An Investigator-initiated Double-blind, Parallel-group Randomised Controlled Trial of GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA Using Clinical and Whole Body MRI Outcomes: the GOLMePsA Study.
Phase: PHASE3
Conditions: Psoriatic Arthritis
Sponsor: The Leeds Teaching Hospitals NHS Trust

GOLMePsA Clinical Protocol 
 
                             
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Sponsor Ref: RR13/10782 
EudraCT: 2013-004122-28 
REC: 14/EM/0124 
 
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NIHR Leeds Biomedical Research Centre & 
Leeds Institute of Rheumatic and Musculoskeletal Medicine 
 
GOLMePsA study 
 
Study Full Title: An investigator-initiated double-blind, parallel-group 
randomised controlled trial of GOLimumab and Methotrexate versus 
Methotrexate in very early PsA using clinical and whole body MRI outcomes: the 
GOLMePsA study. 
 
 
Sponsor Name:  
 
The Leeds Teaching Hospitals NHS Trust 
Sponsor Number:   
RR13/10782 
EudraCT Number:   
2013-004122-28 
REC:    
 
 
14/EM/0124 
 
 
 
 
 
 

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KEY CONTACTS 
Chief Investigator (CI) 
Dr Helena Marzo-Ortega 
Consultant Rheumatologist and Honorary Clinical Associate Professor 
Sub-Investigators 
 
 
Dr Philip Helliwell, Consultant Rheumatologist 
 
 
Professor Dennis McGonagle, Professor of Experimental Rheumatology 
 
 
Professor Paul Emery, Professor of Rheumatology 
 
 
Dr Laura C Coates, NIHR Clinician Scientist & Senior Clinical Research Fellow 
 
 
Dr Gabriele De Marco, Clinical Research Fellow 
 
Statistician 
 
 
Dr Elizabeth M A Hensor, Biostatistician 
Trial Coordinator 
 
 
Mrs Sayyora Alieva, Spondyloarthritis Research Portfolio Manager 
Address 
Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM) 
2nd Floor, Chapel Allerton Hospital 
Chapeltown Road 
Leeds, LS7 4SA 
United Kingdom 
 
 
Telephone 
+44 (0)113 39 24848 
 
 
+44 (0)113 39 24396 
Fax 
 
+44 (0)113 39 24991 
E-mail  
leedsth-tr.golmepsa@nhs.net  
 
 
medhmo@leeds.ac.uk  
 

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INVESTIGATOR DECLARATION AND SIGNATURE(S) 
GOLMePsA Protocol v8.0, 9th March 2022 
DECLARATION OF PROTOCOL ACCEPTANCE 
I confirm that I am fully informed and aware of the requirements of the protocol and agree to conduct 
the study as set out in this protocol. 
 
 
 
 
 
 
 
 
 
 
Signed: 
Dr Helena Marzo-Ortega 
Chief Investigator  
 
Date 
 

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TABLE OF CONTENTS 
KEY CONTACTS .................................................................................................................................. 2 
INVESTIGATOR DECLARATION AND SIGNATURE(S) .......................................................................... 3 
ABBREVIATIONS .............................................................................................................................. 10 
PROTOCOL SYNOPSIS ..................................................................................................................... 12 
SCHEMATIC DIAGRAM OF RECRUITMENT, RANDOMISATION & TREATMENT .............................. 15 
INTRODUCTION .............................................................................................................................. 16 
1.1 Background ........................................................................................................................... 16 
1.2 Golimumab background ....................................................................................................... 17 
1.3 Rationale for the proposed study ......................................................................................... 17 
STUDY AIM AND OBJECTIVES ......................................................................................................... 18 
2.1 Study aim .............................................................................................................................. 18 
2.2 Primary objective .................................................................................................................. 18 
2.3 Secondary objective(s) ......................................................................................................... 18 
2.4 
Exploratory objective(s) ................................................................................................ 19 
STUDY ENDPOINTS ......................................................................................................................... 19 
3.1 Primary endpoint .................................................................................................................. 19 
3.2 Secondary endpoint(s).......................................................................................................... 19 
3.3 Exploratory endpoints .......................................................................................................... 21 
STUDY VARIABLES ........................................................................................................................... 21 
4.1 Standard variables ................................................................................................................ 21 
4.2 Efficacy variables .................................................................................................................. 21 
4.3 Safety variables ..................................................................................................................... 22 
STUDY DESIGN ................................................................................................................................ 24 
5.1 Study description .................................................................................................................. 24 
5.2 Study duration ...................................................................................................................... 26 
5.3 Rationale for study design and selection of dose................................................................. 26 
SELECTION AND WITHDRAWAL OF SUBJECTS ................................................................................ 26 
6.1 Target population ................................................................................................................. 26 
6.2 Estimated number of eligible patients ................................................................................. 26 
6.3 Eligibility criteria ................................................................................................................... 26 
6.3.1. Inclusion criteria .................................................................................................................. 26 
6.3.2. Exclusion criteria ................................................................................................................. 28 

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6.3.3. Exclusions for general safety ............................................................................................... 28 
6.4 Screening failures ................................................................................................................. 30 
6.5 Withdrawal criteria ............................................................................................................... 30 
6.6 Recruitment, consent and randomisation processes ........................................................... 30 
6.6.1. Eligibility Screening ............................................................................................................. 30 
6.6.2. Recruitment and informed consent .................................................................................... 31 
6.6.3. Randomisation process ....................................................................................................... 31 
6.6.4. Study Blinding ..................................................................................................................... 32 
6.6.5. Patients who withdraw consent ......................................................................................... 33 
6.6.6. Managing/replacing patients who withdraw early ............................................................. 33 
6.6.7. Definition for the end of the trial ........................................................................................ 33 
STUDY TREATMENTS ...................................................................................................................... 34 
7.1 General information on the products (trial drugs) to be used ............................................. 34 
7.2 Investigational medicinal product (IMP) .............................................................................. 34 
7.2.1. Summary of product characteristics (SmPC) ...................................................................... 34 
7.3 Non-Investigational Medicinal Product (NIMPs) .................................................................. 34 
7.4 Administration/handling of the trial drugs........................................................................... 35 
7.4.1. Handling, storage and supply .............................................................................................. 35 
7.4.2. Administration of the trial drugs......................................................................................... 35 
7.5 Prior and concomitant illnesses ........................................................................................... 35 
7.6 Prior and concomitant medications ..................................................................................... 35 
7.6.1. Prohibited prior medications .............................................................................................. 35 
7.6.2. Permitted concomitant medications .................................................................................. 35 
7.6.3. Prohibited concomitant medications.................................................................................. 36 
7.6.4. Surgical procedures ............................................................................................................. 37 
7.7 Special warnings and precautions for use ............................................................................ 37 
7.8 Dose modifications ............................................................................................................... 37 
7.9 Assessing subject compliance with trial treatment(s) .......................................................... 37 
7.10 Withdrawal of trial treatment ............................................................................................ 37 
7.10.1. General/study-related withdrawal criteria ....................................................................... 38 
METHODS OF ASSESSMENT............................................................................................................ 38 
8.1 Assessment of primary efficacy variable .............................................................................. 38 
8.2 Assessment of secondary efficacy variable(s) ...................................................................... 38 

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8.2.1. C-Reactive Protein ............................................................................................................... 38 
8.2.2 Tender joint count................................................................................................................ 39 
8.2.3 Swollen joint count .............................................................................................................. 39 
8.2.4 Patient’s Assessment of Pain Visual Analogue Scale ........................................................... 39 
8.2.5 Patient’s Global Assessment of Disease Activity Visual Analogue Scale.............................. 39 
8.2.6 Physician’s Global Assessment of Disease Activity Visual Analogue Scale .......................... 39 
8.2.7 Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) .............................................. 39 
8.2.8 Leeds Enthesitis Index (LEI) .................................................................................................. 40 
8.2.9 Leeds Dactylitis Index ........................................................................................................... 40 
8.2.10 Health Assessment Questionnaire-Disability Index ........................................................... 40 
8.2.11 Minimal Disease Activity (MDA) ........................................................................................ 40 
8.2.12 Psoriatic Arthritis Response Criteria (PsARC) ..................................................................... 40 
8.2 13 American College of Rheumatology 20 Responder Index (ACR20) .................................... 41 
ACR50 and ACR70 ......................................................................................................................... 41 
8.2.14 Composite Psoriatic Disease Activity Index ....................................................................... 41 
8.2.15 Measures of skin disease activity ....................................................................................... 41 
8.2.16 Quality of life and health status measures ........................................................................ 42 
8.3 Assessment of other efficacy variables ................................................................................ 42 
8.3.1 Ultrasound of joints and entheses ....................................................................................... 42 
8.3.2 Radiographs of hands and feet ............................................................................................ 44 
8.4 Clinical assessments for evaluating safety ........................................................................... 44 
8.4.1 Physical examination ........................................................................................................... 44 
8.4.2 Chest x-ray ........................................................................................................................... 44 
8.4.3 Electrocardiogram ................................................................................................................ 44 
8.5 Assessment of exploratory variables .................................................................................... 45 
8.5.1 Whole-Body MRI .................................................................................................................. 45 
8.5.2 Laboratory exploratory biomarkers ..................................................................................... 45 
8.6 Summary schedule of study assessments. ........................................................................... 47 
8.7 Screening visit ....................................................................................................................... 52 
8.8 Baseline (week 0) .................................................................................................................. 53 
8.9 Safety/Monitoring Visit (week 4, ± 7 days) .......................................................................... 54 
8.10 Week 8 (± 7 days) ............................................................................................................... 54 
8.11 Week 12, ± 7 days (secondary endpoint) ........................................................................... 55 
8.12 Weeks 16 (± 7 days) and 20 (± 7 days) ............................................................................... 56 

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8.13 Week 24, ± 7 days (primary endpoint). .............................................................................. 56 
8.14 Subsequent visits (Week 28 [±7 days] and Week 36 [± 7 days]) for both treatment arms:
 
57 
8.15 Withdrawal visit (week X) ................................................................................................... 57 
8.16 
Extra visit (week Y) ........................................................................................................ 58 
8.18 Definition and Management of Disease Flare .................................................................... 60 
PHARMACOVIGILANCE ................................................................................................................... 61 
9.1 Defining adverse events ....................................................................................................... 61 
9.2 Defining serious adverse events (SAEs) ................................................................................ 61 
9.3 AEs of special interest........................................................................................................... 62 
9.3.1 Pregnancy ............................................................................................................................. 62 
9.3.2 Lactation ............................................................................................................................... 62 
9.3.3 Overdose .............................................................................................................................. 62 
9.3.4 Accidental exposure to an IMP ............................................................................................ 62 
9.3.5 Product Quality Complaint ................................................................................................... 62 
9.4 Defining unexpected and suspected unexpected serious adverse reactions (SUSARs) ....... 62 
9.5 Exemptions from safety reporting ....................................................................................... 62 
9.5.1 Efficacy endpoints and disease progression events ............................................................ 62 
9.6 Recording and reporting of AEs ............................................................................................ 63 
9.6.1 Recording and reporting of all AEs ....................................................................................... 63 
9.6.2. SAE and SUSAR reporting requirements ............................................................................. 63 
9.6.2.1 SAE/SUSAR reporting to the Sponsor ............................................................................... 64 
9.6.2.2 SAE/SUSAR reporting to Janssen ...................................................................................... 64 
9.7 Urgent safety measures........................................................................................................ 65 
9.8 Serious breaches of protocol ................................................................................................ 65 
9.9 Laboratory measurements ................................................................................................... 65 
9.10 Annual reports .................................................................................................................... 65 
9.11 End of trial report ............................................................................................................... 65 
STUDY MANAGEMENT AND ADMINISTRATION ............................................................................. 65 
10.1 Good clinical practice (GCP) and regulatory compliance ................................................... 65 
10.2 Adherence to protocol ....................................................................................................... 66 
10.3 Monitoring, audit and inspection ....................................................................................... 66 
10.3.1. Procedures for monitoring subject compliance ................................................................ 66 

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10.3.2. Definition of source data .................................................................................................. 66 
10.3.3. Quality assurance .............................................................................................................. 66 
10.3.4. Trial oversight: trial steering committee .......................................................................... 67 
10.4 Data handling ..................................................................................................................... 67 
10.4.1. Paper-based data collection tools and electronic (e) CRF completion ............................. 67 
10.4.2. Database entry and reconciliation .................................................................................... 67 
10.4.3. Screening and enrolment logs .......................................................................................... 67 
10.5 Archiving and data retention .............................................................................................. 67 
10.6 Study suspension, termination and completion ................................................................ 68 
DATA EVALUATION ......................................................................................................................... 68 
11.1 Responsibilities ................................................................................................................... 68 
11.2 Hypotheses ......................................................................................................................... 68 
11.3 General statistical considerations ...................................................................................... 69 
11.4 Analysis populations ........................................................................................................... 69 
11.5 Planned efficacy analyses ................................................................................................... 69 
11.5.1. Primary endpoint analysis ................................................................................................. 69 
11.5.2. Secondary endpoint analyses ........................................................................................... 69 
11.5.3. Other analyses .................................................................................................................. 70 
11.6 Safety analyses ................................................................................................................... 70 
11.7 Handling of dropouts and missing data .............................................................................. 70 
11.8 Planned interim analysis and data monitoring................................................................... 71 
11.9 Determination of sample size and randomization method ............................................... 71 
11.10 Procedure for un-blinding the study prior to analysis ..................................................... 71 
ETHICS AND REGULATORY REQUIREMENTS ................................................................................... 71 
12.1 Good Clinical Practice ......................................................................................................... 71 
12.2 Delegation of Investigator duties ....................................................................................... 72 
12.3 Subject information and informed consent ....................................................................... 72 
12.4 Subject confidentiality ........................................................................................................ 73 
12.5 Approval of clinical study protocol and amendments........................................................ 73 
12.6 Protocol amendments ........................................................................................................ 73 
12.7 On-going information for MHRA/REC ................................................................................ 74 
13. FINANCE AND INSURANCE ....................................................................................................... 74 
13.1 Indemnity and insurance .................................................................................................... 74 

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13.2 Financial disclosure............................................................................................................. 74 
14. PUBLICATION ............................................................................................................................ 74 
REFERENCES ................................................................................................................................... 76 
APPENDICES .................................................................................................................................... 80 
APPENDIX 1: Definition of Women of Childbearing Potential (WCBP) ...................................... 80 
APPENDIX 2: Common Terminology Criteria for Adverse Events (CTCAE) Grading ................... 81 
APPENDIX 3: CASPAR Classification Criteria for PsA .................................................................. 82 
APPENDIX 4: mNAPSI Score ........................................................................................................ 83 
APPENDIX 5: Trial Steering Committee (TSC) ............................................................................. 84 
APPENDIX 6: Visual Analogue Scales (VAS) ................................................................................ 85 
APPENDIX 7: Tender and swollen joints assessments instructions ............................................ 87 
APPENDIX 8: Magnetic Resonance Imaging (MRI) scoring methods planned for GOLMePsA trial
 
89 
 
 
 

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ABBREVIATIONS 
Abbreviation 
Term 
ACR 
American College of Rheumatology 
AE 
Adverse Event 
BSA 
Body Surface Area 
CI 
Chief Investigator 
eCRF 
[electronic] Case Report Form 
DLQI 
DMEC 
Dermatology Life Quality Index 
Data Monitoring and Ethics Committee 
DRMD 
Division Of Rheumatic And Musculoskeletal Disease 
DSUR 
Developmental Safety Update Report 
ECG 
Electrocardiogram 
EQ-5D 
EuroQol 5 Dimension 
ESR 
Erythrocyte Sedimentation Rate 
GCP 
Good Clinical Practice 
GOL 
Golimumab 
GP 
IA 
General Practitioner 
Intra-articular 
HAQ-DI 
Health Assessment Questionnaire-Disability Index 
ICH 
International Conference On Harmonisation 
IM 
Intra-muscular 
IMP 
Investigational Medicinal Product 
IV 
Intravenous 
LDI 
Leeds Dactylitis Index 
LEI 
Leeds Enthesitis Index 
MDA 
Minimal Disease Activity 
MHRA 
Medicines And Healthcare Products Regulatory Agency 
mNAPSI 
Modified Nail Psoriasis Severity Index 
MRI 
Magnetic Resonance Imaging 
MTX 
Methotrexate 
NIMP 
Non-Investigational Medicinal Product 
PASDAS 
Psoriatic arthritis Disease Activity Score 

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Abbreviation 
Term 
PASI 
Psoriasis Area and Severity Index 
PsA 
Psoriatic Arthritis 
PBMC 
Peripheral Blood Mononuclear Cells 
PIS/ICF 
Patient Information Sheet / Informed Consent Form 
PO 
Oral Route [Per Os] 
PsA 
Psoriatic arthritis 
PsAQoL 
Psoriatic Arthritis Quality of Life index 
PsARC 
Psoriasis Arthritis Response Criteria 
Pso 
Psoriasis 
QA 
Quality Assurance 
RA 
Rheumatoid arthritis 
RDMS 
Research Data Management System 
REC 
RSI 
Research Ethics Committee 
Reference Safety Information 
SAE 
Serious Adverse Event 
SC 
Subcutaneous 
SD 
Standard Deviation 
SF-36 
Short Form Health Index 
SmPC 
Summary Of Product Characteristics 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TMF 
Trial Master File 
TNF 
Tumour necrosis factor 
ULN 
Upper limit of normal 
US 
Ultrasound 
VAS 
Visual analogue scale 
WB-MRI 
Whole-Body Magnetic Resonance Imaging 
 
 
 

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PROTOCOL SYNOPSIS 
GENERAL INFORMATION 
Short Title 
GOLMePsA 
Full Title 
An investigator-initiated double-blind, parallel-group randomised 
controlled trial of GOLimumab and Methotrexate versus 
Methotrexate in very early PsA using clinical and whole body MRI 
outcomes: the GOLMePsA study 
Sponsor 
The Leeds Teaching Hospitals NHS Trust 
Sponsor ID 
RR13/10782 
EudraCT No. 
2013-004122-28 
MREC No. 
14/EM/0124 
Chief Investigator 
Dr Helena Marzo-Ortega 
Co-ordinating Centre 
Chapel Allerton Hospital, Leeds 
National / International 
National 
TRIAL INFORMATION 
Phase 
Phase IIIb 
Indication 
Early Psoriatic Arthritis 
Design 
Investigator initiated, double-blind, randomized, placebo-
controlled, two-armed, parallel-group, single centre trial 
Number of sites 
1 
Primary Objective 
To assess whether the combination of golimumab with 
methotrexate and steroids is superior to standard care (MTX 
monotherapy plus steroids) in reducing clinical disease activity in 
patients with early, treatment naïve PsA 
Secondary Objective(s) 
• 
To assess superiority of combination therapy over 
standard care in improving US imaging disease activity 
• 
To assess superiority of combination therapy over 
standard care in improving patient-reported quality of life 
and health status 
• 
To assess whether responses on US imaging outcomes are 
associated with steroid therapy 
• 
To assess the extent of association between clinical and 
US imaging joint assessments at baseline 
• 
To assess the extent of association between clinical and 
US imaging responses to therapy 
• 
To identify baseline variables which may be modifiers of 
clinical or imaging response (e.g. symptom duration, 
immunological parameters) 

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• 
To assess the test-retest reliability of the PASDAS 
composite index 
Exploratory Objective(s) 
• 
To assess the extent of association between clinical and 
WB-MRI imaging joint assessments at baseline 
• 
To assess the extent of association between clinical and 
WB-MRI imaging responses to therapy 
• 
To quantify the potential treatment effect with respect to 
WB-MRI disease activity 
 
Primary Endpoint 
Clinical disease activity (PASDAS) at 24 weeks 
Secondary Endpoint(s) 
 
Clinical measures of disease activity and achievement of 
acceptable state or response at 12, 24, 36 and 52 weeks. 
 
US Imaging measures of disease activity and achievement 
of acceptable state at 12, 24 and 36 weeks. 
 
Patient-reported outcomes at 24 and 52 weeks. 
Exploratory Endpoint(s) 
 
WB-MRI measures of disease activity and achievement of 
acceptable state at 24 and 36 weeks 
TRIAL TIMELINES 
Expected start date 
October 2015 
Patient enrolment phase 
October 2015 - February 2022 
Follow-up duration 
52 weeks 
End of Trial Definition 
Last Patient Last Data Item 
Expected completion date 
December 2023 
TRIAL PATIENT INFORMATION 
Number of trial patients 
84 
Age group of trial patients 
≥18 
Inclusion criteria 
1. Adult patients with a diagnosis of PsA (CASPAR criteria) 
of up to 24-month duration. 
2. Active joint disease as defined by at least 3 swollen and 
3 tender joints or 2 swollen and 2 tender joints plus one 
affected entheseal site (Achilles tendon and/or plantar 
fascia). 
3. Treatment naïve to DMARDs including biologics 
Exclusion criteria 
1. Age <18  
2. Previous treatment with a DMARD or biological therapy 
for PsA. 
 
 

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INVESTIGATIONAL MEDICINAL PRODUCT 
IMP name(s) 
Golimumab (Simponi®) 
IMP mode of administration 
Subcutaneous injections 
Duration of IMP Treatment 
24 weeks 
IMP Supplier(s) 
Janssen Biologics BV 
Non IMP name(s) 
Methotrexate, corticosteroids 
 

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SCHEMATIC DIAGRAM OF RECRUITMENT, RANDOMISATION & TREATMENT 
 

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INTRODUCTION 
1.1 Background 
Psoriatic arthritis (PsA) is a chronic, systemic, inflammatory arthritis, which may be associated to skin 
psoriasis (Pso). PsA is one of the commonest inflammatory arthritis occurring in up to 0.1% of the 
general population and in 6%-42% of patients with Pso. In the majority of cases Pso precedes the onset 
of arthritis by several years.  The course of PsA is heterogenous and variable, with some patients 
having mild disease whilst others evolve into a severe, erosive arthropathy that is often refractory to 
conventional treatments and may be associated with functional disability and accelerated morbidity 
(1, 2). Traditionally there has been a delay on patients presenting to outpatient clinics of over 9 years 
by which time the majority (67%) will have an established, erosive arthropathy with a substantial 
degree of functional impairment (3-5). 
Psoriatic arthritis has many clinical manifestations including arthritis, enthesitis, dactylitis, axial 
disease, and skin/nail involvement. Traditionally the primary outcome measure used in interventional 
studies has been the American College of Rheumatology 20% improvement (ACR20) criteria(6), a 
measure originally developed for rheumatoid arthritis (RA) and which focuses on peripheral joint 
activity.  In addition, a number of studies have used another rheumatoid arthritis measure, the Disease 
Activity Score for 28 joints (DAS28). However, in PsA, the number of joints assessed should optimally 
include a 68-tender, 66-swollen joint count, which includes the distal interphalangeal (DIP) joints of 
the fingers. The Psoriatic Arthritis Response Criteria (PsARC) (7, 8) were developed for a specific 
Veterans Administration study of sulfasalazine in PsA but are also primarily articular response criteria. 
Several other candidate composite measures have been proposed, some of which capture aspects of 
PsA other than the peripheral arthritis.  These include the Psoriatic Arthritis Disease Activity Score 
(PASDAS) and the Composite Psoriatic Disease Activity Index (CPDAI). The newer measures are more 
responsive in clinical trials and are better able to distinguish different doses of trial medication (9, 10). 
The PASDAS is a weighted index comprising assessments of joints, function, acute phase response, 
quality of life (QOL), and patient and physician global by VAS. The score range of the PASDAS is 0–10, 
with worse disease activity represented by higher scores. Cut-offs for disease activity and response 
have now been developed and validated using interventional trial data (11). 
The use of imaging techniques such as ultrasound (US) and magnetic resonance (MRI) in particular has 
transformed the understanding of PsA and also provided a useful technique for therapy evaluation. 
MRI is a sensitive imaging modality that allows for the comprehensive assessment of joints and soft 
tissues. Whole body MRI (WB-MRI) uses multiple phased arrays coils to allow for multi-joint 
assessment in one session, which includes both axial and peripheral joints. A recent study has shown 
that WB-MRI is a feasible technique that confirms sites of active disease but is also sensitive for 
detection of subclinical disease in patients with PsA particularly with enthesitis and bone marrow 
oedema (12). Evidence from the RA literature suggests that subclinical bone marrow oedema is one 
of the main predictors for on-going radiographic progression even in the presence of clinical remission 
(13). In SpA, there is evidence that bone oedema may be a predictor of future spinal fusion. Therefore, 
the ability to delineate the total disease burden in PsA, particularly on those joints and/or enthesis 
not obviously inflamed on clinical examination, may have important implications for understanding 
the basis for true disease remission following therapy. No study with anti-TNF agents has explored this 
to date.  

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Ultrasound allows visualization of different joint areas such as enthesis, bone, bursa and tendons and 
other soft tissue structures. It is non-invasive, providing easier joint access than MRI at the bedside 
and can scan multiple joints in one sitting.  
 
Mounting evidence over the past two decades in rheumatoid arthritis (RA) has shown that early and 
aggressive treatment of RA with DMARDs and biologics reduces the effects of the disease in terms of 
joint damage and disability (14). This has indeed led to clinical remission being an achievable goal in 
many patients receiving biologics, chiefly TNF blockers received early in the disease course (15) (16). 
Although the optimal treatment strategy in RA is still being debated, strategies utilizing combination 
therapy with biologics and corticosteroids have proven extremely effective particularly when used 
early in the disease course (15, 17). In fact, it has been suggested that this favourable outcome is 
attributable mainly to a treat-to-target strategy rather than the superiority of any specific drug (18, 
19). Data in PsA sparse, with only limited evidence on the efficacy of conventional DMARDs such as 
methotrexate or leflunomide (20). To date, TNF inhibitors have been the only drugs shown to be 
efficacious in the treatment of the heterogenous clinical manifestations of the disease including joints, 
spine, skin and nails (21-24). Similar to RA, TNF inhibitors have also been shown to halt the progression 
of structural damage in peripheral joints in PsA (25). Recently, treatment agents that act through the 
inhibition of TNF, such as golimumab, have shown good efficacy for joint and skin manifestations of 
PsA in advanced disease resistant to conventional DMARDs (26). 
1.2 Golimumab background 
Golimumab (SIMPONI®) is a human IgG1κ monoclonal antibody against tumor necrosis factor-α (TNF-
α). Golimumab (alone or in combination with methotrexate (MTX) is indicated for the treatment of 
active and progressive psoriatic arthritis in adult patients when the response to previous disease-
modifying anti-rheumatic drug (DMARD) therapy has been inadequate. The safety and efficacy of 
subcutaneous (SC) golimumab used for reducing signs and symptoms of active PsA, associated skin 
and nail disease, and inhibition of structural damage was evaluated in the GO-REVEAL trial (21). At 
Week 14, treatment with golimumab 50 mg resulted in a significantly greater proportion of patients 
who achieved an ACR 20 response, compared to placebo (51% vs 9%; p<0.001). Further, golimumab 
also demonstrated inhibition of structural damage at 24 and 52 Weeks with significant improvements 
in joints, skin, and radiographic benefits have been observed through Week 104. From the point of 
patients’ reported outcomes, golimumab significantly improved physical function and health-related 
quality of life through Week 52. 
It is therefore postulated that aggressive intervention in PsA with golimumab together with a step-up 
methotrexate protocol immediately after diagnosis combined with intra-articular or intramuscular 
corticosteroid use could lead to a state of minimal disease activity (MDA) (27) or near clinical remission 
and complete ablation of inflammation as shown by WB-MRI and US at 24 weeks. 
1.3 Rationale for the proposed study 
Psoriatic arthritis can cause a considerable amount of disability in affected patients, which is 
equivalent to that of RA and can be present from earlier on in the disease process. To date TNF 
blockers are shown to be the more efficacious agents in the treatment of PsA, however a subset of 
patients will not achieve a significant response to single therapy. Further the use of biologics on 
treatment naïve patients has not been studied in PsA. Experience from RA shows that early 
implementation of a treat-to-target strategy in early disease leads to prompt control of inflammation 
which is sustained over 5 years and reflected in persistent halting of radiographic progression. 
Radiographic involvement in the early disease stages in PsA is not widespread and does not represent 

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a sensitive measurable outcome. Some factors contributing to this may be the heterogeneity of the 
disease affecting different joint groups or restrictions on the study designs. We therefore aim to 
address these issues by using a recently-developed clinical efficacy outcome, PASDAS, which has been 
shown to have good sensitivity to change, and by including WB-MRI as an exploratory endpoint.  
WB-MRI is a safe and sensitive imaging technique with the capability to perform multi-joint imaging. 
The advantage of WB-MRI is that it can give information on subclinical inflammation, which is 
particularly relevant in oligo-articular joint patterns. 
It is hypothesized that: 
Early prompt intervention in PsA with a treatment strategy using a combination of golimumab and 
methotrexate plus corticosteroids will lead to improvement in a new clinical disease activity measure 
at week 24, which will be superior to that shown by the combination of methotrexate plus placebo 
plus corticosteroids, by at least 1 unit on the scale. 
A subset of PsA patients at presentation have a substantial amount of subclinical joint/entheseal 
inflammation that can be identified by WB-MRI and US. Using WB-MRI and US will permit 
identification of patients whose response to therapy has been successful even at the subclinical level. 
STUDY AIM AND OBJECTIVES 
2.1 Study aim 
The aim of the study is to assess the clinical efficacy of a treatment strategy in early, treatment naïve 
PsA patients, using a combination of early TNFi therapy (golimumab) plus methotrexate plus steroids 
versus standard care (MTX monotherapy plus steroids) at 24 weeks. 
2.2 Primary objective 
The primary objective of this study is to assess whether the combination of golimumab with 
methotrexate and steroids is superior to standard care (MTX monotherapy plus steroids) in reducing 
disease activity in patients with early, treatment naïve PsA. 
2.3 Secondary objective(s) 
• 
To assess superiority of combination therapy over standard care in improving US-detected 
joint and entheseal pathology 
• 
To assess superiority of combination therapy over standard care in improving patient-
reported quality of life and health status 
• 
To assess whether responses on US imaging outcomes are associated with steroid therapy 
• 
To assess the extent of association between clinical and US imaging joint assessments at 
baseline 
• 
To assess the extent of association between clinical and US imaging responses to therapy 
• 
To identify baseline variables which may be modifiers of clinical or imaging response (e.g. 
symptom duration, immunological parameters) 
• 
To assess the test-retest reliability of the PASDAS composite index. 

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2.4 Exploratory objective(s) 
 
• 
To assess the extent of association between clinical and WB-MRI joint assessments at baseline 
• 
To assess the extent of association between clinical and WB-MRI responses to therapy 
• To quantify the potential treatment effect with respect to WB-MRI disease activity 
STUDY ENDPOINTS 
3.1 Primary endpoint 
Disease activity 
o Disease activity (PASDAS score) at 24 weeks. 
3.2 Secondary endpoint(s) 
The following endpoints will be assessed: 
Efficacy measures 
 
Clinical measures of disease activity 
o Disease activity measures: 
 
PASDAS at 12, 36 and 52 weeks 
 
Enthesitis score at 12, 24, 36 and 52 weeks 
 
Dactylitis score at 12, 24, 36 and 52 weeks  
 
PASI score (28) at 12, 24, 36 and 52 weeks 
 
mNAPSI score (29) at 12, 24, 36 and 52 weeks 
 
CPDAI score (30) at 24 and 52 weeks 
o Acceptable state or response: 
 
Proportion achieving MDA at 12, 24, 36 and 52 weeks 
 
Proportion achieving PsARC response at 8, 12, 24, 36 and 52 weeks 
 
Proportions achieving ACR20/50/70 responses at 12, 24, 36 and 52 weeks 
 
Proportion achieving at least PASI75 at 12, 24, 36 and 52 weeks in the subset 
of patients in whom at least 3% of the BSA was affected by psoriasis at 
baseline 
o Composite index test-retest reliability 
 
PASDAS score at screening and at baseline visit. 
 
Imaging measures of disease activity 
o Measures of joint/enthesis pathology 
 
Total scores for synovitis/enthesitis identified by US at 12, 24 and 36 weeks 
o Acceptable state 
 
Proportion achieving US remission at 12, 24 and 36 weeks 
 
Patient-reported outcomes 
o Patient VAS global disease Activity at 24 and 52 weeks 
o DLQI at 24 and 52 weeks (31) 
o SF-36 Mental Component Summary and Physical Component Summary at 24 and 52 
weeks (32) 

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Other secondary endpoints 
 
Treatment-related endpoints 
o Proportion of patients requiring additional steroid therapy up to week 12 
o Cumulative steroid dose received up to week 12 
3.3 Exploratory endpoints 
 
Established scores for inflammatory lesions (bone marrow oedema or osteitis and synovitis) 
identified by WB-MRI at 24 and 36 weeks  (see section 8.5.1) (in a subset of patients) 
 
Imaging measures of disease activity in expanded set of sites (the expanded ultrasound 
variables will only be available for a subset of patients) 
o Measures of joint/enthesis pathology 
• 
Total scores for synovitis/enthesitis identified by US at 12, 24 and 36 weeks 
(using OMERACT joint/enthesis sets; using OMERACT scoring) 
o Acceptable state 
• 
Proportion achieving US remission at 12, 24 and 36 weeks (using OMERACT 
joint/enthesis sets) 
 
Immunological parameters 
o T and B cell frequencies at 24 and 52 weeks in a subset of patients who agree to take 
part in the biomarker sub-study. 
STUDY VARIABLES 
4.1 Standard variables 
 
Age 
 
Sex 
 
Ethnicity 
 
Height 
 
Weight 
 
Medical / surgical / family history 
 
Concomitant medication 
4.2 Efficacy variables 
 
PASDAS (0-10) 
 
Leeds Enthesitis Index (0-6) 
 
Physician assessment of arthritis, Likert scale (1-5; used in composite outcomes) 
 
Physician global assessment of psoriatic disease VAS (mm; used in composite outcomes) 
 
Leeds Dactylitis Index (0-~40) 
 
Psoriasis Area Severity Index (0-72) 
 
Modified Nail Psoriasis Severity Index (0-140) 
 
Tender joint count (out of 68; used in composite outcomes) 
 
Swollen joint count (out of 66; used in composite outcomes) 
 
Composite Psoriatic Disease Activity Index (range 0-15) 
 
Minimal disease activity (yes/no) 
 
PsARC response (yes/no) 
 
ACR response (yes/no) 
 
Percentage of Body Surface Area (%) 

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 
C-reactive protein level (mg/L; used in composite outcomes) 
 
US grey scale score (total 0-72; 0-144 for OMERACT definition subset) 
 
US power Doppler score (total 0-72; 0-144 for OMERACT definition subset) 
 
US Global OMERACT-EULAR Score System (GLOESS) score (total 0-72; 0-144 for OMERACT 
definition subset) 
 
US number of entheses with grey scale abnormalities (0-10; 0-12 for OMERACT definition 
subset) 
 
US enthesis power Doppler score (total 0-30; 0-36 for OMERACT definition subset) 
 
US total enthesis thickness score (0-30; 0-36 for OMERACT definition subset) 
 
US total enthesis erosion score (0-30; 0-36 for OMERACT definition subset) 
 
US number of entheses with calcification (0-10)US number of entheses with enthesophytes 
(0-10) 
 
US enthesis inflammation score (0-70) 
 
US enthesis chronicity score (0-50) 
 
US remission (yes/no) 
 
Patient assessment of arthritis, Likert scale (1-5; used in composite outcomes) 
 
Patient global assessment of psoriatic disease activity VAS (mm) 
 
Patient articular pain assessment VAS (mm; used in composite outcomes) 
 
ASQoL (0-18; used in composite outcomes) 
 
Health Assessment Questionnaire Disability Index (0-3; used in composite outcomes) 
 
Dermatology Life Quality Index (0-30) 
 
SF-36 mental and physical component scores (0-100) 
 
Cumulative dose of steroid (mg) 
 
SPARCC spinal inflammation score (0-108) 
 
SPARCC sacro-iliac joint inflammation score (0-72) 
 
HIMRISS BML score (0-100) 
 
HIMRISS effusion & synovitis score (0-30) 
 
KIMRISS score (0-763) 
 
CANDEN spine inflammation score (0-614) 
 
CANDEN spine fat score (0-510) 
 
CANDEN spine bone erosion score (0-208) 
 
CANDEN new bone formation score (0-460) 
 
HEMRIS score (inflammation sum score 0-24; structural sum score 0-18) 
 
MRI-WIPE score (0-738) 
 
T-cell subset frequencies (IRC, naïve, Treg) 
 
B-cells 
4.3 Safety variables 
 
Number of patients experiencing SAEs and AEs. 
 
Any clinically significant worsening of a pre-existing condition. 
 
An AE occurring from overdose of an IMP, whether accidental or intentional. 
 
An AE occurring from abuse (e.g. use for nonclinical reasons) of an IMP. 
 
An AE that has been associated with the discontinuation of the use of an IMP. 

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STUDY DESIGN 
5.1 Study description 
GOLMEPsA is an investigator initiated, randomised, double-blind, placebo-controlled, two-armed, 
parallel-group, single-centre imaging study. Patients with the following criteria will be recruited: 
 
Treatment-naïve PsA patients classified according to CASPAR criteria (33) 
 
Up to 24 month diagnosis 
 
At least 3 swollen and 3 tender joints or 2 swollen and 2 tender joints and one tender 
enthesis. 
The trial will start with a four-week screening phase, and informed consent will be obtained at the 
screening visit. A (revised) total of 84 patients will be randomised on a 1:1 basis to receive one of the 
following: 
Treatment Arm 1 (Group A): Immediate golimumab (50 mg SC four weekly) and MTX (starting at 15 
mg weekly with rapid escalation up to 25 mg over 4 weeks) combination therapy administered for a 
total duration of 24 weeks. 
Treatment Arm 2 (Group B): MTX monotherapy (starting at 15 mg weekly with rapid escalation up to 
25 mg over 4 weeks) plus placebo SC injections four weekly for 24 weeks. 
Both treatment arms will receive a “bolus” dose of methylprednisolone (120mg IM or equivalent 
amount intra-articularly in case of oligoarticular, 4 swollen joints, presentation) with the aim to 
achieve rapid ablation of inflammation at baseline. In addition, both treatment arms will adopt a 
“treat-to-target” (TT) algorithm (see Schematic Diagram) involving further corticosteroid injections 
(intra-muscular or intra-articular) if not achieving a PsARC response at weeks 8 and 12 (secondary 
endpoint). Steroid amount given between both visits will not exceed a maximum amount of 120mg 
methylprednisolone per patient. 
No further steroids will be allowed beyond week 12. Any patients showing an unacceptable degree of 
disease activity (as judged by the study clinician by clinical assessment in conjunction with PsARC ) 
beyond this point and before the week 24 assessment will cease to follow the study treatment 
protocol (withdrawal) and will be treated as deemed necessary by the study physician according to 
clinical protocols and NICE guidelines. In these cases, subjects in the subset in whom WB-MRI was to 
be collected will undergo WB-MRI as per exploratory objective (see Week X ‘withdrawal visit’, 
summary schedule of study assessments section 8.6) and will continue to be observed for the rest of 
the study duration. 
All subjects reaching 24 weeks (primary endpoint) will be invited for  repeat WB-MRI (if in WB-MRI 
subset) and US examination of a set core of joints and entheses (as per baseline assessment). Subjects 
will also be assessed for PASDAS (primary outcome), MDA and PsARC and other relevant clinical 
outcomes. 
Subjects in Treatment arm 1 (GOL+MTX) will have GOL discontinued at week 24, will continue MTX 
and will be observed thereafter for the duration of the observational phase of the study (until week 
52). In case of disease flare during this period (defined as in section 8.18), subjects will be invited to 
have repeated imaging assessments (US and WB-MRI as per “Extra visit” section 8.6) and will be 
treated according to existing clinical protocols and NICE guidelines. Observation will not be 
interrupted and all data from these participants will be collected until the end of the study period. 

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Subjects in Treatment arm 1 not achieving PsARC improvement by week 24 will have GOL discontinued 
and will be treated according to existing clinical protocols and NICE guidelines, and will be observed 
until the end of the study period. 
Subjects on Treatment arm 2 (MTX+placebo) achieving PsARC improvement at week 24 will be allowed 
to continue their MTX treatment and shall be observed for the duration of the observational phase of 
the study (until week 52). In case of disease flare (defined as in section 8.18) beyond week 24, subjects 
will be invited to have repeated imaging assessments (WB-MRI if in WB-MRI subset), US as per “Extra 
visit”) and will be treated according to existing clinical protocols and NICE guidance. 
Subjects on Treatment arm 2 not achieving PsARC improvement by week 24 will be treated according 
to existing clinical protocols and NICE guidance and observed until the end of the study Period. 
 
Corticosteroids: Patients on both groups can receive further IM/IA corticosteroids at weeks 8 and 12 
if a PsARC response is not achieved at these visits. The maximum amount of corticosteroids given 
between these 2 visits should not exceed 120mg intramuscular methylprednisolone (or comparable 
amount intra-articularly; unless contraindicated or not tolerated). No further corticosteroids are 
allowed between weeks 12 and 24. 
At and/or after the primary endpoint (week 24) intramuscular or intra-articular steroids are permitted 
unless a clinical or imaging assessment is scheduled within the following 6 weeks. The same applies to 
oral formulation of steroids. 
 
Methotrexate: All patients will receive (from the research team) a prescription for oral MTX (if 
tolerated, more details in section 7.3) at a starting dose of MTX 15mg weekly. If tolerated, MTX will 
be increased to 20mg and 25 mg weekly at weeks 2 (patient given prescription at baseline visit by the 
research team) and 4 respectively. Subcutaneous MTX may be administered if intolerance to oral MTX 
is observed. All patients will receive oral folic acid at a dose of 5mg daily except the day of MTX, i.e. 6 
days per week. 
All patients will receive haematology and biochemistry monitoring on DMARD therapy according to 
local guidelines. 
All patients recruited to this study, irrespective of therapy change (as outlined above), will continue 
to be followed up for the 52 week study duration with imaging and immunological studies as per 
protocol (unless consent is withdrawn). 
Patients will undergo all of the following radiological assessments (eligibility limitation may apply) at 
baseline and at visits as stated below: 
 
WB-MRI (if eligible and in WB-MRI subset) at baseline, weeks 24 and 36 and time of 
withdrawal (Week X) or flare (Week Y) if applicable (section 8.6). 
 
Ultrasound (US) of a set core of joints and entheses will be performed at baseline, weeks 24 
and 36 and/or at time of withdrawal (Week X) and/or at time of flare (Week Y) if applicable. 
 
Radiographs of hands and feet will be taken at screening to confirm the patient meets CASPAR 
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 
Patients consenting to the biomarker sub-study will provide samples (PBMC, serum at 
baseline and weeks 12, 24, 36 and 52 and at the time of flare in the case of an initial responder 
or study withdrawal (week X) to evaluate for changes in immunological parameters. 
This study will take place in the rheumatology department and the associated research facilities at 
Chapel Allerton Hospital / The Leeds Teaching Hospitals NHS Trust. 
The study will also use Patient Identification Centres (PICs) from within the Yorkshire region, patients 
referred to the study team via PICs will also be seen at the rheumatology outpatient department in 
Chapel Allerton Hospital, Leeds. 
5.2 Study duration 
The total duration of the study for patients completing all visits from screening to final assessment 
will be 52 weeks plus up to 4 weeks. 
5.3 Rationale for study design and selection of dose 
Based on data from the GO-REVEAL trial (21) golimumab treated patients experienced significant 
improvements in joint, skin, and nail disease, compared with patients in the placebo group through 
24 weeks of therapy. Two different doses of golimumab (50 mg and 100 mg) were tested with no clear 
evidence of improved ACR responses with golimumab 100 mg compared to golimumab 50 mg. Current 
product licensing recommends dose of 100 mg to be used on subjects 100 kg in weight. This 
recommendation will also be applied to study subjects whenever applicable. Methotrexate initiation 
at 15mg and escalation to 25mg is in line with current clinical practice in Leeds. Methylprednisolone 
120mg injection IA/IM is the standard dose used in Leeds and represents a pragmatic approach to 
induce rapid suppression of inflammation. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
6.1 Target population 
Patients with early, treatment-naive PsA, of up to 24-month from diagnosis. 
6.2 Estimated number of eligible patients 
A (revised) total of 84 patients are planned for enrolment. This number is estimated allowing for a 
10% drop-out rate. At present we see approximately 4-6 patients meeting the clinical eligibility criteria 
per month yielding at least 48 eligible patients per year. 
6.3 Eligibility criteria 
6.3.1. Inclusion criteria 
Patients meeting all of the following criteria will be considered for enrolment into the study: 
INCL1. 
Male and female patients aged ≥18 years at the time of signing the Informed Consent 
Form. 
INCL2. 
Subjects with a diagnosis of psoriatic arthritis as per the Classification for Psoriatic 
Arthritis (CASPAR) criteria (see appendix 3) confirmed up to 24 months prior to 
screening. 
INCL3. 
Subjects with active PsA defined as the presence of at least 3/78 tender and at least 
3/76 swollen joints (see section 8.2.3 and section 8.2.4) or 2 swollen and 2 tender joints 
plus one affected entheseal site (Achilles tendon and/or plantar fascia) at baseline. 

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INCL4. 
Are capable of understanding and signing an informed consent form. 
INCL5. 
Women of childbearing potential or men capable of fathering children must be using 
adequate birth control measures (e.g.: abstinence, oral contraceptives, intrauterine 
device, barrier method with spermicide, surgical sterilization) during the study and for 
6 months after receiving the last administration of study agent. Female subjects of 
childbearing potential must test negative for pregnancy. Female subjects must agree 
to not donate eggs (ova, oocytes) during the study and for 6 months after last dose of 
study agent. Male subjects must agree to not donate sperm while in the study and for 
6 months after last dose of study agent. 
INCL6. 
Patients fulfilling the following TB criteria: 
INCL6.1. 
Have no history of latent or active TB prior to screening. An exception is made for 
subjects with a history of latent TB and documentation of having completed 
appropriate treatment for latent TB 3 years prior to the first administration of study 
agent. It is the responsibility of the investigator to verify the adequacy of previous 
antituberculous treatment and provide appropriate documentation. 
INCL6.2. 
Have no signs or symptoms suggestive of active TB upon medical history and/or 
physical examination. 
INCL6.3. 
Have had no close contact with a person with active TB or, if there has been such a 
contact, will be referred to a physician specializing in TB to undergo additional 
evaluation, and if warranted, receive appropriate treatment as if having latent TB prior 
to or simultaneously with the first administration of study agent. 
INCL6.4. 
Have confirmed either: 
 
Within 6 weeks prior to the administration of study agent, a negative 
QuantiFERON-TB Gold test result; 
or 
 
Within 12 weeks from a newly identified positive QuantiFERON-TB Gold test 
result (in which active TB has been ruled out) and for which appropriate 
treatment for latent TB has been initiated either prior to, or simultaneously with, 
the first administration of study agent. 
INCL6.5. 
In the event of 2 indeterminate QuantiFERON-TB Gold in-tube tests results, the 
subjects will be treated as if having latent TB prior or simultaneously with the first 
administration of study agent. 
INCL6.6. 
Have a chest radiograph (posterior-anterior view), read by a qualified radiologist, 
whose diagnostic assessment is consistent with no evidence of current active TB or old 
inactive TB, and taken within 12 months of the study. 
INCL6.7. 
Have a screening laboratory test result as follows: 
 
INCL6.7.1. - Hb≥8.5 g/dL or ≥5.3 mmol/L 
 
INCL6.7.2. - White blood cell (WBC) count ≥3.5x10^3 cells/uL 
 
INCL6.7.3. - Neutrophils ≥1.5 x10^3 cells/uL 
 
INCL6.7.4. - Platelets ≥100x10^3 cells/uL 
 
INCL6.7.5. - Serum alanine aminotransferase (ALT) and aspartate aminotransferase 
(AST) levels not exceeding 1.5 times the upper limit of normal (ULN) for the 
central laboratory conducting the test. 
 
INCL6.7.6. - Serum creatinine not exceeding 1.5 mg/dL 
 
 
 

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6.3.2. Exclusion criteria 
Patients fulfilling any of the following conditions or characteristics will be excluded from study 
enrolment: 
EXCL 1.  
Previous treatment with any conventional or biological DMARDs, where “treatment” 
is defined as a therapeutic dosage according to each product’s SmPC. Topical 
preparations for psoriasis are not considered DMARDs (examples include, but are not 
limited to, steroids, salicylic acid, tar). 
EXCL 2. 
Any chronic inflammatory arthritis diagnosed before 16 years old. 
6.3.3. Exclusions for general safety 
EXCL3. 
Patients with significant concurrent medical diseases including uncompensated 
congestive heart failure, myocardial infarction within 52 weeks from screening, 
unstable angina pectoris, uncontrolled hypertension (BP>160/95), severe pulmonary 
disease, 
or 
history 
of 
human 
immunodeficiency 
virus 
(HIV) 
infection, 
immunodeficiency syndromes, central nervous system (CNS) demyelinating events 
suggestive of multiple sclerosis, renal or gastrointestinal conditions, which in the 
opinion of the investigator places the patient at an unacceptable risk for participation 
in the study or would make implementation of the protocol difficult. 
EXCL4. 
Patients with cancer or a history of cancer (other than resected cutaneous basal cell 
carcinoma, and in situ cervical cancer) within 5 years of screening. 
EXCL5. 
Patients with current crystal or infective arthritis. 
EXCL6. 
Patients with chronic infection of the upper respiratory tract (e.g. Sinusitis), chest (e.g. 
Bronchiectatic lung disease), urinary tract or skin (e.g. Paronychia, chronic ulcers, open 
wounds) within 4 weeks of screening. 
EXCL7. 
Patients who have a chest radiograph within 3 months prior to the first administration 
of study agent that shows an abnormality suggestive of a malignancy or current active 
infection, including (but not limited to) TB, histoplasmosis or coccidioidomycosis. 
EXCL8. 
Patients with any ongoing or active infection or any major episode of infection 
requiring hospitalization or treatment with IV antibiotics within the preceding 30 days 
of screening and/or orally administered antibiotics in the preceding 15 days of 
screening. 
EXCL9. 
Patients with abnormal liver function including known liver cirrhosis, fibrosis, or known 
alcoholic steatohepatitis (NASH) at the time of screening or abnormal blood tests as 
shown by: 
 
Aminotransferase (AST) / alanine aminotransferase (ALT) > 3x ULN, OR 
 
Bilirubin >51umol/L. 
EXCL10. 
Patients with known severe hypoproteinaemia at the time of screening, e.g.: in 
nephrotic syndrome; OR impaired renal function, as shown by: Serum Creatinine > 133 
mol/L. 
EXCL11. 
Patients with known significantly impaired bone marrow function as for example 
significant anaemia, leukopaenia, neutropaenia or thrombocytopaenia as shown by 
the following laboratory values at the time of screening: 
 
White blood cells < 3000 x 106/L; 
 
Platelets < 125 x 109/L; 
 
Haemoglobin < 9.0 g/dL for males and < 8.5 g/dL for females. 
EXCL12. 
Patients with a history of latent or active TB prior to screening will not be eligible. For 
exceptions, refer to inclusion criteria (INCL6 group). 

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EXCL13. 
Subjects must undergo screening for hepatitis B and C virus (HBV, HBC). At a minimum, 
this includes testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody 
(anti-HBc) and Hepatitis C antibody (Anti-HCV Ab), 
 
Subjects who test positive for surface antigen (HBsAg+) are not eligible for this 
study, regardless of the results of other hepatitis B tests. 
 
Subjects who test negative for surface antigen (HBsAg-) and test positive for 
core antibody (anti-HBc+) are eligible for this study provided that the HBV DNA 
test is done. All subjects who test positive for core antibody (anti-HBc+) must 
undergo further testing for hepatitis B deoxyribonucleic acid (HBV DNA test). 
o If the HBV DNA test is positive, the subject is not eligible for this study. 
o If the HBV DNA test is negative, the subject is eligible for this study. 
 
In the event the DNA test cannot be performed, the subject is not eligible for 
the study. 
EXCL14. 
Primary or secondary immunodeficiency (history of or currently active) unless related 
to primary disease under investigation. 
EXCL15. 
Pregnancy, lactation (nursing) or women of child-bearing potential (WCBP) unwilling 
to use an effective birth control measure (see appendix 1) whilst receiving treatment 
and after the last dose of protocol treatment as indicated in the relevant SmPC. 
EXCL16. 
Men whose partners are of child-bearing potential but who are unwilling to use an 
effective birth control measure whilst receiving treatment and after the last dose of 
protocol treatment as indicated in the relevant SmPC. 
EXCL17. 
Patients who have received any systemic/intra-articular corticosteroids within 4 weeks 
prior to screening. 
Topical preparations with steroids for cutaneous use, or inhalers for the treatment of 
asthma are not considered systemic/intra-articular corticosteroids. 
EXCL18. 
Patients with a history of confirmed blood dyscrasia. 
EXCL19. 
Patients with a history of mental illness that would interfere with their ability to comply 
with the study protocol. 
EXCL20. 
Patients with a history of drug and/or alcohol abuse that would interfere with their 
ability to comply with the study protocol. 
EXCL21. 
Patients with a history of any viral hepatitis within 1 year of screening 
EXCL22. 
Patients who have received or are expected to receive any live virus or bacterial 
vaccinations or treatments that include live organisms (eg. a therapeutic infectious 
agent such as BCG that is instilled into the bladder for the treatment of cancer) within 
3 months prior to the first administration of study agent, during the trial, or within 6 
months after the last administration of the study agent. 
EXCL23. 
Patients who demonstrate Hypersensitivity to the IMP’s active substance, or any of the 
excipients detailed in the SmPC. 
 
 
 

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6.4 Screening failures 
Patients who sign an informed consent form and fail to meet the inclusion and/or exclusion criteria 
are defined as screen failures. For all screen failures, the investigator is to maintain a screen log that 
documents the screening number, patient initials, and reason(s) for screen failure. A copy of the log 
should be retained in the trial master file. 
 
6.5 Withdrawal criteria 
Subjects will be fully withdrawn from the study (i.e. from any further study medication or study 
procedure) for the following reasons: 
1. At their own request or at the request of their legally authorized representative*. Patients will be 
reminded during the informed consent process that they remain free to withdraw from the study 
at any time without giving a reason – their care will not be compromised. 
2. If, in the investigator's opinion, continuation in the study would be detrimental to the subject's 
well-being. 
3. At the specific request of the sponsor. 
 
* “Legally authorized representative” means an individual or judicial or other body authorized under 
applicable law to consent on behalf of a prospective subject to the subject’s participation in the 
procedure(s) involved in the research. 
In all cases, the reason for and date of withdrawal must be recorded in the eCRF and in the subject's 
medical records. The study team will request the permission of the subject to be followed up to 
establish whether the reason was an AE, and, if so, this must be reported in accordance with the 
procedures in section 9.6. Every attempt will be made to follow up the patient, unless the patient 
decides otherwise, in which case it is accepted this will not be possible. Exact status determined by 
the subject e.g. withdrawal from treatment but follow-up permitted, withdrawal from study with 
follow-up not permitted, will be recorded on the eCRF. 
6.6 Recruitment, consent and randomisation processes 
6.6.1. Eligibility Screening 
All participants screened for eligibility for the trial, including those who go on to be randomized, will 
be included on the trial-specific screening log. Anonymised information will be collected including: 
 
Age 
 
Gender 
 
Ethnicity 
 
Date screened 
 
Randomised/Not randomised 
 
If not randomised, reason for non-randomisation: 
o Not eligible for trial participation and reason for this, or 

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o Eligible but declined and reason for this, or  
o Other reason for non-randomisation 
This information will be collected and reviewed throughout the trial.  
6.6.2. Recruitment and informed consent 
Patients will be approached during routine appointments and will be provided with verbal and written 
details about the trial. A verbal explanation of the trial together with the Patient Information Sheet 
(PIS) and Informed Consent Form (ICF) will be provided by the patient‘s clinical team (medical and 
nursing). This will include detailed information about the rationale, design and personal implications 
of the trial. 
Following information provision, patients will have as long as they need to consider participation (a 
minimum of 24 hours is advised) and will be given the opportunity to discuss the trial with their family 
and other healthcare professionals before they are asked whether they would be willing to participate. 
Assenting patients will then be formally assessed for eligibility and invited to provide informed, written 
consent. The eligibility decision will be recorded by a clinician delegated to do so and will be recorded 
in the patient’s notes and in the eCRF. The Chief Investigator, or any other clinically qualified member 
of the trial team who has received Good Clinical Practice (GCP) training and is authorised on the trial 
delegation log, are permitted to receive informed consent. Where the patient is able to provide fully 
informed consent but is unable to sign or otherwise mark the consent form, provision for completion 
of the consent form by a witness will be made. This should be a carer, friend/family member, or a local 
member of the clinical team who is independent of the research team. Where English is not the 
patient’s first language every effort will be made to provide a Trust interpreter according to normal 
Trust procedures. The right of the patient to refuse consent without giving reasons will be respected. 
Further, the patient will remain free to withdraw from the study at any time without giving reasons 
and without prejudicing any further treatment. 
A record of the consent process detailing the date of consent will be kept in the patient‘s notes. The 
original ICF will be retained in the Trial Master File (TMF), a copy of the ICF will be given to the patient 
and a second copy filed in the hospital notes (as per local practice). 
Where valid, informed consent is obtained from the patient and the patient subsequently becomes 
unable to give informed consent by virtue of physical or mental incapacity, the consent previously 
given when capable remains legally valid. Patients who lose capacity after informed consent has been 
obtained will continue with protocol treatment and follow-up at the discretion of the treating 
investigator. 
6.6.3. Randomisation process 
Patients will be randomised on a 1:1 basis to receive combination therapy of golimumab and 
methotrexate or methotrexate monotherapy and placebo. Randomly-permuted block sizes will be 
used; randomisation will be stratified by the number of involved joints (oligoarticular: ≤4 joints 
involved /polyarticular: >4 joints involved).  
Informed written consent for entry into the trial must be obtained prior to randomisation. 
Randomisation is subject to the participant fulfilling all the eligibility criteria. Randomization should 
take place as soon as possible after consent is provided and must be performed by an authorized 
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Note that patients must complete their baseline quality of life questionnaires prior to 
randomisation (see section 8.8). 
The following information is required in order for the patient to be randomized. The delegated 
member of the research team operating the randomization should have all necessary details to hand: 
 
Patient initials and date of birth  
 
Name of person undertaking randomisation  
 
Name of the treating investigator  
 
Confirmation of eligibility  
 
Confirmation of written informed consent and date  
 
Oligo/polyarthritis status  
 
Confirmation that baseline quality of life questionnaires have been completed 
A unique GOLMePsA trial IMP kit identifier will be assigned at randomization but neither patients nor 
the clinical team will be informed of their allocated treatment arm.  
After randomization the research team will: 
 
Ensure that patients are notified of their appointment dates. 
 
Notify the patient’s GP of their participation in the trial (using the current REC-approved letter 
template) 
Following patient randomisation, the authorised person performing the randomisation must complete 
the Patient Randomisation form. The Patient Randomisation will contain the patient’s details (initials, 
date of birth, trial number) and the date of randomisation.  
LTHT Pharmacy will also complete a Patient Randomisation form. The Patient Randomisation form 
completed by LTHT Pharmacy will contain the patient’s details (initials, date of birth, trial number), 
the date of randomisation and treatment allocation. 
6.6.4. Study Blinding  
6.6.4.1. Type of blinding 
The trial will be double-blind. 
6.6.4.2. Procedure for production and maintenance of blind 
Pre-filled syringes will be available from pharmacy (provided by Janssen Biologics BV) with identical 
external appearance and no identifiers aside from the patient’s study number. The internal fluid will 
be visible to the naked eye. It will be impossible for either the patient or the study nurse/doctor to 
identify the product as either golimumab or placebo. The placebo injections will also be provided by 
Janssen Biologics BV and will consist of an aqueous medium of histidine sorbitol and polysorbate 80 
at pH 5.5. 
6.6.4.3. Breaking the blind in an emergency 
Emergency unblinding (during normal working hours and out of hours) refers to breaking the blind 
revealing to which arm the patient has been randomized. This should be done only when, in the 
judgement of the treating physician, emergency unblinding is absolutely necessary for the 

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management of an individual patient and where stopping the blinded medication is not sufficient. 
Blinding codes should, if possible, be broken on the instruction of the Chief Investigator. However, 
where emergency unblinding is deemed necessary, the inability to contact the Chief Investigator will 
not preclude the act of unblinding. During working hours unblinding can be facilitated by contacting 
the clinical trials pharmacy team. Out of hours the treating physician should contact the on-call 
pharmacist. The LTHT pharmacy will follow the emergency unblinding procedures as identified in their 
Standard Operating Procedure. 
6.6.5. Patients who withdraw consent 
All patients have the right to withdraw consent at any time without prejudice. At the time of 
withdrawal of consent, a full efficacy and safety evaluation should be performed if patient consents. 
Patients who withdraw from study treatment will be encouraged to continue to attend for follow-up 
after that point but they remain free to entirely withdraw from all trial procedures at any time. 
Unless the patient specifically withdraws consent for their data to be stored, all data and samples 
collected from them will continue to be stored as per the original patient consent. 
6.6.6. Managing/replacing patients who withdraw early 
Follow-up information will be obtained at the time of withdrawal for patients who discontinue study 
participation or are withdrawn from the study. 
For patients who prematurely withdraw from the study, final procedures will be performed at the time 
of the withdrawal visit (see section 8.15). 
Patients withdrawn from the study will not be replaced, regardless of the reason for withdrawal. An 
effort must be made to determine why a patient fails to return for the necessary visits or is dropped 
from the study. This information should be recorded on the patient's eCRF. 
6.6.7. Definition for the end of the trial 
The end of the trial is defined as the date when the last recruited patient’s last data item is captured 
in the eCRF. 
 
 
 

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STUDY TREATMENTS 
7.1 General information on the products (trial drugs) to be used 
Product 
Dosage Form 
Dosage Regimen 
Duration 
Golimumab 
50 mg* SC injection 
4 weekly 
24 weeks 
Placebo 
SC injection 
4 weekly 
24 weeks  
Methotrexate 
2.5 mg or 10 mg tablets 
(50mg/mL prefilled 
syringes) 
Weekly (maximum 25 
mg) 
For duration of study 
(& post study 
completion) 
*100 mg Golimumab will be used if patient ≥100 kg in weight. 
7.2 Investigational medicinal product (IMP) 
Within the trial the following are classed as Investigational Medicinal Products (IMPs): 
 Golimumab (Simponi®): 
- Golimumab (Simponi®) and placebo solution for injection in pre-filled syringe. 
- Composition: One 0.5 ml pre-filled pen or pre-filled syringe contains 50 mg of 
golimumab, histidine, sorbitol and polysorbate 80 at pH5.5. 
- Golimumab and placebo provided by Janssen Biologics BV 
7.2.1. Summary of product characteristics (SmPC) 
The SmPC for golimumab (Simponi®), with particular reference to its section 4.8, will be used in this 
study as the main RSI document (see section 9.4). 
7.3 Non-Investigational Medicinal Product (NIMPs) 
Within the trial treatment intervention, the following are classed as Non-Investigational Medicinal 
Product (NIMPs): 
 
Methotrexate 
Methotrexate will be administered orally in both treatment arms at a starting dose of 15mg weekly. 
If tolerated, it will be increased to 20mg and 25mg weekly at weeks 2 and 4 respectively in both 
treatment arms. 
Subcutaneous MTX may be administered if intolerance to oral MTX is observed. 
MTX will be prescribed by the research team and supplied by the hospital pharmacy. 
 
Corticosteroids: methylprednisolone 
Both groups will receive corticosteroids at baseline up to a dose of 120 mg methylprednisolone (unless 
contraindicated or not tolerated). This will be performed either as a stat bolus intra-muscular injection 
(if 4 swollen joints) or as intra-articular injections (to a maximum of 4 joints injected per visit; 20-
80mg per joint with the remainder, if appropriate, given as an intra-muscular injection). The steroid 
dose administered per joint will be as follows: 80 mg for shoulders, knees or hips; 40 mg if ankles, 
wrists or elbows; 20 mg if small joints of hands or feet. 
Oral steroids (regardless of the indication) are not allowed until week 24. Failure to comply will result 
in withdrawal from trial medication (section 7.10). The use of other forms of steroids until week 24 is 
restricted (as mentioned in exclusion criteria 17, section 6.3.3 of this protocol). 

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After the completion of trial-related procedures pertaining to week 24, any form of steroid is allowed 
in accordance to indication and national/local guidance. 
7.4 Administration/handling of the trial drugs 
7.4.1. Handling, storage and supply 
Study drug(s) will be delivered to pharmacy and labelled according to the terms of the trial’s MHRA 
approval. 
7.4.2. Administration of the trial drugs 
Golimumab (Simponi®) should be injected subcutaneously once every four weeks. 
In patients weighing 100 kg or more at baseline, the starting dose of golimumab will be 100 mg four 
weekly to be continued for the duration of the interventional period (week 0 to 24), even in cases of 
subsequent intentional weight loss.  
In these cases, the investigators, taking into account the increased risk of certain serious adverse drug 
reactions with the 100 mg dose compared with the 50 mg dose (see section 7.7 and section 7.8) will 
perform regular monitoring as specified in the summary schedule of study assessments (section 8.6). 
The IMP will be administered by a suitably qualified and authorised member of the research team (i.e. 
study doctor or nurse) in an outpatient clinic setting within The Leeds Teaching Hospitals NHS Trust. 
7.5 Prior and concomitant illnesses 
Any concomitant diseases not included in the exclusion criteria are to be controlled using appropriate 
medication before the patient enters the study and if medically appropriate, the medication is to be 
continued during the entire study period. Concomitant medical conditions, any relevant medications, 
and any changes to both of these will be documented appropriately in the eCRF. Any new illness or 
worsening of a previous medical condition is to be recorded as an AE. 
7.6 Prior and concomitant medications 
7.6.1. Prohibited prior medications 
Prohibited prior medications are listed on the exclusion criteria.  
7.6.2. Permitted concomitant medications 
All concomitant medication taken during the study must be recorded on the source data worksheets. 
Treatment with concomitant PsA and coexisting Pso therapies during the study is permitted only as 
outlined in the exclusion criteria (section 6.3.2 and section-6.3.3) and described in the paragraphs 
below. Patients taking permitted medication should be on chronic stable doses at the baseline visit 
(week 0). 
The following medications will be permitted during the interventional period (week 0 to 24): 
1. Folic Acid 
All patients will receive folic acid prophylaxis with generic 5mg tablets 6 days/week given orally (except 
day of methotrexate). Folic acid will be supplied locally by the  Trust’s pharmacy. 
2. Corticosteroids 
Period 1 (Double blind randomised phase): Both groups will receive corticosteroids at baseline up to 
a dose of 120 mg methylprednisolone (unless contraindicated or not tolerated). This will be performed 

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either as a stat bolus intra-muscular injection (if 4 swollen joints) or as intra-articular injections (to a 
maximum of 4 joints injected per visit; 20-80mg per joint with the remainder, if appropriate, given as 
an intra-muscular injection). In addition, any swollen joint observed at subsequent visits (only at either 
week 8 or at week 12) may be injected with methylprednisolone (20-80 mg per joint) to a maximum 
dose of 120 mg methylprednisolone into a maximum of four joints between both visits. In case of 4 
swollen joints at either week 8 or at week 12, a dose of methylprednisolone 120 mg IM could be 
administered instead of intra-articular injections. Any injections at baseline will ONLY be done after 
the baseline US and WB-MRI scan has been performed. No corticosteroid injections will be allowed 
between weeks 12 and 24. Other limitations apply as outlined in section 7.3. 
Use of oral corticosteroid will not be permitted until week 24. 
Period 2 (Observational phase): use of steroids will be permitted after completion of trial-related 
procedures pertaining to week 24. Patients will be allowed to receive up to 240 mg IM or IA 
corticosteroid injections if the investigator deems that there is still on-going disease activity until the 
end of the study period and unless a clinical or imaging assessment is scheduled within the following 
6 weeks. The joint(s) injected must be recorded along with the medication taken on the examination 
section of the corresponding eCRF. 
3. NSAIDs 
Patients will be permitted to be on non-steroidal anti-inflammatory drugs (NSAIDs) for the duration 
of the study. Every effort should be made to maintain stable doses of concomitant NSAIDs during the 
study. In the event of tolerability issues, the NSAID dose may be decreased or discontinued, with the 
substitution of another NSAID. Data will be collected on NSAID use throughout the trial. NSAIDs should 
not exceed the maximum recommended dose and patients should be on only one NSAID at a time. 
4. Analgesics 
Simple analgesics with no anti-inflammatory action may be used. 
5. Aspirin 
Aspirin at daily doses of up to 150 mg is permitted if indicated for cardiovascular protection. 
Any concomitant diseases not included in the exclusion criteria are to be controlled using appropriate 
medication before the patient enters the study and, if medically appropriate, the medication is to be 
continued during the entire study period. Concomitant medical conditions, any relevant medications, 
and any changes to both of these will be documented appropriately in the eCRF. Any new illness or 
worsening of a previous medical condition is to be recorded as an AE. 
After the first 24 weeks (Period 2: Observational phase phase), the addition of DMARDs will be 
allowed at the discretion of the investigator if it is thought that there is on-going disease activity. 
During the double-blind treatment period (week 0 to week 24) any dose adjustment, changes of 
NSAIDs, and/or introduction of a new NSAID is not permitted, unless required for safety reasons or 
for rescue therapy. 
7.6.3. Prohibited concomitant medications 
The following therapies will NOT be permitted during the interventional period (week-0-baseline-visit 
to week 24): 
- 
PsA and coexisting Pso therapies that are defined as prohibited in the exclusion criteria. 

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- 
Any therapy within the washout periods specified in the exclusion criteria (see exclusion 
criteria 17, section 6.3.3). 
- 
Live vaccines (including BCG) 
7.6.4. Surgical procedures 
Planned surgery within the study period which is expected to require omission of any study 
medication of 28 days or more will not be permitted during the course of the study. 
7.7 Special warnings and precautions for use 
Please consult the SmPC for further details. 
7.8 Dose modifications 
Patients will receive 50mg of golimumab unless at the time of baseline they are 100 kg of weight or 
over (see also section 7.4) In this case they will be eligible for 100mg golimumab. Golimumab dose will 
not be altered throughout the interventional period of the trial (week 0 to 24). 
7.9 Assessing subject compliance with trial treatment(s) 
Every attempt will be made to select patients who have the ability to understand and comply with 
study instructions. The investigator is responsible for discussing methods to ensure high treatment 
compliance with the patient before randomization. 
If a patient is noncompliant with any study procedure, the investigator should assess the patient to 
determine the reason and educate and/or manage the patient as appropriate to improve compliance. 
Specific instances of non-compliance to trial treatment, which would result in withdrawal, are 
mentioned in section 7.3. 
7.10 Withdrawal of trial treatment 
Patients showing an unacceptable degree of disease activity (not achieving a PsARC response) beyond 
week 12 and before the week 24 assessment may be withdrawn from study medication (i.e.: trial 
intervention) at the discretion of the chief investigator (or medically-qualified delegate) and treated 
as clinically indicated. At week 24 patients with MDA will continue with their allocated treatment and 
undergo further assessments as per protocol (see section 5.1). 
Patients MUST be withdrawn from the study treatment if any of the following occur: 
 
Pregnancy 
 
Grade 4 or 5 systemic toxicity (see appendix 2) or a serious adverse event (SAE) thought to be 
related to study treatment and not alleviated by symptomatic treatment after cessation of 
the IMP for up to 2 weeks. 
 
Recurrent serious infection requiring parenteral (intravenous or intramuscular) antimicrobial 
agents or hypotension suggestive of impending sepsis syndrome.  
 
Confirmed blood dyscrasia or a demyelinating disorder (such as multiple sclerosis or optic 
neuritis) 
 
Lack of patient compliance with the trial intervention (section 7.3) 
 
If missing 2 or more consecutive IMP doses. 
 
When visit attendance during period 1 of the trial (between week 0 and week 24) is delayed 
by more than 10 days of the mandated window visit date (see also timeline reference in the 
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 
Withdrawal of consent (during either interventional period or observational period, see 
section 8.6) 
 
Chief Investigator decision 
All patients recruited to this study, irrespective of therapy change (as outlined above) will continue to 
be followed up for the 52 week study duration with imaging and immunological studies as per 
protocol, with the exception of those who withdraw consent to continue with study assessments. 
 
As far as possible, all examinations scheduled for the final study day must be performed on all subjects 
who receive the investigational product but do not complete the study according to protocol. 
The investigator must make every effort to contact subjects lost to follow-up. Attempts to contact 
such subjects must be documented in the subject’s records (e.g., times and dates of attempted 
telephone contact, receipt for sending a registered letter). 
7.10.1. General/study-related withdrawal criteria 
 
When personal circumstances mean that the regular visits required by the protocol can no 
longer be guaranteed  
 
Inability of the subject to comply with study requirements 
 
If intercurrent disorders develop which rule out continuation of study medication i.e. 
determination by the investigator that it is no longer safe for the subject to continue therapy 
 
If disallowed drugs are administered (see section 7.6.3). 
 
If a SAE occurs, the patient could be withdrawn at the discretion of the investigator. 
METHODS OF ASSESSMENT 
8.1 Assessment of primary efficacy variable 
PASDAS is a recently developed composite measure of disease activity in Psoriatic arthritis that is 
represented by a single score and which provides quantitative measures of improvement based on 
baseline scores and changes from baseline. The PASDAS has been shown to perform well not only in 
polyarticular but also oligoarticular PsA (34). 
The PASDAS will not be performed at the bedside when assessing participants as it is a composite 
measure. Individual components will be assessed to allow calculation of the PASDAS at the time of 
data analysis as only an outcome measure. Its formula is calculated as follows: 
PASDAS= (((0.18 x √Physician global VAS) + (0.159 x √Patient global VAS) - (0.253 x √SF36 - PCS) + 
(0.101 x LN (Swollen joint count + 1)) + (0.048 x LN (Tender joint count + 1)) + (0.23 x LN (Leeds 
Enthesitis Count + 1)) + (0.377 LN (Tender dactylitis count + 1)) + (0.102 x LN (CRP + 1)) +2)*1.5. 
 
8.2 Assessment of secondary efficacy variable(s) 
 
8.2.1. C-Reactive Protein 
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8.2.2 Tender joint count 
The number of tender and painful joints will be determined by examination of 78 joints (39 joints on 
each side of the patient’s body, see appendix 7). Joints will be assessed for tenderness by pressure 
and joint manipulation on physical examination. The patient will be asked for pain sensations on these 
manipulations and watched for spontaneous pain reactions. Any positive response on pressure, 
movement, or both will then be translated into a single tender-versus-non tender dichotomy. The 
same assessor should preferably perform the TJC and SJC for a given patient particularly during the 
first 24 weeks of the study to minimize inter-observer variation. Missing, replaced, ankylosed, or 
arthrodesed joints will be identified by the investigator at the Screening Visit and will be excluded 
from evaluation during the trial. 
8.2.3 Swollen joint count 
The number of swollen joints will be determined by examination of 76 joints (38 joints on each side of 
the patient’s body, hip joints not encompassed, see appendix 7). Joints will be classified as either 
swollen or not swollen. Swelling is defined as palpable fluctuating synovitis of the joint. Swelling 
secondary to osteoarthritis will be assessed as not swollen, unless there is unmistakable fluctuation. 
Where possible, the same assessor should preferably perform the TJC and SJC for a given patient 
particularly during the first 24 weeks of the study to minimize inter-observer variation. Missing, 
replaced, ankylosed, or arthrodesed joints will be identified by the investigator at the Screening Visit 
and will be excluded from evaluation during the trial. 
8.2.4 Patient’s Assessment of Pain Visual Analogue Scale  
The patient will be asked to assess their current level of joint pain by marking a vertical line on a 100 
mm horizontal VAS where 0 represents no joint pain (“excellent”) and 100 represents worst 
imaginable joint pain (“poor”). The Patient’s Assessment of Pain VAS should be administered prior to 
the TJC and SJC examinations. Results will be expressed in millimetres measured between the left end 
of the scale and the crossing point of the vertical line; this procedure is applicable for all VAS used in 
the trial (see appendix 6). 
8.2.5 Patient’s Global Assessment of Disease Activity Visual Analogue Scale 
The patient’s overall assessment of their PsA activity will be recorded using the 100 mm horizontal 
VAS where 0 or left end represents “no disease activity” or “excellent” and 100 or right end represents 
extremely active disease “poor”. The wording proposed by Cauli et al (35) referring specifically to PsA 
will be used (see appendix 6). 
8.2.6 Physician’s Global Assessment of Disease Activity Visual Analogue Scale 
The Investigator will be asked to give an overall assessment of the severity of the patient’s current PsA 
activity using a 100 mm horizontal VAS, where 0 at the left end represents no disease activity (“Disease 
not active”) and 100 on the right end represents extremely active disease (“Disease extremely active”). 
The investigator making the assessment must be a rheumatologist or medically qualified physician. 
The same assessor should preferably perform the Physician’s Global Assessment of Disease Activity 
VAS for a given patient particularly during the first 24 weeks of the study to minimize inter-observer 
variation. 
8.2.7 Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 
The BASDAI is a self-administered questionnaire measure used to answer 6 questions (on a Likaert 
scale ranging from 0-10) pertaining the 5 major symptoms of axial activity: 1) fatigue, 2) neck, back or 
hip pain, 3) joint pain/swelling other than neck, back or hips, 4) areas of localized tenderness, 5) overall 
level of morning stiffness, and 6) duration of morning stiffness (36). To give each symptom equal 

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weighting, the mean of the 2 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.  
8.2.8 Leeds Enthesitis Index (LEI) 
The LEI has been developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral 
epicondyle, left and right, medial femoral condyle, left and right, Achilles tendon insertion, left and 
right) (37). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site are then 
added to produce a total score (range 0 to 6). The LEI will be administered by a suitably trained 
member of the research team. 
8.2.9 Leeds Dactylitis Index 
If a patient has dactylitis, the LDI-will be administered by site personnel. The LDI has been developed 
to measure the severity of dactylitis. Once the presence of dactylitis is established in each digit, the 
ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand 
or foot is measured (38). Each dactylitic digit is defined by a minimum increase of 10% in circumference 
over the contra-lateral digit. If the same digits on each hand or foot are thought to be involved, the 
clinician will refer to a table of normative values for a value which will be used to provide the 
comparison. The calculated ratio is then multiplied by a tenderness score of 0 (non-tender), 1 (tender), 
2 (tender and wince) or 3 (tender and withdraw). Tenderness is assessed in the area between the 
joints. The results of each digit are then added to produce a total score (39). 
8.2.10 Health Assessment Questionnaire-Disability Index 
The HAQ-DI is a patient-reported standardized questionnaire that is commonly used in PsA to measure 
disease-associated disability (assessment of physical function). It consists of 24 questions referring to 
8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily 
activities(40). 
The disability section of the questionnaire scores the patient’s self-perception on the degree of 
difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable 
to do), covering the 8 domains. The reported use of special aids or devices and/or the need for 
assistance of another person to perform these activities is also assessed. The scores for each of the 
functional domains will be averaged to calculate the functional disability index. 
 
8.2.11 Minimal Disease Activity (MDA) 
Minimal disease activity or MDA (27) is defined as any patient who meets at least 5 of the 7 following 
criteria:  
Tender joint count ≤1; Swollen joint count ≤1; PASI ≤1; Patient pain VAS ≤15; Patient global disease 
activity VAS ≤20; HAQ ≤0.5; Enthesitis count ≤1. 
8.2.12 Psoriatic Arthritis Response Criteria (PsARC) 
The PsARC (7, 8) is a composite assessment reported in terms of the percentage of patients achieving 
response according to the following criteria: Physician’s Global Assessment of Disease Activity, Patient 
Global Assessment of Articular Disease Activity, tender joints grading, and swollen joints grading. 
Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which 
must be a joint count; there must not be worsening in any of the 4 criteria: 
1. At least 30% reduction in tender joints grading (grading of 68 joints instructions: as in appendix 
7; CMC and DIP of the feet excluded) 

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2. At least 30% reduction in swollen joints grading (grading of 66 joints instructions: as in 
appendix 7; CMC, hips and DIP of the feet excluded) 
3. At least a 1 point reduction in physician’s assessment of articular disease (1-5 Likaert scale) 
4. At least a 1 point reduction in patient’s assessment of articular disease (1-5 Likaert scale) 
8.2 13 American College of Rheumatology 20 Responder Index (ACR20) 
ACR20 response (6) is an efficacy measure for which a patient must have: 
 
≥20% improvement in both TJC (68 joints count: as in appendix 7; CMC and DIP of the feet 
excluded) and SJC (66 joints count: as in appendix 7; CMC, hips and DIP of the feet excluded) 
and 
 
≥20% improvement in at least 3 of the following 5 ACR Core set criteria: 
1. Patient’s Assessment of Pain on Visual Analogue Scale (VAS) 
2. Patient’s Global Assessment of Articular Disease Activity VAS 
3. Physician’s Global Assessment of Disease Activity VAS 
4. Patient’s Assessment of Physical Function as measured by the HAQ-DI 
5. Acute phase reactant as measured by CRP 
 
ACR50 and ACR70 
ACR50 and ACR70 responses are secondary efficacy endpoints and are improvements of at least 50% 
and of at least 70%, respectively, in the multiple disease assessment ACR criteria. The ACR50 and 
ACR70 are calculated similarly to ACR20, as described above. 
8.2.14 Composite Psoriatic Disease Activity Index 
Composite Psoriatic Disease Activity Index is a validated instrument intended to assess composite 
psoriatic disease activity and response to therapy (30). This instrument assesses individual domains 
involved as well as the global effect of disease in all dimensions by which each patient may be affected. 
Domains include peripheral arthritis as assessed by the number of tender (68 joints count: as in 
appendix 7; CMC and DIP of the feet excluded) and swollen (66 joints count: as in appendix 7; CMC, 
hips and DIP of the feet excluded) joint and the Health Assessment Questionnaire (HAQ), skin as 
assessed by the PASI and the DLQI, enthesitis as assessed by the number of sites with enthesitis and 
the HAQ, dactylitis as assessed by the number of digits affected, and spinal disease as assessed by the 
BASDAI and ASQoL (41). Scores range from 0 to 15 for assessment including spinal disease (BASDAI 
and ASQoL) and 0 to 12 for assessment excluding spinal disease, with a higher score indicating higher 
disease activity. 
8.2.15 Measures of skin disease activity 
8.2.15.1 Percentage of Body Surface Area (BSA) 
The investigator will evaluate the percentage involvement of skin psoriasis (Pso) on each patient’s BSA 
on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponds 
to the size of the patient’s handprint including the palm, fingers, and thumb. 
8.2.15.2 Psoriasis Area and Severity Index (PASI 75, PASI 90, PASI 100) 
If the patient has skin affected by plaque Pso, the PASI will be administered by site personnel. The 
PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, 
trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration 
(thickness) in each region, yielding an overall score of 0 for no Pso to 72 for the most severe disease 

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(28). Patients achieving PASI 75, 90, or 100 are defined as having an improvement of at least 75%, 
90%, or 100%, respectively, in the PASI compared to baseline. 
8.2.15.3 Modified Nail Psoriasis Severity Index (mNAPSI) 
A modification to the NAPSI (the modified Nail Psoriasis Severity Index, mNAPSI) removed the division 
of the nail into quadrants and scores pitting and crumbling on a scale from 0-3. Oil drop discolouration 
and onycholysis were also combined, as it was felt they represent the same pathology. In the newly 
modified method, each fingernail is scored for the presence and the severity of pitting, onycholysis/oil-
drop dyschromia and nail plate crumbling (score 0-3) and the presence or absence of splinter 
haemorrhages, leuconychia, red spots in the lunula and nail bed hyperkeratosis (score 1 for each if 
present). We are planning to assess the oil drop dyschromia or discolouration as an independent 
feature (0-1) (see appendix 4).  This gives a total possible score of 140. Validation as part of the original 
study found excellent inter-rater reliability, along with good correlation with a physician nail VAS and 
good intra-rater reliability (29) . 
8.2.16 Quality of life and health status measures 
8.2.16.1 SF-36 
The SF-36 is a multi-purpose, short-form health survey with 36 questions (32). It yields an 8-scale 
profile of functional health and well-being scores as well as psychometrically-based physical and 
mental health summary measures and a preference-based health utility index. It is a generic measure, 
as opposed to one that targets a specific age, disease, or treatment group. 
8.2.16.2 Dermatology Life Quality Index 
The DLQI is a simple, patient administered, 10 question, validated, quality of life questionnaire that 
covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal 
relationships and treatment. Response categories include “not at all”, “a lot” and “very much” with 
corresponding scores of 1, 2 and 3 respectively and unanswered (“not relevant”) responses scored as 
“0”. Totals range from 0 to 30 (less to more impairment) and a 5-point change from baseline is 
considered clinically relevant (31). 
8.3 Assessment of other efficacy variables 
8.3.1 Ultrasound of joints and entheses 
Ultrasound (US) of hands and feet and lower and upper limb joints and entheses (Achilles, plantar 
fascia insertion, quadriceps insertion, patellar tendon origins and insertions and common extensor 
tendon origins of the elbow ) will be performed at week 0, 12, 24 and 36 within ten days before or 
after the scheduled visit attendance using a multiplanar technique with symmetrical scanning. All 
scans will be performed, whenever possible, by the same ultrasonographer with specialist training in 
scanning entheses. The room will be maximally darkened starting from the beginning of the 
ultrasound assessment. Joints and entheseal sites will be assessed for the presence of grey scale (GS) 
abnormalities and power Doppler (PD) signal. 
Pre-defined joints will be scanned for the presence of synovitis and bone erosions as per established 
rheumatoid arthritis (RA) protocols as there is currently no validated system for PsA. Synovitis will be 
scored according to the EULAR-OMERACT definitions for RA (42, 43) for gray scale, power Doppler and 
a combined PDUS score for each joint (0 if GS=0, otherwise highest of either gray scale or power 
Doppler score); the total of these individual PDUS scores is the Global OMERACT-EULAR Score System 
(GLOESS). US enthesopathy will be identified according to OMERACT definitions (44, 45). 
Enthesopathy is defined as ‘abnormally hypoechoic (loss of fibrillar architecture) and/or thickened 

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tendon or ligament at its bony attachment (may occasionally contain hyperechoic foci consistent with 
calcification), seen in two perpendicular planes, which may exhibit Doppler signal and/or bony 
changes including enthesopathy, erosions or irregularity.’ 
Entheseal thickening will be evaluated relative to the body of the tendon. When PD signal is detected 
at the cortical bone insertion, it will be considered entheseal. When PD signal is detected at the tendon 
body and/or adjacent bursitis, it will be considered perientheseal and therefore not documented. 
Thickness and erosion assessments will be scored quantitatively. Thickness findings will be scored on 
a scale between 0 and 3. 
Grade 0: <1mm exceeding the normal threshold 
Grade 1: ≥ 1mm but < 2mm exceeding the normal threshold 
Grade 2: ≥ 2mm but < 3mm exceeding the normal threshold 
Grade 3: ≥ 3mm exceeding the normal threshold 
The maximum diameter of erosions will also be scored quantitatively: 
Grade 1: >0 but <2mm 
Grade 2: ≥2 but <3mm 
Grade 3: ≥3mm 
Entheseal power Doppler will be scored on a semi-quantitative basis: 
 
 
 
Grade 1: Mild changes 
Grade 2: Moderate changes 
Grade 3: Severe changes 
The remainder of the assessments (hypoechogenicity, enthesophytes, calcifications) will be scored 
present (1) or absent (0). 
Once all aspects have been scored, the cumulative totals will be calculated to formulate and 
‘inflammation score’ and a ‘chronicity score’ 
Inflammation score:  
GS changes related to inflammation (entheseal hypoechogenicity and 
thickening) will be added to the PD scores. 
Chronicity score: 
GS changes related to chronic findings (calcifications, erosions and 
enthesophytes) will be totalled. 
 
US scores forming secondary endpoints will include 24 joints (bilateral wrists, MCPs 2&3, PIPs 2&3, 
knees, MTPs 1-5, ankle) and 10 entheses (bilateral quadriceps insertion, patellar ligament proximal 
insertion, patellar ligament distal insertion, Achilles tendon, plantar fascia). Exploratory analysis of 
synovitis and enthesitis will be performed in a subset of patients using scores calculated according to 
the newly published OMERACT definitions which include 48 joints (bilateral wrists, MCP1-5, PIP1-5, 
DIP2-5, knees, MTP1-5, tibiotalar, talonavicular and subtalar) and 12 entheses (bilateral lateral 

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epicondyle, quadriceps insertion, patellar ligament proximal insertion, patellar ligament distal 
insertion, Achilles tendon, plantar fascia) (42, 43).  
Patients will be considered to be in US remission if the maximum score for any of the joints forming 
part of the established RA scoring protocol, and for any of the entheses scanned in all patients, is GS 
entheseal hypoechogenicity score <2 and power Doppler score=0. On an exploratory basis this will be 
repeated using scores calculated in the joints and entheses included in the OMERACT definitions, in 
the subset of patients with these scores available.  
8.3.2 Radiographs of hands and feet 
During screening all patients meeting entry criteria will have a single postero-anterior radiographic 
assessment of the left and right hand/wrist and a single dorso-plantar radiographic image taken of the 
left and right foot, unless these have been performed within 3 months of the screening visit. Images 
will be assessed by the study physician and/or radiologist and assessed for the presence of ill-defined 
ossification near joint margins (excluding osteophyte formation) for the purpose of fulfilment of 
CASPAR criteria(33). 
8.4 Clinical assessments for evaluating safety 
8.4.1 Physical examination 
A complete physical examination will be performed that will include the examination of general 
appearance, head, neck, thyroid, ears, nose, throat, cardiovascular apparatus, respiratory apparatus, 
abdomen, neurological apparatus, skin, musculoskeletal system (related and non-related to PsA). 
Information for all physical examinations must be included in the source documentation. 
8.4.2 Chest x-ray 
During screening all patients meeting entry criteria will have a single postero-anterior radiographic 
assessment of the chest, unless this has been performed within 3 months of the screening visit. Images 
will be evaluated by the study physician and/or radiologist and assessed for the presence of findings 
compatible with exclusion criteria. 
8.4.3 Electrocardiogram 
During screening a standard 12-lead ECG will be performed. The study physician must review and 
initial the tracing. The tracing must then be stored in the participant’s source documents. Tracings will 
be evaluated by the study physician and assessed for the presence of findings compatible with 
exclusion criteria. If the ECG findings are clinically relevant and would prevent the patient from 
participating in the study (taking into account the participant’s overall health status as well as the 
medication profile), the participant should be recorded as screening failure, should NOT be enrolled 
and should not receive the trial intervention. 
 
 
 

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8.5 Assessment of exploratory variables 
8.5.1 Whole-Body MRI 
Whole body MRI scan will be performed to assess for entheseal, bone marrow and synovial 
involvement of both the axial and peripheral skeleton at baseline and weeks 24 and 36, within ten 
days before or after the scheduled visit attendance. 
Scans will be performed using a commercially available 3T scanner. Fitness to undergo MRI scan will 
be assessed during the screening process. To comply with MRI guidance, the blood test urea & 
electrolytes (U&Es) needs to be up-to-date (within 4 weeks of each scan): see also section 8.6.  
Participants unable to undergo MRI scanning (due to contraindication) remain eligible to the 
GOLMePsA trial. 
MR sequences 
Systematic scanning of the axial and peripheral skeleton will be performed in all subjects, using the 
following sequences: 
- 
T1-weighted spin echo (SE) before and after an IV Gadolinium contrast injection. 
- 
Short Tau Inversion Recovery (STIR). 
It is expected that each scan will take around 60 min to be performed. Images will be acquired in two 
phases with patients allowed to mobilize from the scanner for a short time. 
WB-MRI images will be assessed for incidental abnormalities –and not for scoring- by LTHT radiologists 
blinded to treatment allocation. Findings unrelated to PsA and implicating safety concerns or 
conditions requiring clinical (as per NHS guidance) action will be reported to the research team. 
Image evaluation and features to be scored 
All MRI images produced by GOLMePsA data collection will be assessed and scored using the following 
reading methods: SPARCC – SPINAL INFLAMMATION (46); SPARCC – SACRO-ILIAC JOINTS 
INFLAMMATION (47); HIMRISS (48); KIMRISS (49); CANDEN MRI spine scoring system (50); HEMRIS 
(51); MRI-WIPE (52). Methods are detailed in appendix 8. 
 
8.5.2 Laboratory exploratory biomarkers 
In total, this study will require an additional 60 ml of blood to be collected as specified in the schedule 
of study procedures (section 8.6) time of early discontinuation, and at time of flare for determination 
of exploratory biomarkers. This will include collection of red-topped clotted tubes, EDTA tubes and 
lithium heparin green-topped tubes. 
A sample of urine will also be collected. 
The exploratory biomarker variables include inflammation biomarkers i.e. to explore prediction of 
response/non-response. 
The sampling, handling, and shipment (if appropriate) of samples for the exploratory biomarkers 
should be performed as per local LIRMM laboratory Standard Operating Procedures.  

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Patients can opt out of this part of the study, as they will be asked to sign a specific consent form for 
a Biological Sub-study. 
8.5.2.1 Soluble biomarkers 
Serum samples collected will also be stored (at baseline and at time-points of sample collection 
previously stipulated) for future evaluation of disease categorisation, auto-antibodies, inflammatory, 
immunological and vascular biomarkers and products of synovial, cartilage and bone turnover in this 
and future studies (subject to ethical review of such studies). 
8.5.2.2 Genetic Studies 
Diseases such as psoriatic arthritis may be associated with the presence of specific changes in an 
individual’s genetic makeup, contributing to the disease process and predicting susceptibility or 
severity to the disease and/or response to specific therapies. An aliquot of all DNA samples will 
ultimately be entered into both national and international genetics studies, since large numbers of 
samples are required to undertake these studies. However, the genetic information will be used solely 
for research purposes. 
8.5.2.3 Sample Storage 
Personal details will be removed from all biological research blood samples after separation into the 
component parts, and a pseudo-anonymisation code will be generated. It will be possible to link the 
clinical and laboratory databases through this unique laboratory code so that we can look at long-term 
disease outcomes and predictors of response to future treatments. Any samples and residual cellular 
materials that are not used at the end of this study will be stored in an HTA licensed sample repository 
once project specific approval expires and will be used in future studies within this research remit. 

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Study Period 
Period 1: Double-blind randomised 
Period 2: Observational* 
** 
Withdrawal 
visit 
Study Phase 
Screen 
Baseline 
(Safety) (Safety) Secondary 
outcome 
(Safety) (Safety) 
Primary 
outcome 
(Safety) 
Secondary 
outcome 
End of 
study visit 
Extra 
Visit 
 
Week 
–4 to 0 
0 
4 
(±7 days) 
8 
(±7 days) 
12 
(±7 days) 
16 
(±7 days) 
20 
(±7 days) 
24 
(±7 days) 
28 
(±7 days) 
36 
(±7 days) 
52 
(±7 days) 
Y*** 
X 
Visit number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
98 
99 
Full informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Confirmation of on-going consent 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PsA CASPAR criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Inclusion / Exclusion Criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Randomisation 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Adverse events evaluation 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Demographic data (smoking, alcohol intake) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical, surgical and family history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
PsA-related history 
(Articular symptoms onset date; PsA 
diagnosis date; skin psoriasis onset date; 
psoriasis diagnosis date) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Duration of articular morning stiffness 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Back pain symptoms 
 
X 
 
 
 
 
 
 
 
 
 
 
 
PsA-related comorbidities 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Vital signs (blood pressure; heart rate; 
bodily temperature) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Weight 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Height; body mass index 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Physical Examination 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
8.6 Summary schedule of study assessments. 

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Study Period 
Period 1: Double-blind randomised 
Period 2: Observational* 
** 
Withdrawal 
visit 
Study Phase 
Screen 
Baseline 
(Safety) (Safety) Secondary 
outcome 
(Safety) (Safety) 
Primary 
outcome 
(Safety) 
Secondary 
outcome 
End of 
study visit 
Extra 
Visit 
 
Week 
–4 to 0 
0 
4 
(±7 days) 
8 
(±7 days) 
12 
(±7 days) 
16 
(±7 days) 
20 
(±7 days) 
24 
(±7 days) 
28 
(±7 days) 
36 
(±7 days) 
52 
(±7 days) 
Y*** 
X 
Visit number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
98 
99 
76/78 joints Tender and Swollen Joint 
assessment (count and grading) 
X 
X 
 
X 
X 
 
 
X 
 
X 
X 
X 
X 
PsA type classification 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Leeds Dactylitis Index 
X 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
Leeds Enthesitis Index 
X 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
PASI 
 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
BSA 
 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
mNAPSI 
 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
Psoriasis subtype and site classification 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Psoriasis-related symptoms 
 
X 
 
 
 
 
 
 
 
 
 
 
 
PsARC 
 
 
 
X 
X 
 
 
X 
 
X 
X 
X 
X 
Infectious hepatitis serology/ 
HIV test 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Biochemistry (including CRP) / 
Haematology, ESR 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Immunology tests1: 
ANA (including dsDNA) 
anti-CCP and RF 
X 
 
 
 
 
 
 
 
 
 
X 
X 
X 
Blood and urine collection for biomarkers 
(Biological Sub-study) 
 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
Urinalysis2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy test3 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Whole-Body MRI (WB-MRI)4 
X 
 
 
 
 
 
 
X 
 
X 
 
X6 
X6 

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Study Period 
Period 1: Double-blind randomised 
Period 2: Observational* 
** 
Withdrawal 
visit 
Study Phase 
Screen 
Baseline 
(Safety) (Safety) Secondary 
outcome 
(Safety) (Safety) 
Primary 
outcome 
(Safety) 
Secondary 
outcome 
End of 
study visit 
Extra 
Visit 
 
Week 
–4 to 0 
0 
4 
(±7 days) 
8 
(±7 days) 
12 
(±7 days) 
16 
(±7 days) 
20 
(±7 days) 
24 
(±7 days) 
28 
(±7 days) 
36 
(±7 days) 
52 
(±7 days) 
Y*** 
X 
Visit number 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
98 
99 
Musculoskeletal US scan5 
X 
 
 
 
X 
 
 
X 
 
X 
 
X7 
X7 
Chest-X-ray1, ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Plain X-ray of Hands and Feet1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X-ray of the orbits1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Physician VAS global disease Activity 
X 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
Physician Likaert scale, articular disease 
Activity 
X 
X 
 
X 
X 
 
 
X 
 
X 
X 
X 
X 
Patient VAS global disease Activity 
X 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
Patient VAS articular pain 
X 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
Patient Likaert scale, articular disease 
Activity 
X 
X 
 
X 
X 
 
 
X 
 
X 
X 
X 
X 
HAQ 
X 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
DLQI 
 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
SF-36 
X 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
ASQoL 
 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
BASDAI 
 
X 
 
 
X 
 
 
X 
 
X 
X 
X 
X 
Administration of SC IMP8 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 

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1. At screening visit; end of study visit (visit 11, week 52); extra visit (week Y); and withdrawal visit (week X), immunology tests should not be repeated if results available 
within 20 days prior to study visit. 
If subjects do not have a chest x-ray or hands/feet x-ray performed within 3 months of screening, an x-ray should be performed after it is certain the subject meets the 
inclusion/exclusion criteria (in order to minimize exposure to x-ray radiation).  
X-ray of the orbits should be performed only in subjects contraindicated to WB-MRI, who report a personal history suggestive of metallic fragments present in the orbits. 
2, 3. Urinalysis and Pregnancy test can be repeated in other visits as clinically indicated. 
4. WB-MRI (if required) should be performed within ten days before or after the scheduled follow-up visit attendance. To comply with MRI guidance, the blood test urea & 
electrolytes (U&Es) needs to be up-to-date (within 4 weeks of each scan). Baseline scans should always be performed before randomization. 
IMPORTANT: WB-MRI data is being used to support an exploratory endpoint, from a subset of randomised participants; WB-MRI scans will not be performed in any patients 
once the required sample size has been reached. 
5. US should be performed within ten days before or after the scheduled follow-up visit attendance. 
6, 7. No imaging (WB-MRI and/or US) to be performed if: a) withdrawal visit (numbered 99) occurs within 6 weeks of last imaging; b) flare visit (numbered 98) occurs after 
week 36; or if within 6 weeks of last imaging.  
8. IMP administration should be every four weeks. In the case of a missed dose of IMP, the IMP can be administered at the next scheduled visit. Exposure to IMP should be 
captured in the medication workbook. All timed visits should take place within a seven-day window of the ideal target visit date (with the exception of the screening and 
baseline visits). 
 
* Week 44: Participants will be re-supplied with anti-rheumatic drugs at this time-point, as part of NHS standard of care. The study physician will prescribe the relevant 
drug(s) according to local procedures. Laboratory tests will be performed according to the prescription-related monitoring requirements. No trial-related data will be collected 
at this time-point. 
**Study week X: withdrawal visit. Subjects who discontinue prematurely during Period 1 should return for assessments associated with Week 24 visit. Participants who 
withdraw their consent at either period 1 or 2 should return for assessments associated with Week 24 visit (exceptions apply as per points 6,7 of this legend). See also 
section 6.5 
*** Study week Y: extra visit to be performed only in case of flare of psoriatic arthritis. It applies only to period 2 (observational, after week 24 until week 52). For definition 
and management of flare between week 0 and week 24, refer to section 8.18 

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8.7 Screening visit  
The screening period should not last longer than four weeks. The aim of the screening visit is to identify 
a patient who might be suitable for inclusion in the study. The following will be performed either at 
this visit (or during the permitted 4 week screening period) and recorded in the eCRF: 
 
Full informed consent.  
The patient will have received information, including the Patient Information Sheet, at least 24 
hours before the screening visit. Their knowledge of the nature and objectives of the study will 
be verified and his/her informed consent will be obtained. The screening period will provide 
further opportunity for a patient to re-consider and consent will be confirmed at the baseline 
visit. 
 
Inclusion/exclusion criteria available at this time will be recorded. 
 
Demographic variables describing the patient (age, sex, and ethnic group), smoking and 
alcohol intake history  
 
Medical and surgical history, family history, PsA-related history will be recorded. 
 
Concomitant medications. 
 
Duration of articular morning stiffness. 
 
PsA-related comorbidities. 
 
Physical examination. 
 
Measurement of body weight and height; body mass index. 
 
Vital signs (blood pressure after a 5-minute rest, pulse rate and body temperature). 
 
12-lead ECG. 
 
Articular examination (76 swollen and 78 tender joint counts and grading). 
 
Laboratory tests: 
o Haematology, blood chemistry. 
o CRP and ESR. 
o Immunology tests (ANA, anti-dsDNA, anti-CCP, RF - (unless already performed within 20 
days prior to screening visit) 
o Infectious hepatitis screen (Hep B surface antigen, Hep B core antibody, anti-HCV antibody). 
o QuantiFERON test for TB testing. 
o HIV testing 
o Urinary tests: 
- 
Pregnancy test in female patients with child-bearing potential (see appendix 1). 
- 
Urinalysis (dipstick for blood, protein and nitrites). 

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 
Patient-reported outcomes (disease activity and pain VAS, assessment of articular disease on 
Likaert scale, HAQ, SF-36) 
 
Physician VAS assessment of global disease activity and assessment of articular disease on 
Likaert scale. 
 
LEI and LDI 
 
MRI eligibility checklist (only to be conducted during WB-MRI subset recruitment period) 
 
WB-MRI (if in WB-MRI subset; to be performed between screening visit and week 0) 
 
US (to be performed between screening visit and week 0) 
 
Radiographs of chest, hands and feet (unless performed within 3 months of screening). 
 
Radiographs of the orbits, in subjects candidate to WB-MRI who report a personal history 
suggestive of metallic fragments present in the orbits. 
Note: Whenever possible, physician VAS assessments should be performed by the same investigator, 
and joint examinations should be performed by the same assessor throughout the time course of the 
study to reduce potential investigator bias. 
8.8 Baseline (week 0) 
 
Check consent has been provided and confirmed with the patient. 
 
Inclusion/exclusion criteria reviewed and eligibility statement recorded. 
 
Randomization to treatment arm (see section 6.6.3 - randomisation process). 
 
Concomitant medication reviewed and recorded. 
 
Duration of articular morning stiffness. 
 
Back pain symptoms 
 
PsA-related comorbidities. 
 
Vital signs (blood pressure after a 5-minute rest, pulse rate and body temperature). 
 
Measurement of body weight. 
 
Joint examination (76/78 swollen and tender joint counts and grading). 
 
PsA type classification. 
 
Blood tests: 
o Haematology, blood chemistry. 
o CRP and ESR. 
o Samples for biological research sub-study (see section 8.4.1, section 8.4.2 and section 
8.4.3). 
 
Enthesis, dactylitis, skin and fingernail assessments. 
 
Psoriasis subtype and site classification, psoriasis-related symptoms. 

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 
Physician VAS assessment of global disease activity and assessment of articular disease on 
Likaert scale. 
 
Patient-reported outcomes (disease activity and pain VAS, assessment of articular disease on 
Likaert scale, HAQ, BASDAI, ASQoL, SF-36, DLQI). 
 
Dispense study drugs according to treatment arm (see section 7.4.2). 
 
Administer 120mg intramuscular methylprednisolone if 4 synovitic joints (unless 
contraindicated or not tolerated) or consider intra-articular steroid injections (as per an 
equivalent dose of methylprednisolone; see section 7.3 and section 7.6.2). 
 
Prescribe MTX according to instructions in section 7.3. 
8.9 Safety/Monitoring Visit (week 4, ± 7 days) 
 
Confirmation of on-going consent 
 
Review of previous blood results/reports (from Week 2 – Baseline visit). 
 
Adverse events evaluation. 
 
Concomitant medication. 
 
Duration of articular morning stiffness. 
 
PsA-related comorbidities. 
 
Vital signs (blood pressure after a 5-minute rest, pulse rate and body temperature). 
 
Measurement of body weight. 
 
Blood tests: 
o Haematology, blood chemistry. 
o CRP and ESR. 
 
Compliance assessment. 
 
Dispense study drugs according to treatment arm. MTX (oral or SC) to be increased to 25 mg 
(section 7.3). 
8.10 Week 8 (± 7 days) 
 
Confirmation of on-going consent 
 
Adverse events evaluation. 
 
Concomitant medication. 
 
Duration of articular morning stiffness. 
 
PsA-related comorbidities. 
 
Vital signs (blood pressure after a 5-minute rest, pulse rate and body temperature). 
 
Measurement of body weight. 
 
Blood tests: 

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o Haematology, blood chemistry. 
o CRP and ESR. 
 
Compliance assessment  
 
Response Assessment - Joint examination with swollen and tender joint counts/grading and 
patient and physician assessments of articular disease on Likaert scale for PsARC assessment. 
 
Dispense study drugs according to treatment arm. 
 
Administer 120mg intramuscular methylprednisolone if 4 synovitic joints (unless 
contraindicated or not tolerated) or consider intra-articular steroid injections (as per an 
equivalent dose of methylprednisolone – see section 7.3 and section 7.6.2) if PsARC response 
not achieved. 
8.11 Week 12, ± 7 days (secondary endpoint) 
 
Confirmation of on-going consent 
 
Adverse events evaluation. 
 
Concomitant medication. 
 
Duration of articular morning stiffness. 
 
PsA-related comorbidities. 
 
Vital signs (blood pressure after a 5-minute rest, pulse rate and body temperature). 
 
Measurement of body weight. 
 
Blood tests: 
o Haematology, blood chemistry. 
o CRP and ESR. 
 
Compliance assessment. 
 
Response Assessment - Joint examination with  swollen and tender joint counts/grading and 
patient and physician assessments of articular disease on Likaert scale for PsARC assessment. 
 
US scan (performed as per footnote following summary schedule, section 8.6). 
 
Enthesitis, dactylitis, nail and skin assessments 
 
Physician VAS 
 
Patient-reported outcomes (disease activity and pain VAS, HAQ, SF-36, DLQI, ASQoL, BASDAI) 
 
Sample collection for biological sub-study. 
 
Dispense study drugs according to treatment arm. 
 Administer 120 mg intramuscular methylprednisolone if 4 joints involved (unless 
contraindicated or not tolerated) or consider intra-articular steroid injections (as per an 
equivalent dose of methylprednisolone – see section 7.6.2) if PsARC response not achieved. 

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8.12 Weeks 16 (± 7 days) and 20 (± 7 days) 
 
Confirmation of on-going consent 
 
Adverse events evaluation. 
 
Concomitant medication. 
 
Duration of articular morning stiffness. 
 
PsA-related comorbidities. 
 
Vital signs (blood pressure after a 5-minute rest, pulse rate and body temperature). 
 
Measurement of body weight. 
 
Blood tests: 
o Haematology, blood chemistry. 
o CRP and ESR. 
 
Compliance assessment. 
 
Dispense study drugs according to treatment arm. 
8.13 Week 24, ± 7 days (primary endpoint). 
 
Confirmation of on-going consent 
 
Adverse events evaluation. 
 
Concomitant medication. 
 
Duration of articular morning stiffness. 
 
PsA-related comorbidities. 
 
Vital signs (blood pressure after a 5-minute rest, pulse rate and body temperature). 
 
Measurement of body weight. 
 
Blood tests: 
o Haematology, blood chemistry. 
o CRP and ESR. 
 
Compliance assessment. 
 
Response Assessment - Joint examination with  swollen and tender joint counts/grading and 
patient and physician assessments of articular disease on Likaert scale for PsARC assessment. 
 
Imaging: WB-MRI (if in WB-MRI subset) and US (performed as per footnote following summary 
schedule, section 8.6) 
 
Physician VAS. 
 
Enthesitis, dactylitis, skin and nail assessments. 
 
Sample collection for biological sub-study. 

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 
Patient-reported outcomes (disease activity and pain VAS, HAQ, BASDAI, ASQoL, SF-36, DLQI) 
 Dispense study drugs according to treatment arm. 
8.14 Subsequent visits (Week 28 [±7 days] and Week 36 [± 7 days]) for both 
treatment arms: 
 
Confirmation of on-going consent 
 
Adverse events evaluation. 
 
Concomitant medication. 
 
Duration of articular morning stiffness. 
 
PsA-related comorbidities. 
 
Vital signs (blood pressure after a 5-minute rest, pulse rate and body temperature). 
 
Measurement of body weight. 
 
Joint examination with swollen and tender joint counts/grading (WEEK 36 ONLY). 
 
Enthesitis, dactylitis, skin and nail assessments (WEEK 36 ONLY). 
 
Imaging: WB-MRI (if in WB-MRI subset) and US (performed as per footnote following summary 
schedule, section 8.6) (WEEK 36 ONLY) 
 
Blood tests: 
o Haematology, blood chemistry. 
o CRP and ESR. 
o Samples for scientific research (WEEK 36 ONLY). 
 
Response Assessment – taking into account joint examination (with swollen and tender joint 
counts/grading) and patient and physician assessments of articular disease (Likaert scale for 
PsARC assessment) (WEEK 36 ONLY). 
 
Physician VAS (WEEK 36 ONLY) 
 
Patient-reported outcomes (disease activity and pain VAS, HAQ, ASQoL, SF-36, DLQI, BASDAI) 
(WEEK 36 ONLY). 
8.15 Withdrawal visit (week X) 
 
Confirmation of consent for continued data collection after withdrawal procedures. 
 
Adverse events evaluation. 
 
Concomitant medication. 
 
Duration of articular morning stiffness. 
 
PsA-related comorbidities. 
 
Physical examination. 
 
Vital signs (blood pressure after a 5-minute rest, pulse rate and body temperature). 

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 
Measurement of body weight. 
 
Blood tests: 
o Haematology, blood chemistry. 
o CRP and ESR. 
 
Immunology tests (ANA, anti-dsDNA, anti-CCP, RF) 
 
Response Assessment – taking into account joint examination (with swollen and tender joint 
counts/grading) and patient and physician assessments of articular disease (Likaert scale for 
PsARC assessment). 
 
Physician VAS. 
 
Enthesitis, dactylitis, skin and nail assessments. 
 
Patient-reported outcomes (disease activity and pain VAS, HAQ, BASDAI, ASQoL, SF-36, DLQI) 
 
Sample collection for biological sub-study. 
 
WB-MRI (if in WB-MRI subset) and US (not required if withdrawal visit occurs within 6 weeks 
of last imaging; perform as per footnote following summary schedule, section 8.6). 
8.16 Extra visit (week Y) 
(Applicable to period 2 (observational) only) 
 
Confirmation of on-going consent 
 
Adverse events evaluation. 
 
Concomitant medication. 
 
Duration of articular morning stiffness. 
 
PsA-related comorbidities 
 
Vital signs (blood pressure after a 5-minute rest, pulse rate and body temperature). 
 
Measurement of body weight. 
 
Blood tests: 
o Haematology, blood chemistry. 
o CRP and ESR. 
o Immunology tests (ANA, anti-dsDNA, anti-CCP, RF) 
 
Response Assessment - taking into account joint examination (with swollen and tender joint 
counts/grading) and patient and physician assessments of articular disease (Likaert scale for 
PsARC assessment). 
 
Physician VAS. 
 
Enthesitis, dactylitis, skin and nail assessments. 
 
Patient-reported outcomes (disease activity and pain VAS, HAQ, BASDAI, ASQoL, SF-36, DLQI) 

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 
Sample collection for biological sub-study. 
 
WB-MRI (if in WB-MRI subset) and US (not required if flare visit occurs after week 36 or if 
within 6 weeks of last imaging). 
 
8.17 Completion visit (week 52, ± 7 days) 
 
Confirmation of on-going consent 
 
Adverse events evaluation. 
 
Concomitant medication. 
 
Duration of articular morning stiffness. 
 
PsA-related comorbidities. 
 
Vital signs (blood pressure after a 5-minute rest, pulse rate and body temperature). 
 
Measurement of body weight. 
 
Blood tests: 
o Haematology, blood chemistry. 
o CRP and ESR. 
o Immunology tests (ANA, dsDNA, anti-CCP, RF) 
 
Response Assessment - Joint examination with  swollen and tender joint counts/grading and 
patient and physician assessments of articular disease on Likaert scale for PsARC assessment. 
 
Physician VAS. 
 
Enthesitis, dactylitis, skin and nail assessments. 
 
Sample collection for biological sub-study. 
 
Patient-reported outcomes (disease activity and pain VAS, HAQ, BASDAI, ASQoL, SF-36, DLQI) 
 
Patients will be given a follow up appointment in the normal rheumatology clinic as per 
routine clinical practice. 
 
 

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8.18 Definition and Management of Disease Flare 
Flare is defined as an increase in disease activity compared to previous assessment in a patient 
previously improving or stable, requiring a change in treatment. For patients on MDA, flare would be 
defined as a loss of MDA. 
Flares of disease activity can be managed, at the investigators discretion, as follows: 
• 
By altering analgesics. 
• 
Steroids are only permitted at certain time points (weeks 8 and 12 and after week 24.). 
Prior to Week 24: Treatment Arms 1 and 2: patients that are judged as clear non-responders (not 
achieving a PsARC response at week 12) or are intolerant of GOL/MTX may receive change in 
therapy (at the physician’s discretion) but will be withdrawn from the interventional part of the 
study. A repeat WB-MRI  may be performed at this stage (according to section 8.6). If they consent, 
patients will continue to be observed until the end of the study (week 52) and to undergo all the 
procedures as set per protocol timeline. Steroids IM/IA will be allowed only until week 12. From 
week 12 to week 24 only analgesics can be used. 
• 
After Week 24: Subjects on both treatment arms will have IMP SC injections discontinued 
(GOL or placebo) at week 24. After this, participants will be observed for the remaining of 
the study period (i.e. until week 52). Disease flares occurring after week 24 and until week 
52 will be treated according to normal clinical protocols and NICE guidelines. 
• 
Other procedures at the time of flare: A response assessment will be carried out including 
a joint examination with swollen and tender joint counts/grading and patient and physician 
assessments of articular disease on Likaert scale for PsARC assessment; MDA (where 
applicable); blood testing for ESR, CRP; and patient-reported outcomes (disease activity and 
pain VAS, HAQ, BASDAI, ASQoL, SF-36, DLQI), physician’s VAS (disease activity). 
Blood samples will be taken for use in the biological sub-study. 
 
 

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PHARMACOVIGILANCE 
9.1 Defining adverse events 
An adverse event (AE) is any untoward medical occurrence in a patient during or following 
administration of an investigational product and which does not necessarily have a causal relationship 
with treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporarily associated with the use of the trial drugs, 
whether or not considered related to the trial drugs. As the sponsor of the study, the Sponsor 
Institution and the CI or their research team, shall be the solely responsible for complying, within the 
required timelines, with any safety reporting obligation towards the competent Health Authorities, 
and the REC, as defined in the applicable laws and regulations.  
9.2 Defining serious adverse events (SAEs) 
A serious adverse event (SAE) is an adverse event which is defined as serious, i.e. that it: 
 
Results in death. Death may occur as a result of the basic disease process. Nevertheless, all 
deaths occurring within 24 hours of the last administration of the study agent must be treated 
as an SAE and reported as such. All deaths which may be considered as related to the trial 
agent, regardless of the interval, must be treated as a SAE and reported as such if occurred 
during the trial period. 
 
Is life-threatening. 
 
Requires inpatient (overnight) hospitalization or prolongation of an existing hospitalization. 
 
Results in a persistent or significant disability or incapacity. 
 
Results in a congenital anomaly or birth defect. 
Additionally, important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered SAEs when, based on appropriate medical judgment, they may 
jeopardize the subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
Any other significant clinical event, not falling into any of the criteria above, but which in the opinion 
of the Investigator requires reporting. 
Other Reportable Information: Certain information, although not considered an SAE, must be 
recorded, reported, and followed up as indicated for an SAE. This includes the following: 
 
Pregnancy exposure to an IMP, except for exposure to prenatal vitamins.  
 
Lactation exposure to an IMP, with or without an AE. 
 
Overdose of an IMP as specified in this protocol, with or without an AE. 
 
Inadvertent or accidental exposure to an IMP, with or without an AE. 
 
 

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9.3 AEs of special interest 
9.3.1 Pregnancy 
Pregnancy is considered a form of SAE. If a pregnancy is confirmed, use of the IMP must be 
discontinued immediately. Both maternal and paternal exposures are considered other reportable 
information. Paternal exposure occurs when there is a possibility of intrauterine exposure to drug via 
semen from the male partner who is taking the Study Product (IMP) at the time of conception, thereby 
possibly exposing the foetus to the product. For example, a male patient’s partner becomes pregnant 
while the male patient is using the Study Product (IMP). For exposure involving the female partner of 
a male subject, the necessary information must be collected from the subject, while respecting the 
confidentiality of the partner. All pregnancies will be followed up until birth. 
9.3.2 Lactation 
Lactation exposure of an IMP as specified in this protocol, with or without an AE. 
9.3.3 Overdose 
Overdose of an IMP as specified in this protocol, with or without an AE. 
9.3.4 Accidental exposure to an IMP 
Inadvertent or accidental exposure to an IMP, as specified on this protocol with or without an AE. 
9.3.5 Product Quality Complaint 
Any discrete concern that questions the identity, quality, durability, reliability, safety, efficacy or 
intended performance of a drug product. A complaint may allege an adverse reaction, injury or 
malfunction associated with the used of the drug product. It may also involve the design, literature, 
packaging, advertising, availability, physical appearance or promotion of the drug product. Any 
product quality complaint (PQC), with or without an AE (including reports of suspicion of 
counterfeiting, diversion or tampering, and suspected transmission of pathogens) will be transmitted 
by the Institution or Chief Investigator in an electronic format (as supplied by Janssen) to Janssen 
Biologicals BV within 24 hours of becoming aware of the events. 
9.4 Defining unexpected and suspected unexpected serious adverse reactions 
(SUSARs) 
An Unexpected Adverse Event is any adverse event, the specificity or severity of which is not 
consistent with the current labelling for the product. 
A Suspected Unexpected Serious Adverse Reaction (SUSAR) is a serious adverse event suspected to 
have a reasonable causal relationship to the investigational medicinal product where the nature or 
severity of the reaction is inconsistent with the available product information (referring to the 
Summary Product Characteristics (SmPC)). All SAEs assigned by the CI (or delegated clinician) as both 
suspected to be related to the trial drugs and unexpected are subject to expedited reporting. 
9.5 Exemptions from safety reporting 
9.5.1 Efficacy endpoints and disease progression events 
All events that are unequivocally due to progression of moderate to severe psoriatic arthritis or lack 
of response should not be recorded or reported as an AE or SAE. This type of information will be 
captured in the study assessments. Disease progression would include: increased joint pain, 
musculoskeletal pain, generalized body aches, uncontrolled PsA, joint swelling, increased stiffness, 
limited motion, joint aspirations (in or out of the hospital), and hospitalizations for PsA-related 
procedures (joint replacement surgery, joint arthroscopy, synovectomy). 

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9.6 Recording and reporting of AEs 
9.6.1 Recording and reporting of all AEs 
Determination of AEs should be based on the signs or symptoms detected during the physical 
examination and on clinical evaluation of the subject, and should be assessed and recorded at every 
visit. Signs and symptoms must be recorded using standard medical terminology.  
AEs and SAEs will be collected from first dose of protocol treatment until week 52 (visit 11). The 
Investigator must instruct the subject to report AEs and SAEs during this time period. 
All adverse events must be evaluated by a medically qualified and authorised member of the study 
research team, and graded (in terms of severity) in accordance with the Common Terminology 
Criteria for Adverse Events (CTCAE) (see appendix 2). 
During the time period specified above, the Investigator will: 
 
Record all AEs and SAEs on source documents. 
 
Record all AEs and SAEs in the eCRF for subjects who are not screen failures. 
 
Report all SAEs on a ‘Serious Adverse Event/Expedited Report from a Clinical Trial’. 
Instructions on where to send this form will be provided by the Sponsor. 
The Investigator must follow up on all AEs and SAEs until the events have subsided, returned to 
baseline, or, in case of permanent impairment, until the condition has stabilized whilst the subject 
remains under follow up as per study protocol. All adverse events that are still ongoing when the 
patient finishes study follow-up will be coded as ‘ongoing’ in the eCRF , after which time appropriate 
follow up will be organized as per standard clinical care.   
The Sponsor will maintain detailed records of all AEs and SAEs reported by an Investigator in 
accordance with good clinical practice and applicable local regulations. 
9.6.2. SAE and SUSAR reporting requirements 
Where applicable, all SAEs assessed by Investigators as being both suspected to be related to protocol-
treatment and unexpected, will be reviewed by the Chief Investigator (CI).  
If the SAE is suspected to be related to the study treatment/s and is deemed to be unexpected against 
the Reference Safety Information (RSI) (specifically Section 4.8 ‘Undesirable effects’ of the SmPc), the 
SAE qualifies as a Suspected Unexpected Serious Adverse Reaction (SUSAR) and requires expedited 
reporting. 
The expectedness assessment can be undertaken by the CI or other medically qualified delegate. In 
absence of both the CI/delegated investigator, a SUSAR must nevertheless be reported to the Sponsor 
and the regulator within the legislatively specified timelines. 
All SAEs, other information reportable as SAEs and follow-up information must be reported to the 
Sponsor and to Janssen Biologics BV within 24 hours of the research team becoming aware of them 
as follows:  
 
 

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9.6.2.1 SAE/SUSAR reporting to the Sponsor 
The investigator or named delegate must report the SAE/SUSAR to the Sponsor QA office immediately 
and within 24 hours of awareness using the CTT21 SAE report form outlined in SOP QCRES_01 via 
email to the following address:  
 
 
 
 
 
 
9.6.2.2 SAE/SUSAR reporting to Janssen 
The investigator or named delegate must report the SAE/SUSAR to ‘Janssen Biologics” to the following 
number:  
 
 
 
 
 
 
 
Identifiable patient data, other than linked anonymised data required by the SAE form, must not be 
included when reporting SAEs and SUSARs.  
Suspected adverse reactions that are both serious and unexpected are subject to expedited reporting 
to the REC and MHRA. 
The Sponsor then will inform the MHRA via the MHRA eSUSAR web portal and the Main Research 
Ethics Committee (Main REC) of SUSARs within the required expedited reporting timescales. 
1. All SUSARs must be reported to the Sponsor QA office within 1 working day of the event being 
reported to the CI (or their research team). 
2. SUSARs must be reported to the REC / MHRA within 7 calendar days of the CI (or their research 
team) being informed of the event, if they result in Death or are deemed to be life-
threatening. Follow-up information must be reported within 8 calendar days. 
3. Any SUSARs not resulting in death or deemed to be life-threatening must be reported to the 
REC / MHRA within 15 Calendar days of the CI (or their research team) being informed of the 
event. Follow-up information must be reported within 8 calendar days. 
SUSARs will be reported in accordance with the requirements and provisions of the applicable national 
laws. They will all be signed off by the Chief Investigator or, in their absence, by a delegated individual. 
 
 
SPONSOR E-MAIL ACCOUNT FOR 
SERIOUS ADVERSE EVENT/EXPEDITED REPORT 
leedsth-tr.sponsorqa@nhs.net  
JANSSEN BIOLOGICALS FAX NUMBER FOR 
SERIOUS ADVERSE EVENT/EXPEDITED REPORT 
+44 149 456 7799 or +44 800 389 3644 

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9.7 Urgent safety measures 
If the research team becomes aware of information affecting the risk/benefit balance of the trial they 
may take immediate action to ensure patient safety. Urgent safety measures deemed necessary must 
be reported immediately by telephone to the MHRA (in conjunction with the Sponsor) and to the main 
REC for the trial, and must be followed within three days by notice in writing setting out the reasons 
for the urgent safety measures and the plan for further action. The REC co-ordinator will acknowledge 
within 30 days. 
9.8 Serious breaches of protocol 
A serious breach is a breach which is likely to affect to a significant degree either: 
 
The safety or physical or mental integrity of the subjects of the trial; or 
 
The scientific value of the trial. 
Serious breaches of GCP, the trial protocol or the Clinical Trial Authorisation will be reported to the 
Sponsor QA office within 3 working days from the time the research team becomes aware of the 
incident. 
9.9 Laboratory measurements 
In total, this study will require an additional 60 ml blood (alongside with a sample of urine) to be taken 
for the purposes of the biological sub-study at baseline and weeks 12, 24, 36, 52, withdrawal visit, and 
at time of flare (extra visit, during the observational period).  
This will include storage of serum, white cell pellets, peripheral blood mononuclear cells (PBMCs), 
whole blood and urine. These may be used for soluble biomarkers, flow cytometry, functional studies 
or DNA/RNA extraction using methods/techniques applicable to the study. 
9.10 Annual reports 
An annual report describing the general progress and any relevant safety data related to the trial must 
be submitted to the main REC, MHRA and the Sponsor on the anniversary of the Clinical Trial 
Authorisation being granted. The annual report should follow the format of a Developmental Safety 
Update Report (DSUR). A template and guidance for the completion of this report is available from 
the Sponsor office. An annual report of AEs will also be sent to Janssen Biologics. The CI must review 
and sign / date the report. 
9.11 End of trial report 
Upon completing the trial, as defined in section 6.6.7, an end of trial report must be submitted to the 
MHRA within one year of the end of the trial by the Sponsor or Sponsor-delegated individual. A copy 
of this end of trial report should also be supplied to all support departments involved in the study, for 
example pharmacy and or radiology. 
The CI must review and sign / date the report. 
STUDY MANAGEMENT AND ADMINISTRATION 
10.1 Good clinical practice (GCP) and regulatory compliance 
This clinical trial, which involves the use of an investigational medicinal product, has been designed 
and will be run in accordance with the Principles of GCP and the current regulatory requirements, as 
detailed in the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK S.I. 2004 / 1031) and 
any subsequent amendments of the clinical trial regulations. 

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10.2 Adherence to protocol 
The Investigator should not deviate from the protocol. In medical emergencies, the Investigator may 
use his/her medical judgment and may remove a study patient from immediate hazard before 
notifying the Sponsor, the MHRA and the REC in writing regarding the type of emergency and the 
course of action taken. 
10.3 Monitoring, audit and inspection 
The Sponsor reserves the right to monitor and/or audit the site (i.e. where the trial is being conducted) 
at any time. The Sponsor will visit the study centre to check the completeness of patient records, 
accuracy of entries on paper documents and eCRFs, and the adherence to the protocol and to GCP.   
The site may be monitored or audited, by the Sponsor (or their appointed representative) or internally 
by the LIRMM Clinical Research Associate. 
The trial may be subject to inspection by the MHRA in order to ensure compliance with UK Trials 
regulations, and the Investigator should allow direct access to trial documentation. 
10.3.1. Procedures for monitoring subject compliance 
Patient compliance with the trial intervention will be assessed at each visit. Further reference is 
presented in sections 6.5, 7.3, 7.6, 7.9, 7.10.1. A patient will be considered overall compliant for each 
study period if he/she is missing no more than 20% of the expected doses and not missing 2 
consecutive doses of IMP. 
10.3.2. Definition of source data 
Source documents are original records in which raw data are first recorded, as defined by the source 
data location document kept in the study Trial Master File. These may include, e.g. 
hospital/clinic/general practitioner records, charts, diaries, x-rays, laboratory results, printouts, 
pharmacy records, care records, ECG or other printouts, completed scales, or Quality of Life 
Questionnaires. Source documents should be kept in a secure, limited access area. 
Electronic data records such as x-ray, US and MRI records will be saved and stored in an appropriately 
secure centralised location. 
Source data verification ensures accuracy and credibility of the data obtained. During monitoring 
reported data are reviewed with regard to being accurate, complete, and verifiable from source 
documents (e.g. subject files, recordings from automated instruments, ECG tracings, x-ray films, 
laboratory notes). All data reported on the eCRF should be supported by source documents. Data 
Verification will be carried out by the investigators and members of the study team who will check the 
case report forms for completeness and clarity, and crosscheck them with source documents. 
A Source Data Location Sheet (SDLS) specific to the GOLMePsA trial can be found in a dedicated section 
on the study TMF.  
10.3.3. Quality assurance 
Investigators will promptly notify the Sponsor Quality Assurance Office of the following within the 
required timeframe: 
 
Serious breaches of GCP 
 
Urgent safety measures 
 
Protocol violations 

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 
Any amendments to the trial 
 
Any changes to the Sponsor’s Clinical Trial Risk Assessment (form A). 
 
Any other issues as stated in the study contract or agreement 
10.3.4. Trial oversight: trial steering committee 
Independent oversight of the study will be conducted by the Trial Steering Committee. Amongst its 
members will be an independent chair, a lay individual (from the NIHR Leeds Biomedical Research 
Centre and Patient Advocacy Group), a clinician who is independent of the study research team, and 
a representative of the LIRMM study management team. They are expected to meet at least annually. 
For its terms of reference see appendix 5. 
10.4 Data handling 
10.4.1. Paper-based data collection tools and electronic (e) CRF completion 
The research team is responsible for prompt reporting of accurate, complete, and legible data in the 
paper based source documents and in all required reports. Any change or correction to the paper-
based documents should be dated, initialled, and explained (if necessary) and should not obscure the 
original entry. Use of correction fluid (e.g. Tipp-Ex) is not permitted. 
Designated investigator staff will enter the data required by the protocol into an electronic (e) CRF 
system. Any change or correction to the eCRF will be time-stamped and documented within the data 
storage system, with all previous versions of the form retained. The Investigator should maintain a list 
of personnel authorized to enter data into the eCRF. 
10.4.2. Database entry and reconciliation 
Data will be entered via an eCRF into a validated electronic data collection system. Computerized data 
cleaning checks will be used in addition to manual review to check for discrepancies and to ensure 
consistency of the data. 
After the eCRF has been submitted initially, an electronic audit trail system will be maintained within 
the data collection system to track all data changes in the database. Regular backups of the electronic 
data will be performed in line with local SOPs for the backup of systems. 
10.4.3. Screening and enrolment logs 
Patients screening will be recorded in the Patient Screening Log which will contain a record of the date 
of informed consent signing and the date of randomisation. The Investigator will also keep a list 
containing all patients enrolled and randomized into the study (Subject Identification [ID] Log). This 
list remains with the Investigator, kept in the Trial Master File and is used for unambiguous 
identification of each patient. The list contains the patient identification number, full name, date of 
birth and the hospital number and/or National Health Service number, if applicable. In addition a Pre-
screening log will be kept to record all patients approached as possible study candidates. 
The patient’s consent and enrolment in the study must be recorded in the patient’s medical record. 
These data should identify the study and document the dates of the patient’s participation. 
10.5 Archiving and data retention 
In line with the principles of GCP/UK Clinical Trial Regulations, at the end of the trial, essential 
documents will be securely archived for a minimum of 15 years. Arrangements for confidential 
destruction will then be made. If a patient withdraws consent for their data to be used, it will be 

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confidentially destroyed immediately. No records/study documentation/data may be destroyed 
without first obtaining written permission from the Sponsor. 
Essential documents include (this list is not exhaustive): 
 
Signed informed consent documents for all subjects. 
 
Patient Screening Log, Subject Identification Log and Pre-Screening Log. 
 
Record of all communications between the Investigator, the REC and the Sponsor. 
 
List of sub-investigators and other appropriately qualified persons to whom the Investigator 
has delegated significant trial-related duties, together with their roles in the study and their 
signatures. 
 
Copies of case report forms and documentation of corrections for all subjects. 
 
Investigational product accountability records. 
 
All other source documents (subject medical records, hospital records, laboratory records, 
etc.). 
 
All other documents as listed in section 8 of the ICH E6 Guideline for Good Clinical Practice 
(Essential Documents for the Conduct of a Clinical Trial). 
*European Union legislation requires this list to be maintained for a minimum of 15 years. 
10.6 Study suspension, termination and completion 
Suspension or termination of the study may occur at any time for any reason, following discussion 
between the Investigator and the Sponsor. In the case of early study termination the Sponsor or 
Sponsor-delegated individual will be responsible for completing a premature end of study report to 
the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics 
Committee (REC) within 15 days. Upon study completion, the Sponsor or Sponsor-delegated individual 
will be responsible for sending the Declaration of the End of a Clinical Trial to the MHRA within 90 
days. The Sponsor or Sponsor-delegated individual will be responsible for providing the End of Trial 
Report to the MHRA within 1 year of the end of the trial. 
DATA EVALUATION 
11.1 Responsibilities 
The Leeds Institute of Rheumatic and Musculoskeletal Medicine statistician will be responsible for 
producing the final data report. 
11.2 Hypotheses 
The analysis of the primary endpoint will test the following hypothesis: 
H0: The difference* between the two treatment arms in the PASDAS score at week 24 is equal to zero. 
H1: The difference* between the two treatment arms in the PASDAS score at week 24 is not equal to 
zero. 
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11.3 General statistical considerations 
In general, analyses will be adjusted for the randomisation stratification factor(s) and baseline values 
of the outcome measure; 2-tailed tests will be performed and will be considered statistically significant 
if p<0.05. A final analysis plan will be completed prior to the final data lock before unblinding. Any 
deviations from this plan will be documented in the final data report. 
Unless otherwise specified, the last valid measurement before study medication administration will 
be utilized as the baseline value. In general, summary statistics [n (number of available 
measurements), arithmetic mean, standard deviation, median, minimum, and maximum] for 
quantitative variables and absolute and relative frequency tables for qualitative data will be 
presented.  
Wherever possible the trial will be reported in accordance with the recommendations of the CONSORT 
(Consolidated Standards of Reporting Trials) statement (53-55). 
11.4 Analysis populations 
 
Full Analysis Set (FAS): The full analysis set will include all patients 
 
Safety Set (SS): The safety set will include all patients who received at least one dose of study 
medication 
 
Per Protocol Set (PPS): The per protocol set will include all patients deemed to fulfil the 
protocol in terms of eligibility, interventions and outcome assessment. 
11.5 Planned efficacy analyses 
11.5.1. Primary endpoint analysis 
The primary endpoint will be assessed in the Full Analysis Set, with patients assigned to the study arms 
to which they were originally randomised (intention-to-treat analysis).  
Full descriptive data will be provided for the PASDAS score at week 24. Unadjusted and adjusted 
estimates of the treatment effect will be obtained; the unadjusted estimate will be considered 
supplementary to the primary adjusted estimate. We will present the difference between treatment 
group means and the 95% confidence interval around the difference. Analysis of covariance by 
multiple linear regression will be used to compare PASDAS between the two treatment groups at week 
24, controlling for the PASDAS values at baseline, and whether or not the patient had clinical 
polyarthritis at baseline (stratification factor).  
11.5.2. Secondary endpoint analyses 
Full descriptive data will be provided for all secondary endpoints. Adjusted estimates of effect size will 
be obtained for binary secondary endpoints using multiple binary logistic regression; odds ratios and 
95% confidence intervals will be presented. Continuous interval outcomes will be analysed using 
multiple linear regression; differences between treatment group means and 95% confidence intervals 
will be presented. Count outcomes will be analysed using an appropriate generalised linear model; 
incident rate ratios and 95% confidence intervals will be presented. Severely skewed outcomes for 
which an appropriate generalised linear model cannot be identified will be analysed using quantile 
regression; differences between medians and 95% confidence intervals will be presented. All analyses 
will control for the stratification factor and baseline values of the outcome. Where the aim is to relate 
clinical or imaging responses to baseline joint counts or to symptom duration, these variables will be 
added to the relevant models as covariates after the initial estimate of the treatment effect has been 
obtained; interactions between each variable and treatment will be assessed and will be considered 
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differences in treatment response according to oligo/polyarthritis status, disease duration at baseline. 
The total amount of steroids received by week 12, as a post-randomisation variable, will not be 
adjusted for in the analysis but will instead be compared between groups. 
11.5.3. Other analyses 
A number of sensitivity analyses will be conducted. These will include restricting analysis of the data 
to the observed values only, imputing non-response for patients who withdraw for any reason, using 
post-withdrawal data observed for patients who withdrew from study therapy early rather than 
carrying forward data from their withdrawal visit, and amending imputed values for continuous 
variables to investigate the robustness of response estimates to a variety of deviations from the 
missing at random assumption. A per protocol analysis will also be performed, repeating the primary 
endpoint analysis in the PPS. Further details of these sensitivity analyses will be set out in the statistical 
analysis plan. 
In a subset of patients, total synovitis and enthesitis scores calculated in expanded sets of joints 
defined in the newly published OMERACT definitions will be compared between groups according to 
the same methods as for secondary outcomes. In addition, for patients in the WB-MRI subset the MRI 
outcomes will be compared between groups on an exploratory basis using the same methods as for 
secondary outcomes. However, the focus will be on quantifying the potential treatment effect. A 
range of confidence intervals (75%, 85%, 95%) around the difference between the treatment arms will 
be calculated, to indicate the level of confidence with which we could say there was potential for a 
substantive difference between groups.  
An assessment of the test-retest reliability of the PASDAS will be performed, by calculating the 
intraclass correlation coefficient between PASDAS measurements collected a screening and baseline 
with a 95% confidence interval. 
11.6 Safety analyses 
Line listings of all SAEs will be provided in the end of trial report. Safety analyses will be conducted in 
the SS. The frequency of all SAEs during the study period will be presented for each treatment group 
separately. The data will be displayed as number of subjects experiencing the SAEs, percentage of 
subjects, and number of SAEs. Data will also be corrected for exposure by 100 patient-years. Quarterly 
listings of SAEs will be sent to Janssen Biologics. 
11.7 Handling of dropouts and missing data 
The primary analysis will include all patients, as originally randomised (ITT analysis). This will require 
missing data to be imputed. For patients who withdraw early, data from the withdrawal visit will be 
imputed for subsequent visits for continuous outcomes, and non-response will be imputed for binary 
outcomes. For all other instances of missing data, multiple imputation will be used to obtain at least 
20 full datasets; this number may be increased should Monte Carlo error estimates indicate instability 
of model coefficients. Outcomes will be imputed according to data type; in general for measures of 
disease activity the achievement of thresholds of response (e.g. PsARC) will be computed passively 
following imputation of the underlying score or components via predictive mean matching, provided 
sample size is sufficient for the imputation models to converge. Analyses from the imputed datasets 
will be combined according to Rubin’s rules. Should multiple imputation not prove possible due to the 
level of attrition, mixed models will be investigated as an alternative. 

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11.8 Planned interim analysis and data monitoring 
There are no interim analyses planned. The biostatistician will conduct an initial inspection of the data 
prior to breaking of the blind to identify any issues with data quality, which will be resolved in the 
RDMS before the database is locked for final analysis. 
11.9 Determination of sample size and randomization method 
Using in-house unpublished data we estimated the minimum clinically important difference to be 0.7 
units on the PASDAS; this is similar to a published value for smallest detectable difference of 0.8 units 
(11). We will aim to detect a difference of at least 1 unit between the treatment arms in this study. 
The standard deviation of PASDAS in the TICOPA MTX rapid escalation arm (56, 57) at 24 weeks 
(restricted to patients who remained on methotrexate throughout) was 1.57. Assuming δ=1, σ=1.57, 
at alpha=0.05 and 1-Beta=0.8 this would require 78 patients. Originally the sample size for the trial 
was adjusted to account for 10% drop-out, requiring a total of 88 (44 per group). However, because 
recruitment had been slower than anticipated, in part due to the SARS-CoV-2 pandemic, drop-out was 
reassessed once 76 participants had the opportunity to reach the primary endpoint. Only 4 (5%) had 
withdrawn from follow-up prior to that point. Therefore, the total required sample size was revised 
down to 84 (42 per group) i.e. allowing for 5% drop-out.  
For the whole-body MRI subset, published rules of thumb for pilot studies indicate that between 12 
and 30 patients per group should be included. We will aim to continue recruiting patients into the WB-
MRI subset until there are at least 30 patients (15 per group) with scans available at both baseline and 
week 24, at which point WB-MRI will cease to be performed in the remaining patients.  
To estimate the ICC between two repeated readings of the PASDAS composite index with a confidence 
interval of width 0.2, we would need 31 patients assuming the ICC is 0.85. For the patient’s global 
assessment of disease activity VAS, which provides the greatest loading on the PASDAS score, ICC = 
0.87(35). We will aim to obtain data from at least 31 patients. 
11.10 Procedure for un-blinding the study prior to analysis 
Prior to un-blinding the statistician will conduct an initial review of the data (see section 11.8); the 
final statistical analysis plan will be signed off by the CI and a copy will be stored in the trial master 
file. Once all of these steps have been completed the randomisation status of each patient will be 
requested from pharmacy and treatment allocation will be stored in the database prior to export for 
analysis. 
ETHICS AND REGULATORY REQUIREMENTS 
12.1 Good Clinical Practice 
This study will be conducted in accordance with applicable laws and regulations including, but not 
limited to, the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice 
(GCP) and the recommendations guiding ethical research involving human subjects adopted by the 
18th World Medical Assembly, Helsinki, Finland, 1964, amended at the 48th General Assembly, 
Somerset West Republic of South Africa, October 1996. The Research Ethics Committee (REC) and 
MHRA must review and approve the protocol and informed consent form before any subjects are 
enrolled. Before any protocol-required procedures are performed, the subject must sign and date the 
REC-approved informed consent form. The right of a patient to refuse participation without giving 
reasons must be respected. The patient must remain free to withdraw at any time from the study 
without giving reasons and without prejudicing his/her further treatment. The study will be submitted 

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to and approved by a main Research Ethics Committee (REC) and the appropriate regulatory 
authorities prior to entering patients into the study. 
12.2 Delegation of Investigator duties 
The Investigator should ensure that all persons assisting with the trial are adequately qualified and 
informed about the protocol, any amendments to the protocol, the study treatments, and their 
trial-related duties and functions. 
The Investigator should maintain a delegation log of co-investigators and other appropriately qualified 
persons to whom he or she has delegated significant trial-related duties. 
12.3 Subject information and informed consent 
Before being enrolled in the clinical study, subjects must consent to participate after the nature, scope, 
and possible consequences of the clinical study have been explained in a form understandable to 
them. 
An informed consent document (Patient Information Leaflet (PIS)) that includes both information 
about the study and the consent form will be prepared and given to the subject at least 24 hours prior 
to the screening visit. This document will contain all the elements required by the ICH E6 Guideline for 
Good Clinical Practice and any additional elements required by local regulations.  
Where English is not the patient’s first language, every effort will be made to provide a Trust 
interpreter in accordance with normal Trust procedures. The document (PIS) will be translated 
verbally (by a Trust appointed interpreter) into a language understandable to the subject. Additionally 
in such instances, the completed informed consent document must specify the name of the individual 
translating and informing the subject.  
At the screening visit, patients will be given the opportunity to ask questions and the nature and 
objectives of the study will be explained. A research nurse may help in this process but the study 
doctor is responsible for the informed consent discussions. 
After reading the informed consent document, the subject must give consent in writing. The subject's 
consent must be confirmed at the time of consent by the personally dated signature of the subject 
and by the personally dated signature of the person conducting the informed consent discussions, the 
study doctor. 
The original signed consent document will be retained in the Trial Master File. Further copies of the 
consent form are required: 
 
One copy of the informed consent document will be kept in the patient’s clinical notes. 
 
One copy will be given to the patient. 
Consent is an ongoing process and will be reassessed at each study visit. 
The Investigator will not undertake any measures specifically required only for the clinical study until 
valid consent has been obtained. 
The Investigator must inform the subject’s primary physician about the subject’s participation in the 
trial if the subject has a primary physician and if the subject agrees to the primary physician being 
informed. 

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12.4 Subject confidentiality 
If a subject’s name (or any other personally identifiable information) appears on any document (e.g. 
laboratory report), it will first be redacted on a copy of the document before being supplied to anyone 
outside the clinical care team (for the purposes of the trial).  
The subjects will be informed that representatives of the Sponsor, Research Ethics Committee (REC) 
or regulatory authorities may inspect their medical records to verify the information collected, and 
that all personal information made available for inspection will be handled in strictest confidence. 
All information collected during the course of the trial will be kept strictly confidential. 
Information will be held securely on paper and electronically at the Leeds Institute of Rheumatic and 
Musculoskeletal Medicine (LIRMM). LIRMM will comply with all aspects of the Data Protection Act 
2018. 
Upon a patient providing informed consent to participate in the study, the research team will maintain 
a personal patient identification list in the form of a ‘Subject ID Log’ held in the Trial Master File (TMF). 
This log will consist (at a minimum) of subject ID numbers with the corresponding patient name, date 
of birth and NHS/hospital number) to enable research records/data to be cross-referenced and 
identified. 
12.5 Approval of clinical study protocol and amendments 
Before the start of the study, the clinical study protocol, informed consent document, and any other 
appropriate documents will be submitted to the REC, the MHRA and the Sponsor with a cover letter 
or a form listing the documents submitted, their dates of issue, and the site (or region or area of 
jurisdiction, as applicable) for which approval is sought. If applicable, the documents will also be 
submitted to the authorities, in accordance with local legal requirements. 
Investigational products can only be supplied Sponsor after documentation on all ethical and legal 
requirements for starting the study has been received by the product provider. 
Before the first subject is enrolled in the study, all ethical and legal requirements must be met, 
including approval of the study by the NHS, the Sponsor Research and Development department, the 
REC and the MHRA. 
Amendments must be evaluated to determine whether formal approval must be sought and whether 
the informed consent document should be revised, thus all protocol amendments and administrative 
changes must first be discussed with and approved by the Sponsor before being submitted to the REC 
and the MHRA, in accordance with legal requirements. 
The Investigator must keep a record of all communication with the REC, the MHRA, and the Sponsor. 
This also applies to any communication between the Investigator and the authorities. 
12.6 Protocol amendments 
Requests for any amendments to the study must be sent to the Sponsor by the Chief Investigator. The 
Sponsor will determine whether said amendments are substantial or non-substantial prior to their 
submission to the appropriate bodies for approval.  
Patients should be re-consented to the study if the amendments affect the information they have 
received, patient safety, or if the change alters the type or quality of the data collected for the study. 
Patients should only be re-consented AFTER an amendment has been fully approved. 

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12.7 On-going information for MHRA/REC 
Unless otherwise instructed by the MHRA, REC and the Sponsor, the Investigator must submit to the 
MHRA, REC and the Sponsor: 
 
Information on serious or unexpected adverse events (SUSARs) from the Investigator’s site, 
as soon as possible and within 24 hours (one business day) of the research team becoming 
aware of them. 
 
Expedited safety reports, as soon as possible. 
 
Annual reports on the progress of the study, both DSURs and REC progress reports. 
 
The Declaration of the End of a Trial form 
13. FINANCE AND INSURANCE  
13.1 Indemnity and insurance 
Clinical negligence indemnification will rest with The Leeds Teaching Hospitals NHS Trust, under 
standard NHS arrangements. As Sponsor, the Trust does not provide indemnification against claims 
arising from non-negligent harm. 
Further details of liability and insurance provisions for this study are given in separate agreements. 
13.2 Financial disclosure 
None of the investigators or members of the research team have any financial involvement with the 
sponsorship or funding bodies or will receive personal benefits, incentives or payment over and above 
normal salary. 
14. PUBLICATION 
The trial will be registered with an authorised registry, according to ICMJE Guidelines, prior to the start 
of recruitment. 
The success of the trial depends upon the collaboration of all patients. For this reason, credit for the 
main results will be given to all those who have collaborated in the trial, through authorship and 
contributor ship. Uniform requirements for authorship for manuscripts submitted to medical journals 
will guide authorship decisions. These state that authorship credit should be based only on substantial 
contribution to: 
 
conception and design, or acquisition of data, or analysis and interpretation of data 
 
drafting the article or revising it critically for important intellectual content, and  
 
final approval of the version to be published, and  
 
that all these conditions must be met (www.icmje.org). 
In light of this, the Chief Investigator, and relevant staff will be named as authors in any publication. 
In addition, all collaborators will be listed as contributors for the main trial publication, giving details 
of roles in planning, conducting and reporting the trial. 
To maintain the scientific integrity of the trial, data will not be released prior to the end of the trial, 
either for trial publication or oral presentation purposes, without the permission of the Trial Steering 
Committee or the Chief Investigator. In addition, individual collaborators must not publish data 

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directly relevant to the questions posed in the trial until the main results of the trial have been 
published and following written consent from the Sponsor. 
 
 

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REFERENCES 
1. 
Kane D, Stafford L, Bresnihan B, FitzGerald O. A prospective, clinical and radiological 
study of early psoriatic arthritis: an early synovitis clinic experience. Rheumatology (Oxford). 
2003;42(12):1460-8. 
2. 
McHugh NJ, Balachrishnan C, Jones SM. Progression of peripheral joint disease in 
psoriatic arthritis: a 5-yr prospective study. Rheumatology (Oxford). 2003;42(6):778-83. 
3. 
Torre Alonso JC, Rodriguez Perez A, Arribas Castrillo JM, Ballina Garcia J, Riestra 
Noriega JL, Lopez Larrea C. Psoriatic arthritis (PA): a clinical, immunological and radiological 
study of 180 patients. Br J Rheumatol. 1991;30(4):245-50. 
4. 
Sokoll KB, Helliwell PS. Comparison of disability and quality of life in rheumatoid and 
psoriatic arthritis. J Rheumatol. 2001;28(8):1842-6. 
5. 
Gladman DD, Shuckett R, Russell ML, Thorne JC, Schachter RK. Psoriatic arthritis (PSA)-
-an analysis of 220 patients. The Quarterly journal of medicine. 1987;62(238):127-41. 
6. 
Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American 
College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. 
Arthritis Rheum. 1995;38(6):727-35. 
7. 
Clegg DO, Reda DJ, Mejias E, Cannon GW, Weisman MH, Taylor T, 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):2013-20. 
8. 
Clegg DO, Reda DJ, Weisman MH, Blackburn WD, Cush JJ, Cannon GW, et al. 
Comparison of sulfasalazine and placebo in the treatment of ankylosing spondylitis. A 
Department of Veterans Affairs Cooperative Study. Arthritis Rheum. 1996;39(12):2004-12. 
9. 
FitzGerald O, Helliwell P, Mease P, Mumtaz A, Coates L, Pedersen R, et al. Application 
of composite disease activity scores in psoriatic arthritis to the PRESTA data set. Ann Rheum 
Dis. 2012;71(3):358-62. 
10. 
Helliwell PS, Kavanaugh A. Comparison of composite measures of disease activity in 
psoriatic arthritis using data from an interventional study with golimumab. Arthritis Care Res 
(Hoboken). 2014;66(5):749-56. 
11. 
Helliwell PS, FitzGerald O, Fransen J. Composite disease activity and responder indices 
for psoriatic arthritis: a report from the GRAPPA 2013 meeting on development of cutoffs for 
both disease activity states and response. J Rheumatol. 2014;41(6):1212-7. 
12. 
Weckbach S, Schewe S, Michaely HJ, Steffinger D, Reiser MF, Glaser C. Whole-body 
MR imaging in psoriatic arthritis: Additional value for therapeutic decision making. Eur J 
Radiol. 2011;77(1):149-55. 
13. 
Brown AK, Conaghan PG, Karim Z, Quinn MA, Ikeda K, Peterfy CG, et al. An Explanation 
for the Apparent Dissociation Between Clinical Remission and Continued Structural 
Deterioration in Rheumatoid Arthritis. Arthritis Rheum-Us. 2008;58(10):2958-67. 
14. 
McInnes IB, O'Dell JR. State-of-the-art: rheumatoid arthritis. Ann Rheum Dis. 
2010;69(11):1898-906. 
15. 
Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, 
et al. The PREMIER study: A multicenter, randomized, double-blind clinical trial of 
combination therapy with adalimumab plus methotrexate versus methotrexate alone or 
adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had 
previous methotrexate treatment. Arthritis Rheum. 2006;54(1):26-37. 
16. 
Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, et al. 
Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected 

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subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid 
arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, 
placebo-controlled study of golimumab before methotrexate as first-line therapy for early-
onset rheumatoid arthritis. Arthritis Rheum. 2009;60(8):2272-83. 
17. 
Hetland ML, Stengaard-Pedersen K, Junker P, Lottenburger T, Ellingsen T, Andersen 
LS, et al. Combination treatment with methotrexate, cyclosporine, and intraarticular 
betamethasone compared with methotrexate and intraarticular betamethasone in early 
active rheumatoid arthritis: an investigator-initiated, multicenter, randomized, double-blind, 
parallel-group, placebo-controlled study. Arthritis Rheum. 2006;54(5):1401-9. 
18. 
Sokka T, Pincus T. Rheumatoid arthritis: strategy more important than agent. Lancet. 
2009;374(9688):430-2. 
19. 
Smolen JS, Landewe R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, et al. 
EULAR recommendations for the management of rheumatoid arthritis with synthetic and 
biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2010;69(6):964-75. 
20. 
Kaltwasser JP, Nash P, Gladman D, Rosen CF, Behrens F, Jones P, 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-
50. 
21. 
Kavanaugh A, McInnes I, Mease P, Krueger GG, Gladman D, Gomez-Reino J, et al. 
Golimumab, a new human tumor necrosis factor alpha antibody, administered every four 
weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety 
results of a randomized, placebo-controlled study. Arthritis Rheum. 2009;60(4):976-86. 
22. 
Antoni C, Krueger GG, de Vlam K, Birbara C, Beutler A, Guzzo C, et al. Infliximab 
improves signs and symptoms of psoriatic arthritis: results of the IMPACT 2 trial. Ann Rheum 
Dis. 2005;64(8):1150-7. 
23. 
Mease PJ, Gladman DD, Ritchlin CT, Ruderman EM, Steinfeld SD, Choy EH, et al. 
Adalimumab for the treatment of patients with moderately to severely active psoriatic 
arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 
2005;52(10):3279-89. 
24. 
Mease PJ, Kivitz AJ, Burch FX, Siegel EL, Cohen SB, Ory P, et al. Etanercept treatment 
of psoriatic arthritis: safety, efficacy, and effect on disease progression. Arthritis Rheum. 
2004;50(7):2264-72. 
25. 
Kavanaugh A, Antoni CE, Gladman D, Wassenberg S, Zhou B, Beutler A, et al. The 
Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT): results of radiographic 
analyses after 1 year. Ann Rheum Dis. 2006;65(8):1038-43. 
26. 
Kavanaugh A, McInnes I, Mease P, Krueger GG, Gladman D, Gomez-Reino J, et al. 
Golimumab, a new human tumor necrosis factor alpha antibody, administered every four 
weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety 
results of a randomized, placebo-controlled study. Arthritis and rheumatism. 2009;60(4):976-
86. 
27. 
Coates LC, Fransen J, Helliwell PS. Defining minimal disease activity in psoriatic 
arthritis: a proposed objective target for treatment. Ann Rheum Dis. 2010;69(1):48-53. 
28. 
Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. 
Dermatologica. 1978;157(4):238-44. 
29. 
Cassell SE, Bieber JD, Rich P, Tutuncu ZN, Lee SJ, Kalunian KC, et al. The modified Nail 
Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in 
patients with psoriatic arthritis. J Rheumatol. 2007;34(1):123-9. 

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30. 
Mumtaz A, Gallagher P, Kirby B, Waxman R, Coates LC, Veale JD, et al. Development 
of a preliminary composite disease activity index in psoriatic arthritis. Ann Rheum Dis. 
2011;70(2):272-7. 
31. 
Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 
1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 
2008;159(5):997-1035. 
32. 
Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health 
Econ. 1993;2(3):217-27. 
33. 
Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H, et al. 
Classification criteria for psoriatic arthritis: development of new criteria from a large 
international study. Arthritis Rheum. 2006;54(8):2665-73. 
34. 
Helliwell PS, Fitzgerald O, Fransen J, Gladman DD, Kreuger GG, Callis-Duffin K, et al. 
The development of candidate composite disease activity and responder indices for psoriatic 
arthritis (GRACE project). Ann Rheum Dis. 2013;72(6):986-91. 
35. 
Cauli A, Gladman DD, Mathieu A, Olivieri I, Porru G, Tak PP, et al. Patient global 
assessment in psoriatic arthritis: a multicenter GRAPPA and OMERACT study. J Rheumatol. 
2011;38(5):898-903. 
36. 
Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach 
to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease 
Activity Index. J Rheumatol. 1994;21(12):2286-91. 
37. 
Healy PJ, Helliwell PS. Measuring clinical enthesitis in psoriatic arthritis: assessment of 
existing measures and development of an instrument specific to psoriatic arthritis. Arthritis 
Rheum. 2008;59(5):686-91. 
38. 
Helliwell PS, Firth J, Ibrahim GH, Melsom RD, Shah I, Turner DE. Development of an 
assessment tool for dactylitis in patients with psoriatic arthritis. J Rheumatol. 
2005;32(9):1745-50. 
39. 
Healy PJ, Helliwell PS. Measuring dactylitis in clinical trials: which is the best 
instrument to use? J Rheumatol. 2007;34(6):1302-6. 
40. 
Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. 
Arthritis Rheum. 1980;23(2):137-45. 
41. 
Doward LC, Spoorenberg A, Cook SA, Whalley D, Helliwell PS, Kay LJ, et al. 
Development of the ASQoL: a quality of life instrument specific to ankylosing spondylitis. Ann 
Rheum Dis. 2003;62(1):20-6. 
42. 
D'Agostino MA, Terslev L, Aegerter P, Backhaus M, Balint P, Bruyn GA, et al. Scoring 
ultrasound synovitis in rheumatoid arthritis: a EULAR-OMERACT ultrasound taskforce-Part 1: 
definition and development of a standardised, consensus-based scoring system. RMD Open. 
2017;3(1):e000428. 
43. 
Terslev L, Naredo E, Aegerter P, Wakefield RJ, Backhaus M, Balint P, et al. Scoring 
ultrasound synovitis in rheumatoid arthritis: a EULAR-OMERACT ultrasound taskforce-Part 2: 
reliability and application to multiple joints of a standardised consensus-based scoring 
system. RMD Open. 2017;3(1):e000427. 
44. 
Wakefield RJ, Balint PV, Szkudlarek M, Filippucci E, Backhaus M, D'Agostino MA, et al. 
Musculoskeletal ultrasound including definitions for ultrasonographic pathology. J 
Rheumatol. 2005;32(12):2485-7. 
45. 
Terslev L, Naredo E, Iagnocco A, Balint PV, Wakefield RJ, Aegerter P, et al. Defining 
enthesitis in spondyloarthritis by ultrasound: results of a Delphi process and of a reliability 
reading exercise. Arthritis Care Res (Hoboken). 2014;66(5):741-8. 

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46. 
Maksymowych WP, Inman RD, Salonen D, Dhillon SS, Krishnananthan R, Stone M, et 
al. Spondyloarthritis research consortium of Canada magnetic resonance imaging index for 
assessment of spinal inflammation in ankylosing spondylitis. Arthrit Rheum-Arthr. 
2005;53(4):502-9. 
47. 
Maksymowych WP, Inman RD, Salonen D, Dhillon SS, Williams M, Stone M, et al. 
Spondyloarthritis research consortium of Canada magnetic resonance Imaging index for 
assessment of sacroiliac joint inflammation in ankylosing spondylitis. Arthrit Rheum-Arthr. 
2005;53(5):703-9. 
48. 
Maksymowych WP, Cibere J, Loeuille D, Weber U, Zubler V, Roemer FW, et al. 
Preliminary Validation of 2 Magnetic Resonance Image Scoring Systems for Osteoarthritis of 
the Hip According to the OMERACT Filter. J Rheumatol. 2014;41(2):370-8. 
49. 
Jaremko JL, Jeffery D, Buller M, Wichuk S, McDougall D, Lambert RGW, et al. 
Preliminary validation of the Knee Inflammation MRI Scoring System (KIMRISS) for grading 
bone marrow lesions in osteoarthritis of the knee: data from the Osteoarthritis Initiative. Rmd 
Open. 2017;3(1). 
50. 
Krabbe S, Ostergaard M, Pedersen SJ, Weber U, Krober G, Makysmowych W, et al. 
Canada-Denmark MRI scoring system of the spine in patients with axial spondyloarthritis: 
updated definitions, scoring rules and inter-reader reliability in a multiple reader setting. Rmd 
Open. 2019;5(2). 
51. 
Mathew AJ, Krabbe S, Eshed I, Gandjbakhch F, Bird P, Pedersen SJ, et al. The OMERACT 
MRI in Enthesitis Initiative: Definitions of Key Pathologies, Suggested MRI Sequences, and a 
Novel Heel Enthesitis Scoring System. J Rheumatol. 2019;46(9):1232-8. 
52. 
Krabbe S, Eshed I, Gandjbakhch F, Pedersen SJ, Bird P, Mathew AJ, et al. Development 
and Validation of an OMERACT MRI Whole-Body Score for Inflammation in Peripheral Joints 
and Entheses in Inflammatory Arthritis (MRI-WIPE). J Rheumatol. 2019;46(9):1215-21. 
53. 
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of 
reporting of randomized controlled trials - The CONSORT statement. Jama-J Am Med Assoc. 
1996;276(8):637-9. 
54. 
Moher D, Schulz KF, Altman D, Grp C. The CONSORT statement: Revised 
recommendations for improving the quality of reports of parallel-group randomized trials. 
Jama-J Am Med Assoc. 2001;285(15):1987-91. 
55. 
Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated 
guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152(11):726-
32. 
56. 
Coates LC, Helliwell PS. Methotrexate Efficacy in the Tight Control in Psoriatic Arthritis 
Study. Journal of Rheumatology. 2016;43(2):356-61. 
57. 
Coates LC, Moverley AR, McParland L, Brown S, Navarro-Coy N, O'Dwyer JL, et al. 
Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, 
open-label, randomised controlled trial. Lancet. 2015;386(10012):2489-98. 
 
 
 

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APPENDICES 
APPENDIX 1: Definition of Women of Childbearing Potential (WCBP) 
A woman of childbearing potential (WCBP) is defined as one who is biologically capable of becoming 
pregnant. This includes women who are using contraceptives or whose sexual partners are either 
sterile or using contraceptives. Sexually active women participating in the study must use a medically 
acceptable form of contraception during the study and for 6 months after the last dose of study 
medications. Medically acceptable forms of contraception for women include oral contraception, 
injectable or implantable methods, intrauterine devices, or properly used barrier contraception. 
 
 
 
 

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APPENDIX 2: Common Terminology Criteria for Adverse Events (CTCAE) 
Grading 
 
Grade 
Definition 
Grade 1  
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
Grade 2  
Moderate; minimal, local or non-invasive intervention indicated; limiting age-
appropriate instrumental ADL*. 
Grade 3  
Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL**. 
Grade 4 
Life-threatening consequences; urgent intervention indicated. 
Grade 5 
Death related to AE. 
 
Activities of Daily Living (ADL): 
*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, 
managing money, etc.  
**Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking 
medications, and not bedridden. 
Reference: CTCAE v4.03 - June 14, 2010 
US National Cancer Institute, https://evs.nci.nih.gov/ftp1/CTCAE/About.html 

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APPENDIX 3: CASPAR Classification Criteria for PsA 
Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease P, Mielants H; CASPAR Study Group. Classification criteria 
for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum, 2006. 54(8): 
p. 2665-73. 
The CASPAR criteria 
Inflammatory articular disease (joint, spine, or entheseal) with 3 or more points from the following: 
1. Evidence of psoriasis (one of a, b, c) 
(a) Current psoriasis * 
Psoriatic skin or scalp disease present today as judged by a rheumatologist or dermatologist 
(b) Personal history of psoriasis 
A history of psoriasis that may be obtained from patient, family doctor, dermatologist, rheumatologist 
or other qualified health-care provider 
(c) Family history of psoriasis 
A history of psoriasis in a first or second degree relative according to patient report 
 
2. Psoriatic nail dystrophy 
Typical psoriatic nail dystrophy including onycholysis, pitting and hyperkeratosis observed on current 
physical examination 
 
3. A negative test for rheumatoid factor 
By any method except latex but preferably by ELISA or nephelometry, according to the local laboratory 
reference range 
 
4. Dactylitis (one of a, b) 
(a) Current 
Swelling of an entire digit 
(b) History 
A history of dactylitis recorded by a rheumatologist 
 
5. Radiological evidence of juxta-articular new bone formation 
Ill-defined ossification near joint margins (but excluding osteophyte formation) on plain xrays of hand 
or foot 
* Current psoriasis scores 2 whereas all other items score 1 CASPAR  
 
 

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APPENDIX 4: mNAPSI Score 
 
Does the patient have nail disease?                           Yes  
                No  
          Assessment not possible  
 (give reason)   
 
 
Features (circle appropriate number) 
Fingernails Right 
Fingernails Left 
5 
4 
3 
2 
1 
1 
2 
3 
4 
5 
Onycholysis 
0 = none 
 
 
 
 
 
 
 
 
 
 
1 = 1-10% of nail surface 
 
 
 
 
 
 
 
 
 
 
2 = 11-30% of nail surface 
 
 
 
 
 
 
 
 
 
 
3 = >30% of nail surface 
 
 
 
 
 
 
 
 
 
 
Pitting 
0 = 0 
 
 
 
 
 
 
 
 
 
 
1 = 1-10 pits 
 
 
 
 
 
 
 
 
 
 
2 = 11-49 pits 
 
 
 
 
 
 
 
 
 
 
3 = >50 pits 
 
 
 
 
 
 
 
 
 
 
Nail plate 
crumbling 
0 = none 
 
 
 
 
 
 
 
 
 
 
1 = 1-25% of nail 
 
 
 
 
 
 
 
 
 
 
2 = 26-50% of nail 
 
 
 
 
 
 
 
 
 
 
3 = >50% of nail 
 
 
 
 
 
 
 
 
 
 
Features (tick if present) 
Fingernails Right 
Fingernails Left 
5 
4 
3 
2 
1 
1 
2 
3 
4 
5 
Leukonychia 
 
 
 
 
 
 
 
 
 
 
Splinter haemorrhage 
 
 
 
 
 
 
 
 
 
 
Nail bed hyperkeratosis 
 
 
 
 
 
 
 
 
 
 
Red spots in lunula 
 
 
 
 
 
 
 
 
 
 
Oil spot dyschromia 
 
 
 
 
 
 
 
 
 
 
Total  
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX 5: Trial Steering Committee (TSC) 
Trial Steering Committee Terms of Reference: 
1. To monitor and supervise the progress of the trial towards its interim and overall objectives. 
2. To review, at regular intervals, relevant information from other sources (e.g. other related 
trials). 
3. To consider the recommendations of the Data Monitoring and Ethics Committee if 
applicable. 
4. In the light of 1, 2 and 3, to inform the Sponsor (The Leeds Teaching Hospitals NHS Trust) on 
the progress of the trial. 
 
Specifically, the Trial Steering Committee will be responsible for monitoring the following (See MRC 
Guidelines for Good Clinical Practice in Clinical Trials 1998 document) 
 
Patient safety 
 
Progress of the Trial 
 
Adherence to Protocol 
 
Consideration of New Information 
 
 

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APPENDIX 6: Visual Analogue Scales (VAS) 
Patient Global Assessment of Disease Activity 
The patient’s perception of disease will be a 0-100 mm VAS as a global score encompassing both joints 
and skin. The left end corresponds to “no activity” or “excellent” and the right end to ‘poor’ (35). The 
patients will mark their own assessment on the scales in the case report forms by themselves by 
placing a single vertical line through the bar.  
Patient Assessment of Pain 
The patient is instructed to rate their level of pain corresponding to their arthritis. The   wording of 
the question asks about the way the patient feels. This is the wording proposed by Cauli et al which 
been validated in psoriatic arthritis (35). The left end corresponds to no pain or “excellent” state and 
the right end to the worst pain imaginable or “poor”. The patients will mark their own assessment on 
the scales in the case report forms by themselves by placing a single vertical line through the bar.  
Physician Global Assessment of Disease Activity 
The investigator's evaluation of psoriatic disease activity should be completed before the patient's 
global assessment is received. The investigator will assess the patient’s psoriatic arthritis condition 
taking into account not only impressions from the assessments made in the study, but also any other 
information available. A 100 mm VAS is used: the left end corresponds to “Disease not active” (0) and 
the right end to “Disease extremely active” (100).  
 
 

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Visual analogue scales 
Please tell us about how you are feeling today by placing a vertical mark on each line to represent your 
answer, like this for example: 
 
 
 
 
Patient Global Assessment of Disease Activity: 
In all the ways in which your PSORIASIS and ARTHRITIS, as a whole, affects you, how would you rate the 
way you felt over the past week? 
 
Excellent 
Poor 
 
 
Patient Global Assessment of Pain 
In all the ways your ARTHRITIS affects you, how would you rate the way you felt over the past week? 
Excellent 
Poor 
 
 
Physician Global Assessment of Disease Activity: 
What is your assessment of the patient’s current disease activity? 
Disease not active 
Disease 
extremely 
active 
 
 
 
 
Visual Analogue Scales (VAS) 

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APPENDIX 7: Tender and swollen joints assessments instructions 
 
 
 
76/78 joints list encompasses all the joints depicted in the above mannequin (TMJ; SCJ/ACJ/Shoulder; 
Elbow; Wrist; CMC; MCPJ; hand PIPJ; hand DIPJ; HIP; Knee; Ankle (that is: tibio-tarsal joint); Tarsi; feet 
MTPJ; feet PIPJ; feet DIPfJ). 66/68 joints list encompasses all the above mentioned joint with the 
exception of CMC and feet DIPJ. HIPs are always excluded from the assessment of articular swelling. 

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Total grading for tender joints ranges 0-234; total grading for articular swelling ranges 0-228. The 
grading range of tender joints for PsARC calculation is 0-204 (CMC and feet DIPJ excluded). The grading 
range of articular swelling for PsARC calculation is 0-198 (CMC and feet DIPJ excluded). 
Definitions of articular grading 
Articular grading (tenderness) 
Articular grading (swelling) 
0 = none 
0 = no swelling 
1 = mild (positive response on questioning) 
1 = mild (detectable synovial thickening without 
loss of bony contours) 
2 = moderate (spontaneous response elicited) 
2 = moderate (loss of distinctiveness of bony 
contours) 
3 = severe (withdrawal on examination) 
3 = severe (bulging synovial proliferation with 
cystic characteristics) 
 
 
 

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APPENDIX 8: Magnetic Resonance Imaging (MRI) scoring methods planned for 
GOLMePsA trial 
 
SPARCC – SPINAL INFLAMMATION 
Original citation: 
Arthritis Rheum 2005 Aug 15;53(4):502-9. doi: 10.1002/art.21337. 
Spondyloarthritis Research Consortium of Canada magnetic resonance imaging index for assessment 
of spinal inflammation in ankylosing spondylitis 
 
Description: 
Scoring of MRI lesions | The scoring method (www.altarheum.com/research.html) for active 
inflammatory lesions in the spine relied on the use of a T2-weighted sequence that incorporated 
suppression of normal marrow fat signal. We opted for the STIR sequence, which offered greater 
reliability when using large fields of view compared with T2 spin echo with spectral presaturation. 
Signal from marrow fat frequently obscures signal emanating from BME associated with inflammation. 
Consequently, the use of fat suppression improves sensitivity for detection of abnormal water 
content. 
To score lesions in defined regions of the spine, the following definition of a discovertebral unit was 
used: the region between 2 virtual lines through the middle of each vertebra and includes the 
intervertebral disc and the adjacent vertebral endplates. Each vertebral endplate was scored 
independently for BME. T1 spin echo images were included for anatomic reference only and were not 
scored. For each lesion, a total of 3 consecutive sagittal slices were assessed. This allowed assessment 
of the extent of the lesion in the coronal and the sagittal planes. Discal lesions were not scored because 
they are often abnormal in patients with mechanical low back pain and degenerative disc disease. 
Definition of abnormal STIR signal | Bone marrow signal in the center of the vertebra constituted the 
reference for designation of normal signal. 
Scoring of depth and intensity | The signal from cerebrospinal fluid constituted the reference for 
designating an inflammatory lesion as intense. A lesion was graded as deep if there was a 
homogeneous and unequivocal increase in signal >1 cm. Assessment of depth was made possible by 
including a scale on the image. 
Scoring method | Each discovertebral unit was divided into 4 quadrants: upper anterior endplate, 
upper posterior endplate, lower anterior endplate, and lower posterior endplate. The presence of 
increased STIR signal in each of these 4 quadrants was scored on a dichotomous basis: 1 = increased 
signal, 0 = normal signal. This was repeated for each of 3 consecutive sagittal slices resulting in a 
maximum score of 12 per discovertebral unit. On each slice, the presence of a lesion exhibiting intense 
signal in any quadrant was given an additional score of 1. Similarly, the presence of a lesion exhibiting 
depth ≥1 cm in any quadrant was given an additional score of 1, leading to a maximum additional 
score of 6 for each specific vertebral unit and bringing the total maximum score to 18 per unit. Because 
our preliminary analyses indicated that scoring only 6 discovertebral units would be sufficient (see 
below), this brought the total maximum score for SPARCC-spinal inflammation method to 108. 
 
 

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SPARCC – SACRO-ILIAC JOINTS INFLAMMATION 
Original citation: 
Arthritis Rheum 2005 Oct 15;53(5):703-9. doi: 10.1002/art.21445. 
Spondyloarthritis research Consortium of Canada magnetic resonance imaging index for assessment 
of sacroiliac joint inflammation in ankylosing spondylitis 
 
Description: 
Scoring of MRI lesions | The scoring method for active inflammatory lesions in the SI joint relied on 
the use of a T2-weighted sequence that incorporates suppression of normal marrow fat signal. In other 
sequences, signal from marrow fat frequently obscures signal emanating from marrow edema 
associated with inflammation. Consequently, the use of fat suppression improves sensitivity for 
detection of abnormal water content. 
Scoring of the SI joints was confined to those coronal slices depicting the synovial portion of the joint. 
In a preliminary overview of SI joint MR images from other patients with AS, the synovial portion was 
consistently evident in 6 consecutive coronal slices. Of the 12 acquisitions from posterior to anterior, 
this was typically slices 4 to 9. We therefore scored 6 consecutive coronal slices from posterior to 
anterior. T1-weighted SE images were included for anatomic reference only and were not scored. All 
lesions within the iliac bone and within the sacrum up to the sacral foramina were scored. Increased 
signal within the sacroiliac joint space or in the ligamentous portion of the joint was not scored. 
Definition of abnormal lesion on STIR sequence | Sacral interforaminal bone marrow signal formed 
the reference for assignment of normal signal in the joint. 
Scoring of depth and intensity | The signal from presacral blood vessels defined a lesion that was 
scored as intense. A lesion was graded as deep if there was a homogeneous and unequivocal increase 
in signal extending over at least 1 cm from the articular surface. Assessment of depth was made 
possible by including a scale on the image. 
Scoring method | Each SI joint is divided into 4 quadrants: upper iliac, lower iliac, upper sacral, and 
lower sacral. The presence of increased signal on STIR in each of these 4 quadrants was scored on a 
dichotomous basis, where 1 = increased signal and 0 = normal signal. The maximum score for abnormal 
signal in the 2 SI joints of 1 coronal slice was therefore 8. Joints that included a lesion exhibiting intense 
signal were each given an additional score of 1 per slice that demonstrated this feature. Similarly, each 
joint that included a lesion demonstrating continuous increased signal of depth ≥1 cm from the 
articular surface was also given an additional score of 1. This brought the maximal score for a single 
coronal slice to 12. The scoring was repeated in each of the 6 consecutive coronal slices leading to a 
maximum score of 72. 
 
 

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HIMRISS 
Original citation: 
J Rheumatol 2014 Feb;41(2):370-8. doi: 10.3899/jrheum.131083. Epub 2013 Nov 15. 
Preliminary validation of 2 magnetic resonance image scoring systems for osteoarthritis of the hip 
according to the OMERACT filter 
 
Description: 
Bone Marrow Lesion (BML) is defined as increased signal within bone on STIR sequences, excluding 
bone cysts. The contralateral hip is the normal reference signal for this assessment using bladder signal 
and T1 images to assist with identification of cysts. The closest normal bone marrow is used if the 
contralateral hip is significantly abnormal or arthroplasty is present. 
BML in the femoral head is scored in 5 central slices as well as the 5 slices that are anterior and 5 that 
are posterior to these central slices. The image where the femoral head is largest defines the most 
central slice of the 5 central slices. On each central slice the femoral head is considered a circle that is 
segmented into 8 equal sectors (octants) of 45° of arc with a ninth sector being an inner circle 
representing one-half the diameter of the femoral head. BML is scored dichotomously in each of these 
sectors, giving a scoring range of 0–45. For each of the anterior and posterior slices, the slice is divided 
into 2 sectors, superior and inferior, and BML is scored dichotomously in sectors defined as 
anterosuperior, anteroinferior, posterosuperior, and posteroinferior so that the total scoring range 
for the sum of anterior and posterior slices is 0–20 and total femoral BML score is 0–65. For 
assessment of acetabular BML, a 2-cm radius from the rim of the acetabulum is evaluated if the rim 
can be identified on the image. A part of the BML must contact the articular surface/subchondral bone 
plate at some stage within the set of images to be evaluated. If rim is not identifiable (out of the field 
of view), then the 2- cm radius limit is taken from the template horizontal line (that will traverse the 
center of the femoral head). 
The acetabulum is scored in the same slices, the 5 central slices being divided into 3 sectors 
(superolateral, superomedial, and medial), and 5 anterior and 5 posterior slices being divided into 
superior and inferior halves so that the total scoring range for acetabular BML is 0–35. 
The total BML scoring range per subject is 0–100. 
Effusion and synovitis are scored together according to a 0–2 grading scheme [0 = 0–1.9 mm (normal), 
1 = 2–3.9 mm, 2 = ≥ 4 mm] on the same central, anterior, and posterior slices, resulting in a scoring 
range of 0–30. The fluid signal contacting a part of the femoral head and/or neck is assessed at the 
greatest short axis dimension perpendicular to the underlying bone (which will be femoral neck or 
femoral head). If no bone is visible (it is just off the slice being measured), the greatest short axis 
diameter of the synovial recess is measured. A transparency outlining the sectors was developed and 
used as an overlay being placed over the femoral head so that the outer circle approximates the 
femoral head. 
 
 

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Page 92 of 98 
KIMRISS 
Original description: 
RMD Open 2017 Jan 18;3(1):e000355. doi: 10.1136/rmdopen-2016-000355. eCollection 2017. 
Preliminary validation of the Knee Inflammation MRI Scoring System (KIMRISS) for grading bone 
marrow lesions in osteoarthritis of the knee: data from the Osteoarthritis Initiative 
 
Description: 
The KIMRISS web interface is accessible free to registered users at www.carearthritis.com. This site 
includes a customized HTML5 DICOM viewer which allows users to upload and score their own DICOM 
data sets, an introductory slide presentation explaining KIMRISS and demonstrating examples of 
proper use and pitfalls, and for training purposes, several fully scored sample cases prepared by two 
expert musculoskeletal radiologist readers. Readers can practice scoring these cases and instantly 
review their performance slice-by-slice compared to the expert readings. 
KIMRISS Overlay placement | The tibia is scored with the template positioned and locked once on the 
“central slice” where the ACL and PCL are seen to cross on a single image. If the knee is ACL or PCL 
deficient the central slice is placed where the intact ligament is best seen. Ten segments can be 
defined for each slice (5 immediately subarticular and 5 deeper). Using 3 mm MRI slice thickness, we 
have found in pilot work that knees are covered by 29 slices containing the tibia (10 medial, 10 lateral, 
and 9 central), resulting in a maximum score of 290 for the tibia (i.e., scoring range 0-290). 
The femur is scored with the template positioned and locked three times: once outlining the femoral 
trochlea on the “central slice” (as chosen for the tibia) and once for each femoral condyle, outlining 
the respective condyle where the cross-sectional area appears largest. The web-based interface will 
automatically adjust the template position between “locked” positions to best match the femoral 
contour, using interpolation between the “lock” points. As for the tibia, 29 3-mm slices provide full 
coverage of the femur (10 slices for each condyle and 9 central slices for the trochlea). Each slice 
contains 13 segments, resulting in a maximum score of 377 for the femur. 
The patella is scored with the template positioned and locked once on the slice with the largest 
patellar cross-sectional area, and kept in that position to score all slices that contain the patella 
(maximum of 12 3-mm slices in pilot work). We define 8 segments per slice (4 immediately subarticular 
and 4 deeper), resulting in a maximum score of 96 for the patella. 
Overall maximum score is 290 (tibia) + 377 (femur) + 96 (patella) = 763. 
In the rare event that a BML is missed due to being outside the limit of the 29 femur/tibia slices and/or 
the 12 patellar slices, the template center can be adjusted to include the missed BML. This did not 
occur in any of the 80 subjects in this study. MRI slices less than 3 mm in thickness should be post-
processed to 3 mm prior to scoring. 
For ease of use, the KIMRISS BML score at a region is automatically recorded as 1 when a user simply 
clicks a mouse or touches a touch-screen within that region. Scores are automatically populated into 
a data table which is maintained in the computer memory cache and can be exported when the scan 
has been fully reviewed. An overall KIMRISS score can be calculated by summing each segment(s) 
containing a BML, for each bone (tibia, patella, femur), region (e.g., trochlea, medial condyle, lateral 
condyle), or subregions. This allows several permutations of region based analysis or calculation of a 
“total score” for each knee. 
 

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Page 93 of 98 
CANDEN MRI spine scoring system 
Original citation: 
RMD Open 2019 Oct 13;5(2):e001057. doi: 10.1136/rmdopen-2019-001057. eCollection 2019. 
Canada-Denmark MRI scoring system of the spine in patients with axial spondyloarthritis: updated 
definitions, scoring rules and inter-reader reliability in a multiple reader setting 
 
Description: 
Scoring rules 
CANDEN 
MRI 
spine 
inflammation 
score 
The following lesions are scored as 0 (absent) or 1 (present): aCIL, pCIL, NIL, aLIL, pLIL,
FIL, TIL, RIL, SPIL and STIL. A score of 1 is added for large aCIL and pCIL. Non-corner
lesions (NIL) are scored as 0 (absent) or 2 (present), and a score of 2 is added for large 
non-corner 
lesions 
(NIL).
The CANDEN MRI spine inflammation score has a total scoring range of 0–614. The 
vertebral body subscore has a score range of 0–464 (11 cervical endplates from C2 to 
C7, each with a maximum score of 4, 35 thoracic/lumbar endplates from T1 to S1 each 
with a maximum score of 12). The posterior elements subscore has a score range of 
0–150 (facet joints at all 23 levels from C2/C3 to L5/S1, transverse process at 17 levels 
from T1 to L5, rib at 12 levels from T1 to T12, spinous process at 23 levels from C2 to 
L5, 
soft 
tissue 
inflammation 
at 
23 
levels 
from 
C2/C3 
to 
L5/S1).
The CANDEN MRI spine inflammation score may also be divided into the following four 
subscores: 
 
A, ‘Vertebral body corner inflammation subscore’, defined as the sum of the 
anterior and posterior corner lesions, and anterolateral and posterolateral 
vertebral body lesions (posterolateral vertebral body lesions only at levels 
T12/L1 to L5/S1), which may predominantly represent enthesitis related to 
the anterior and posterior longitudinal ligament and the annulus fibrosus 
(range 0–254). 
 
B, ‘Spondylodiscitis subscore’, defined as the sum of non-corner vertebral 
body lesions, which may predominantly represent inflammation from the disc 
or endplate itself (range 0–162). 
 
C, ‘Facet joint inflammation subscore’, defined as the sum of facet joint 
lesions, representing inflammation of the synovial facet joints (range 0–46). 
 
D, ‘Posterolateral elements inflammation subscore’, defined as the sum of rib, 
transverse process, spinous process, soft tissue inflammation and 
posterolateral vertebral body lesions (posterolateral vertebral body only at 
levels C7/T1 to T11/T12 because pLIL in the thoracic spine is considered to be 
related to the costovertebral joint), representing inflammation related to 
these synovial joints and enthesitis of ligaments of the posterior elements of 
the spine (range 0–152). 

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CANDEN 
MRI 
spine fat score 
The following lesions are scored as 0 (absent) or 1 (present): aCFAT, pCFAT, aLFAT, 
pLFAT and FFAT. A score of 1 is added for large aCFAT and pCFAT. Non-corner lesions 
(NFAT) are scored as 0 (absent) or 2 (present), and a score of 2 is added for large non-
corner 
lesions 
(NFAT).
The total scoring range for the CANDEN MRI spine fat score is 0–510. The range for the 
vertebral body subscore is 0–464 (11 cervical endplates each with a maximum score
of 4, 35 thoracic/lumbar endplates each with a maximum score of 12). The range for 
the fat posterior elements subscore is 0–46 (facet joints at all 23 levels). 
CANDEN 
MRI 
spine 
bone 
erosion score 
The following lesions are scored as 0 (absent) or 1 (present): aCOBE, pCOBE and FABE. 
A 
score 
of 
1 
is 
added 
for 
large 
aCOBE 
and 
pCOBE.
The total scoring range for the CANDEN MRI spine bone erosion score is 0–208. The 
range for the vertebral body subscore is 0–162 (11 cervical endplates each with a 
maximum score of 2, 35 thoracic/lumbar endplates each with a maximum score of 4). 
The range for the posterior elements subscore is 0–46 (facet joints at all 23 levels). 
CANDEN 
MRI 
spine 
new
bone 
formation 
score 
Anterior corner, posterior corner and non-corner ankylosis are scored as 0 (absent) or 
6 (present). Anterior corner, posterior corner and non-corner bone spurs are scored 
as 0 (absent) or 2 (present). Facet joint ankylosis is scored as 0 (absent) or 1 (present).
The total scoring range for the CANDEN MRI spine new bone formation score is 0–460. 
The range for the vertebral body subscore is 0–414 (23 levels with a maximum score 
of 18). The range for the posterior elements subscore is 0–46 (facet joints at all 23 
levels). 
 
aCFAT, anterior corner fat lesion; aCIL, anterior corner inflammatory lesion; aCOBE, anterior 
corner bone erosion; aLFAT, anterolateral vertebral body fat lesion; aLIL, anterolateral 
vertebral body inflammatory lesion; CANDEN, Canada-Denmark; FABE, facet joint bone 
erosion; FFAT, facet joint fat lesion; FIL, facet joint inflammatory lesion; NFAT, non-corner fat 
lesion; NIL, non-corner inflammatory lesion; pCFAT, posterior corner fat lesion; pCIL, posterior 
corner inflammatory lesion; pCOBE, posterior corner bone erosion; pLFAT, posterolateral 
vertebral body fat lesion; pLIL, posterolateral vertebral body inflammatory lesion; RIL, rib 
inflammatory lesion; SPIL, spinous process inflammatory lesion; STIL, soft tissue inflammatory 
lesion; TIL, transverse process inflammatory lesion. 
 
 
 

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Page 95 of 98 
HEMRIS 
Original citation: 
J Rheumatol 2019 Sep;46(9):1232-1238. doi: 10.3899/jrheum.181093. Epub 2019 Feb 1. 
The OMERACT MRI in Enthesitis Initiative: Definitions of Key Pathologies, Suggested MRI Sequences, 
and a Novel Heel Enthesitis Scoring System 
 
Description: 
 

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Page 96 of 98 
For Achilles tendon and plantar fascia entheses, the possible range of the HEMRIS inflammation sum 
score will be 0–12 and 0–9, respectively, and the corresponding range of the HEMRIS structural sum 
scores will be 0–9, respectively. 
 
 

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Page 97 of 98 
MRI-WIPE 
Original citation: 
J Rheumatol . 2019 Sep;46(9):1215-1221. doi: 10.3899/jrheum.181084. Epub 2019 Feb 15. 
Development and Validation of an OMERACT MRI Whole-Body Score for Inflammation in Peripheral 
Joints and Entheses in Inflammatory Arthritis (MRI-WIPE) 
 
Description: 
Inflammation in joints (arthritis) and at entheses (enthesitis) are both assessed separately for soft 
tissues (synovitis at joints, soft tissue inflammation at entheses) and bone (osteitis). 
Preferably, synovitis and soft tissue inflammation are assessed on T1-post-Gd images and osteitis on 
short-tau inversion recovery (STIR)/T2-weighted fat-sat (T2FS) images. But if STIR/T2FS is the only 
method available, synovitis and soft tissue inflammation can be assessed based on it. Each component 
is scored on a semiquantitative scale of 0–3 (none/mild/moderate/severe). In total, 83 peripheral 
joints and 33 entheses are assessed. The MRI-WIPE score is derived by adding all scores together; the 
total range is 0–738 (joints 0–537; entheses 0–201). 

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Page 98 of 98