit or after the last dose of golimumab 
(whichever is earlier), to inquire about any AEs experienced by the patient.  
A diagram of the study design is provided below in Figure 1 


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Visit 1 (Day -7 to Day -1) 
 
Written Informed Consent and Screening Procedures (to select 
100 eligible subjects) 
Safety of the subjects will be assessed throughout the study beginning from 
signing the informed consent form to EOS 
 
 
 
 
 
Visit 2 (Week 0/Day 1 ± 4) 
 
Treatment Visit 
Eligible subjects will receive the first dose of golimumab 50 mg 
subcutaneous (SC) 
 
 
 
 
 
Visit 3 (Week 4/Day 28 ± 4) 
Visit 4 (Week 8/Day 56 ± 4) 
Visit 5 (Week 12/Day 84 ±4) 
 
Treatment Visits 
Subjects will continue to receive golimumab 50 mg SC, every 4 
weeks 
 
 
 
 
 
Visit 6 (Week 14/Day 98 ±4) 
 
Assessment Visit 
Efficacy assessments will be performed at this visit. 
 
 
 
 
 
Visit 7 (Week 16/Day 112 ±4) 
Visit 8 (Week 20/Day 140 ±4) 
 
Treatment Visits 
Subjects will continue to receive golimumab 50 mg SC, every 4 
weeks 
 
 
 
 
 
Visit 9 (Week 24/Day 168 ±4) 
 
End of Treatment (EOT) Visit 
Subjects will receive golimumab 50 mg SC, as the last dose of 
the study treatment and undergo EOT assessments. 
 
Subjects may continue golimumab treatment per discretion of 
the treating physician, but they will no longer be part of the 
study. 
 
If a subject discontinues golimumab treatment before Week 24, 
he/she will undergo EOT assessments on the day of 
discontinuation. 
Visit 10 (8 weeks after the last dose 
of golimumab) 
 
End of Study (EOS) Visit 
EOS visit (in-person or telephonic as per convenience of the 
patient) will be conducted 8 weeks after the EOT visit or after 
the last dose of golimumab (whichever is earlier), to inquire 
about any AEs experienced by the patient. 
 
Figure 1: 
Schematic Overview of the Phase IV clinical study for a single subject 
 
3.2. 
Study Design Rationale 
This is an open-label, multicentre, interventional, noncomparative, single-arm, Phase IV study to 
assess the safety and efficacy of golimumab in Indian patients with active spondyloarthropathy of 
AS or PsA. Approximately, 100 patients (50 patients of AS and 50 patients with PsA) selected by 
investigators and determined to be eligible for golimumab treatment per protocol eligibility criteria 
will be enrolled in the study, after obtaining written informed consent. Patients will be monitored 
for AEs during 24 weeks of treatment with golimumab and till EOS visit. Participating investigator 
will be trained on the locally approved prescribing information of golimumab by the sponsor 
designee before the enrolment of first patient. Commercial stocks of SIMPONI® will be used for 
the patients enrolled in the study with appropriate labelling and will be provided free of cost to the 
subject enrolled for 24 weeks treatment. Patients will procure SIMPONI® from the existing 
distribution channel (regular supply chain) as obtained by routine patients but the drug will be free 
of cost for clinical trial patients as per the mentioned duration in the study protocol. 


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4. 
SUBJECT POPULATION 
Screening for eligible patients will be performed within 7 days before administration of the study 
drug. 
The inclusion and exclusion criteria for enrolling patients in this study are described in the following 
2 subsections. If there is a question about the inclusion or exclusion criteria below, the investigator 
must consult with the appropriate sponsor representative and resolve any issues before enrolling a 
patient in the study. Waivers are not allowed.  
For a discussion of the statistical considerations of subject selection, refer to Section 11.2, Sample 
Size Determination. 
4.1. 
Inclusion Criteria 
All potential subject must satisfy all of the following criteria to be enrolled in the study: 
1. Are man or woman 18 years of age or older. 
2. Women of childbearing potential or men capable of fathering children must be using 
adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, 
barrier method with spermicide, surgical sterilization) during the study and must be willing 
to use such birth control measures for 6 months after receiving the last administration of 
study drug. Female subjects of childbearing potential must test negative for pregnancy. 
3. Are considered eligible per the following tuberculosis (TB) screening criteria: 
a. Have no history of TB prior to screening. 
b. Have no signs or symptoms suggestive of active TB upon medical history and/or 
physical examination. 
c. 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 to or 
simultaneously with the first administration of study drug. 
d. Within 6 weeks prior to the first administration of study drug, have a negative 
QuantiFERON-TB Gold and a negative tuberculin skin test result, or have a newly 
identified positive QuantiFERON-TB Gold or tuberculin skin test result during 
screening in which active TB has been ruled out and for which appropriate treatment 
for latent TB has been initiated either prior to or simultaneously with the first 
administration of study drug.  
e. Have a chest radiograph (both posterior-anterior and lateral views), taken within 
3 months prior to the first administration of study drug and read by a qualified 
radiologist, with no evidence of current active TB or old inactive TB. 
4. Have screening laboratory test results as follows: 
a. Haemoglobin more than or equal to 8.5 g/dL 
b. White blood cells (WBC) count more than or equal to 3.5 × 103 cells/micro-litre 
c. Platelets more than or equal to 100 x 103 cells/micro-litre 


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d. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level 
not exceeding 1.5 times the upper limits of normal for the laboratory conducting the 
test. 
e. Serum creatinine not exceeding 1.5 mg/dL 
5. Are willing and able to adhere to the study visit schedule and other protocol requirements. 
6. Are capable of giving informed consent, which must be obtained prior to any study-related 
procedures. 
For Patients with AS: 
1. Have a diagnosis of definite AS (according to the Modified New York Criteria).21 
2. Have symptoms of active disease at screening and at baseline, as determined by the treating 
physician. 
3. Either has an inadequate response (defined as BASDAI ≥4) to current or past therapies 
(including biologics naïve patients). Patients who were receiving NSAIDs or DMARDs had 
to have received continuous therapy for 3 months at the highest recommended doses or had 
to have been unable to receive a full 3-month course of full-dose NSAID or DMARD 
therapy because of intolerance, toxicity, or contraindications. Maximum recommended 
dosages for DMARDs if used, would be: methotrexate 25 mg/week, oral corticosteroids 
(≤10 mg/day of prednisone or equivalent) or sulfasalazine 3 g/day. 
For Patients with PsA: 
1. Have PsA that was diagnosed at least 6 months prior to the first administration of study drug 
(according to the CASPAR).22 
2. Have active PsA at the time of screening and at baseline, as determined by the treating 
physician. 
3. Have at least 1 of the PsA subsets: DIP joint arthritis, polyarticular arthritis with the absence 
of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis 
with peripheral arthritis. 
4. Are negative for rheumatoid factors according to the reference range of the local laboratory 
conducting the test. 
5. Have inadequate response (defined by presence of active arthritis [presence of any swollen 
or any tender joint]) despite current or previous therapies (including biologics naïve 
patients). Patients who were receiving NSAIDs or DMARDs had to have received 
continuous therapy for 3 months at the highest recommended doses or had to have been 
unable to receive a full 3-month course of full-dose NSAID or DMARD therapy because of 
intolerance, toxicity, or contraindications. Maximum recommended dosages for DMARDs, 
if used would be: methotrexate 25 mg/week, oral corticosteroids (≤10 mg/day of prednisone 
or equivalent), sulfasalazine 3 g/day or leflunomide 20 mg/day. 
4.2. 
Exclusion Criteria 
1. Are pregnant, nursing, or planning a pregnancy or fathering a child during the study or 
within 6 months after receiving the last administration of study drug. 


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2. Have a known hypersensitivity to human immunoglobulin proteins or other components of 
golimumab. 
3. Have been treated with any investigational drug within 5 half-lives of that drug prior to the 
first administration of study drug. 
4. Have a history of latent or active granulomatous infection, including histoplasmosis, or 
coccidioidomycosis, prior to screening. Refer to inclusion criteria for information regarding 
eligibility with a history of latent TB. 
5. Have a chest radiograph within 3 months prior to the first administration of study drug that 
shows an abnormality suggestive of a malignancy or current active infection, including TB. 
6. Have had a nontuberculous mycobacterial infection or opportunistic infection (eg, 
cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening. 
7. Have received, or are expected to receive, any live virus or bacterial vaccination within 
3 months before the first administration of study drug, during the study, or within 6 months 
after the last administration of study drug. 
8. Have a history of an infected joint prosthesis, or have received antibiotics for a suspected 
infection of a joint prosthesis, if that prosthesis has not been removed or replaced. 
9. Have had a serious infection (including but not limited to, hepatitis, pneumonia, sepsis, or 
pyelonephritis), or have been hospitalized for an infection, or have been treated with IV 
antibiotics for an infection within 2 months prior to first administration of study drug. Less 
serious infections (eg, acute upper respiratory tract infection, simple urinary tract infection) 
need not be considered exclusionary at the discretion of the investigator. 
10. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not 
limited to, chronic renal infection, chronic chest infection (eg,  bronchiectasis), sinusitis, 
recurrent urinary tract infection (eg, recurrent pyelonephritis, chronic non-remitting 
cystitis), an open, draining, or infected skin wound, or an ulcer. 
11. Are currently infected (including carriers) with Human Immunodeficiency Virus (HIV), 
hepatitis B virus (HBV) or hepatitis C virus (HCV). 
12. Have a history of known demyelinating diseases such as multiple sclerosis or optic neuritis. 
13. Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, 
hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric, or 
cerebral disease. 
14. Have a history of, or concurrent congestive heart failure (CHF), including medically 
controlled, asymptomatic CHF. 
15. Have a history of lymphoproliferative disease, including lymphoma, or signs suggestive of 
possible lymphoproliferative disease such as lymphadenopathy of unusual size or location, 
or clinically significant splenomegaly. 
16. Have any known malignancy or have a history of malignancy within the previous 5 years 
(except for a nonmelanoma skin cancer that has been treated with no evidence of 
recurrence). 
17. Have a transplanted organ (except for a corneal transplant performed >3 months prior to 
first administration of study drug). 


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18. Have or have had a substance abuse (drug or alcohol) problem within the previous 3 years. 
19. Are unwilling or unable to undergo multiple venipunctures. 
20. Are participating in another study with an investigational drug or procedure. 
NOTE: Investigators should ensure that all study enrolment criteria have been met at screening. If 
a patient's clinical status changes (including any available laboratory results or receipt of additional 
medical records) after screening but before the first dose of study drug is given such that he or she 
no longer meets all eligibility criteria, then the patient will be excluded from participation in the 
study. Section 17.4, Source Documentation, describes the required documentation to support 
meeting the enrolment criteria. 
4.3. 
Prohibitions and Restrictions 
Potential patients 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. Prohibitions and restrictions regarding concomitant therapy during the study (refer to 
Section 8 Prestudy and Concomitant Therapy for details regarding prohibited and restricted 
therapy during the study). 
2. Agree to follow all requirements that must be met during the study as noted in Section 4.1 
and 4.2 the Inclusion and Exclusion Criteria, respectively (eg, contraceptive requirements). 
5. 
TREATMENT ALLOCATION AND BLINDING 
Treatment Allocation 
This, being a single-arm study, eligible patients will be sequentially enrolled in the study and will 
receive golimumab 50 mg SC injections starting at Week 0 and every 4 weeks thereafter, up to 
Week 24. Randomization is not applicable to this study design.  
Blinding 
As this is an open study, blinding procedures are not applicable. 
6. 
DOSAGE AND ADMINISTRATION 
Golimumab will be prescribed to the patients as per locally approved prescribing information. The 
recommended dose of SIMPONI® is 50 mg administered by SC injection once a month for both AS 
and PsA with or without MTX or other nonbiologic DMARDs (as long as the patient eligibility 
criteria are adhered to when the subject is administered golimumab as part of this study). 
Golimumab will be available as a sterile, liquid for SC injection at a volume of 0.5 mL in prefilled 
single-use syringes (as pen-device Simponi Smartject®). Each prefilled Smartject® will contain 
50 mg golimumab in an aqueous medium of histidine, sorbitol, and polysorbate 80 at pH 5.5. No 
preservatives are present. 
The needle cover may contain dry natural rubber (a derivative of latex), which may cause allergic 
reactions in individuals sensitive to latex. 


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Study drug will be administered at the investigator study site by the investigator or an appropriately 
licensed and authorized health professional (under the supervision of the investigator). All 
administrations through the Week 24 database lock will be given as a single SC injection, containing 
0.5 mL of study drug. Patients will procure study drug from the existing distribution channel 
(regular supply chain) as obtained by routine patients but the drug will be provided free of cost for 
patients enrolled in clinical trial till Week 24. 
7. 
TREATMENT COMPLIANCE 
The appropriate doses of golimumab (50 mg) will be administered as SC injections by designated 
study personnel at the study sites and the details of each administration will be recorded in the 
electronic case report forms (eCRF).  
Injections will be administered at Week 0, 4, 8, 12, 16, 20 and 24 (last dose of golimumab). A 
window period of ±4 days will be allowed for each treatment visit. 
Treatments that are administered outside of the scheduled windows, as well as missed injections or 
visits, will be recorded on the eCRFs. A site monitor designated by the sponsor will monitor all 
eCRFs and Drug Accountability Logs. During these monitoring visits, all procedures will be 
evaluated for compliance with the protocol. 
8. 
PRESTUDY AND CONCOMITANT THERAPY 
Patients should not initiate any new treatment for AS or PsA during the 24-week study period. 
Prestudy therapies administered up to 30 days before first dose of study drug must be recorded at 
screening. 
Concomitant therapies must be recorded throughout the study beginning with start of the first dose 
of study drug until the last dose of study drug. Every effort should be made to keep subject’s 
concomitant medications stable through Week 24 or as specified in the following sections. 
All therapies (prescription or over-the-counter medications, including vaccines, vitamins, herbal 
supplements; non-pharmacologic therapies such as electrical stimulation, acupuncture, special 
diets, exercise regimens) different from the study drug must be recorded in the eCRF. Recorded 
information will include a description of the type of the drug, dosing regimen, route of 
administration, and its indication.  
9. 
STUDY EVALUATIONS 
9.1. 
Study Procedures 
9.1.1. 
Overview 
The TIME AND EVENTS SCHEDULE summarizes the frequency and timing of efficacy, and 
safety measurements applicable to this study. 


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Written informed consent will be obtained from all patients by the principal investigator or his/her 
designee prior to the performance of any protocol-specific procedure. 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 patient's participation in the 
study. 
Once patient is considered eligible to be enrolled in the study, patient will receive golimumab 
treatment for a period of 24 weeks (6 months), which will be provided free of cost. During the study 
period, safety data will be collected at 4-week intervals until 24 weeks and efficacy data will be 
collected at Week 0, Week 4, Week 14 and Week 24. Study visits through and including Week 32 
may occur at the week indicated with an allowed window period of ±4 days. If the recommended 
acceptable window cannot be observed, the sponsor must be contacted before scheduling a visit and 
a deviation in process must be noted in study documents. 
9.1.2. 
Screening Visit: Visit 1 / Day (-7 to -1) 
After informed consent has been obtained at screening, each patient will be assigned a unique 
number for the duration of the trial. 
Indian patients who are eligible to receive SIMPONI® will be considered in the present study. Prior 
to data collection, all patients and/or their legally acceptable representative (LAR) where applicable 
will sign an informed consent form (ICF) allowing data collection and source data verification in 
accordance with local regulations.  
The below mentioned procedure and measurements will be performed at screening visit: 
• Obtaining written informed consent 
• Confirming eligibility criteria check 
• Collection of demographic data 
• Measurement of height and weight 
• Physical examination 
• Examination of vital signs (blood pressure, heart rate, respiratory rate and temperature) 
• Confirmation of diagnosis of AS or PsA and history of the disease 
• Other medical history 
• Electrocardiogram 
• Serum Pregnancy test 
• HIV (ELISA test), HBV (HBsAg test), and HCV (Anti-HCV test)  
• Routine laboratory tests: haemoglobin, haematocrit, platelet count, total and differential 
WBC count, blood urea nitrogen (BUN), creatinine, total bilirubin, alkaline phosphatase, 
ALT, AST, sodium, potassium, blood glucose, albumin and total protein 
• Qualitative urinalysis (dipstick) of protein, glucose, ketones, blood, leucocyte esterase or 
nitrate. If dipstick urine analysis is positive for blood, WBC (eg, leucocyte esterase or 
nitrates), or protein, then complete urinalysis (dipstick and microscopy) will be performed. 
• Chest x-ray 
• QuantiFeron-TB Gold test and tuberculin skin test 


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• Documentation of HLA B-27 status 
• Erythrocyte sedimentation rate (ESR) 
• CRP 
• Bath AS Disease Activity Index (BASDAI) evaluation, 
• Spinal Pain (Numerical Rating Scale [NRS]) assessment 
• Concomitant medications review 
• AE/SAE review (the collection of AE information will start from the time of provision of 
written informed consent) 
9.1.3. 
Treatment and Assessment Visits 
Week 0 (Visit 2/Day 1) 
Patients who qualify will be enrolled in the study and will receive the study drug on confirmation 
of their enrolment status. Before the first administrations of the study drug (Week 0, Day 1), 
assessments/procedures should be performed as indicated in TIME AND EVENTS SCHEDULE. 
Patients must meet all of the inclusion and none of the exclusion criteria that are assessable in the 
clinic at the time of the baseline visit before enrolment in the study. 
The below mentioned procedure and measurements will be performed at this visit: 
• Eligibility Criteria 
• AE/SAE review 
• Concomitant medications review 
• Vital signs (blood pressure, heart rate, respiratory rate and temperature) 
• Urine pregnancy test 
• TB suspicion & evaluation (If TB is suspected at any time during the study, a chest x-ray, 
QuantiFERON-TB Gold test, and tuberculin skin test should be performed) 
• ASAS20 (for AS patient) response evaluation:  
- 
BASDAI evaluation 
- 
Bath AS Functional Index (BASFI) evaluation 
- 
Spinal Pain (NRS) assessment 
- 
Patient global assessment (PGA) (NRS) 
• ACR20 (for PsA patient) response evaluation: 
- 
tender and swollen joint count assessment, 
- 
Patient’s assessment of pain, 
- 
Patient’s global assessment of disease activity,  
- 
Physician’s global assessment of disease activity, 
- 
Health Assessment Questionnaire (HAQ) 
- 
ESR 
- 
CRP 
• Study drug administration 
• Study drug injection-site evaluation 
 


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Week 4 (Visit 3/Day 28) 
The below mentioned procedure and measurements will be performed at this visit: 
• AE/SAE review 
• Vital signs (blood pressure, heart rate, respiratory rate and temperature) 
• Urine pregnancy test 
• TB suspicion & evaluation (If TB is suspected at any time during the study, a chest x-ray, 
QuantiFERON-TB Gold test, and tuberculin skin test should be performed) 
• Concomitant medications review 
• ASAS20 (for AS patient) response evaluation:  
- 
BASDAI evaluation 
- 
BASFI evaluation 
- 
Spinal Pain (NRS) assessment 
- 
PGA (NRS) 
• ACR20 (for PsA patient) response evaluation: 
- 
tender and swollen joint count assessment, 
- 
Patient’s assessment of pain, 
- 
Patient’s global assessment of disease activity,  
- 
Physician’s global assessment of disease activity, 
- 
HAQ 
- 
ESR 
- 
CRP 
• Study drug administration 
• Study drug injection-site evaluation 
 
Week 8 (Visit 4/Day 56) and Week 12 (Visit 5/Day 84) 
The below mentioned procedure and measurements will be performed at these visits: 
• AE/SAE review 
• Vital signs (blood pressure, heart rate, respiratory rate and temperature) 
• Urine pregnancy test 
• TB suspicion & evaluation (If TB is suspected at any time during the study, a chest x-ray, 
QuantiFERON-TB Gold test, and tuberculin skin test should be performed) 
• Concomitant medications review 
• Study drug administration 
• Study drug injection-site evaluation 
 
Week 14 (Visit 5/Day 98) - Efficacy Endpoint Assessment Visit 
In this visit, all the assessments will be performed for evaluating the efficacy endpoint at Week 14. 
The below mentioned procedure and measurements will be performed this visit: 
• AE/SAE review 


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• TB suspicion & evaluation (If TB is suspected at any time during the study, a chest x-ray, 
QuantiFERON-TB Gold test, and tuberculin skin test should be performed) 
• Concomitant medications review 
• Vital signs (blood pressure, heart rate, respiratory rate and temperature) 
• Urine pregnancy test 
• ASAS20 (for AS patient) response evaluation:  
- 
BASDAI evaluation 
- 
BASFI evaluation 
- 
Spinal Pain (NRS) assessment 
- 
PGA (NRS) 
• ACR20 (for PsA patient) response evaluation: 
- 
tender and swollen joint count assessment, 
- 
Patient’s assessment of pain, 
- 
Patient’s global assessment of disease activity,  
- 
Physician’s global assessment of disease activity, 
- 
HAQ 
- 
ESR 
- 
CRP 
 
Week 16 (Visit 6/Day 112) and Week 20 (Visit 8/Day 140) 
All procedures performed at Week 8 and Week 12 will also be performed at Week 16 and Week 20. 
 
Week 24 (Visit 7/Day 168) – End of Treatment Visit 
The EOT visit will be conducted after the completion of 24 weeks of golimumab treatment (at 
Visit 9) or on the day on which the patient discontinues the golimumab treatment or study. The 
below mentioned procedure and measurements will be performed at this visit: 
• AE/SAE review 
• TB suspicion & evaluation (If TB is suspected at any time during the study, a chest x-ray, 
QuantiFERON-TB Gold test, and tuberculin skin test should be performed) 
• Concomitant medications review 
• Vital signs (blood pressure, heart rate, respiratory rate and temperature) 
• Routine laboratory tests: haemoglobin, haematocrit, platelet count, total and differential 
WBC count, BUN, creatinine, total bilirubin, alkaline phosphatase, ALT, AST, sodium, 
potassium, blood glucose, albumin and total protein 
• Urine pregnancy test 
• ASAS20 (for AS patient) response evaluation:  
- 
BASDAI evaluation 
- 
BASFI evaluation 
- 
Spinal Pain (NRS) assessment 
- 
PGA (NRS) 
• ACR20 (for PsA patient) response evaluation: 


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- 
tender and swollen joint count assessment, 
- 
Patient’s assessment of pain, 
- 
Patient’s global assessment of disease activity,  
- 
Physician’s global assessment of disease activity, 
- 
HAQ 
- 
ESR 
- 
CRP 
• Study drug administration 
• Study drug injection-site evaluation 
 
 
End of Study Visit 
End of study visit (in-person or telephonic as per convenience of the patient) will be conducted 
8 weeks after the EOT visit or after the last dose of golimumab (whichever is earlier). In this 
follow-up visit/call, enquiry about any AEs experienced or concomitant medications taken by the 
subject will be made and recorded in the CRF unless the patient has died, or is lost to follow-up, or 
has withdrawn consent. If the information on safety is obtained via telephone contact, written 
documentation of the communication must be available for review in the source documents. If the 
patient has died, the date and cause of death will be collected and documented in the CRF. 
9.2. 
Safety Evaluations 
Any clinically relevant changes occurring during the study must be recorded on the AE section of 
the eCRF. 
Safety assessments will be based on medical review of AE reports and the results of vital sign 
measurements, physical examinations, clinical laboratory tests, and other safety evaluations at 
specified time points as described in the TIME AND EVENTS SCHEDULE. Safety will be assessed 
by evaluating the incidence and type of AEs including SAEs, causality, or clinically significant AEs 
(as per principal investigator’s discretion), and discontinuations due to AEs and routine clinical 
laboratory values. Frequency of serious infections, including TB, demyelinating disorders, new 
onset of autoimmune diseases, and malignancies will be summarized. The incidence of study drug 
injection-site reactions will be noted. End of study visit (in-person or telephonic as per convenience 
of the patient) will be conducted 8 weeks after the EOT Visit or after the last dose of golimumab 
(whichever is earlier). Any clinically significant abnormalities persisting at the EOS/early 
withdrawal will be followed by the investigator until resolution or until a clinically stable endpoint 
is reached.  
The study will include the evaluations of safety and tolerability according to the time points 
provided in the TIME AND EVENTS SCHEDULE. 


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Adverse Events 
Adverse events will be reported by the patient (or, when appropriate, by a caregiver, surrogate, or 
the patient's LAR) for the duration of the study. Adverse events will be reported by the investigator 
as specified in Section 12, Adverse Event Reporting. 
Clinical Laboratory Tests  
Results of clinical laboratory tests from the local laboratory will be used at the screening visit to 
confirm eligibility of potential patients through the EOT visit (Week 24) for monitoring safety. 
Blood samples for serum chemistry, haematology and pregnancy test will be collected. The 
investigator must review the laboratory results, document this review, and record any clinically 
relevant changes occurring during the study in the AE section of the eCRF. The laboratory reports 
must be filed with the source documents. The laboratory (hematology and chemistry) parameters 
and change from baseline in laboratory parameters will be assessed. The incidence of markedly 
abnormal laboratory (hematology and chemistry) parameters will also be evaluated. 
Vital Signs: temperature, pulse/heart rate, respiratory rate, blood pressure 
Physical Examination: The extent of the physical examination will be conducted by the site per 
usual local standard-of-care. 
9.3. 
Efficacy Evaluations for Ankylosing Spondylitis 
The ASAS Response Criteria (ASAS 20) is defined as:21,23 
• 
An improvement from baseline of >20% and >1 unit in at least 3 of the 4 ASAS domains on a 
scale of 0 to 10 units, and 
• 
No worsening from baseline of >20% and >1 unit in the remaining ASAS domain on a scale of 
0 to 10 units 
The four ASAS domains are the following: 
1. PGA of Disease (0 to 10 unit NRS): It is the patient’s assessment of how active their spondylitis 
was on average during the last week and last six months. The patient will be asked to mark the 
box with an X on a 0 to 10 unit NRS on which the left-hand box (0) represents “not active,” 
and the right-hand box (10) represents “very active”. (Appendix B) 
2. Total and Night Spinal Pain (NRS): Pain assessment represented by the average of total and 
nocturnal pain scores, both are assessed by two questions rated on a 0 to 10 NRS, where 0=no 
pain and 10=most severe pain. Total spine pain is assessed by ‘How much pain in your spine 
due to spondyloarthritis do you have?’, and nocturnal spine pain: ‘How much pain in your spine 
due to spondyloarthritis do you have at night? (Appendix C) 
3. BASFI: The BASFI is a composite score based on a patient self-administered survey of 10 
questions using a 0 to 10 unit NRS that assesses a patient’s degree of mobility and functional 
ability. The questionnaire consists of eight questions regarding function in AS and the two last 
questions reflecting the patient’s ability to cope with everyday life. The patient will be asked 
to mark the box with an X on a 0 to 10 unit NRS for each of the 10 questions, on which the 


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left-hand box (0) represents “easy,” and the right-hand box (10) represents “impossible.” The 
resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI 
score correlates to reduced functional ability. (Appendix D) 
4. BASDAI: The BASDAI is a composite score based on a patient self-administered survey of six 
questions using a 0 to 10 unit NRS that assesses the patient’s five major symptoms of AS: 1) 
fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5) 
morning stiffness severity upon wakening; 6) morning stiffness duration upon wakening. The 
patient will be asked to mark the box with an X on a 0 to 10 unit NRS for each of the 6 questions. 
To give each of the five symptoms equal weighting, the mean of the two scores relating to 
morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 
BASDAI score. A BASDAI score of 4 or greater is considered to be indicative of active AS 
disease (Appendix E) 
9.4. 
Efficacy Evaluations for PsA 
The ACR20 response is defined as (Appendix G):24 
• 
≥ 20% improvement in swollen joint count - ACR swollen joint count, an assessment of 28 
or more joints, which includes the shoulders, elbows, wrists, metacarpophalangeal (MCP) 1-5, 
proximal interphalangeal (PIP) 1-5 and the knees, bilaterally. Joints are classified as either 
swollen or not swollen. 
• 
≥ 20% improvement in tender joint count - ACR tender joint count, an assessment of 28 or 
more joints, which includes the shoulders, elbows, wrists, MCPs 1-5, PIPs 1-5 and the knees, 
bilaterally. The joint count should be done by scoring several different aspects of tenderness, 
as assessed by pressure and joint manipulation on physical examination. The information on 
various types of tenderness should then be collapsed into a single tender-versus-nontender 
dichotomv. 
• 
≥ 20% improvement in 3 of the following 5 assessments: 
1. Patient’s assessment of pain - A horizontal visual analogue scale (VAS) (usually 10 cm) 
assessment of the patient’s current level of pain. 
2. Patient’s global assessment of disease activity – The patient global assessment of disease 
activity is a simple VAS which assesses the patient’s general health and the effect of their 
arthritis at that point in time. The VAS is scored by measuring from 0 to where the patient 
marks on the line.  
3. Physician’s global assessment of disease activity - A physician’s global assessments of 
disease activity will be recorded on a VAS Scale. 
4. Patient’s assessment of physical function as measured by the HAQ - The functional status 
of the patient will be assessed by means of the Disability Index of the HAQ.25 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. 
5. Acute-phase reactant: (A Westergren ESR and a CRP level) 


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10. 
SUBJECT COMPLETION/DISCONTINUATION OF STUDY TREATMENT/ 
WITHDRAWAL FROM THE STUDY 
10.1. 
Completion 
The study will be considered completed with the EOS within the study for the last subject 
participating in the study. A patient will be considered as having completed the study if he/she has 
completed the EOS assessments (in-person or telephonically) or has experienced a clinical endpoint 
that precludes further evaluation. 
Last completed assessment of patients who prematurely discontinue study treatment for any reason 
before completion of this Phase IV study will be considered for analysis. 
The sponsor reserves the right to close a participating site for data collection or to terminate the 
study at any time for any reason at the sole discretion of the sponsor. A participating site is 
considered closed when all required documents and study specific supplies have been collected and 
a site closure assessment has been performed. 
The participating physician may initiate 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 participating site by the sponsor or participating physician may 
include but are not limited to: 
• Failure of the participating physician to comply with the protocol, requirements of the IRB 
or local health authorities, or the sponsor's procedures, or Good Clinical Practice (GCP) 
guidelines; 
• Inadequate recruitment of subjects by the participating physician. 
10.2. 
Discontinuation of Treatment 
If a patient must be discontinued from treatment before the EOT regimen, this will not result in 
automatic withdrawal of the patient from the study. 
A patient should be discontinued from study treatment if:  
• 
The investigator believes that for any safety reasons (ie, AE) as mentioned below, it is in the 
best interest of the patient to stop treatment: 
- 
opportunistic infection 
- 
malignancy, excluding nonmelanoma skin cancer 
- 
CHF 
- 
demyelinating disease 
- 
subject is deemed ineligible according to the TB screening criteria 
• 
The patient becomes pregnant. 
• 
The patient initiates the use of prohibited medications or treatments. 


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• 
The patient develops a severe or serious injection-site reaction or serious infection. 
• 
Noncompliance defined as any missed visit which results to missed doses. The investigator 
should contact the medical monitor to discuss any unexplained study drug non-compliance. 
If a patient discontinues treatment before the EOT, all Week 24 evaluations should be performed. 
10.3. 
Withdrawal from the Study 
A patient will be withdrawn from the study for any of the following reasons: 
• 
Lost to follow-up 
• 
Withdrawal of consent 
• 
Death 
If a patient withdraws from the study before the EOT visit, all EOT and post-treatment assessments 
should be obtained. If a patient is lost to follow-up, every reasonable effort must be made by the 
study-site personnel to contact the patient and determine the reason for discontinuation/withdrawal. 
The measures taken to follow up must be documented.  
When a patient withdraws before completing the study, the reason for withdrawal is to be 
documented in the eCRF and in the source document. Patients who withdraws will not be replaced. 
11. 
STATISTICAL METHODS 
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 analyse the safety and efficacy data is outlined 
below. Specific details will be provided in the Statistical Analysis Plan.  
Statistical Analysis Plan will be issued as a separate document, providing detailed methods for 
analysis planned in the study. All statistical analysis will performed using SAS® software version 
9.4 or later. For study endpoints analysis, intention-to-treat (ITT) population will be considered. 
Continuous data variables will be summarized using descriptive statistics (number of subjects, 
mean, standard deviation [SD], median, minimum and maximum). Change from baseline will be 
calculated where appropriate. Subject-wise data listing will be provided. All categorical data will 
be summarized using frequency counts and percentages. Statistical analysis will be performed 
separately for each indication. 
Disposition, Demographics and Baseline Characteristics:  
Disposition will be summarized for all subjects. Demographics and disease baseline characteristics 
will be summarized for ITT population. 
Descriptive statistics (mean, SD, median, minimum and maximum) will be presented for continuous 
data. Frequency and percentage will be presented for all categorical data. 


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Handling of missing data: 
For subjects who discontinue treatment but continue to be followed up and for whom some 
end-point component data are missing, the last observation carried forward will be followed to 
Week 14 or Week 24 as applicable.  
No other imputation is planned for missing data assessments. 
11.1. 
Analysis Population 
11.1.1. 
Safety Population 
The safety population will include all subjects who were enrolled and received at least one dose of 
the study drug. 
11.1.2. 
Intent-to-Treat Population 
The ITT population will include all subjects who were enrolled and received at least one dose of a 
study drug and have completed Week 24 visit. 
11.2. 
Sample Size Determination 
Approximately 100 patients with spondyloarthropathy (50 patients of AS and 50 patients of PsA) 
will be enrolled in this Phase IV noncomparative open-label study as per Indian Health Regulatory 
Authority (DCGI office, n=100) requirements. Enrollment of participants with the diagnosis of AS 
and PsA will start simultaneously. After enrollment of all 50 participants with one of the disease 
condition (AS or PsA) the recruitment of participants for that particular disease condition should be 
stopped, while recruitment for the other disease condition should continue until 50 participants are 
recruited. 
Based on available literature, prevalence rate of AS is approximately 0.25% and prevalence rate of 
PsA is approximately 0.22% in India.26,27 So considering this, close to 50% subjects would be 
enrolled for each indication. 
11.3. 
Endpoints: 
Safety Endpoint 
• 
Occurrence of an AE/SAE (clinical or laboratory safety event) 
Efficacy Endpoints 
• 
Proportion of AS patients achieving ASAS20 criteria at Week 14. 
• 
Proportion of PsA patients meeting the ACR20 at Week 14. 
• 
Proportion of AS patients achieving ASAS20 criteria at Week 24. 
• 
Proportion of PsA patients meeting the ACR20 criteria at Week 24. 


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11.4. 
Safety Analyses 
Safety will be recorded at time points specified in the TIME AND EVENTS SCHEDULE and the 
analysis will be summarized using safety population. Incidence of AEs will be tabulated. Laboratory 
abnormalities will be reported if clinically significant. 
Adverse Events 
All AEs will be coded by system organ class and preferred term using the latest Medical Dictionary 
for Regulatory Activities version. Summaries, listing, datasets or subjects narratives may be 
provided, as appropriate, for subjects who die, who discontinue treatment due to an AE, or who 
experience an SAE. 
Clinical Laboratory Tests 
Clinical laboratory evaluations will be performed and the results if considered clinically significant 
(as per principal investigator’s discretion) and/or reported as AE/SAE will be reported and 
summarized. 
11.5. 
Efficacy Analyses 
For the efficacy endpoints, to assess the improvement in ASAS20 (for AS patients) or ACR20 (for 
PsA patients). 
11.6. 
Interim Analysis 
No interim analysis is planned for this study. 
12. 
ADVERSE EVENT REPORTING 
Timely, accurate, and complete reporting and analysis of safety information from clinical studies 
are crucial for the protection of patients, investigators, and the sponsor, and are mandated by 
regulatory agencies worldwide. The sponsor has established Standard Operating Procedures in 
conformity with regulatory requirements worldwide to ensure appropriate reporting of safety 
information; all clinical studies conducted by the sponsor or its affiliates will be conducted in 
accordance with those procedures. 
The undesirable effects known to be associated with the use of golimumab are summarised in the 
current issue of the prescribing information of SIMPONI®. 
12.1. 
Definitions 
12.1.1. 
Adverse Event Definitions and Classifications 
Adverse Event 
An AE is 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 unfavourable and unintended sign 
(including an abnormal finding), symptom, or disease temporally associated with the use of a 
medicinal (investigational or non-investigational) product, whether or not related to that medicinal 


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(investigational or non-investigational) product. (Definition per International Conference on 
Harmonisation [ICH]). 
This includes any occurrence that is new in onset or aggravated in severity or frequency from the 
baseline condition, or abnormal results of diagnostic procedures, including laboratory test 
abnormalities. 
Note: The sponsor collects AEs starting with the signing of the ICF (refer to Section 12.3.1, All 
AEs, for time of last AE recording). 
Serious Adverse Event 
An SAE based on ICH and European Union Guidelines on Pharmacovigilance for Medicinal 
Products for Human Use is any untoward medical occurrence that at any dose: 
• 
Results in death 
• 
Is life-threatening 
(The 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. 
Unlisted (Unexpected) Adverse Event 
An AE is considered unlisted if the nature or severity is not consistent with the applicable product 
reference safety information. For golimumab, the expectedness of an AE will be determined by 
whether or not it is listed in the prescribing information. 
Adverse Event Associated With the Use of the Drug 
An AE is considered associated with the use of the drug if the attribution is possible, probable, or 
very likely by the definitions listed in Section 12.1.2, Attribution Definitions. 
12.1.2. 
Attribution Definitions 
Not Related 
An AE that is not related to the use of the drug. 


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Doubtful 
An AE for which an alternative explanation is more likely, eg, concomitant drug(s), concomitant 
disease(s), or the relationship in time suggests that a causal relationship is unlikely. 
Possible 
An AE that might be due to the use of the drug. An alternative explanation, eg, concomitant drug(s), 
concomitant disease(s), is inconclusive. The relationship in time is reasonable; therefore, the causal 
relationship cannot be excluded. 
Probable 
An AE that might be due to the use of the drug. The relationship in time is suggestive (eg, confirmed 
by dechallenge). An alternative explanation is less likely, eg, concomitant drug(s), concomitant 
disease(s). 
Very Likely 
An AE that is listed as a possible adverse reaction and cannot be reasonably explained by an 
alternative explanation, eg, concomitant drug(s), concomitant disease(s). The relationship in time is 
very suggestive (eg, it is confirmed by dechallenge and rechallenge). 
12.1.3. 
Severity Criteria 
The severity assessment for an adverse event or serious adverse event should be completed using 
the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) 
Version 4.03. Any adverse event or serious adverse event not listed in the NCI-CTCAE Version 
4.03 will be graded according to investigator clinical judgment by 
• 
Grade 1: (Mild): Awareness of symptoms that are easily tolerated, causing minimal discomfort 
and not interfering with everyday activities. 
• 
Grade 2: (Moderate): Sufficient discomfort is present to cause interference with normal 
activity. 
• 
Grade 3: (Severe): Extreme distress, causing significant impairment of functioning or 
incapacitation. Prevents normal everyday activities. 
• 
Grade 4: Life-threatening of disabling adverse event 
• 
Grade 5: Death related to the adverse event 
The investigator should use clinical judgment in assessing the severity of events not directly 
experienced by the subject (e.g., laboratory abnormalities). 
12.2. 
Special Reporting Situations 
Safety events of interest on golimumab that may require expedited reporting or safety evaluation 
include, but are not limited to: 
• 
Overdose of a sponsor study drug 
• 
Suspected abuse/misuse of a sponsor study drug 


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• 
Accidental or occupational exposure to a sponsor study drug 
• 
Any failure of expected pharmacologic action (ie, lack of effect) of a sponsor study drug 
• 
Unexpected therapeutic or clinical benefit from use of a sponsor study drug 
• 
Medication error involving a sponsor product (with or without subject/patient exposure to the 
sponsor study drug, eg, name confusion) 
• 
Exposure to a sponsor study drug from breastfeeding 
• 
Drug exposure during pregnancy (maternal and paternal) 
Special reporting situations should be recorded in the eCRF. Any special reporting situation that 
meets the criteria of a SAE should be recorded on the SAE page of the eCRF and reported to the 
local sponsor within 24 hours of them becoming aware of the event. 
12.3. 
Procedures 
In this Phase IV clinical study, SIMPONI® (golimumab) is the Johnson & Johnson product under 
study. 
The sponsor will provide appropriate pharmacovigilance training to the participating site personnel. 
The sponsor assumes responsibility for appropriate reporting of AEs/SAEs and significant safety 
information originating from the data collected for Johnson & Johnson medicinal products to the 
regulatory authorities. All collected AEs will be summarized in the final study report.  
The names (and corresponding telephone numbers) of the individuals who should be contacted 
regarding product safety issues and/or quality issues are listed on the contact information page(s), 
which is/are provided separately. 
Sponsor’s Contact Details: 
Local Safety Officer 
Johnson & Johnson Private Limited 
501, Arena Space, 8th Floor, 
Behind Majas Bus Depot, 
Off. J.V. Link Road, Jogeshwari (East), 
Mumbai 400060, India. 
Telephone: +91 22 6664 6629 
Fax: +91 22 6671 8204 
Email: drugsafe@its.jnj.com 
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 ICF is obtained until completion of the subject's last study-related 
procedure, which may include contact for follow-up of safety. Serious adverse events, including 
those spontaneously reported to the investigator within 30 days after the last dose of study drug, 
must be reported using the Serious Adverse Event Form. The sponsor will evaluate any safety 


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information that is spontaneously reported by an investigator beyond the time frame specified in the 
protocol. 
All events that meet the definition of a SAE will be reported as SAEs, regardless of whether they 
are protocol-specific assessments. 
All AEs, regardless of seriousness, severity, or presumed relationship to study drug, must be 
recorded using medical terminology in the source document and the eCRF. Whenever possible, 
diagnoses should be given when signs and symptoms are due to a common etiology (eg, cough, 
runny nose, sneezing, sore throat, and head congestion should be reported as "upper respiratory 
infection"). Investigators must record in the eCRF their opinion concerning the relationship of the 
AE to study therapy. All measures required for AE management must be recorded in the source 
document and reported according to sponsor instructions. 
The sponsor assumes responsibility for appropriate reporting of AEs to the regulatory authorities. 
The sponsor will also report to the investigator (and the head of the investigational institute where 
required) all suspected unexpected serious adverse reactions (SUSARs). The investigator (or 
sponsor where required) must report SUSARs to the appropriate Independent Ethics Committee 
(IEC) /Institutional Review Board (IRB) that approved the protocol unless otherwise required and 
documented by the IEC/IRB. 
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:  
• 
Study number 
• 
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) 
• 
Site number 
• 
Subject number 
• 
Any other information that is required to do an emergency breaking of the blind 
12.3.2. 
Serious Adverse Events 
All SAEs occurring during the study must be reported to the appropriate sponsor contact person by 
study-site personnel within 24 hours of their knowledge of the event. 
Information regarding SAEs will be transmitted to the sponsor using the Serious Adverse Event 
Form and Safety Report Form of the eCRF, which must be completed and reviewed by a physician 
from the study site, and transmitted to the sponsor within 24 hours. The initial and follow-up reports 
of an SAE should be transmitted electronically or by facsimile (fax). 


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All SAEs that have not resolved by the end of the whole 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: 
• 
The event resolves 
• 
The event stabilizes 
• 
The event returns to baseline, if a baseline value/status is available 
• 
The event can be attributed to agents other than the study drug or to factors unrelated to study 
conduct 
• 
It becomes unlikely that any 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: 
• 
Hospitalizations not intended to treat an acute illness or AE (eg, social reasons such as pending 
placement in long-term care facility) 
• 
Surgery or procedure planned before entry into the study (must be documented in the eCRF). 
Note: Hospitalizations that were planned before the signing of the ICF, and where the 
underlying condition for which the hospitalization was planned has not worsened, will not be 
considered SAEs. Any AE that results in a prolongation of the originally planned 
hospitalization is to be reported as a new SAE. 
• 
For convenience the investigator may choose to hospitalize the subject for the duration of the 
treatment period. 
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 personnel within 24 hours of their knowledge of the event using the 
appropriate pregnancy notification form. Abnormal pregnancy outcomes (eg, spontaneous abortion, 
fetal death, stillbirth, congenital anomalies, ectopic pregnancy) are considered SAEs and must be 
reported using the Serious Adverse Event Form.  
Any subject who becomes pregnant during the study must promptly discontinue further study 
treatment. Because the effect of the study drug on 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. 


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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 
A product quality complaint (PQC) is defined as any suspicion of a product defect related to 
manufacturing, labelling, or packaging, ie, any dissatisfaction relative to the identity, quality, 
durability, or reliability of a product, including its labelling or package integrity. A PQC may have 
an impact on the safety and efficacy of the product. Timely, accurate, and complete reporting and 
analysis of PQC information from studies are crucial for the protection of 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 a SAE, the study-site personnel must report the PQC to the sponsor 
according to the SAE reporting timelines (refer to Section 12.3.2, 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 DRUG INFORMATION 
14.1. 
Physical Description of Study Drug(s) 
The golimumab supplied for this study is a mAb with an immunoglobulin - IgG1 heavy chain 
isotype (G1m[z] allotype) and a kappa light chain isotype. The molecular weight of golimumab 
ranges from 149,802 to 151,064 daltons. Golimumab binds TNFα with high affinity. It will be 
manufactured and provided under the responsibility of the sponsor. Refer to the prescribing 
information for a list of excipients. 
14.2. 
Packaging 
Commercial stocks of SIMPONI® will be used for the patients enrolled in the study with appropriate 
labelling and will be provided free of cost to the patient enrolled for 24 weeks treatment. Patients will 
procure SIMPONI® from the existing distribution channel (regular supply chain) as obtained by 


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routine patients but the drug will be free of cost for clinical trial patients as per the mentioned duration 
in the study protocol. 
14.3. 
Labelling 
Commercial stocks of SIMPONI® supplied to the patients enrolled in the study with appropriate 
labelling. 
14.4. 
Preparation, Handling, and Storage 
Golimumab will be available as a sterile liquid for SC injection at a volume of 0.5 mL in prefilled 
single-use Smartject® device (a kind of prefilled pen-device for injection). Each Simponi Smartject® 
will contain 50 mg golimumab in an aqueous medium of histidine, sorbitol, and polysorbate 80 at 
pH 5.5. No preservatives are present. The needle cover may contain dry natural rubber (a derivative 
of latex), which may cause allergic reactions in individuals sensitive to latex. Aseptic procedures 
must be used during the preparation and administration of the study material. Exposure to direct 
sunlight should be avoided during administration. Prior to administration, the drug product should 
be inspected visually for particulate matter and discoloration. If discoloration (other than a slight 
yellow colour), visible opaque particles, or other foreign particles are observed in the solution, the 
product should not be used. 
• 
Store in a refrigerator: 2 ºC to 8 ºC (36 ºF to 46 ºF) 
• 
Store in original carton until time of use 
• 
Do not freeze 
• 
Do not shake 
14.5. 
Drug Accountability 
The investigator will be responsible for ensuring that all study drug received at the site is inventoried 
and accounted for throughout the study. The study drug administered to the patient must be 
documented on the drug accountability form. All study drug will be stored and disposed of 
according to the sponsor's instructions. Study-site personnel must not combine contents of the study 
drug containers. Study drug must be handled in strict accordance with the protocol. 
Potentially hazardous materials such as used ampules, needles, syringes and vials containing 
hazardous liquids, should be disposed of immediately in a safe manner and therefore will not be 
retained for drug accountability purposes. 
15. 
STUDY-SPECIFIC MATERIALS 
The investigator will be provided with the following supplies: 
• 
Prescribing information for SIMPONI® 
• 
Pharmacy manual/study site investigational product and procedures manual 
• 
Study Laboratory Manual 
• 
NCI-CTCAE Version 4.03 


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• 
Electronic data capture (eDC) manual 
• 
Sample ICF 
• 
CRF and CRF completion guidelines 
16. 
ETHICAL ASPECTS 
16.1. 
Study-Specific Design Considerations 
Potential patients will be fully informed of the risks and requirements of the study and, during the 
study, patients 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 patients who are fully able to understand the risks, benefits, and 
potential AEs of the study, and provide their consent voluntarily will be enrolled. 
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 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 patients. 
Compliance with this standard provides public assurance that the rights, safety, and well-being of 
study patients 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 patients) 
• 
Latest local prescribing information 
• 
Sponsor-approved patient recruiting materials 
• 
Information on compensation for study-related injuries or payment to patients 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 patients 
• 
Any other documents that the IEC/IRB requests to fulfil its obligation 


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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 
patients, data or study conduct, unless required locally), the ICF, applicable recruiting materials, 
and patient 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. 
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 patients, data or study conduct) 
• 
Revision(s) to ICF and any other written materials to be provided to patients 
• 
If applicable, new or revised patient recruiting materials approved by the sponsor 
• 
Revisions to compensation for study-related injuries or payment to patients for participation in 
the study, if applicable 
• 
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 drug 
• 
New information that may adversely affect the safety of the patients or the conduct of the study 
• 
Deviations from or changes to the protocol to eliminate immediate hazards to the patients 
• 
Report of deaths of patients under the investigator's care 
• 
Notification if a new investigator is responsible for the study at the site 
• 
Development Safety Update Report and Line Listings, where applicable 
• 
Any other requirements of the IEC/IRB 
For all protocol amendments (excluding the ones that are purely administrative, with no 
consequences for patients, 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 whole study, the investigator (or sponsor where required) will notify the IEC/IRB 
about the study completion. 
16.2.3. 
Informed Consent 
Each patient will have to 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 patient can read and understand. The informed 


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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 enrolment in the study, the investigator or an authorized member of the study-site personnel 
must explain to potential patients the aims, methods, reasonably anticipated benefits, and potential 
hazards of the study, and any discomfort participation in the study may entail. Patients 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 patient 
will receive for the treatment of his or her disease. Finally, they will be told that the investigator 
will maintain a patient 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 patient, to the extent permitted by the applicable law(s) or 
regulations. By signing the ICF the patient is authorizing such access. It also denotes that the patient 
agrees to allow his or her study physician to recontact the patient for the purpose of obtaining 
consent for additional safety evaluations, if needed. 
The patient 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 patient's personally dated signature. After having obtained the consent, a copy of the ICF 
must be given to the patient. 
If the patient or LAR 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 patient or LAR is obtained. 
16.2.4. 
Privacy of Personal Data 
The collection and processing of personal data from patients enrolled in this study will be limited 
to those data that are necessary to fulfil the objectives of the study. 
These data must be collected and processed with adequate precautions to ensure confidentiality and 
compliance with applicable data privacy protection laws and regulations. Appropriate technical and 
organizational measures to protect the personal data against unauthorized disclosures or access, 
accidental or unlawful destruction, or accidental loss or alteration must be put in place. Sponsor 
personnel whose responsibilities require access to personal data agree to keep the identity of patients 
confidential. 
The informed consent obtained from the patient or his or her LAR 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 patient 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 


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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. 
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 patients, 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 eCRF 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 will 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 drug to 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, patient compensation programs. This approval must clearly identify the specific 
protocol by title and number and must be signed (or sealed, where appropriate per local 
regulations) by the chairman or authorized designee. 
• 
Name and address of the IEC/IRB, including a current list of the IEC/IRB members and their 
function, with a statement that it is organized and operates according to GCP and the applicable 


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laws and regulations. If accompanied by a letter of explanation, or equivalent, from the 
IEC/IRB, a general statement may be substituted for this list. If an investigator or a member of 
the study-site personnel is a member of the IEC/IRB, documentation must be obtained to state 
that this person did not participate in the deliberations or in the vote/opinion of the study. 
• 
Regulatory authority approval or notification, if applicable 
• 
Documentation of investigator qualifications (eg, curriculum vitae) 
• 
Completed investigator financial disclosure form from the principal investigator, where 
required 
• 
Signed and dated clinical trial agreement, which includes the financial agreement 
• 
Any other documentation required by local regulations 
 
The following documents must be provided to the sponsor before enrolment of the first patient: 
• 
Completed investigator financial disclosure forms from all subinvestigators 
• 
Documentation of subinvestigator qualifications (eg, curriculum vitae) 
• 
Photocopy of the site signature log, describing delegation of roles and responsibilities at the 
start of the study 
• 
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. 
Patient Identification, Enrolment, and Screening Logs 
The investigator agrees to complete a patient identification and enrolment log to permit easy 
identification of each patient during and after the study. This document will be reviewed by the 
sponsor study-site contact for completeness. 
The patient identification and enrolment log will be treated as confidential and will be filed by the 
investigator in the study file. To ensure patient confidentiality, no copy will be made. All reports 
and communications relating to the study will identify patients by patient identification and date of 
birth. In cases where the patient is not enrolled into the study, the date seen and date of birth will be 
used. 
The investigator must also complete a patient screening log, which reports on all patients who were 
seen to determine eligibility for inclusion in the study. 
17.4. 
Source Documentation 
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: 
patient 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 


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protocol; record of all AEs and follow-up of AEs; concomitant medication; drug 
receipt/dispensing/return records; study drug administration information; and date of study 
completion and reason for early discontinuation of study drug or withdrawal from the study, if 
applicable.  
The author of an entry in the source documents should be identifiable. 
Specific details required as source data for the study and source data collection methods will be 
reviewed with the investigator before the study and will be described in the monitoring guidelines 
(or other equivalent document). 
The following data will be recorded directly into the eCRF and will be considered source data:  
• 
Race 
• 
History of smoking (all nicotine use, eg, cigarettes or the equivalent of e-cigarettes, cigars, 
chewing tobacco, patch, gum), alcohol intake 
• 
Vital Signs (blood pressure, heart rate, respiratory rate and temperature) 
• 
Height and weight 
• 
Details of physical examination 
• 
The minimum source documentation requirements for Section 4.1, Inclusion Criteria and 
Section 4.2, Exclusion Criteria that specify a need for documented medical history are as 
follows: 
− 
Referral letter from treating physician or 
− 
Complete history of medical notes at the site 
− 
Discharge summaries 
Inclusion and exclusion criteria not requiring documented medical history must be verified at a 
minimum by patient 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 eCRF in 
the protocol include the electronic source system but information collected through the electronic 
source system may not be limited to that found in the eCRF. Data in this system may be considered 
source documentation. 
17.5. 
Case Report Form Completion 
Case report forms will be prepared and provided by the sponsor for each patient in electronic format. 
All eCRF entries, corrections, and alterations must be made by the investigator or authorized study-
site personnel. The investigator must verify that all data entries in the eCRF are accurate and correct. 


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The study data will be transcribed by study-site personnel from the source documents onto an eCRF, 
if applicable. Study-specific data will be transmitted in a secure manner to the sponsor. 
The eCRF must be completed as soon as possible after a patient 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 an eCRF are needed after 
the initial entry into the eCRF, this can be done in either of the following ways: 
• 
Investigator and study-site personnel can make corrections in the eDC tool at their own 
initiative or as a response to an auto query (generated by the eDC tool). 
• 
Sponsor or sponsor 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, and periodic monitoring visits by the sponsor. Written 
instructions will be provided for collection, handling, storage, and shipment of samples.  
The sponsor will review eCRF for accuracy and completeness during on-site monitoring visits and 
after transmission to the sponsor; any discrepancies will be resolved with the investigator or 
designee, as appropriate. After upload of the data into the study database they will be verified for 
accuracy and consistency with the data sources. 
17.7. 
Record Retention 
In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all eCRF and 
all source documents that support the data collected from each patient, as well as all study 
documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical 
Trial, and all study documents as specified by the applicable regulatory requirement(s). The 
investigator/institution will take measures to prevent accidental or premature destruction of these 
documents. 
Essential documents must be retained until at least 2 years after the last approval of a marketing 
application in an ICH region and until there are no pending or contemplated marketing applications 
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical 
development of the investigational product. These documents will be retained for a longer period if 
required by the applicable regulatory requirements or by an agreement with the sponsor. It is the 
responsibility of the sponsor to inform the investigator/institution as to when these documents no 
longer need to be retained. 


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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. 
If it becomes necessary for the sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the investigator/institution must permit access to such reports. 
17.8. 
Monitoring 
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 enrolment has begun. At these visits, the 
monitor will compare the data entered into the eCRF with the source documents 
(eg, hospital/clinic/physician’s office medical records). The nature and location of all source 
documents will be identified to ensure that all sources of original data required to complete the 
eCRF are known to the sponsor 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. 
17.9. 
Study Completion/Termination 
17.9.1. 
Study Completion/End of Study 
The study is considered completed with the last visit of the last patient participating in the study. 
The final data from the investigational site will be sent to the sponsor (or designee) after completion 
of the final patient visit at that 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 
reason at the sole discretion of the sponsor. Study sites will be closed upon study completion. A 
study site is considered closed when all required documents and study supplies have been collected 
and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are not 
limited to: 


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• 
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 patients by the investigator 
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. Patient privacy must, however, be respected. The 
investigator and study-site personnel are responsible for being present and available for consultation 
during routinely scheduled study-site audit visits conducted by the sponsor or its designees.  
Similar auditing procedures may also be conducted by agents of any regulatory body, either as part 
of a national GCP compliance program or to review the results of this study in support of a 
regulatory submission. The investigator should immediately notify the sponsor if he or she has been 
contacted by a regulatory agency concerning an upcoming inspection. 
17.11. Use of Information and Publication 
All information, including but not limited to information regarding golimumab or the sponsor's 
operations (eg, patent application, formulas, manufacturing processes, basic scientific data, prior 
clinical data, formulation information) supplied by the sponsor to the investigator and not previously 
published, and any data, including research data, generated as a result of this study, are considered 
confidential and remain the sole property of the sponsor. The investigator agrees to maintain this 
information in confidence and use this information only to accomplish this study, and will not use 
it for other purposes without the sponsor's prior written consent. 
The investigator understands that the information developed in the study will be used by the sponsor 
in connection with the continued development of golimumab, and thus may be disclosed as required 
to other clinical investigators or regulatory agencies. To permit the information derived from the 
clinical studies to be used, the investigator is obligated to provide the sponsor with all data obtained 
in the study. 
The results of the study will be reported in a Clinical Study Report 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. Study patient identifiers will not be used 
in publication of results. Any work created in connection with performance of the study and 
contained in the data that can benefit from copyright protection (except any publication by the 
investigator as provided for below) shall be the property of the sponsor as author and owner of 
copyright in such work. 
Consistent with Good Publication Practices and International Committee of Medical Journal Editors 
guidelines, the sponsor shall have the right to publish such primary (multicentre) data and 
information without approval from the investigator. The investigator has the right to publish study 


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site-specific data after the primary data are published. If an investigator wishes to publish 
information from the study, a copy of the manuscript must be provided to the sponsor for review at 
least 60 days before submission for publication or presentation. Expedited reviews will be arranged 
for abstracts, poster presentations, or other materials. If requested by the sponsor in writing, the 
investigator will withhold such publication for up to an additional 60 days to allow for filing of a 
patent application. In the event that issues arise regarding scientific integrity or regulatory 
compliance, the sponsor will review these issues with the investigator. The sponsor will not mandate 
modifications to scientific content and does not have the right to suppress information. For 
multicentre 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 multicentre 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 12 months of the availability of the final data (tables, listings, graphs), or the 
sponsor confirms there will be no multicentre 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. 
Registration of Clinical Studies and Disclosure of Results 
The sponsor will register and disclose the existence of and the results of clinical studies as required 
by law. 
 


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REFERENCES 
1. 
Prescribing 
Information 
of 
SIMPONI® 
(golimumab). 
Updated 
January 
2017. 
Available 
from: 
https://www.accessdata fda.gov/drugsatfda_docs/label/2011/125289s0064lbl.pdf . 
2. 
van der Linden S, van der Heijde D. Ankylosing Spondylitis. In: Ruddy S, Harris ED, Sledge CB, ed. Kelley’s 
Textbook of Rheumatology. 6th ed, 2001;1039-1053. 
3. 
Dean LE, Jones GT, MacDonald AG, Downham C, Sturrock RD and Macfarlane GJ. Global prevalence of 
ankylosing spondylitis. Rheumatology 2014;53:650-657. 
4. 
Stolwijk C, Boonen A, Tubergen A Reveille JD. Epidemiology of Spondyloarthritis. Rheum Dis Clin North Am. 
2012; 38(3): 441–476. 
5. 
Clegg DO, Reda DJ, Mejias E, et al. Comparison of sulfasalazine and placebo in the treatment of psoriatic arthritis: 
a Department of Veterans Affairs Cooperative Study. Arthritis Rheum. 1996;39(12):2013-2020. 
6. 
McVeigh CM, Cairns AP. Diagnosis and management of ankylosing spondylitis. BMJ 2006;333:581–5. 
7. 
Parikh T, Joshi VR. Recent Advances in Psoriatic Arthritis from Obscurity to Prominence. Journal of The 
Association of Physicians of India 2015; Vol. 63. 
8. 
Boumpas DT, Illei GG, Tassiulas IO. Psoriatic arthritis. In: Klippel JH, Crofford LJ, Stone JH, Weyand CM, eds. 
Primer on the Rheumatic Diseases. 12th ed. Atlanta, Georgia: Arthritis Foundation; 2001:233-238. 
9. 
Gladman DD, Shuckett R, Russell ML, Thorne JC, Schachter RK. Psoriatic arthritis (PsA)-an analysis of 220 
patients. Q J Med. 1987;62(238):127-141. 
10. Torre Alonso J, Perez AR, Castrillo J, et al. Psoriatic Arthritis (PA): a clinical immunological and radiological 
study of 180 patients. Br J Rheumatol. 1991;30:245-250. 
11. Sokoll K, Helliwell P. Comparison of disability and quality of life in rheumatoid and psoriatic arthritis. J 
Rheumatol. 2001;28(8):1842-1846. 
12. Wong K, Gladman D, Husted J, et al. Mortality studies in psoriatic arthritis. Results from a single outpatient clinic, 
I: causes and risk of death. Arthritis Rheum. 1997;40(10):1868-1872. 
13. Gladman D, Farewell V, Wong K, Husted J. Mortality studies in psoriatic arthritis. Results from a single outpatient 
center, I: prognostic indicators for death. Arthritis Rhuem. 1998;41(6):1103-1110. 
14. Dougados M, van der Linden S, Leirisalo-Repo M, et al. Sulfasalazine in the treatment of spondylarthropathy: a 
randomized, multicenter, double-blind, placebo-controlled study. Arthritis Rheum. 1995:38(5):618-627. 
15. Jones G, Crotty M, Brooks P. Psoriatic arthritis: a quantitative overview of therapeutic options. The Psoriatic 
Arthritis Meta-Analysis Study Group. Br J Rheumatol.1997;36(1):95-99. 
16. Salvarani C, Macchioni P, Olivieri I, et al. A comparison of cyclosporine, sulfasalazine, and symptomatic therapy 
in the treatment of psoriatic arthritis. J Rheumatol. 2001:28(10):2274-2282. 
17. Kaltwasser J, Nash P, Gladman, et al. Efficacy and safety of leflunomide in the treatment of psoriatic arthritis and 
psoriasis: a multinational, double-blind, randomized, placebo controlled clinical trial. Arthritis Rheum. 
2004;50(6):1939-1950. 
18. Mease PJ, Gladman DD, Ritchlin CT, et al. Adalimumab therapy in patients with psoriatic arthritis; 24-week 
results of a phase III study ADEPT (adalimumab effectiveness in psoriatic arthritis trial). [Abstract] Presented at 
the American College of Rheumatology (ACR) Annual Scientific Meeting, 2004. 
19. Mease PJ, Kivitz AJ, Burch FX, et al. Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on 
disease progression. Arthritis Rheum. 2004a;50(7):2264-2272. 
20. Antoni CE, Kavanaugh A, Kirkham B et al. Sustained benefits of infliximab therapy for dermatologic and 
articular manifestations of psoriatic arthritis: results from the infliximab multinational psoriatic arthritis 
controlled trial (IMPACT). Arthritis Rheum. 2005a;52(4):1227-1236. 
21. Zochling J and Braun J. Assessment of ankylosing spondylitis. Clin Exp Rheumatol 2005; 23 (Suppl. 39): S133-
S141. 


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22. Philipose J and Deodhar A. Classification Criteria for Psoriatic Arthritis: CASPAR. The Journal of 
Musculoskeletal Medicine 2012. Available from: http://www.rheumatologynetwork.com/psoriatic-
arthritis/classification-criteria-psoriatic-arthritis-caspar  
23. EMEA Guideline on Clinical Investigation of Medicinal Products for the Treatment of Ankylosing Spondylitis. 
Committee for Medicinal Products for Human Use, 2005. 
24. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary definition of 
improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38(6):727-735. 
25. Fries JF, Spitz P, Kraines RG and Holman HR. Measurement of patient outcome in arthritis. Arthritis and 
Rheumatism 1980;Vol 23(2):137-145. 
26. Dogra S and Yadav S. Psoriasis in India: Prevalence and pattern. Indian J Dermatol Venereol Leprol. 
2010;76(6):595-601. 
27. Kumar R, Sharma A and Dogra S. Prevalence and clinical patterns of psoriatic arthritis in Indian patients with 
psoriasis. Indian Journal of Dermatology, Venereology, and Leprology 2014;Vol 80-Issue 1. 
 
 


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APPENDIX A: EVALUATION OF ANKYLOSING SPONDYLITIS 
Modified New York criteria for classification of ankylosing spondylitis* 
Criteria 
Description 
Clinical criteria 
(a) Low back pain and stiffness for more than 3 months which improves with exercise, 
but is not relieved by rest 
 
(b) Limitation of motion of the lumbar spine in both the sagittal and frontal planes 
 
(c) Limitation of chest expansion relative to normal values correlated for age and sex 
Radiological criterion 
Sacroiliitis grade ≥2 bilaterally or grade 3-4 unilaterally 
– Grade 0 = normal 
– Grade 1 = suspicious 
– Grade 2 = sclerosis, some erosions 
– Grade 3 = severe erosions, widening of the joint space, some ankylosis 
– Grade 4 = complete ankylosis 
Definite AS is present if the radiological criterion is associated with at least 1 clinical criterion 
The ASAS 20 is defined as achieving: 
 An improvement from baseline of >20% and >1 unit in at least 3 of the 4 ASAS domains on a scale of 0 to 
10 units, and 
 No worsening from baseline of >20% and >1 unit in the remaining ASAS domain on a scale of 0 to 10 units. 
The four ASAS domains are the following: 
1. Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale [NRS]); 
2. Total Back Pain NRS; 
3. Function Bath Ankylosing Spondylitis Functional Index (BASFI) score NRS; 
4. Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] NRS Question #5 
and #6 for morning stiffness). 
 
Reference: 
• Dureza CJ. Approaches to Missing Data in the Analysis of SpondyloArthritis International Society (ASAS 20) 
Response and the Creation of the Related CDISC Compliant Analysis Data Sets. PharmaSUG China, 2015. 
• Zochling J and Braun J. Assessment of ankylosing spondylitis. Clin Exp Rheumatol 2005; 23 (Suppl. 39): S133-
S141. 
 
 


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APPENDIX B: PATIENT GLOBAL ASSESSMENT (PGA) - NRS: 
The Patient Global Assessment of Disease Activity is the patient’s assessment of how active their spondylitis was on 
average during the last week. The BAS-G consists of two questions which ask patients to indicate, the effect the disease 
has had on their well-being over the last week and last 6 months. The patient will be asked to mark the box with an X 
on a 0 to 10 unit NRS on which the left-hand box of 0 represents “none,” and the right-hand box represents “very 
severe”. 
 
References: 
• Irons K, Harrison H, Thomas A and Martindale J. An updated synopsis of the Bath Indices – outcome measures for 
use with Ankylosing Spondylitis patients and their broader application. 2016. Available from: 
https://nass.co.uk/download/5723760081867/ 
• Dureza CJ. Approaches to Missing Data in the Analysis of SpondyloArthritis International Society (ASAS 20) 
Response and the Creation of the Related CDISC Compliant Analysis Data Sets. PharmaSUG China, 2015. 
 
 


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APPENDIX C: TOTAL AND NIGHT SPINAL PAIN - NRS: 
The total back pain NRS is the patient’s assessment of, on average last week, how much pain they have in their spine 
due to AS and how much pain they have at night. The patient will be asked to mark the box with an X on a 0 to 10 unit 
NRS on which the left-hand box of 0 represents “no pain,” and the right-hand box represents “most severe pain”. 
 
 
References: 
• 
Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas et.al. The Assessment of 
SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis 
2009;68(Suppl II):ii1–ii44. 
 


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APPENDIX D: BATH ANKYLOSING SPONDYLITIS FUNCTIONAL INDEX (BASFI) ASSESSMENT 
The BASFI is a composite score based on a patient self-administered survey of ten questions using a 0 to 10 unit 
numerical rating scale (NRS) that assesses a patient’s degree of mobility and functional ability. The questionnaire 
consists of eight questions regarding function in AS and the two last questions reflecting the patient’s ability to cope 
with everyday life. The patient will be asked to mark the box with an X on a 0 to 10 unit NRS for each of the 10 
questions, on which the left-hand box of 0 represents “none,” and the right-hand box represents “impossible.” The 
resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced 
functional ability. 
 
References: 
• Irons K, Harrison H, Thomas A and Martindale J. An updated synopsis of the Bath Indices – outcome measures for 
use with Ankylosing Spondylitis patients and their broader application. 2016. Available from: 
https://nass.co.uk/download/5723760081867/ 
• Dureza C. Approaches to Missing Data in the Analysis of SpondyloArthritis International Society (ASAS 20) 
Response and the Creation of the Related CDISC Compliant Analysis Data Sets. PharmaSUG China 2015 - Paper 
067. 
 


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APPENDIX E: THE BATH ANKYLOSING SPONDYLITIS DISEASE ACTIVITY INDEX (BASDAI) 
SCALE: 
The BASDAI is a composite score based on a patient self-administered survey of six questions using a 0 to 10 unit 
numerical rating scale (NRS) that assesses the patient’s five major symptoms of AS: 1) fatigue; 2) spinal pain; 3) 
peripheral joint pain/swelling; 4) areas of localized tenderness; 5) morning stiffness severity upon wakening; 6) morning 
stiffness duration upon wakening. The patient will be asked to mark the box with an X on a 0 to 10 unit NRS for each 
of the 6 questions. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning 
stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score 
of 4 or greater is considered to be indicative of active AS disease. 
References 
• Irons K, Harrison H, Thomas A and Martindale J. An updated synopsis of the Bath Indices – outcome measures for 
use with Ankylosing Spondylitis patients and their broader application. 2016. Available from: 
https://nass.co.uk/download/5723760081867/ 
• Dureza C. Approaches to Missing Data in the Analysis of SpondyloArthritis International Society (ASAS 20) 
Response and the Creation of the Related CDISC Compliant Analysis Data Sets. PharmaSUG China 2015 - Paper 
067. 
 


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APPENDIX F: THE 
CLASSIFICATION 
CRITERIA 
FOR 
PSORIATIC 
ARTHRITIS 
[CASPAR] 
CLASSIFICATION CRITERIA FOR PSORIATIC ARTHRITIS 
 
a Current psoriasis scores 2; all other items score 1. 
 
References 
• Philipose J and Deodhar A. Classification Criteria for Psoriatic Arthritis: CASPAR. The Journal of Musculoskeletal 
Medicine 2012. Available from: http://www rheumatologynetwork.com/psoriatic-arthritis/classification-criteria-
psoriatic-arthritis-caspar  
 
 
 


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APPENDIX G: AMERICAN COLLEGE OF RHEUMATOLOGY PRELIMINARY DEFINITION OF 
IMPROVEMENT IN RHEUMATOID ARTHRITIS* (ACR20) 
Required   ≥20% improvement in tender joint count 
                  ≥20% improvement in swollen joint count 
 
                  ≥20% improvement in 3 of following 5: 
                            Patient pain assessment 
                            Patient global assessment 
                            Physician global assessment 
                            Patient self-assessed disability 
                            Acute-phase reactant (ESR or CRP) 
Tender joint count 
ACR tender joint count, an assessment of 28 or more joints. The joint count should 
be done by scoring several different aspects of tenderness, as assessed by pressure 
and joint manipulation on physical examination. The information on various types of 
tenderness should then be collapsed into a single tender-versus-nontender dichotomv. 
Swollen joint countt 
ACR swollen joint count, an assessment of 28 or more joints. Joints are classified as 
either swollen or not swollen. 
Patient’s assessment of 
pain 
A horizontal visual analog scale (usually 10 cm) or Likert scale assessment of the 
patient’s current level of pain. 
Patient’s global assessment 
of disease activity 
The patient’s overall assessment of how the arthritis is doing. One acceptable method 
for determining this is the question from the AIMS instrument: “Considering all the 
ways your arthritis affects you, mark ‘X’ on the scale for how well you are doing.” 
An anchored, horizontal, visual analog scale (usually 10 cm) should be provided. A 
Likert scale response is also acceptable. 
Physician’s global 
assessment of disease 
activity 
A horizontal visual analog scale (usually 10 cm) or Likert scale measure of the 
physician’s assessment of the patient’s current disease activity. 
Patient’s assessment of 
physical function 
Any patient self-assessment instrument which has been validated, has reliability, has 
been proven in RA trials to be sensitive to change, and which measures physical 
function in RA patients is acceptable. Instruments which have been demonstrated to 
be sensitive in RA trials include the AIMS, the HAQ, the Quality (or Index) of Well 
Being, the MHIQ, and the MACTAR. 
Acute-phase reactant value 
A Westergren ESR or a CRP level. 
ACR = American College of Rheumatology; AIMS = Arthritis Impact Measurement Scales; CRP = C-reactive protein; 
ESR = erythrocyte sedimentation rate; HAQ = Health Assessment Questionnaire; MACTAR = McMaster Toronto 
Arthritis Patient Preference Disability Questionnaire; MHIQ = McMaster Health Index Questionnaire; RA = 
rheumatoid arthritis 
 
 


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1. 
TENDER JOINT COUNT ASSESSMENT (28 JOINT COUNT) 
A 28 tender joint count, includes the shoulders, elbows, wrists, MCPs 1-5, PIPs 1-5 and the knees, bilaterally. Although 
the 28 joint count excludes some joints characteristically involved in PsA, such as the DIP joints, it has been shown to 
perform acceptably in PsA. 
 
Right  
Left 
Shoulder 
Shoulder 
Elbow 
Elbow 
Wrist 
Wrist 
Metacarpophalangeal 
First 
Second 
Third 
Fourth 
Fifth 
Metacarpophalangeal 
First 
Second 
Third 
Fourth 
Fifth 
Proximal interphalangeal 
First 
Second 
Third 
Fourth 
Fifth 
Proximal interphalangeal 
First 
Second 
Third 
Fourth 
Fifth 
Knee 
Knee 
2. 
SWOLLEN JOINT COUNT ASSESSMENT (28 JOINT COUNT) 
A 28 swollen joint count, includes the shoulders, elbows, wrists, MCPs 1-5, PIPs 1-5 and the knees, bilaterally. 
Although the 28 joint count excludes some joints characteristically involved in PsA, such as the DIP joints, it has been 
shown to perform acceptably in PsA. 
 
Right  
Left 
Shoulder 
Shoulder 
Elbow 
Elbow 
Wrist 
Wrist 
Metacarpophalangeal 
First 
Second 
Third 
Fourth 
Fifth 
Metacarpophalangeal 
First 
Second 
Third 
Fourth 
Fifth 
Proximal interphalangeal 
First 
Second 
Third 
Fourth 
Fifth 
Proximal interphalangeal 
First 
Second 
Third 
Fourth 
Fifth 
Knee 
Knee 
 
3. 
PATIENT’S ASSESSMENT OF PAIN 
The patient will be asked – “How severe was the pain you have experienced in the last 24 hours?” 
 
 
 




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6. 
HEALTH ASSESSMENT QUESTIONNAIRE (HAQ-DI)© 
 
The HAQ focuses on 2 dimensions of health status, physical disability (8 subscales) and pain.  
 
Name:    
 
 
 
 
 
 
Date:  _________________ 
 
Please place an “x” in the box which best describes your abilities OVER THE PAST WEEK: 
 
Without any 
difficulty 
With some 
difficulty 
With much 
difficulty 
Unable to 
do 
DRESSING & GROOMING 
 
Are you able to: 
 
Dress yourself, including shoelaces and buttons? 
 
Shampoo your hair? 
 
ARISING 
 
Are you able to: 
 
Stand up from a straight chair? 
 
Get in and out of bed? 
 
EATING 
 
Are you able to: 
 
Cut your own meat? 
 
Lift a full cup or glass to your mouth? 
 
Open a new milk carton? 
 
WALKING 
 
Are you able to: 
 
Walk outdoors on flat ground? 
 
Climb up five steps? 
 
 


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Please check any AIDS OR DEVICES that you usually use for any of the above activities: 
 
 
 
 
 
 
 
Please check any categories for which you usually need HELP FROM ANOTHER PERSON: 
 
          Dressing and grooming 
 
  Arising 
 
Eating  
 
Walking 
 
Please place an “x” in the box which best describes your abilities OVER THE PAST WEEK: 
 
Without any 
difficulty 
With some 
difficulty 
With much 
difficulty 
Unable 
to do 
HYGIENE 
 
Are you able to: 
 
Wash and dry your body? 
 
Take a tub bath? 
 
Get on and off the toilet? 
 
REACH 
 
Are you able to: 
 
Reach and get down a 5 pound object  
(such as a bag of sugar) from above your head? 
 
Bend down to pick up clothing from the floor? 
 
GRIP 
 
Are you able to:  
 
Open car doors? 
 
Open previously opened jars? 
 
Turn faucets on and off? 
 
ACTIVITIES 
 
Are you able to: 
 
Run errands and shop? 
 
Get in and out of a car? 
 
Do chores such as vacuuming or yard work? 
 
 
Devices used for Dressing  
(button hook, zipper pull, etc.) 
Built up or special utensils 
Crutches 
Special or built up chair 
Cane 
Walker 
Wheelchair 


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Please check any AIDS OR DEVICES that you usually use for any of the above activities: 
 
Raised toilet seat 
Bathtub bar 
          Long-handled appliances for reach 
Bathtub seat 
Long-handled appliances in bathroom 
          Jar opener (for jars previously opened) 
Please check any categories for which you usually need HELP FROM ANOTHER PERSON: 
 
             Hygiene                 Reach                     Gripping and opening things                  Errands and chores 
 
Your ACTIVITIES: To what extent are you able to carry out your everyday physical activities such as walking, 
climbing stairs, carrying groceries, or moving a chair? 
 
Completely 
Mostly 
Moderately 
A Little 
Not At All 
 
 
 
Your PAIN: How much pain have you had IN THE PAST WEEK? 
On a scale of 0 to 100 (where zero represents “no pain” and 100 represents “severe pain”), please record the number 
below. 
 
 
Your HEALTH: Please rate how well you are doing on a scale of 0 to 100 (0 represents “very well” and 100 
represents “very poor” health), please record the number below. 
 
 
7. 
ACUTE-PHASE REACTANT VALUE 
 
A westergren erythrocyte sedimentation rate (ESR) or a C-reactive protein (CRP) level will be assessed. 
 
 
References 
• Felson DT, Anderson JJ and Boers M et. al. American College of Rhematology preliminary definition of 
improvement in rhematoid arthritis. Athritis & Rheumatism 1995; 38: 727-735. 
• Kavanaugh A, Cassell S. The assessment of disease activity and outcomes in psoriatic arthritis. Clin Exp Rheumatol 
2005; 23 (Suppl. 39):S142-S147. 
• Kirkham B et. al. Assessing Psoriatic Arthritis in your clinic. 2014. Available from: www.psoriatic-
arthritis.co.uk/healthcareprofessionals-psa.aspx 
• Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas et.al. The Assessment of SpondyloArthritis 
international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis 2009;68(Suppl II):ii1–
ii44. 
• Sokka T and Pincus T. Quantitative joint assessment in rheumatoid arthritis. Clin Exp Rheumatol 2005; 23 (Suppl. 
39):S58-S62. 
• THE HEALTH ASSESSMENT QUESTIONNAIRE©. Stanford University School of Medicine Division of 
Immunology & Rheumatology. Available from: www.chcr.brown.edu/pcoc/ehaqdescrscoringhaq372.pdf  
 
 


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APPENDIX H: TUBERCULIN SKIN TESTING 
An intradermal tuberculin skin test (Mantoux) must be performed within 1 month prior to the first administration of 
study drug following the instructions provided below. Multiple puncture tests (Tine and Heaf) are not acceptable 
methods of 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 should not be used to determine whether a person is infected. 
Multiple puncture tests are not reliable because the amount of tuberculin injected intradermally cannot be precisely 
controlled. Tuberculin skin testing is both safe and reliable throughout the course of pregnancy. The Mantoux tuberculin 
test is performed by placing an intradermal injection of 0.1 mL of tuberculin into the inner surface of the forearm. The 
test must be performed with tuberculin that has at least the same strength as either 5 tuberculin units (TU) of standard 
purified protein derivative (PPD)-S or 2 TU of PPD-RT 23, Statens Seruminstitut, as recommended by the World Health 
Organization. PPD strengths of 1 TU or 250 TU are not acceptable (Menzies, 2000). Using a disposable tuberculin 
syringe with the needle bevel facing upward, the injection should be made just beneath the surface of the skin. This 
should produce a discrete, pale elevation of the skin (a wheal) 6 mm to 10 mm in diameter. To prevent needle stick 
injuries, needles should not be recapped, purposely bent or broken, removed from disposable syringes, or otherwise 
manipulated by hand. After they are used, disposable needles and syringes should be placed in puncture-resistant 
containers for disposal. Institutional guidelines regarding universal precautions for infection control (eg, the use of 
gloves) should be followed. A trained health care worker, preferably the investigator, should read the reaction to the 
Mantoux test 48 to 72 hours after the injection. Patients should never be allowed to read their own tuberculin skin test 
results. If a patient fails to show up for the scheduled reading, a positive reaction may still be measurable up to 1 week 
after testing. However, if a patient 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 here, even though the patients entering this study 
may or may not be immunocompromised at baseline. The purpose of using this conservative definition of positivity is 
to maximize the likelihood of detecting latent TB. In the US and Canada, an induration of 5 mm or greater in response 
to the intradermal tuberculin skin test is considered to be a positive result and evidence for either latent or active TB. 
In countries outside the United States and Canada, country-specific guidelines for immunocompromised patients 
should be consulted for the interpretation of tuberculin skin test results. If no local guidelines for immunocompromised 
patients exist, US guidelines must be followed. 
Treatment of Latent Tuberculosis 
Local country guidelines for immunocompromised patients should be consulted for acceptable antituberculous 
treatment regimens for latent TB. If no local guidelines for immunocompromised patients exist, US guidelines must be 
followed. 
References 
• Centers for Disease Control and Prevention. Core curriculum on tuberculosis: What the clinician should know 
(Fourth Edition). Atlanta, GA: Department of Health and Human 
• 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. 
• Services; Centers for Disease Control and Prevention; National Center for HIV, STD, and TB Prevention; Division 
of Tuberculosis Elimination; 2000:25-86. 
 
 


SIMPONI (Golimumab) 
 
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Approved, Date: 2 July 2018 
APPENDIX I: 
QUANTIFERON-TB GOLD TESTING 
A QuantiFERON-TB Gold test must be performed within 1 month prior to the first administration of study drug. 
Background 
The Mantoux tuberculin skin test (CDC, 2000) is the currently accepted, standard method of identifying persons 
infected with Mycobacterium tuberculosis. However, the tuberculin skin test has less specificity due to cross-reactivity 
with BCG and environmental mycobacteria, and reduced sensitivity, especially in immunocompromised persons (ATS, 
2000, Huebner et al, 1993, Jasmer et al, 2002, Shafer and Edlin, 1996). Variability in application and interpretation of 
the tuberculin skin test is also associated with the inaccuracy of the test (Pouchot et al, 1997). False-positive tuberculin 
skin test reactions lead to inappropriate treatment with long-term antibiotics, and false-negative tuberculin skin test 
reactions can result in morbidity and mortality from active TB that could have been prevented. Because of these 
tuberculin skin test inadequacies, research has focused on new testing methods for detecting TB infection. 
The QuantiFERON-TB Gold test is one of the new interferon-γ (IFN-γ) based blood assays for TB screening (Cellestis, 
2004). 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-γ produced by sensitized T-cells when stimulated with 
the synthetic M. tuberculosis specific antigens. In M. tuberculosis-infected persons, sensitized T lymphocytes will 
secrete IFN-γ 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. tuberculosis and not found in BCG, 
the test is not confounded by BCG vaccination, unlike the tuberculin skin test. However, there is some crossreactivity 
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 3 species of Mycobacterium, in the absence of M. tuberculosis infection.  
In a study of the QuantiFERON-TB Gold test in subjects with active TB, sensitivity has been shown to be approximately 
89% (Mori et 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 tuberculin skin test was noted to be only about 66% and 35% in 
a study of Japanese patients with active TB and healthy BCG-vaccinated young adults. However, sensitivity and 
specificity of the tuberculin skin test depends on the population being studied, and the tuberculin skin test performs best 
in healthy young adults that have not been BCG-vaccinated. 
The sensitivity of the tuberculin skin test can decrease significantly in immunocompromised individuals. In 
asymptomatic HIV-positive persons who developed active TB, the sensitivity of the tuberculin skin test has been 
reported to be only 40 to 60% (Shafer and Edlin, 1996). There are yet no published studies of the performance of the 
QuantiFERON-TB Gold assay in immunosuppressed populations, but studies are ongoing and preliminary data suggest 
that sensitivity is maintained and better than the tuberculin skin test (personal communication, Cellestis). There has 
been 1 published study using a similar IFN-γ based blood test for M. tuberculosis infection (T Spot-TB test), which 
demonstrated a sensitivity of 90% in HIV-positive persons with active TB (Chapman et al, 2002). The ability of the 
new IFN-γ-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 new tests correlated better with the 
degree of exposure that contacts had to the index TB case than the tuberculin skin test (Brock et al, 2004, Ewer et al, 
2004). 
Although the performance of the new IFN-γ-based blood tests for active or latent M. tuberculosis infection have not 
been well-validated in the immunosuppressed population, experts believe these new tests will be at least as sensitive, if 
not more, and definitely more specific than the tuberculin skin test (Barnes, 2004). For these reasons, this protocol 
includes the use of the QuantiFERON-TB Gold assay in addition to the tuberculin skin test, the current standard for TB 
screening, to improve detection of latent TB infection and thereby enhance patient safety. 
 
Performing the QuantiFERON-TB Gold Test 
The QuantiFERON-TB Gold test is available in 2 formats, a standard method and an In-Tube method. The 2 formats 
differ logistically in the manner in which they are performed. In addition, the In-Tube format contains 1 additional M. 
tuberculosis-specific antigen, TB7.7(p4), which is thought to increase the specificity of the test. Results of the 
QuantiFERON-TB Gold test using either format are acceptable for subjects to enter this trial; however, only the In-
Tube format will be provided for this study.  
Published studies have only used the QuantiFERON-TB Gold test with the standard method; however, the 
manufacturing company Cellestis has performed some unpublished studies that demonstrate the comparability of the 2 


SIMPONI (Golimumab) 
 
Clinical Protocol CNTO148SPD4001 
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Approved, Date: 2 July 2018 
formats (personal communication, Cellestis). Both formats of the QuantiFERON-TB Gold test are currently approved 
for commercial use in Europe and certain other countries in which this trial will be conducted. The QuantiFERON-TB 
Gold test with the standard method was recently approved by the FDA for use in the US. The In-Tube format will be 
submitted to the FDA for review in the next few years.  
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 patient, each requiring 
1 mL 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 done by shaking the tubes. The blood is 
then incubated for 16 to 24 hours at 37°C, after which tubes are centrifuged for approximately 5 to 10 minutes at 1500 
to 2200 g. Following centrifugation, plasma may be harvested from each tube and placed in aliquot tubes, or the 
centrifuged tubes themselves may be shipped to the central laboratory at 2°C to 8°C. The central laboratory will perform 
an enzyme-linked immunosorbent assay (ELISA) to quantify the amount of IFN-γ present in the plasma using 
spectrophotometry and computer software analysis 
Interpreting the QuantiFERON-TB Gold Test Results 
The central laboratory will analyze and report results for each subject, and study sites will be informed of the results 
prior to enrolment. Subjects who have a positive QuantiFERON-TB Gold test must receive the same treatment and 
evaluations for latent TB infection as subjects who have a positive tuberculin skin test to be enrolled in this trial. 
Treatment of Latent Tuberculosis 
Local country guidelines for immunocompromised patients should be consulted for acceptable antituberculous 
treatment regimens for latent TB. If no local guidelines for immunocompromised patients exist, US guidelines must be 
followed. 
 
References 
• American Thoracic Society (ATS). Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J 
Respir Crit Care Med 2000;161:S221-S247. 
• 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, September 2004. 
• Centers for Disease Control and Prevention. Core curriculum on tuberculosis: What the clinician should know 
(Fourth Edition). Atlanta, GA: Department of Health and Human. 
• Chapman ALN, Munkanta M, Wilkinson KA, et al. Rapid detection of active and latent tuberculosis infection in 
HIV-positive individuals by enumeration of Mycobacterium tuberculosis-specific T cells. AIDS 2002;16:2285-
2293. 
• Ewer K, Deeks J, Alvarez L, et al. Comparison of T-cell-based assay with tuberculin skin test for diagnosis of 
Mycobacterium tuberculosis infection in a school tuberculosis outbreak. Lancet 2003;361:1168-73. 
• Huebner RE, Schein MR, Bass JB JR. The tuberculin skin test. Clinical Infectious Diseases 1993;17(6):968-975. 
• Jasmer RM, Nahid P, and Hopewell PC. Latent tuberculosis infection. New Engl J Med 2002;347(23):1860-1866. 
• Mori T, Sakatani M, Yamagishi F, et al. Specific detection of tuberculosis infection: An interferon-γ-based assay 
using new antigens. Am J Respir Crit Care Med 2004;170:59-64. 
• Pouchot J, Grasland A, Collet C, et al. Reliability of tuberculin skin test measurement. Ann Intern Med 
1997;126(3):210-214. 
• Schafer RW and Edlin BR. Tuberculosis in patients infected with Human Immunodeficiency Virus: Perspective on 
the past decade. Clinical Infectious Diseases 1996;22:683-704. 
• Services; Centers for Disease Control and Prevention; National Center for HIV, STD, and TB Prevention; Division 
of Tuberculosis Elimination; 2000:25-86. 
 



SAP_001.pdf: 
Janssen Research & Development 
Statistical Analysis Plan 
A Phase-IV, Multicenter, Noncomparative, Open-Label Study Evaluating the Safety and 
Efficacy of Golimumab (a Fully Human Anti-TNFα Monoclonal Antibody, Administered 
Subcutaneously) in the Treatment of Indian Patients with Active Spondyloarthropathy of 
Ankylosing Spondylitis or Psoriatic Arthritis 
Protocol CNTO148SPD4001; Phase 4 
 SIMPONI  (Golimumab)  
Status: 
Approved   
Date: 
21 January 2022 
Prepared by: 
Johnson & Johnson Private Limited 
Document No.: EDMS-RIM-540788, 2.0 
Compliance:  The study described in this report was performed according to the principles of Good Clinical Practice (GCP). 
Confidentiality Statement 
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 disclosed 
by them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as 
privileged or confidential. 
NCT03733925


SIMPONI  (Golimumab) 
Statistical Analysis Plan CNTO148SPD4001 
2 
Approved, Date: 21 January 2022 
TABLE OF CONTENTS 
TABLE OF CONTENTS ............................................................................................................................... 2 
AMENDMENT HISTORY .............................................................................................................................. 3 
ABBREVIATIONS ........................................................................................................................................ 3 
1.
INTRODUCTION .................................................................................................................................. 4 
1.1. 
Trial Objectives ................................................................................................................................ 4 
1.1.1 
Primary Objective ............................................................................................................................. 4 
1.1.2 
Secondary Objective ........................................................................................................................ 4 
1.2. 
Trial Design ...................................................................................................................................... 4 
1.3. 
Statistical Hypotheses for Trial Objectives ....................................................................................... 6 
1.4. 
Sample Size Justification ................................................................................................................. 6 
1.5. 
Randomization and Blinding ............................................................................................................ 6 
2.
GENERAL ANALYSIS DEFINITIONS ................................................................................................ 6 
2.1. 
Visit Windows ................................................................................................................................... 6 
2.2. 
Analysis Sets .................................................................................................................................... 7 
2.3. 
Study Day and Relative Day ............................................................................................................ 8 
2.4. 
Baseline ........................................................................................................................................... 8 
2.5. 
General Analysis Rules .................................................................................................................... 8 
2.6. 
Handling Missing Data ..................................................................................................................... 8 
3.
SUBJECT INFORMATION .................................................................................................................. 8 
3.1. 
Demographics and Baseline Characteristics ................................................................................... 9 
3.2. 
Disposition Information ................................................................................................................... 10 
3.3. 
Protocol Deviations ........................................................................................................................ 11 
3.4. 
Prior and Concomitant Medications ............................................................................................... 11 
4.
EFFICACY ......................................................................................................................................... 12 
4.1. 
Efficacy Endpoint(s) ....................................................................................................................... 12 
4.1.1. 
Definition of Endpoints ................................................................................................................ 12 
4.1.2. 
Analysis Methods ........................................................................................................................ 13 
5.
SAFETY ............................................................................................................................................. 14 
5.1. 
Clinical Laboratory Tests................................................................................................................ 14 
5.2. 
Adverse Events .............................................................................................................................. 14 
5.3. 
Medical History ............................................................................................................................... 15 
5.4. 
Physical Examination ..................................................................................................................... 15 
5.5. 
Vital Signs ...................................................................................................................................... 15 
5.6. 
Electrocardiogram .......................................................................................................................... 15 
5.7. 
Other Safety Parameters ............................................................................................................... 15 


SIMPONI  (Golimumab)  
 
 
 
Statistical Analysis Plan CNTO148SPD4001  
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Approved, Date: 21 January 2022  
AMENDMENT HISTORY 
The SAP is being amended to update the adverse event section. AE listings and tables for subjects 
with at least one major protocol deviations related to COVID-19 has been removed due to no 
infection cases reported. 
SAP Version  
Approval Date 
Original SAP Version 1.0 
23 September 2021 
Amendment 1 SAP Version 2.0 
21 January 2022 
 
ABBREVIATIONS 
ACR20 
American College of Rheumatology 20% Improvement Criteria 
AE 
adverse event 
ASAS20 
Assessment in SpondyloArthritis International Society 20% Improvement Criteria 
BASDI 
Bath AS Disease Activity Index 
BASFI 
Bath AS Functional Index 
BMI 
body mass index 
CI 
confidence interval 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
HAQ 
Health Assessment Questionnaire 
HBV 
HBV Hepatitis B Virus 
HCV 
HCV Hepatitis C Virus 
HIV 
Human Immunodeficiency Virus 
HLA-B27 
Human Leukocyte Antigen-B27 
ICH 
International Conference on Harmonization 
ITT 
Intention-to-Treat 
LOCF 
last observation carried forward 
MedDRA 
Medical Dictionary for Regulatory Activities 
NRS 
Numerical Rating Scale 
PGA 
Patient Global Assessment 
PsA 
Psoriatic Arthritis 
RA 
Rheumatoid Arthritis 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SD 
standard deviation 
TB 
Tuberculosis 
TEAE 
Treatment-emergent adverse event 
VAS 
Visual Analogue Scale (Score) 
 
 
 
 


SIMPONI  (Golimumab)  
 
 
 
Statistical Analysis Plan CNTO148SPD4001  
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Approved, Date: 21 January 2022  
1. 
INTRODUCTION 
This statistical analysis plan (SAP) contains statistical methods for all planned analyses and 
definitions of analysis population for the study. 
1.1. 
Trial Objectives 
1.1.1 Primary Objective  
• To assess the safety of subcutaneous (SC) golimumab in patients with active AS or PsA 
over 24 weeks. 
1.1.2 Secondary Objective  
• To assess the efficacy of SC golimumab in patients with active AS or PsA as measured by 
reduction in signs and symptoms of arthritis in active AS or PsA at Week 14. 
• To assess achievement of sustained arthritis response in patients with active AS or PsA at 
Week 24. 
1.2. 
Trial Design 
This is an open-label, multicenter, interventional, noncomparative, single-arm, Phase IV study to 
evaluate safety and efficacy of golimumab (a fully human anti-TNFα mAb, administered 
subcutaneously) in the treatment of Indian patients with active spondyloarthropathy of AS or PsA. 
A total of 100 patients will be enrolled in this study. Approximately, 50% patients would be 
enrolled for each indication-50 patients with active AS, and another 50 with active PsA.  
The study consists of three phases- Screening phase (Day -7 to Day -1), Treatment phase (Week 0 
to Week 24) and Follow-up phase (Week 25 to Week 32).  
Patients will receive golimumab 50 mg SC injections at Week 0 and every 4 weeks thereafter 
through Week 24. End of treatment (EOT) is defined as the time the last subject completes the 
week 24 visit. End of study (EOS) visit (in-person or telephonic as per convenience of the patient) 
will be conducted 8 weeks after the EOT Visit or after the last dose of golimumab (whichever is 
earlier), to inquire about any AEs experienced by the patient. 
A diagram of the study design is provided below in Figure 1. 
 
 


SIMPONI  (Golimumab)  
 
 
 
Statistical Analysis Plan CNTO148SPD4001  
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Approved, Date: 21 January 2022  
 
 
 
 
 
 
Visit 1 (Day -7 to Day -1) 
 
Written Informed Consent and Screening Procedures (to select 
100 eligible subjects) 
     
 
 
Visit 2 (Week 0/Day 1 ± 4) 
 
                                  Treatment Visit 
Eligible subjects will receive the first dose of golimumab 50 mg 
subcutaneous (SC) 
 
 
 
Visit 3 (Week 4/Day 28 ± 4) 
Visit 4 (Week 8/Day 56 ± 4) 
Visit 5 (Week 12/Day 84 ± 4) 
 
      Treatment Visits 
Subjects will continue to receive golimumab 50 mg SC, every 4 
weeks 
 
 
 
Visit 6 (Week 14/Day 98 ± 4) 
 
                              Assessment Visit 
Efficacy assessments will be performed at this visit. 
 
 
 
Visit 7 (Week 16/Day 112 ± 4) 
Visit 8 (Week 20/Day 140 ± 4) 
 
                             Treatment Visits 
Subjects will continue to receive golimumab 50 mg SC, every 4 
weeks 
 
 
 
Visit 9 (Week 24/Day 168 ± 4) 
 
                      End of Treatment (EOT) Visit 
Subjects will receive golimumab 50 mg SC, as the last dose of 
the study treatment and undergo EOT assessments. 
Subjects may continue golimumab treatment per discretion of 
the treating physician, but they will no longer be part of the 
study. 
If a subject discontinues golimumab treatment before Week 24, 
he/she will undergo EOT assessments on the day of 
discontinuation. 
Visit 10  (8 weeks after the last 
dose of golimumab) 
 
  End of Study (EOS) Visit 
EOS visit (in-person or telephonic as per convenience of the 
patient) will be conducted 8 weeks after the EOT visit or after 
the last dose of golimumab (whichever is earlier), to inquire 
about any AEs experienced by the patient. 
 
Figure 1: Schematic Overview of the Phase IV clinical study for a single subject 
Safety of the subjects will be assessed throughout the study beginning from  
                      signing the informed consent form to EOS 


SIMPONI  (Golimumab)  
 
 
 
Statistical Analysis Plan CNTO148SPD4001  
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Approved, Date: 21 January 2022  
1.3. 
Statistical Hypotheses for Trial Objectives 
No formal hypothesis testing will be tested. 
1.4. 
Sample Size Justification 
Approximately 100 patients with spondyloarthropathy (50 patients of AS and 50 patients of PsA) 
will be enrolled in this Phase IV non-comparative open-label study as per Indian Health Regulatory 
Authority (DCGI office, n=100) requirement. After enrollment of all 50 participants with one of 
the disease condition (AS or PsA) the recruitment of participants for that particular disease 
condition should be stopped, while recruitment for the other disease condition should continue 
until 50 participants are recruited. 
Based on available literature, prevalence rate of AS is approximately 0.25% and prevalence rate 
of PsA is approximately 0.22% in India. So considering this, close to 50% subjects would be 
enrolled for each indication. 
1.5. 
Randomization and Blinding 
As this is an open and single-arm study, randomization and blinding procedures are not applicable. 
2. 
GENERAL ANALYSIS DEFINITIONS 
2.1. 
Visit Windows 
To allow for variation in scheduling, the following set of visit windows (Table 1, Table 2) will 
be used to assign evaluations to a most appropriate visit for analysis. Furthermore, there will be 
no gaps between visit windows in order to include as many data points as possible for 
summarization.  
Regardless of the width of the visit window, if more than 1 visit falls in the defined window, the 
result from the visit closest to the target day will be used. If 2 evaluations are equidistant from 
the target day, the result from the later visit will be used. Results not included for analysis will be 
included in the listings.  
All assignments will be made in chronological order. Once a visit date is assigned to a visit 
window, it will no longer be used for a later time point.  
 
 


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Statistical Analysis Plan CNTO148SPD4001  
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Listed below (Table 1, table 2) are the visit windows and the target days for each visit defined in 
the protocol. 
Table 1– Visit Windows for Vital signs and Urine Pregnancy Tests 
Scheduled 
Visit Number 
Time Interval 
(label on output) 
Time Interval 
(Day)* 
Target Time 
Point (Day) 
1 
Screening 
-7 to -1 
<= -1 
2 
Week 0 
<= 1 
1 
3 
Week 4 
2 to 42 
28 
4 
Week 8 
43 to 70 
56 
5 
Week 12 
71 to 91 
84 
6 
Week 14 
92 to 105 
98 
7 
Week 16 
106 to 126 
112 
8 
Week 20 
127 to 154 
140 
9 
Week 24 
155 to 182 
168 
10 
End of Study 
183 to 228 
224 
 
Table 2- Visit Window for ASAS20 (BASDAI Evaluation (NRS), BASFI Evaluation (NRS),  
Total and Night Spinal Pain Assessment (NRS), Patient Global Assessment (NRS)), ACR20 
Scheduled 
Visit Number 
Time Interval 
(label on output) 
Time Interval 
(Day)* 
Target Time 
Point (Day) 
1 
Screening 
-7 to -1 
<= -1 
2 
Week 0 
<= 1 
1 
3 
Week 4 
2 to 63 
28 
6 
Week 14 
64 to 133 
98 
9 
Week 24 
134 to 203 
168 
 
*Relative to Study Day 1 
If subject discontinues the study at any point of time then the visit will be considered as “End of 
Study” visit.  
2.2. 
Analysis Sets 
The analysis sets used in this study are Safety and Intent to Treat (ITT) analysis sets. The efficacy 
endpoints will be assessed by using ITT analysis set and Efficacy Analysis Set, and safety 
endpoints by Safety Analysis set. 
Safety Analysis Set: The Safety Analysis set includes all subjects who were enrolled and received 
at least one dose of the study drug. 
Intent to Treat (ITT) Analysis Set: The ITT population will include all subjects who were 
enrolled and received at least one dose of the study drug and have completed Week 24 visit 
 
Efficacy Analysis Set for AS subjects: Efficacy analysis set for AS subjects includes all AS 
subjects who were enrolled and received at least one dose of the study drug and having at least 
one non-missing post-baseline ASAS20 score for AS indication. 
 
Efficacy Analysis Set for PsA subjects: Efficacy analysis set for PsA subjects includes all PsA 
subjects who were enrolled and received at least one dose of the study drug and having at least 
one non-missing post-baseline ACR20 score for PsA indication.  


SIMPONI  (Golimumab)  
 
 
 
Statistical Analysis Plan CNTO148SPD4001  
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Approved, Date: 21 January 2022  
2.3. 
Study Day and Relative Day 
Study Day 1 or Day 1 refers to the start of the first study drug administration. All efficacy and 
safety assessments at all visits will be assigned a day relative to this date. 
Study day or relative day for a visit is defined as: 
• 
Visit date - (date of Study Day 1) +1, if visit date is ≥date of Day 1 
• 
Visit date - Date of Day 1, if visit date <date of Day 1 
There is no 'Day 0'. 
2.4. 
Baseline 
Baseline is defined as the last observation prior to the start of the first study drug administration. 
2.5. 
General Analysis Rules 
• Continuous data will be summarized by descriptive statistics, including number of subjects 
(N), mean, standard deviation (SD), median, and range (minimum; maximum). 
• The minimum and maximum will be presented to the same number of decimal places as 
the original data. The mean and median will be rounded to one additional decimal place 
than the original data, while SD will be approximated to two additional decimal places. 
• If a count is 0, the percentage (0%) should not be displayed. The 0 count will be displayed, 
but the corresponding percentage should be omitted. 
• The percentages (%) in tables will be presented to 1 decimal place If the percentage is 
100% then we display it as 100% and not 100.0%. 
• For continuous parameters, descriptive statistics will be presented when n ≥2 
• All safety analysis will be provided for each indication (AS and PsA indications) and 
overall population separately. 
2.6. 
Handling Missing Data 
For subjects who discontinue treatment but continue to be followed up and for whom some end-
point component data are missing, the last observation carried forward will be followed to Week 
14 or Week 24 as applicable. 
For a composite endpoint, if all its components are missing, no imputation will be done; if not all 
its components are missing, LOCF will be used to impute the missing components. 
3. 
SUBJECT INFORMATION 
The number of subjects in Safety analysis set will be summarized by disease indication group and 
overall population, separately. 
The number of subjects in Safety analysis set will be listed by disease indication group. 


SIMPONI  (Golimumab)  
 
 
 
Statistical Analysis Plan CNTO148SPD4001  
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Approved, Date: 21 January 2022  
3.1. 
Demographics and Baseline Characteristics 
Table 3 presents a list of the demographic variables that will be summarized separately for each 
indication and overall population, for the Safety analysis set. 
Descriptive statistics (mean, SD, median, minimum and maximum) will be presented for 
continuous data. Frequency and percentage will be presented for all categorical data. Subject-wise 
data listing will be provided. 
Table 3: Demographic Variables 
Continuous Variables: 
Summary Type 
Age (years) 
Descriptive statistics (N, mean, 
standard deviation [SD], median 
and range [minimum and 
maximum]). 
Weight (kg) 
Height (cm) 
Body Mass Index (BMI) (kg/m2) 
Categorical Variables 
 
Sex (male, female) 
Frequency distribution with the 
number and percentage of subjects 
in each category. 
Race (Indian, Non-Indian) 
Baseline Disease Characteristics: 
The table 4 presents the list of disease characteristics that will be summarized for Ankylosing 
Spondylitis (AS). 
Table 4: Disease Characteristics Variables (For AS) 
Continuous Variables: 
Summary Type 
Patient Global Assessment (PGA) Score 
Descriptive statistics (N, mean, 
standard deviation [SD], median 
and range [minimum and 
maximum]). 
Total and Night Spinal Pain Score 
Bath Ankylosing Spondylitis Functional Index (BASFI) Score 
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score 
HLA B-27 Result  
Counts and Percentage will be 
presented. 
Chest X-Ray Interpretation (categories like Normal, Abnormal, Not 
Evaluable, Latent TB, Active TB will be presented). 
Table 5 presents the list of disease characteristics that will be summarized for Psoriasis Arthritis 
(PsA). 
Table 5: Disease Characteristics Variables (For PsA) 
Continuous Variables: 
Summary Type 
Tender joint count 
Descriptive statistics (N, mean, 
standard deviation [SD], median 
and range [minimum and 
maximum]). 
Swollen joint count 
Patient's Assessment of pain 
Patient's Global Assessment of Disease Activity 
Physician’s Global Assessment of Disease Activity 
Health Assessment Questionnaire (HAQ) 
Erythrocyte Sedimentation Rate (ESR) 
C-reactive Protein (CRP) 
Listings will be provided for disease characteristic. 


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3.2. 
Disposition Information 
Disposition will be summarized for each indication and overall population, separately.  
If the patient has completed the EOS assessments (in person or telephonically) then the disposition 
event of that patient will be considered as “Completed”. 
The summary for the treatment disposition will be as follows: 
 Number of subjects enrolled 
 Number of subjects discontinued the study drug 
The Summary for the study disposition will be as follows: 
 Number of subjects enrolled 
 Number of subjects receiving study drug 
 Number of subjects completed the study 
 Number of subjects terminated study participation prematurely 
The following primary reason for discontinuation will be summarized throughout the study under 
the following categories: 
 Adverse Event 
 Death 
 Disease Relapse 
 Lack of Efficacy 
 Lost to Follow-Up 
 Non-Compliance with Study Drug 
 Received a Disallowed Concomitant Treatment 
 Physician Decision 
 Protocol Violation 
 Study Terminated by Sponsor 
 Withdrawal by Subject 
 Screen Failure (Failure to Meet Eligibility Criterion) 
 Pregnancy 
 Progressive Disease 
 Other 
A listing of subjects will be provided along with the dates, study days and reason for 
discontinuation/ termination for the following categories: 
 Subjects who discontinued study agent 
 Subjects who terminated study prematurely 
The summary tables and listings will be provided separately for each indication and overall 
population separately. 


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3.3. 
Protocol Deviations 
In general, major protocol deviations may impact subjects’ rights, safety or well-being, or the 
integrity and/or result of the clinical study.  
Listing will be provided for major protocol deviations. Covid19-related Major deviations will be 
listed separately. 
3.4. 
Prior and Concomitant Medications 
Prior and Concomitant medications will be coded using the latest World Health Organization Drug 
Dictionary (WHO-DD). Prior medications are defined as any therapy used before the day of first 
dose (partial or complete) of study drug. Concomitant medications are defined as any therapy used 
on or after the same day as the first dose of study drug, including those that started before and 
continue on after the first dose of study drug. If start date and end date of medication is missing 
then this medication will be considered as prior and concomitant medication. If start date is after 
the date of first dose of study drug and end date is missing then decision of ongoing flag will be 
depend on the “Concomitant Medication End Relative to Reference Period”. 
Concomitant medications and prior medications will be listed separately. 
 
 


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4. 
EFFICACY 
4.1. 
Efficacy Endpoint(s) 
• Proportion of AS patients achieving ASAS20 criteria at Week 14. 
• Proportion of PsA patients meeting the ACR20 criteria at Week 14. 
• Proportion of AS patients achieving ASAS20 criteria at Week 24. 
• Proportion of PsA patients meeting the ACR20 criteria at Week 24. 
4.1.1. 
Definition of Endpoints 
The ASAS Response Criteria (ASAS 20) is defined as: 
•  An improvement from baseline of >20% and >1 unit in at least 3 of the 4 ASAS domains 
on a scale of 0 to 10 units, and 
•  No worsening from baseline of >20% and >1 unit in the remaining ASAS domain on a 
scale of 0 to 10 units 
The four ASAS domains are the following: 
a) Patient Global Assessment of Disease (0 to 10 unit NRS): Patient’s assessment of how 
active their spondylitis was on average during the last week and last six months. The patient 
will be asked to mark the box with an X on a 0 to 10 unit NRS (Numerical Rating Scale) 
on which the left-hand box (0) represents ‘not active’ and the right-hand box (10) 
represents ‘very active’. 
b) Total and Night Spinal Pain (NRS): Pain assessment represented by the average of total 
and nocturnal pain scores, both are assessed by two questions rated on a 0 to 10 NRS, 
where 0=’no pain’ and 10=’most severe pain’. Total spine pain is assessed by ‘How much 
pain in your spine due to spondyloarthritis do you have?’, and nocturnal spine pain by 
‘How much pain in your spine due to spondyloarthritis do you have at night?’ 
c) Bath AS Functional Index (BASFI): A composite score based on a patient self-
administered survey of 10 questions using a 0 to 10 unit NRS that assesses a patient’s 
degree of mobility and functional ability. The questionnaire consists of eight questions 
regarding function in AS and the two last questions reflecting the patient’s ability to cope 
with everyday life. The patient will be asked to mark the box with an X on a 0 to 10 unit 
NRS for each of the 10 questions, on which the left-hand box (0) represents ‘easy’ and the 
right-hand box (10) represents ‘impossible’. The resulting 0 to 100 score is divided by 10 
to give a final 0 to 10 BASFI score. A higher BASFI score correlates to reduced functional 
ability. 
d) Bath AS Disease Activity Index (BASDAI): A composite score based on a patient self-
administered survey of six questions using a 0 to 10 unit NRS that assesses the patient’s 
five major symptoms of AS: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 
4) areas of localized tenderness; 5) morning stiffness severity upon wakening; 6) morning 
stiffness duration upon wakening. The patient will be asked to mark the box with an X on 
a 0 to 10 unit NRS for each of the 6 questions. To give each of the five symptoms equal 


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weighting, the mean of the two scores relating to morning stiffness is taken. The resulting 
0 to 50 score is divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 
or greater is considered to be indicative of active AS disease.  
The ACR response criteria (ACR20) is defined as 
• ≥ 20% improvement in swollen joint count – ACR swollen joint count, an assessment of 
28 or more joints, which includes the shoulders, elbows, wrists, metacarpophalangeal 
(MCP) 1-5, proximal interphalangeal (PIP) 1-5 and the knees, bilaterally. Joints are 
classified as either swollen or not swollen. 
• ≥20% improvement in tender joint count –ACR tender joint count, an assessment of 28 
or more joints, which includes the shoulders, elbows, wrists, MCPs 1-5, PIPs 1-5 and the 
knees, bilaterally. The joint count should be done by scoring several different aspects of 
tenderness, as assessed by pressure and joint manipulation on physical examination. The 
information on various types of tenderness should then be collapsed into a single tender-
versus-nontender dichotomy. 
• ≥ 20% improvement in 3 of the following 5 assessments: 
a) Patient’s assessment of pain - A horizontal visual analogue scale (VAS) (usually 
10 cm) assessment of the patient’s current level of pain. The patient will be asked 
for severity of pain and he/she should be marked on the scale as per severity. The 
left side of VAS is of ‘No Pain’ and right side is of ‘Most Severe Pain’. 
b) Patient’s global assessment of disease activity – A simple patient-reported VAS 
which assesses the patient’s general health and the effect of their arthritis at that 
point in time. The VAS is scored by measuring from 0 to where the patient marks 
on the line. 
c) Physician’s global assessment of disease activity - A physician’s global 
assessments of disease activity will be recorded on a VAS Scale. 
d) Patient’s assessment of physical function as measured by the Health Assessment 
Questionnaire - The functional status of the patient will be assessed by means of 
the Disability Index of the HAQ. 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’. 
e) Acute-phase reactant- (A Westergren Erythrocyte Sedimentation Rate and a C-
reactive Protein level). 
4.1.2. 
Analysis Methods 
Intent-to-treat population will be used for efficacy endpoints. Analysis for efficacy endpoints will 
be repeated on the efficacy analysis set. 
The ASAS20 and ACR20 response evaluations will be performed on week 0, week 4, week 14 
and week 24. The scores obtained from the respective domains will decide the responder for 


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ASAS20 or ACR20 criteria. Proportion of patients who achieve ASAS20 or ACR20 criteria at 
week 24 will be calculated, along with a 95% confidence interval.  
For ASAS20, if data for percent improvement from baseline is missing at a particular assessment 
visit, then the response for the subject at that visit will be considered as missing.  
If a subject’s baseline value is zero (i.e. for ACR no disease activity for one assessment,) or 
missing, the subject should be considered as non-responder. 
 
If all its components for a composite endpoint (i.e. score for subdomain as captured in CRF) are 
missing, the response for the endpoint at the particular visit will be set as missing; if not all its 
components are missing, LOCF will be used to impute the missing components and the value of 
the composite endpoint will be derived based on the imputed components. 
If subject discontinues due to lack of efficacy, subject should be considered as non-responder. 
If there is an Increase in the dose of MTX subject should be considered as non-responder. 
 
The analysis will be done separately for each indication.  
The scores for individual domains for both the ASAS20 and ACR20 will be descriptively 
summarized at all analysis visits. 
The individual domain scores will be listed for each criteria. 
5. 
SAFETY 
The summary tables and listings will be provided separately for each indication and overall 
population, separately. 
5.1. 
Clinical Laboratory Tests 
Change from baseline summaries will be presented for chemistry and hematology laboratory tests 
at scheduled time points. 
Number and percentage of subjects with markedly abnormal laboratory values for hematology and 
chemistry will be presented over time. Listings of markedly abnormal laboratory findings will be 
provided. 
Shift tables will be provided summarizing the shift in laboratory values from baseline to week 14 
and week 24 with respect to abnormality criteria (low, normal, high). 
5.2. 
Adverse Events 
All Adverse Events will be coded by system organ class and preferred term using the latest Medical 
Dictionary for Regulatory Activities version (MedDRA 24.0).  
Any AE occurring at or after the initial administration of study drug through the day of last dose 
plus 8 weeks is considered to be treatment emergent. If the event occurs on the day of the initial 
administration of study drug, and either event time or time of administration are missing, then the 
event will be assumed to be treatment emergent. If the event date is recorded as partial or 
completely missing, then the event will be considered to be treatment emergent unless it is known 
to be prior to the first administration of study drug based on partial onset date or resolution date. 


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All reported treatment-emergent adverse events will be included in the analysis.  For each adverse 
event, the number and percentage of subjects who experience at least 1 occurrence of the given 
event will be summarized. 
 
Summary tables will be provided for: 
• 
AEs 
• 
Serious AEs (SAEs) 
• 
TEAEs leading to discontinuation of study agent 
• 
TEAEs by severity 
• 
TEAEs by relationship to study drug 
• 
TEAEs of special Interest by SOC and PT 
• 
TEAEs by SOC and PT 
In addition to the summary tables, listings will be provided for subjects who had: 
• 
Any AE 
• 
SAEs 
• 
AEs leading to discontinuation of study drug 
• 
Deaths due to AE. 
5.3. 
Medical History 
The listing will be provided for medical history. 
5.4. 
Physical Examination 
Abnormal physical examination findings will be listed. 
5.5. 
Vital Signs  
Vital signs parameters include temperature, respiratory rate, pulse and blood pressure (systolic and 
diastolic. These parameters will be descriptively summarized. A listing of all vital sign 
measurements will be presented. Abnormal vital signs records will be listed. 
5.6. 
Electrocardiogram 
ECG assessment will be performed at the screening visit using 12 Lead ECG method. 
Overall interpretation of ECG data will be listed for all subjects. A separate listing will be provided 
for clinically significant results. 
5.7. 
Other Safety Parameters 
Listings will be provided for the following assessments, as collected: 
• 
Smoking and Substance Use 


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• 
Pregnancy Test (Serum/Urine) 
• 
TB Suspicion & Evaluation 
• 
HLA B-27 Status 
• 
Serology tests (HIV, HBV, HCV) 
• 
Chest x-ray 
Incidence (N, %) of study drug injection site reactions will be provided for subjects with injection 
site reaction.  


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REFERENCES 
1. 
Dureza CJ. Approaches to Missing Data in the Analysis of SpondyloArthritis International Society (ASAS 20) 
Response and the Creation of the Related CDISC Compliant Analysis Data Sets. PharmaSUG China, 2015. 
2. 
Felson DT, Anderson JJ and Boers M et. al. American College of Rhematology preliminary definition of 
improvement in rhematoid arthritis. Athritis & Rheumatism 1995; 38: 727-735. 
3. 
THE HEALTH ASSESSMENT QUESTIONNAIRE©. Stanford University School of Medicine Division of 
Immunology & Rheumatology. Available from: www.chcr.brown.edu/pcoc/ehaqdescrscoringhaq372.pdf