Clinical trial NCT03963401
Conditions: Psoriatic Arthritis
Keywords: Spondyloarthritis
Sponsor: Pfizer
Start date: 2019-06-13; Completion date: 2021-01-15
Enrollment: 219 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.

Detailed description:

Arms: arm 1: PF-06700841 60 mg once daily for 52 weeks arm 2: PF-06700841 30 mg once daily for 52 weeks arm 3: PF-06700841 10 mg once daily for 16 weeks, followed by 60 mg once daily until Week 52 arm 4: PF-06700841 10 mg once daily for 16 weeks, followed by 30 mg once daily until Week 52 arm 5: Placebo once daily for 16 weeks, followed by PF-06700841 60 mg once daily until Week 52 arm 6: Placebo once daily for 16 weeks, followed by PF-06700841 30 mg once daily until Week 52
Interventions: intervention 1: PF-06700841 intervention 2: Placebo
Intervention descriptions: intervention 1: Starting after the Week 16 visit, subjects receiving PF-06700841 10 mg once daily will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind. intervention 2: Starting after the Week 16 visit, subjects receiving placebo will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.

Protocol documents:
Prot_000.pdf: 
PF-06700841
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A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 
STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO 
EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH 
ACTIVE PSORIATIC ARTHRITIS
Investigational Product Number:
PF-06700841
Investigational Product Name:
Tyk2/Jak1
United States (US) Investigational New 
Drug (IND) Number:
Not applicable
European Clinical Trials Database 
(EudraCT) Number:
2018-004241-16
Protocol Number:
B7931030
Phase:
2b
This document and accompanying materials contain confidential information belonging to Pfizer.  Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this information in 
confidence and not copy or disclose it to others (except where required by applicable law) or use it for 
unauthorized purposes.  In the event of any actual or suspected breach of this obligation, Pfizer must be 
promptly notified.


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Document History
Document
Version Date
Summary of Changes and Rationale
Amendment 2
22 October 2019
Schedule of Activities (SOA) and 
Section 7.2.8 Electrocardiogram (ECG) were
updated to include the additional ECGs, and 
the requirements for centrally read ECG, 
alongside the locally read ECG.
 
 
 
 
 
 
 
Section 4.4.1. Contraception. Sexually active 
male subjects with female partners of 
child-bearing potential are no longer required
to use a condom to prevent potential transfer 
to and exposure of partner(s) to drug through 
ejaculate.
Rationale: Based on availability of new 
nonclinical developmental toxicity data that 
enabled assessment of the PF-06700841 
systemic exposure risk of females resulting 
from male ejaculate, the requirements for 
condom use have been removed.
Section 7.2.10. Events for 
Adjudication/Review Committee 
Submission, and Section 9.9. Safety 
Adjudication Committees (AC) were added 
to evaluate opportunistic infections,
malignancy and cardiovascular events.
Rationale: Based on emerging safety data 
across the Janus kinase (JAK) inhibitor class 
and regulatory feedback, a program level 
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Document
Version Date
Summary of Changes and Rationale
decision has been made to include AC to 
more thoroughly investigate and interpret 
major safety events of interest.
Appendix 6. Discontinuation Criteria. 
Additional discontinuation criterion added to 
clarify that study drug will be discontinued 
and the subject withdrawn from the study 
treatment in the event of any of the 
following: serious thromboembolic events, 
including venous thrombosis (including but 
not limited to deep vein thrombosis [DVT], 
pulmonary embolism [PE]), arterial 
thrombosis, and cerebrovascular events 
(thromboembolic stroke, transient ischemic 
attack [TIA], etc.) requiring hospitalization 
for treatment, or meeting other criteria that 
require the thromboembolic event to be 
classified as a serious adverse event (SAE).
Rationale: The additional discontinuation 
criterion has been added based on regulatory 
feedback surrounding the emerging safety 
concerns across the JAK inhibitor product 
class.
Appendix 6. Discontinuation Criteria. 
Additional discontinuation criteria added to 
clarify that study drug will be discontinued 
and the subject withdrawn from the study 
treatment in the event of any of the 
following: Two sequential AST or ALT 
elevation 3 times the upper limit of normal 
with at least one total bilirubin value 
2 times the upper limit of normal; Two 
sequential AST or ALT elevation 3 times 
the upper limit of normal accompanied by 
signs or symptoms consistent with hepatic 
injury; Two sequential AST or ALT 
elevation 5 times the upper limit of normal, 
regardless of total bilirubin or accompanying 
signs or symptoms.
Rationale: The additional clarification of 


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Document
Version Date
Summary of Changes and Rationale
discontinuation criteria is similar to other 
ongoing studies with PF-06700841, and 
consistent with the laboratory changes
expected at baseline and over time in 
subjects using background methotrexate.
Amendment 1
29 April 2019
Section 4.4.1 Contraception was updated to 
include an instruction that male subjects 
should refrain from sperm donation during 
the study and for a period of at least 90 days 
after completion of active treatment.
Rationale: to align with Regulatory request.
Section 9. Data Analysis/Statistical Methods, 
on the timing of SAP finalization. It is stated 
that the SAP will be finalized prior to the 
study unblinding. Section 9.7. Interim 
Analysis, clarification added that the interim 
analysis, if performed, will not be used to 
drive any decisions for the current study.
Rationale: to align with Regulatory request.
Original protocol
31 October 2018
Not applicable (N/A)
This amendment incorporates all revisions to date, including amendments made at the 
request of regulatory authorities and institutional review boards (IRBs)/ethics committees 
(ECs).


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TABLE OF CONTENTS
LIST OF TABLES...................................................................................................................10
LIST OF FIGURES .................................................................................................................10
APPENDICES .........................................................................................................................11
PROTOCOL SUMMARY.......................................................................................................12
SCHEDULE OF ACTIVITIES................................................................................................15
1. INTRODUCTION ...............................................................................................................20
1.1. Mechanism of Action/Indication.............................................................................20
1.2. Background and Rationale ......................................................................................20
1.2.1. Drug Development Rationale .....................................................................20
1.2.2. Study Rationale...........................................................................................22
1.2.3. Preclinical Safety Data ...............................................................................23
1.2.4. Clinical Experience with PF-06700841......................................................25
1.2.4.1. Summary of Clinical Safety with PF-06700841 .......................26
1.2.4.2. Summary of Pharmacokinetics (PK).........................................30
1.2.5. Dose Selection Rationale............................................................................31
1.2.6. Summary of Benefit Risk Assessment .......................................................32
2. STUDY OBJECTIVES AND ENDPOINTS.......................................................................33
3. STUDY DESIGN.................................................................................................................35
4. SUBJECT ELIGIBILITY CRITERIA.................................................................................36
4.1. Inclusion Criteria.....................................................................................................37
4.2. Exclusion Criteria....................................................................................................40
4.3. Randomization Criteria ...........................................................................................46
4.4. Lifestyle Requirements ...........................................................................................46
4.4.1. Contraception..............................................................................................46
4.4.2. Fasting Visit Requirements.........................................................................47
4.4.3. Other Requirements....................................................................................47
4.5. Sponsor’s Qualified Medical Personnel..................................................................48
5. STUDY TREATMENTS.....................................................................................................48
5.1. Allocation to Treatment ..........................................................................................49
5.2. Breaking the Blind ..................................................................................................49
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5.3. Subject Compliance.................................................................................................49
5.4. Investigational Product Supplies.............................................................................50
5.4.1. Dosage Form(s) and Packaging..................................................................50
5.4.2. Preparation and Dispensing........................................................................50
5.5. Administration.........................................................................................................50
5.6. Investigational Product Storage ..............................................................................51
5.7. Investigational Product Accountability...................................................................52
5.7.1. Destruction of Investigational Product Supplies ........................................52
5.8. Concomitant Treatments .........................................................................................52
5.8.1. Permitted Background Pain or Other Psoriatic Arthritis Therapy..............53
5.8.2. Prohibited Concomitant Medications .........................................................53
5.8.3. Dietary Supplements...................................................................................54
5.9. Rescue Medications.................................................................................................54
5.10. Vaccination............................................................................................................55
6. STUDY PROCEDURES .....................................................................................................55
6.1. Screening.................................................................................................................55
6.2. Study Period ............................................................................................................57
6.2.1. Baseline Day 1............................................................................................58
6.2.2. Week 2 Visit ...............................................................................................60
6.2.3. Week 4, 8, 12, 16 Visit ...............................................................................62
6.2.4. Week 20, 28, 36, 44 Visit ...........................................................................64
6.2.5. Week 52 Visit or Early Termination Visit..................................................66
6.2.6. Follow-up Visit...........................................................................................68
6.3. Subject Withdrawal.................................................................................................69
7. ASSESSMENTS..................................................................................................................71
7.1. Efficacy Assessments..............................................................................................71
7.1.1. Clinical Rheumatology Assessments..........................................................71
7.1.1.1. Tender/Painful and Swollen Joint Count ..................................71
7.1.1.2. Physician’s Global Assessment of Arthritis..............................72
7.1.1.3. Physician’s Global Assessment of Psoriatic Arthritis...............72
7.1.1.4. Dactylitis Assessment ...............................................................72


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7.1.1.5. Enthesitis Assessment (Spondyloarthritis Research 
Consortium of Canada [SPARCC]), Leeds Enthesitis Index)...........72
7.1.2. Clinical Dermatology Assessments ............................................................73
7.1.2.1. Evaluation of Plaque Psoriasis ..................................................73
7.1.2.3. Body Surface Area (BSA).........................................................74
7.1.2.4. Psoriasis Area and Severity Index (PASI) ................................75
7.1.2.5. Nail Psoriasis Severity Index (NAPSI) .....................................77
7.1.3. Patient Report Outcomes (PROs)...............................................................77
7.1.3.1. Patient’s Assessment of Arthritis Pain......................................77
7.1.3.2. Patient’s Global Assessment of Arthritis ..................................77
7.1.3.3. Health Assessment Questionnaire (HAQ) disability index 
(DI) ....................................................................................................78
7.1.3.4. Patient’s Global Joint and Skin Assessment-Visual 
Analog Scale (PGJS-VAS)................................................................78
 
7.1.3.6. Functional Assessment of Chronic Illness 
Therapy-Fatigue (FACIT-Fatigue; a 13-item FACIT Fatigue 
Scale) .................................................................................................79
7.1.3.7. Short-Form-36 Health Survey (SF-36) Version 2, Acute .........79
7.1.4. Composite Efficacy Endpoints ...................................................................80
7.1.4.1. American College of Rheumatology (ACR) response 
criteria................................................................................................80
7.1.4.2. Minimal Disease Activity (MDA) and Very Low Disease 
Activity (VLDA) Score .....................................................................80
7.1.4.3. Disease Activity Index for Reactive Arthritis/Psoriatic 
Arthritis (DAREA/DAPSA) .............................................................80
7.1.4.4. Disease Activity Score-28 (DAS28) .........................................81
7.1.4.5. Psoriatic Arthritis Response Criteria (PsARC).........................81
7.1.4.7. Psoriatic Arthritis Disease Activity Score (PASDAS)..............81
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7.2. Safety Assessments .................................................................................................82
7.2.1. Laboratory...................................................................................................82
7.2.2. Pregnancy Testing ......................................................................................83
7.2.3. Serum Creatinine, Serum Cystatin C and Estimated Glomerular 
Filtration Rate (eGFR).....................................................................................83
7.2.4. Tuberculosis Testing...................................................................................84
7.2.5. Herpetiform Skin Rash Surveillance ..........................................................85
7.2.6. Medical History, Physical Examination, Height and Weight.....................85
7.2.7. Vital Sign Measurements (Blood pressure, pulse rate, and 
temperature).....................................................................................................86
7.2.8. Electrocardiogram.......................................................................................86
7.2.9. Chest Radiograph........................................................................................87
7.2.10. Events for Adjudication/Review Committee Submission........................87
7.3.1. High-Sensitivity C-Reactive Protein (hsCRP)............................................88
7.3.3. Viral Surveillance .......................................................................................88
7.6. Rater (Assessor) Qualifications...............................................................................91
8. ADVERSE EVENT REPORTING......................................................................................92
8.1. Requirements...........................................................................................................92
8.1.1. Additional Details on Recording Adverse Events on the CRF...................93
8.1.2. Eliciting Adverse Event Information..........................................................93
8.1.3. Withdrawal from the Study Due to Adverse Events (see also the 
Subject Withdrawal section)............................................................................93
8.1.4. Time Period for Collecting AE/SAE Information......................................93
8.1.4.1. Reporting SAEs to Pfizer Safety...............................................94
8.1.4.2. Recording Non-serious AEs and SAEs on the CRF .................94
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8.1.5. Causality Assessment .................................................................................94
8.1.6. Sponsor’s Reporting Requirements to Regulatory Authorities ..................94
8.2. Definitions...............................................................................................................95
8.2.1. Adverse Events ...........................................................................................95
8.2.2. Abnormal Test Findings .............................................................................95
8.2.3. Serious Adverse Events..............................................................................96
8.2.4. Hospitalization............................................................................................96
8.3. Severity Assessment................................................................................................98
8.4. Special Situations ....................................................................................................98
8.4.1. Protocol-Specified Serious Adverse Events...............................................98
8.4.2. Potential Cases of Drug-Induced Liver Injury............................................98
8.4.3. Potential Cases of Decreased eGFR .........................................................100
8.4.4. Infections ..................................................................................................101
8.4.4.1. Serious Infections....................................................................101
8.4.4.2. Treated Infections....................................................................101
8.4.5. Exposure to the Investigational Product during Pregnancy or 
Breastfeeding, and Occupational Exposure...................................................101
8.4.5.1. Exposure During Pregnancy....................................................102
8.4.5.2. Exposure During Breastfeeding ..............................................103
8.4.5.3. Occupational Exposure ...........................................................103
8.4.6. Medication Errors .....................................................................................104
8.4.6.1. Medication Errors....................................................................104
9. DATA ANALYSIS/STATISTICAL METHODS.............................................................104
9.1. Sample Size Determination...................................................................................105
9.2. Efficacy Analysis ..................................................................................................105
9.2.1. Analysis of the Primary Endpoint.............................................................105
9.2.2. Analysis of Secondary Endpoints.............................................................106
9.4. Analysis of Other Endpoints .................................................................................106
9.6. Safety Analysis......................................................................................................107
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9.7. Interim Analysis ....................................................................................................108
9.8. Data Monitoring Committee .................................................................................108
9.9. Safety Adjudication Committees ..........................................................................109
10. QUALITY CONTROL AND QUALITY ASSURANCE...............................................109
11. DATA HANDLING AND RECORD KEEPING ...........................................................110
11.1. Case Report Forms/Electronic Data Record .......................................................110
11.2. Record Retention.................................................................................................110
12. ETHICS............................................................................................................................111
12.1. Institutional Review Board/Ethics Committee....................................................111
12.2. Ethical Conduct of the Study ..............................................................................111
12.3. Subject Information and Consent........................................................................111
12.4. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH 
GCP .........................................................................................................................112
13. DEFINITION OF END OF TRIAL.................................................................................112
13.1. End of Trial in All Participating Countries .........................................................112
14. SPONSOR DISCONTINUATION CRITERIA ..............................................................112
15. PUBLICATION OF STUDY RESULTS........................................................................113
15.1. Communication of Results by Pfizer ..................................................................113
15.2. Publications by Investigators ..............................................................................114
16. REFERENCES ................................................................................................................115
LIST OF TABLES
Table 1.
Treatment Sequence..................................................................................36
Table 2.
Permitted Topical Concomitant Psoriasis Treatment ...............................53
 
Table 5.
Component Scoring Criteria for the Psoriasis Area and Severity 
Index (PASI).............................................................................................76
LIST OF FIGURES
Figure 1.
Schematic of Study Design.......................................................................35
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APPENDICES
Appendix 1. Abbreviations....................................................................................................119
Appendix 2. Prohibited Prior and Concomitant Medications................................................124
Appendix 3. Rescue Therapy.................................................................................................128
Appendix 4. Maximum Allowed Total Daily Dose of Opioid Analgesics............................130
Appendix 5. Oral Corticosteroid Equivalents........................................................................131
Appendix 6. Discontinuation Criteria....................................................................................132
Appendix 7. Laboratory Abnormalities Require Re-Testing.................................................135
Appendix 8. Example of Effective, but Not Highly Effective Methods of Contraception....136


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PROTOCOL SUMMARY 
Background and Rationale:
Psoriatic arthritis (PsA) is a chronic inflammatory disease with heterogeneous manifestations 
affecting the skin, enthesis, synovium, and characterized by peripheral arthritis, axial disease, 
enthesitis, dactylitis, psoriasis, and nail disease. 
PF-06700841 is a potent dual inhibitor of human tyrosine kinase (TYK)2 and Janus kinase 
(JAK)1 with a good selectivity profile over the other human kinases including JAK2 and 
JAK3 (PF-06700841 inhibited the in vitro activities of TYK2, JAK1, JAK2 and JAK3 with 
50% inhibitory concentration (IC50) of 22.7, 16.8 nM, 76.6 nM and 6490 nM, respectively).  
PF-06700841 is capable of inhibiting many cytokines involved in the pathogenesis of 
psoriasis and PsA with signaling pathways mediated by JAK1 and/or TYK2.  Given the 
recent United States (US) and European Union (EU) approvals of tofacitinib (a 
JAK1/3 inhibitor) for PsA, subjects who will receive PF-06700841 in this study are expected 
to experience improvement in their disease.  Compared to other JAK inhibitors, 
PF-06700841 will inhibit a similar mix of cytokines, but with relatively deeper inhibition of 
interleukin (IL)-12 and IL-23, due to TYK2 inhibitory activity.  PF-06700841 has 
demonstrated efficacy in a 4-week Phase 1 psoriasis trial and a 12-week Phase 2 psoriasis 
study completed recently.  PF-06700841 appears to be generally safe and well tolerated in 
clinical studies to date.
This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to 
evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.
Objectives:
1. To evaluate the efficacy of PF-06700841 compared to placebo in subjects with active 
psoriatic arthritis (PsA), and in subjects with active PsA who are Tumour Necrosis 
Factor (TNF) inhibitor naïve.
2. To evaluate the improvement in signs and symptoms related PsA Core Domain Set in 
PF-06700841 treated subjects.
3. To evaluate the improvement in patient reported outcome measures and composite 
outcome measures in PF-06700841 treated subjects.
4. To evaluate the safety and tolerability of PF-06700841.
Study Design:
This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging, parallel 
treatment group, efficacy and safety study designed to characterize the dose response of 
PF-06700841 in subjects with active PsA.  A total of approximately 196 subjects will be 
randomized in a 4:4:1:1:2:2 ratio to one of the six parallel treatment sequences as shown 
below.  For the comparison of each of three active treatment regimens (60 mg once daily 


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[QD], 30 mg QD and 10 mg QD) versus placebo in the primary endpoint of American 
College of Rheumatology (ACR)20 at Week 16, this results in a 2:2:1:2 allocation ratio (in 
the order of 60 mg QD, 30 mg QD, 10 mg QD and placebo).
The study consists of a screening period of up to 5 weeks, a double-blind treatment period of 
52 weeks (ie, one year), including a placebo controlled phase from Day 1 to Week 16 visits 
and an extended active treatment phase from Week 17 through Week 52, and a safety 
follow-up period of 4 weeks from last dose of study drug to last study visit.  The total 
duration of study subject participation will be approximately up to 61 weeks, from the 
screening period through the follow-up period.
All eligible subjects must have active PsA despite previous or current treatment with 
nonsteroidal anti-inflammatory drugs (NSAIDs), and/or non-biologic disease-modifying 
antirheumatic drugs (DMARDs), or apremilast.  Some subjects (up to 30% of study 
population) may also have been previously treated with no more than one TNF inhibitor 
(TNFi).  Randomization will be stratified by prior TNFi exposure.
All subjects will be randomly assigned to one of the six treatment sequences (A-F) shown in 
the table below.  Starting after the Week 16 visit, subjects receiving the 60 mg QD dose 
(sequence A) or the 30 mg QD dose (sequence B) will continue on their initial dose; while all 
other subjects, including those from the 10 mg QD dose arm (sequences C and D) or the 
placebo arm (sequences E and F), will be randomly assigned to receive either the 60 mg QD 
dose or 30 mg QD dose until Week 52 as predetermined at randomization.  All subjects will 
receive blinded dosing throughout the 52 weeks study treatment period in order to maintain 
the study blind. 
Treatment 
Sequence
Treatment
Subject Size
A
PF-06700841 60 mg QD
56
B
PF-06700841 30 mg QD
56
C1
PF-06700841 10 mg QD first & advance to 60 mg QD after
Week 16 visit1
14
D2
PF-06700841 10 mg QD first & advance to 30 mg QD after
Week 16 visit2
14
E1
Placebo QD first & advance to PF-06700841 60 mg QD after
Week 16 visit1
28
F2
Placebo QD first & advance to PF-06700841 30 mg QD after
Week 16 visit2
28
1.
Starting after Week 16 visit, subjects randomized to treatment sequences C or E will receive PF-06700841 
60 mg QD in a blinded fashion for the remainder of the study. 
2.
Starting after Week 16 visit, subjects randomized to treatment sequences D or F will receive PF-06700841 
30 mg QD in a blinded fashion for the remainder of the study. 


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Statistical Methods:
The primary endpoint in this study is the ACR20 response rate at Week 16.  Assuming an 
ACR20 response rate of 25% for the placebo group and 1-sided type-I error rate of 5% and 
using the normal approximation method, the study will have over 90% power under a sample 
size of 50 per arm and 80% power under a sample size of 25 per arm, to detect a treatment 
difference of 30% or greater without multiplicity adjustment.  With the 2:2:1:2 allocation 
ratio (in the order of 60 mg QD, 30 mg QD, 10 mg QD and placebo), and accounting for a 
10% chance of drop out, approximately a total of 196 subjects will be enrolled in this study, 
with 56 subjects per treatment group (with the exception of 28 subjects for the 10 mg QD 
treatment group).
Each of the three PF-06700841 dose regimens (60 mg QD, 30 mg QD and 10 mg QD) will 
be compared with placebo.  In order to control for type-I error, the Dunnett’s method will be 
used for the primary endpoint of ACR20 response rate at Week 16 to adjust for multiplicity 
and serve as a gatekeeper for further testing of secondary endpoints.  Specifically, if any 
PF-06700841 dose regimen is superior to placebo under the Dunnett’s test, selected 
secondary endpoints at Week 16 for that dose regimen will be formally tested for superiority 
against placebo hierarchically in the order of Psoriasis Area and Severity Index 
(PASI)75ACR50PASI90PASI100Health Assessment Questionnaire 
(HAQ) - Disability Index (DI).  This testing strategy will control the family-wise type-I error 
rate at an overall 1-sided 5% level.  The normal approximation method will be used for 
binary endpoints in the superiority testing.  The change from baseline in the HAQ-DI score 
will be analyzed using a repeated measure model that includes the fixed effects of treatment 
group, study visit (at or prior to Week 16), treatment by visit interaction, prior TNFi exposure 
and baseline HAQ-DI score, with an unstructured variance-covariance matrix.  Regardless of 
formal testing results, treatment difference between each PF-06700841 dose regimen and 
placebo will be summarized using descriptive statistics (ie, point estimates and two-sided 
90% confidence intervals [CI]).


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SCHEDULE OF ACTIVITIES
The schedule of activities table provides an overview of the protocol visits and procedures.  Refer to the STUDY PROCEDURES and 
ASSESSMENTS sections of the protocol for detailed information on each procedure and assessment required for compliance with the 
protocol.  The investigator may schedule visits (unplanned visits) in addition to those listed on the schedule of activities table, in order 
to conduct evaluations or assessments required to protect the well-being of the subject.
Visit Identifier1
Screening2 Baseline 
Day 1
Week 2
Week 4
Week 8
Week 12 Week 16 Week 20 Week 28, 
36, 44
Week 52/ 
Early 
Termination
(EOT/ET)
Follow-up21
(EOS; 
4 weeks after 
EOT/ET)
Visit Window
-35 to -1 
day
N/A
3 days
3 days
7 days
7 days
7 days
7 days
7 days
7 days
+7 days
Informed Consent
X
Register Subject Using IRT System
X
Demography
X
Contraception Check3
X
X
X
X
X
X
X
X
X
X
X
Clinical Rheumatology 
Assessments
Psoriatic Arthritis (PsA) Diagnosis4
X
Tender/painful joint count, Swollen 
joint count5
X
X
X
X
X
X
X
X
X
X
Physician’s Global Assessment of 
Arthritis
X
X
X
X
X
X
X
X
X
Physician’s Global Assessment of 
Psoriatic Arthritis
X
X
X
X
X
X
X
X
X
Dactylitis Assessment
X
X
X
X
X
X
X
X
X
Enthesitis Assessment 
(Spondyloarthritis Research 
Consortium of Canada [SPARCC]), 
Leeds Enthesitis Index)
X
X
X
X
X
X
X
X
X
Clinical Dermatology Assessments
Evaluation of Plaque Psoriasis6
X
X
Physician’s Global Assessment of 
Psoriasis
X
X
X
X
X
X
X
X
X
Psoriasis Area and Severity Index 
(PASI), Body Surface Area (BSA)
X
X
X
X
X
X
X
X
X
Nail Psoriasis Severity Index 
(NAPSI)
X
X
X
X
X
X
X
X
X


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Visit Identifier1
Screening2 Baseline 
Day 1
Week 2
Week 4
Week 8
Week 12 Week 16 Week 20 Week 28, 
36, 44
Week 52/ 
Early 
Termination
(EOT/ET)
Follow-up21
(EOS; 
4 weeks after 
EOT/ET)
Visit Window
-35 to -1 
day
N/A
±3 days
±3 days
±7 days
±7 days
±7 days
±7 days
±7 days
±7 days
+7 days
Other Medical Procedures
Concomitant/Prior Treatments7
X
X
X
X
X
X
X
X
X
X
X
Rescue Therapy
X
X
X
X
X
X
X
X
X
Medical History8
X
X
Vital Signs9
X
X
X
X
X
X
X
X
X
X
X
Complete Physical Examination10
X
X
X
X
Targeted Physical Examination10
X
X
X
X
X
X
X
12-Lead ECG11
X
X
X
X
X
X
X
Chest Radiographs12
X
Laboratory
Serum FSH (WONCBP only) or 
Serum Pregnancy test13
X
Urine Pregnancy test (conducted at 
study site)14
X
X
X
X
X
X
X
X
X
X
Hematology
X
X
X
X
X
X
X
X
X
X
X
Chemistry
X
X
X
X
X
X
X
X
X
X
X
Rheumatoid Factor (RF)
X
Cyclic Citrullinated Peptide (CCP) 
Antibodies
X
Fasting Lipid Panel (total 
cholesterol, LDL, HDL, 
triglycerides)
X
X
X
X
X
X
Serum Cystatin C
X
X
X
X
X
X
X
X
X
X
Urinalysis
X
X
X
X
X
X
X
X
X
X
X
HIV Testing
X
HBsAg, HBcAb, HBsAb and HCV 
Ab, HCV RNA PCR if HCV Ab 
positive 
X
Tuberculosis Test
X
Urine Myoglobin15
X
X
High-Sensitivity C-Reactive Protein 
(hsCRP)
X
X
X
X
X
X
X
X
X
X
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Visit Identifier1
Screening2 Baseline 
Day 1
Week 2
Week 4
Week 8
Week 12 Week 16 Week 20 Week 28, 
36, 44
Week 52/ 
Early 
Termination
(EOT/ET)
Follow-up21
(EOS; 
4 weeks after 
EOT/ET)
Visit Window
-35 to -1 
day
N/A
±3 days
±3 days
±7 days
±7 days
±7 days
±7 days
±7 days
±7 days
+7 days
Viral Surveillance: EBV, CMV, 
HSV1, HSV2, and VZV
X
 
Patient Report Outcomes17
Patient’s Assessment of Arthritis 
Pain
X
X
X
X
X
X
X
X
X
Patient’s Global Assessment of 
Arthritis
X
X
X
X
X
X
X
X
X
Health Assessment Questionnaire 
(HAQ) disability index (DI)
X
X
X
X
X
X
X
X
X
Patient’s Global Joint and Skin 
Assessment-Visual Analog Scale 
(PGJS-VAS)
X
X
X
X
X
X
X
X
X
 
 
Functional Assessment of Chronic 
Illness Therapy-Fatigue 
(FACIT-Fatigue)
X
X
X
X
X
X
X
X
X
Short-Form-36 Health Survey 
(SF-36) Version 2, Acute
X
X
X
X
X
X
X
X
 
 
Other Trial Activities
Inclusion/Exclusion review
X
X
Randomization
X
Investigational Product Dispensing
X
X
X
X
X
X
X
X
Investigational Product 
Accountability
X
X
X
X
X
X
X
X
Investigational Product 
Administration19
X
→
→
→
→
→
→
→
X
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Visit Identifier1
Screening2 Baseline 
Day 1
Week 2
Week 4
Week 8
Week 12 Week 16 Week 20 Week 28, 
36, 44
Week 52/ 
Early 
Termination
(EOT/ET)
Follow-up21
(EOS; 
4 weeks after 
EOT/ET)
Visit Window
-35 to -1 
day
N/A
±3 days
±3 days
±7 days
±7 days
±7 days
±7 days
±7 days
±7 days
+7 days
Serious and Non-serious Adverse 
Event Monitoring
X
→
→
→
→
→
→
→
→
→
X
 
Abbreviations: →= ongoing/continuous event; CMV = Cytomegalovirus; ECG = electrocardiogram; EOS = End of Study; EOT = End of Treatment; ET= early 
termination; EBV = Epstein–Barr virus; 
FSH = follicle-stimulating hormone; HBcAb = hepatitis B core antibody; HBsAb = hepatitis B surface antibody; HBsAg = hepatitis B surface antigen;
HCV Ab = hepatitis C antibody; HCV RNA PCR = hepatitis C virus ribonucleic acid polymerase chain reaction; HIV = human immunodeficiency virus;
HSV = herpes simplex virus; IRT = interactive response technology; LDL = low density lipoprotein; HDL = high density lipoprotein; N/A = not applicable; 
WONCBP = women of non-childbearing potential; VZV = Varicella-zoster virus.
1.
Day relative to start of study treatment (Day 1). 
2.
Screening visit occurs within 35 days prior to Baseline (Day 1) visit.
3.
Contraception Check: Male subjects able to father children and female subjects of childbearing potential must agree to use two effective methods (one of 
which is highly effective method) of contraception throughout the study and for at least 28 days after the last dose of assigned treatment.
4.
PsA Diagnosis: Subject must have signs and symptoms consistent with the diagnosis of PsA for at least 6 months and fulfills CASPAR Criteria at Screening.  
Note all subsequent clinical rheumatology and dermatology assessments will be performed by a qualified assessor who is blinded to the subject’s safety data, 
previous efficacy data and treatment randomization. 
5.
Tender/painful Joint Count, Swollen Joint Count: Subject must have evidence of active arthritis as defined by having at least 3 tender/painful joints on 
motion (out of 68 joints assessed) and at least 3 swollen joints (out of 66 joints assessed) at both Screening and Baseline (Day 1/Randomization) visits. 
6.
Evaluation of Plaque Psoriasis: Subject must have active plaque psoriasis, with at least one psoriatic plaque or nail changes consistent with psoriasis, at both 
Screening and Baseline (Day 1/Randomization) which has been diagnosed or confirmed by a dermatologist or a sponsor approved rheumatologist.
7.
Concomitant/Prior Treatments: Subject must have active PsA despite previous or current nonsteroidal anti-inflammatory drug (NSAID) treatment of at least 
4 weeks or intolerance, and/or non-biologic disease-modifying antirheumatic drugs (DMARD) treatment of at least 3 months or intolerance.  Ongoing 
treatment with a single non-biologic DMARD (limited to methotrexate, leflunomide or sulfasalazine) during the study is allowed but is not required. 
8.
Medical History: Medical history includes herpes zoster details.
9.
Vital Signs: Vital Signs include sitting blood pressure, pulse rate and temperature measured after at least 5 minutes of rest. 
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10. Physical Examination: Physical examination must be performed by the investigator, sub-investigator or a qualified health professional per local guidelines.  
Complete Physical Exam includes height (at Screening Visit only), weight, general appearance, skin, HEENT (head, eyes, ears, nose and throat), heart, 
lungs, abdomen, lower extremities, neurologic function and lymph nodes.  Weight and height will be measured without shoes.  Targeted Physical 
Examinations should include skin, heart, lungs, and abdomen and examination of body systems where there are symptom complaints by the subject.
11. ECGs should be performed after the subject has rested quietly for at least 10 minutes in a supine position. At the Screening Visit, a single ECG will be 
collected. On Day 1 only, triplicate ECGs will be obtained, and the average of the triplicate ECG measurements will serve as each subject’s baseline value. 
At the Week 2 visit only, a single ECG will be collected between 2-4 hours postdose. At all the other visits specified, a single ECG will be collected 
pre-dose or post-dose. 
12. Chest X-ray or other appropriate diagnostic image (ie, CT or MRI) may be performed up to 12 weeks prior to Screening.  Official reading must be located 
and available in the source documentation.
13. Serum FSH (WONCBP only) or Serum Pregnancy test: For Women of Non-Childbearing Potential (WONCBP), serum follicle stimulating hormone (FSH) 
test to be performed at Screening to confirm postmenopausal status in female subjects who have been amenorrheic for at least 12 consecutive months.  
Serum Pregnancy test is required for all Women of Childbearing Potential (WOCBP). 
14. Urine Pregnancy Tests must be performed prior to dosing with the investigational product for female subjects of childbearing potential.  Two negative 
pregnancy tests are required before receiving investigational product (1 negative Serum Pregnancy Test at screening and 1 negative Urine Pregnancy Tests at 
the baseline visit before investigational product administration).  Pregnancy tests will also be done whenever 1 menstrual cycle is missed during the active 
treatment period (or when potential pregnancy is otherwise suspected) and at the end of the study.
15. At Screening, Baseline (Day 1/Randomization) and in case of creatine kinase (CK) >3x upper limit normal (ULN).
 
 
 
17. All patient reported outcomes (PROs) should be completed prior to any other assessments made at each visit.
19. Investigational Product Administration: Subjects should take the medication from study Days 1 through Week 52.  Subjects will be encouraged to take the 
medication in the morning whenever possible.  At Week 2 visit only, subjects are to be instructed to refrain from dosing at home, and are to bring the 
Investigational Product with them and take the dose in the clinic when instructed to do so.
 
21. A Follow-up Visit will be completed 4 weeks after the last administration of the investigational product for all subjects who complete the Week 52 Visit or 
Early Termination Visit.  Additional follow-up visit(s) may be warranted (see Section 6.2.6 and Appendix 6 for more details). 
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1. INTRODUCTION
1.1. Mechanism of Action/Indication
PF-06700841 is a potent tyrosine kinase (TYK)2/Janus kinase (JAK)1 inhibitor that is highly 
selective over the other human kinases and is being developed for the treatment of patients 
with active psoriatic arthritis (PsA).
1.2. Background and Rationale
1.2.1. Drug Development Rationale
Role of proinflammatory cytokines in PsA 
PsA is a chronic inflammatory disease with heterogeneous manifestations affecting the skin, 
enthesis, synovium, and characterized by peripheral arthritis, axial disease, enthesitis, 
dactylitis, psoriasis, and nail disease.  There is currently no cure for PsA.  The treatment 
goals are to achieve remission/minimum disease activity in all disease domains, to optimize 
functional status, improve quality of life, prevent structural damage, and to minimize 
complications.1,2  Current treatment of PsA typically involves the use of nonsteroidal 
anti-inflammatory drugs (NSAIDs), glucocorticoid, disease-modifying antirheumatic drugs 
(DMARDs), and subsequently biologics such as tumor necrosis factor (TNF) inhibitors.3
Psoriatic arthritis occurs in about 30% of patients with psoriasis.  Similar to psoriasis, 
accumulating evidence support a central role of the IL-23-IL-17 axis in pathogenesis of PsA.3  
Several monoclonal antibodies that target the IL-23-IL-17 axis have been or are being, 
studied in psoriasis and PsA.  Clinical trials using monoclonal antibodies that target the 
p40 subunit of IL-12 and IL-23 (ustekinumab) or the p19 subunit of IL-23 (guselkumab, 
risankizumab), IL-17A (secukinumab, ixekizumab) and IL-17RA (brodalumab) have been 
conducted in patients with active PsA.  These biologics have been shown to be effective for 
the treatment of psoriasis and PsA in clinical trials.4,5  Evidence-based treatment 
recommendations for PsA have been updated in 2016 by the European League Against 
Rheumatism (EULAR)6 and the Group for Research and Assessment of Psoriasis and 
Psoriatic Arthritis (GRAPPA).1 IL-17 inhibitors and IL-12/23 inhibitors are recommended 
for use alongside TNF inhibitors (with or without TNF inhibitors being preferred as the 
first-line biological DMARD) for PsA after failure of NSAIDs and/or methotrexate.7  A 
JAK1/3 inhibitor, tofacitinib (XELJANZ/XELJANZXR), has been approved in the United 
States and European Union (EU) for the treatment of adult patients with active PsA who have 
had an inadequate response or intolerance to methotrexate or other DMARDs.
Description of Investigational Product 
The Janus kinase (JAK) family, including JAK1, JAK2, JAK3 and tyrosine kinase (TYK) 2, 
is a group of cytoplasmic tyrosine kinases that mediate signal transduction via interactions 
with Type 1 and Type 2 cytokine receptors critical for leukocyte activation, proliferation, 
survival and function.8  Cytokine receptors demonstrate restricted association with JAKs 
such that different receptors or receptor classes preferentially utilize a given JAK pair 
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JAKs are phosphorylated and in turn phosphorylate specific sites on the receptor intracellular 
domain.  Phosphorylation of specific sites on the intracellular domain of the receptor allows 
for the recruitment of signal transducers and activators of transcription (STATs) that can 
subsequently be phosphorylated by JAKs.  Phosphorylated STAT molecules are released 
from the receptor, dimerize and translocate to the nucleus where they bind to specific sites on 
the deoxyribonucleic acid (DNA) and regulate gene transcription.  JAK1 pairs with JAK3 to 
mediate -common cytokine signaling and also with JAK2 and or TYK2 to transmit the 
signals of additional cytokines important in inflammation and immune responses including 
interleukin (IL)-6, interferon (IFN), and IFN.  JAK2 homodimers are critical for the 
signaling of hematopoietic cytokines and hormones including erythropoietin (EPO), IL-3, 
granulocyte-macrophage colony-stimulating factor (GM-CSF) and prolactin.  IL-12 and 
IL-23 are dependent on TYK2 and JAK2 for transmitting their signal.
IL-23 induces the differentiation of naïve cluster of differentiation (CD)4+ T cells into highly 
pathogenic Th17 cells, and type I IFNs exacerbate this Th17 disease by directly stimulating 
granulocytes to release tissue destructive proteases and cytokines.  IL-22 is highly expressed 
in the affected skin of patients suffering from psoriasis.  IL-22 prevents cellular 
differentiation of keratinocytes, and induces the production of chemokines that mediate 
inflammatory skin disorders.  Type I IFNs, IL-22 and IL-23 signal via JAK1 and/or TYK2.  
TNFα and IL-17 do not signal via JAKs but are regulated by upstream cytokines such as IL-6 
and IL-23, which are JAK-dependent.8
Genome-wide association studies (GWAS) have identified TYK2 as a psoriasis susceptibility 
gene in 2010.  Subsequently, genetic variation in TYK2 has also been associated with several 
other seronegative auto-inflammatory conditions, including ankylosing spondylitis, 
ulcerative colitis, and Crohn’s disease.9
PF-06700841 is a potent dual inhibitor of human TYK2 and JAK1 with a good selectivity 
profile over the other human kinases including JAK2 and JAK3.  PF-06700841 inhibited the 
in vitro activities of TYK2, JAK1, JAK2 and JAK3 with IC50 of 22.7, 16.8 nM, 76.6 nM and 
6490 nM, respectively.  PF-06700841 is capable of inhibiting the cytokines with signaling 
pathways mediated by JAK1 and/or TYK2, including type I IFNs, IL-6, IL-12, IL-15, IL-21, 
IL-22, IL-23, and IFN.  Many of these cytokines are involved in the pathogenesis of 
psoriasis and PsA. 
Based on the signaling paradigm and the clinical efficacy of IL-23/IL-17 pathway blockers in 
psoriasis, PF-06700841 may provide a new therapeutic opportunity.  PF-06700841 has 
demonstrated efficacy in a 4-week Phase 1 psoriasis trial (B7931001)10 and a 12-week 
Phase 2 psoriasis study (B7931004).
Given the recent reports of clinical response to JAK inhibitors in PsA11,12 and US/EU 
approval of tofacitinib (JAK1/3 inhibitor) for treatment of adult patients with PsA, 
PF-06700841 is expected to provide therapeutic effects in the treatment of psoriatic arthritis.  
Compared to other JAK inhibitors, PF-06700841 will inhibit a similar mix of cytokines, but 
with relatively deeper inhibition of IL-12 and IL-23 due to the TYK2 inhibitory activity.  It is 
anticipated that the greater inhibition of IL-12 and IL-23 signaling by PF-06700841 
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1.2.2. Study Rationale
The purpose of this study is to evaluate at Week 16 the efficacy in subjects with active PsA.  
The 36 weeks built-in extension period will provide an opportunity for all subjects to receive 
additional active study treatment up to 1 year.
This study is being conducted to explore the clinical efficacy of PF-06700841 in the Core 
Domain Set of PsA, including musculoskeletal disease activity (peripheral joint activity, 
enthesitis, dactylitis, and spondylitis), skin/nail disease activity, pain, patient global 
(assessment of disease-related health status), physical function, health-related quality of life 
(HRQoL), fatigue and systemic inflammation.13,14  The efficacy of PF-06700841 will be 
assessed on all the PsA Core Domain Set utilizing outcome measure instruments tested and 
validated in recently published randomized controlled trials (RCTs) including the tofacitinib 
PsA studies11,12 and systematic reviews.15-17
The assessments include American College of Rheumatology response criteria components 
(tender/swollen joint count, Patient’s Assessment of Arthritis Pain, Patient’s Global 
Assessment of Arthritis, Physician’s Global Assessment of Arthritis, health assessment 
questionnaire disability index [HAQ-DI], C-reactive protein [CRP]), Psoriasis Area and 
Severity Index (PASI), Leeds Enthesitis Index, Dactylitis severity score, 
Nail Psoriasis Severity Index (NAPSI), 
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), 
Short-Form-36 Health Survey (SF-36),
 
 and several other assessments.  Based on the Group for Research 
and Assessment of Psoriasis and Psoriatic Arthritis/Outcome Measures in Rheumatology 
(GRAPPA-OMERACT) recent consensus, the treatment target of minimal disease activity 
(MDA)/very low disease activity (VLDA) will also be assessed.2
The outcome measure instruments selected in this Phase 2 study B7931030 should 
adequately assess the impact of PF-06700841 on these core PsA disease domains within the 
current Phase 2 study timeframe.  The study is also intended to enable selection of dosing 
regimen for the future clinical development of PF-06700841 in PsA, and provide additional 
PF-06700841 safety and tolerability information.  An assessment of inhibition of PsA related 
structural progression will not be interpretable in the absence of a placebo control beyond
16 weeks and therefore not conducted in this study.
Rationale for Population
The population selected for this study is adult subjects with active PsA. 
The study population will consist of active PsA subjects at least 18 years of age, fulfilling the 
CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria,18 and having active disease
despite previous or current NSAID, or corticosteroids, or DMARD and/or TNF inhibitors 
therapy.  The study is incorporating subjects who are DMARD-naïve, and/or subjects who 
have failed non-biological DMARDs, and/or subjects who have inadequate response to (no 
more than one) previous TNFi therapy. 
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Rationale for Placebo Treatment
In this study, placebo treatment is used as comparator which is considered the gold-standard 
for assessing efficacy in short-term PsA studies. 
The study design allows, but does not mandate, concomitant therapy with non-biologic 
DMARDs (limited to methotrexate, leflunomide or sulfasalazine), corticosteroids or 
NSAIDs.  A subject taking placebo can also be treated with a non-biologic DMARD 
concomitantly, if the subject has been on the non-biologic DMARDs for minimum duration 
of therapy of 2-3 months and dose stable for 4 weeks prior to first dose of study drug.  
The placebo control period will be 16 weeks in duration which should be adequate time to 
see effects of active treatment on signs/symptoms of PsA without those subjects who receive 
placebo incurring structural damage.  All subjects including placebo arm will be on active 
treatment after 16 weeks upon entry in the study.  Given the recent reports of clinical 
response to JAK inhibitors in PsA11,12 and US/EU approval of tofacitinib (JAK1/3 inhibitor) 
for treatment of adult subjects with PsA, PF-06700841 (Tyk2/Jak1 inhibitor) is expected to 
provide therapeutic effects in the treatment of psoriatic arthritis in this 52-week treatment 
period study. 
All subjects may be offered an appropriate rescue medication (eg, 
acetaminophen/paracetamol, non-prohibited opioids) during the study if there is an increase 
in pain.  In addition, if subjects do experience an increased or persistent clinical disease 
activity, they will have the option to withdraw from the study at any time at their own 
request, or they may be withdrawn at any time at the discretion of the investigator.
1.2.3. Preclinical Safety Data 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
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In summary, the nonclinical studies adequately support the planned clinical trials with
PF-06700841.
1.2.4. Clinical Experience with PF-06700841
PF-06700841 has been evaluated in 3 completed Phase 1 studies in healthy subjects and 
psoriasis subjects (B7931001, B7931009, and B7931010), 1 complete Phase 2 study in 
psoriasis (B7931004). Two (2) Phase 1 studies in healthy volunteers are clinically complete 
and preparation of the clinical study reports are in progress: assessment of the effect of 
PF-06700841 on interval corrected for heart rate (QTc) interval (B7931019) and of 
PF-06700841 absorption, distribution, metabolism and excretion (ADME) properties and 
absolute oral bioavailability (B7931014). PF-06700841 is currently under assessment in
6 ongoing Phase 2 studies in alopecia areata (B7931005), ulcerative colitis (B7981005),
Crohn’s Disease (B7981007), systemic lupus erythematosus (SLE) (B7931028), vitiligo 
(B7981019), and PsA (this study, B7931030), and 1 planned Phase 2 study in hidradenitis 
suppurativa (C2501007). The PF-06700841 topical development program consists of 1
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completed Phase 1 study in adult Japanese healthy subjects (B7931029), and 2 ongoing Phase 
2 studies in atopic dermatitis (B7931022) and psoriasis (B7931023).
PF-06700841 was administered to 74 subjects (53 healthy volunteers and 21 subjects with 
psoriasis) in Phase 1 study B7931001 up to 200 mg in single-ascending doses, up to 175 mg 
daily (QD) and 50 mg twice daily (BID) for 10 days in multiple ascending doses and up to
100 mg QD for 28 days in psoriasis subjects.10
PF-06700841 was administered to 6 healthy Japanese subjects in the Phase 1 study 
B7931009 at a daily dose of 100 mg.  In the clinically complete Phase 2 psoriasis study, 
PF-06700841 was administered at doses up to 60 mg QD for 4 weeks.
In the completed Phase 2 study B7931004, 212 psoriasis subjects were randomized and 
received at least one dose of study treatment.  Subjects were randomized from 39 sites in 
3 countries (26 United States, 8 Canada, and 5 Poland).  The randomization ratio was 7:1, 
active: placebo. During the first 4 week treatment period, 2 oral daily dose levels (30 mg and 
60 mg) of PF-06700841, plus matching placebo, were investigated.  During the 8 week 
maintenance treatment period (Weeks 5 through 12), subjects received either 10 mg or 30 mg 
PF-06700841 once daily (QD), or a 100 mg once weekly (QW) regimen of PF-06700841, or 
matching placebo.
In the ongoing Phase 2 studies, PF-06700841 is being administered at doses up to 60 mg QD 
for 4 weeks (alopecia areata), 8 weeks (ulcerative colitis) or 12 weeks (Crohn’s disease).
1.2.4.1. Summary of Clinical Safety with PF-06700841
Study B7931001: The first-in human study (B7931001) was a Phase 1 combination, within 
cohort, randomized, double blind, third-party open, placebo-controlled, parallel group study 
with single- and multiple-dose escalation in healthy adult subjects, and multiple dosing in 
subjects with plaque psoriasis.  In addition, the bioavailability of a tablet formulation relative 
to the solution/suspension formulation as well as the effect of a high fat meal on the 
bioavailability of the tablet formulation was determined.  During the single ascending dose 
(SAD) period, healthy subjects received single doses of 1, 3, 10, 30, 100 and 200 mg of 
PF-06700841 or placebo.  In the multiple ascending dose (MAD) period, healthy subjects 
received doses of 10, 30, 100 or 175 mg QD, or 50 mg BID of PF-06700841 or placebo for 
10 days.  Psoriasis subjects received either 30 mg or 100 mg PF-06700841 or placebo (QD) 
for 28 days.10
PF-06700841 demonstrated acceptable safety and tolerability in the Phase 1 clinical study 
B7931001, which included both healthy subjects (n=66 randomized) and subjects with 
plaque psoriasis (n=30 randomized).  Subjects reported 11 treatment-emergent adverse 
events (TEAEs) in the SAD period, 22 TEAEs in the MAD period, 39 TEAEs in the psoriasis 
period, and 3 TEAEs in the bioavailability (BA) period.  There were no deaths or serious 
adverse events during this study. All adverse events (AEs) were mild or moderate in 
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In Study B7931001, serum creatinine (SCr) increases were observed in the study and 6 of 
these AEs led to discontinuation of dosing per protocol.  No cases were accompanied by 
clinical signs or symptoms.  The proposed mechanism for the observed serum creatinine 
increases in study B7931001 is inhibition of creatinine transport (ie, transporter-mediated 
rather than direct nephrotoxicity), and is based on PF-06700841 potential to inhibit 
OCT2 creatinine transporter (IC50=1.1 M; unbound Imax/IC50 ratio=0.25).  To differentiate 
from direct nephrotoxicity, the B7931001 protocol was amended (Protocol Amendment 2) to 
include collection of serum cystatin C.  Elevated serum creatinine in the absence of clinically 
meaningful changes in serum cystatin C-based estimates of estimated glomerular filtration 
rate (eGFR) during study B7931001 supports the transporter inhibition hypothesis.  
Following the implementation of cystatin C-based kidney safety monitoring, no subjects 
were discontinued from treatment/study due to renal concerns.  The lack of clinically 
meaningful decline in serum cystatin C based eGFR indicated that inhibition of renal 
transporters is the likely mechanism for the elevated SCr in PF-06700841-treated subjects 
showing increases in SCr levels. 
Neutropenia (Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 occurred 
at the 175 mg QD and 50 mg BID dose levels during the MAD period.  All laboratory 
abnormalities reported as AEs were mild in severity, except for one case of neutropenia 
which was reported as moderate in severity (Grade 3 neutropenia).  No neutrophil counts 
reached or fell below 500 cells/mm3.  The AE of herpes zoster occurred in a single subject 
after completing 28-day treatment with PF-06700841 at the 100 mg QD dose level.  The 
subject had non-disseminated, herpetiform rash on the upper left back and left arm that was 
reported to have presented on Study Day 30 (2 days after the last dose of PF-06700841).  The 
AE was mild in severity and was treated with acyclovir and Vicodin by the Investigator.  
Please refer to the Investigator's Brochure (IB) for further details from the B7931001 study.
Study B7931009: PF-06700841 demonstrated acceptable safety and tolerability in healthy 
Japanese subjects investigated in study B7931009, in which multiple doses of 100 mg QD or 
placebo was administered for 10 days.  There were no deaths, serious adverse events (SAEs), 
severe AE, discontinuations due to AEs, or dose reductions or temporary discontinuations 
due to AEs during this study.  All AEs were mild or moderate in severity.  An AE of 
palpitations was observed in a placebo subject during the treatment period.  There were no 
clinically significant findings observed in laboratory parameters, vital signs, ECG 
parameters, and physical examinations.  Please refer to the IB for further details from the 
B7931009 study.
Study B7931010: This was an open-label, single dose, 2-period, 2-sequence crossover study 
in 8 healthy subjects to characterize the PF-06700841 pharmacokinetic (PK) profile and
bioavailability following single oral dose formulation of immediate release (IR) tablets and
modified release (MR) tablets each administered as a 30 mg dose in the fasted state. All AEs 
were mild in severity. There were no deaths, SAEs, severe AEs, discontinuations due to 
AEs, or dose reductions or temporary discontinuations due to AEs during this study. 


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Study B7931014: This study was a Phase 1, open-label, non-randomized, 2-period, fixed 
sequence, single-dose study of PF-06700841 in healthy male subjects to characterize the 
absorption, distribution, metabolism, and excretion (ADME) of 14C PF-06700841; and to 
evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of PF-06700841 
following oral administration of unlabeled PF-06700841 and IV and oral administration of 
14C-PF-06700841 to healthy male subjects. All AEs were mild or moderate in severity. 
There were no deaths, SAEs, severe AEs, discontinuations due to AEs, or dose reductions or 
temporary discontinuations due to AEs during this study. There were no clinically 
significant findings observed in laboratory parameters, vital signs, ECG parameters. Please 
refer to the IB for further details from the B7931014 study.
Study B7931019: This was a definitive QT study to determine the effect of PF-06700841 on 
QTc interval in healthy subjects. This was a phase 1, 3-way crossover, 3-treatment,
6-sequence, sponsor-open study, in which, each subject received single oral doses of 
PF-06700841 200 mg, placebo and moxifloxacin 400 mg, according to one of the treatment 
sequences they were randomly assigned. Treatment assignments to PF-06700841 and 
placebo were blinded to the subjects and investigator but moxifloxacin treatment was
unblinded.
 
 
 
 
 
 
 
 
 
 
 
Study B7931004: This was a Phase 2, randomized, double--blind, placebo--controlled, 
parallel group, multicenter study in adult subjects with moderate to severe plaque psoriasis.
PF-06700841 demonstrated acceptable safety and tolerability in subjects with active 
psoriasis, in which multiple doses were administered over 12 weeks.  During the first 4 week 
treatment period, 2 oral daily dose levels (30 mg and 60 mg) of PF-06700841, plus matching 
placebo, were investigated.  During the 8 week maintenance treatment period (Weeks 5 
through 12), subjects received either 10 mg or 30 mg PF-06700841 once daily (QD), or a 
100 mg once weekly (QW) regimen of PF-06700841, or matching placebo.  A total of 
212 subjects were randomized and received at least one dose of study treatment. 
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The incidence of TEAEs by all causalities were comparable across all treatment groups but 
numerically higher in the active treatment groups ( 64% - 77%) than the placebo group 
(57%): 19 subjects (76%) in 60 mg 30 mg QD, 23 subjects (72.4%) in 60 mg 
10 mg QD, 18 subjects (69.2%) in 60 mg 100 mg QW, 18 subjects (72.0%) in 
60 mg placebo, 21 subjects (72.4%) in 30 mg QD, 16 subjects (64.0%) in the 30 mg 
10 mg QD, 23 subjects (76.7%) in the 30 mg 100 mg QW, and 13 subjects (56.5%) in 
the placebo group.  The majority of the TEAEs were mild.Eleven subjects experienced severe 
AEs during the study: 3 in the 60 mg 30 mg QD, 2 each in the 60 mg placebo QD and 
30 mg 100 mg QW groups, and 1 each in the 60 mg 10 mg QD, 60 mg 100 mg QW, 
30 mg 10 mg QD and placebo groups.  There was no severe AE reported in the 
PF-06700841 30 mg QD group.  There were 2 serious infections in 1 subject in the 60 
30 mg QD group. 
Five subjects in the PF-06700841 groups experienced 6 SAEs (angina pectoris, gunshot 
wound, anemia, pneumonia, sepsis, and non-cardiac chest pain), only anemia was a study 
drug-related SAE as evaluated by the investigator. 
For AEs of special interest, one unrelated death due to gunshot wound occurred after the 
subject was discontinued from the study due to noncompliance with study drug.  There was 
1 case of squamous cell carcinoma in the 30 mg QD 100 mg QW group during the 
Induction phase of the study.  The event was not related to the study drug as evaluated by the 
Principal Investigator (PI).  No cases of herpes zoster were reported during the study.  6 cases 
of herpes simplex were reported, all were mild except for 1 moderate case in the 
60 100 mg QW group.  There were 2 Suspected Unexpected Serious Adverse Reactions 
(SUSARs) in the study, including the SAE event of anemia, and a birth defect of ‘fetus cleft 
lip’ that occurred in a fetus after a female subject became pregnant while on the study drug 
for 6 weeks.
A total of 13 subjects discontinued from the study due to AEs, 2 in the 60 mg 30 mg QD, 
4 in the 60 mg 10 mg QD, 1 in the 60 mg 100 mg QW, 2 in the 60 mg placebo, 2 in 
the 30 mg 10 mg QD, and 2 in the 30 mg 100 mg QW group.  One subject in the 
60 mg placebo discontinued the study drug treatment, but remained in the study.  There 
were 5 subjects with dose reduced or temporary discontinued due to AEs, 1 each in the 
60 mg 30 mg QD, 60 mg 100 mg QW, 60 mg placebo, 30 mg 10 mg QD, and 
placebo groups. 
There were no clinically meaningful observable dose dependent neutropenia, lymphopenia, 
thrombocytopenia, and anemia among the active treatment groups, except for 1 SAE of 
anemia in the 60 mg 10 mg QD group.  During the Induction Phase, there was a decrease
in reticulocyte count in the active treatment groups (-12.0% in the 60 mg QD, -7.18% in the 
30 mg QD) compared to placebo (3.77%).  The observed decreases appear to improve during 
the Maintenance phase, with all active treatment groups approaching 10% change from 
baseline (CFB) at Week 12.  Platelet counts were quite stable during the Induction and 
Maintenance periods.  Small increases were observed in lymphocytes in all treatment groups 
during the Induction and Maintenance periods.  There were no clinically meaningful changes 


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from baseline over time in mean or median values in hepatic transaminases in all active 
treatment groups compared to the placebo.  There was no subject withdrawn due to elevation 
of hepatic enzymes.  There were no meaningful changes in cystatin C in all treatment groups 
and placebo, except for the subject who was discontinued because of decline of eGFR 
>30% from the baseline at Week 4 (see above in the discontinuation section).  Elevations of 
creatine kinase (CK) at least 3 times the upper limited of normal (ULN) were observed in 
17 subjects out of 189 (8.9%) who received PF-06700841 during the study, 4 of these 
17 subjects had CK>3x ULN at baseline.  Five subjects had at least one CK elevation greater 
than 10 x ULN.  One adverse event of CK elevation was deemed to be study drug related by 
the investigator.  No subject was discontinued from the study due to CK elevation.  All 
increased CKs were in the creatine kinase MM (CK-MM) subunits.  No subjects with 
increased CK had rhabdomyolysis or cardiovascular events.
Please refer to the IB for further details from the B7931004 study.
There is no evidence to date, of a cardiovascular safety signal associated with PF-06700841 
treatment from the completed and ongoing clinical trials. In the Phase 1 PF-06700841 
clinical program, no clinically significant changes in ECG parameters have been observed, 
including no changes in QTcF >60 msec or an absolute value >500 msec.  In the Phase 2 
PF-06700841 program, no clinically significant changes in ECG parameters have been 
observed.  In addition, there have been no adverse events of ventricular arrhythmia, 
ventricular tachycardia, ventricular fibrillation or flutter, torsade de pointes, syncope, 
seizures, sudden death, or QT prolongation. 
Phase 2 studies in alopecia areata (B7931005), ulcerative colitis (B7981005), Crohn’s 
disease (B7981007), SLE (B7931028) and vitiligo (B7981019) are ongoing and the study 
teams remain blinded.  Blinded data from these studies have not revealed any concerning 
safety signals or signals that alter the overall risk/benefit profile, including exposure to 
PF-06700841 at doses up to 60 mg QD for 4-12 weeks. 
In summary, PF-06700841 has demonstrated an acceptable safety and tolerability profile, and 
is consistent across clinical studies to date.  Please refer to the IB for more details on the 
clinical safety information with PF-06700841.
1.2.4.2. Summary of Pharmacokinetics (PK)
In Study B7931001, following single oral doses of 1 mg to 200 mg under fasted conditions, 
PF-06700841 was absorbed rapidly with median Tmax of 1 hour or less.  Mean terminal 
half-life (t½) ranged from 3.8 to 7.5 hours.  In general, both the area under the plasma 
concentration-time curve from time 0 extrapolated to infinity (AUCinf) and maximum plasma 
concentration (Cmax) appeared to increase proportionally with dose from 1 mg to 100 mg.
Increases from 100 mg to 200 mg appear more than dose proportional, especially for AUCinf.
On Day 10 of multiple-dose administration, PF-06700841 was absorbed rapidly with median 
Tmax of 1.5 hours or less across the entire range of doses, from a total daily dose of 10 mg up 
to 175 mg.  Following attainment of Cmax, the disposition of PF-06700841 was similar with 
that observed following single-dose administration.  Mean terminal half-life (t½) ranged from 
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(AUC) and Cmax generally appeared to increase proportionally with dose from 10 mg to 
100 mg QD, with a trend towards greater than proportional increase from 100 mg to 
175 mg QD.  Accumulations, following once daily dosing, ranged from 1.1 to 1.4 for 
AUCand 0.8 to 1.1 for Cmax.  The urinary recovery of unchanged (Ae%) PF-06700841 on 
Day 10 across all doses ranged from 8.9% to 15.5%.  Following multiple dose administration 
of PF-06700841 to subjects with psoriasis for 28 days, the overall exposure observed was 
comparable to that in healthy subjects at same dose level.
The relative bioavailability of a solid dose formulation of PF-06700841 relative to a solution 
and the food effect on the solid dosage formulation was also evaluated.  Following single oral 
100 mg doses under fasting conditions, median Tmax was 0.5 hours for the tablet formulation 
and 1.0 hours for the solution.  The ratios of adjusted geometric means between tablet versus 
solution formulation were 96.2% for AUCinf and 94.3% for Cmax.  When the tablet was 
administered following a high fat meal, Tmax was delayed with median of 4.0 hours and the 
AUCinf and Cmax were 82.3% and 64.3%, respectively of those observed when tablets were 
given fasted.
In B7931009 study, higher exposure in Japanese subjects (n=6) observed compared to that in 
non-Japanese subjects from B7931001 study: The mean steady state Cmax (CV) were
1114 (14%) vs 734.1 (29%) ng/mL and steady state mean AUC24 (CV) were 9888 (33%) vs 
6089 (38%) ng•h/mL for Japanese subjects and non-Japanese subject respectively after 
multiple doses of 100 mg QD.
B7931004 study was recently completed.  In this study, PK samples were collected at 
pre-dose and/or 0.5 hours post-dose at each visit over 12-week treatment.  Post-dose samples 
were also collected up to 4 hours at Weeks 4 and 12.  Plasma concentrations of PF-06700841 
observed were as expected based on PK in healthy subjects.
1.2.5. Dose Selection Rationale 
A QD regimen (utilizing three doses of PF-06700841 of 10 mg, 30 mg and 60 mg QD) will 
be evaluated in this dose-ranging Phase 2 study in PsA.  The 30 and 60 mg QD dose levels of 
PF-06700841 have demonstrated clinical efficacy in psoriasis subjects in Phase 1 
(B7931001) and/or Phase 2 (B7931004) studies, with the 30 mg dose being studied in both 
studies.  The 60 mg QD demonstrated slightly higher clinical effect compared to 30 mg QD
at Week 4 as measured by PASI in the B7931004 study, however only the 30 mg dose was 
studied for an additional 8 weeks.  The preliminary exposure response analysis based on 
PASI data in B7931004 trial suggested the predicted PASI responder rates (PASI75 and 
PASI90) at Week 16 could be 15% to 20% greater after 60 mg QD compared to 30 mg QD 
treatment in patients with moderate to severe psoriasis. 
Both 30 mg and 60 mg QD dose levels have demonstrated acceptable safety profiles to date.  
The expected steady state exposures following 60 mg QD, the top dose in this study
(Cmax=264 ng/mL and AUC24=2320 ng•h/mL) are 4.6x to 30x below the exposures at the no 
observed adverse effect levels (NOAELs) observed in the 6-month rat (45 mg/kg/day) and 
9-month monkey (20 mg/kg/day) studies (Section 1.2.3).  The 30 mg and 60 mg QD doses 
are also being investigated in ongoing Phase 2 studies in subjects with alopecia areata 


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(B7931005), ulcerative colitis (UC) (B7981005) and Crohn’s disease (CD) (B7981007).  
Since 60 mg QD provided increased efficacy over 30 mg QD in psoriasis over a four week 
dosing period while maintaining an acceptable safety profile, 60 mg QD is selected as the 
highest dose for the current study.  This study will enable assessment of the safety and 
efficacy of this higher dose level of PF-06700841 over 52 weeks.  As doses lower than 
30 mg QD provided lower efficacy in psoriasis in the B7931004 study, inclusion of a 
sub-optimal dose regimen of 10 mg QD will allow a more thorough characterization of the 
dose response curve.  The three QD doses, 10 mg, 30 mg and 60 mg QD are expected to 
provide sufficient information to derive optimal dose(s) for the planned PF-06700841 
Phase 3 program in PsA.
1.2.6. Summary of Benefit Risk Assessment
As previously noted, in view of the reports of clinical response to JAK inhibitors in PsA11,12
and US/EU approval of tofacitinib (JAK1/3 inhibitor) for treatment of adult patients with 
PsA, PF-06700841, a TYK2/JAK1 inhibitor, is expected to offer therapeutic benefit in the 
treatment of psoriatic arthritis.  Indeed, compared with other JAK inhibitors, a more profound 
inhibition of IL-12 and IL-23 signaling mediated by TYK2 inhibitory activity may provide a
new and improved therapeutic benefit. This study will enable a thorough assessment of the 
safety and efficacy of PF-06700841 in PsA over 52 weeks, including the assessment of 
efficacy endpoints that typically require greater than 16 weeks to achieve (including but not 
limited to ACR50/70, PASI90/100 and Minimal Disease Activity (MDA) and Very Low 
Disease Activity (VLDA) responses). All subjects entering the study will have the 
opportunity to receive one of the two higher doses of active treatment starting at week 16, 
including placebo subjects and those on the lowest dose. Study participants could benefit 
from the potential achievement of disease control, improvement of signs and symptoms, as 
well as improvements in quality of life.
Based on the clinical and nonclinical experience with PF-06700841 and/or other JAK 
inhibitors (eg, Xeljanz® [tofacitinib], Jakafi® [ruxolitinib], Olumiant® [baricitinib], and 
Rinvoq® [upadacitinib]), anticipated potential risks with PF-06700841 include: (1) an 
increase in susceptibility to infection, (2) viral reactivation, (3) malignancy and 
lymphoproliferative disorders, (4) alterations in laboratory parameters: decreased neutrophil 
counts, decreased lymphocyte counts, decreased hemoglobin level, decreased platelet counts, 
elevation of hepatic transaminases, alterations in the hepatic transaminases and serum 
creatinine, alterations in the lipid profile, increases in creatine phosphokinase, and (5) QT 
prolongation.  There was one AE of herpes zoster infection in a psoriasis subject treated with 
100 mg PF-6700841 for 4 weeks.  Laboratory changes can be managed by monitoring 
criteria as well as adjustment of the inclusion/exclusion criteria.
There have been events of pulmonary embolism reported with other JAK inhibitor products 
 
 Suspected thrombotic and embolic events will be subject to 
review by an external blinded adjudication committee.
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In conclusion, the sponsor considers that the available information from the nonclinical and 
clinical studies completed to date with PF-06700841 provide a favorable benefit-risk for 
subjects with PsA and support its continued investigation as a potential treatment for PsA.
Additional information for this compound may be found in the single reference safety 
document (SRSD), which for this study is the current Investigator’s Brochure (IB). 
 
 
 
 
 
 
 
 
 
2. STUDY OBJECTIVES AND ENDPOINTS
Primary Objective(s):
Primary Endpoint(s):
•
To evaluate the efficacy of 
PF-06700841 compared to placebo 
in subjects with active psoriatic 
arthritis (PsA).
•
The proportion of subjects achieving an American College of 
Rheumatology 20 (ACR20) response at Week 16.
Secondary Objective(s):
Secondary Endpoint(s):
•
To evaluate the efficacy of 
PF-06700841 compared to placebo 
in subjects with active PsA who are 
TNFα inhibitor naïve.
•
The proportion of subjects achieving an ACR20 response at Week 16 
in the subgroup of subjects who are TNFα inhibitor naïve.
•
To evaluate the improvement in 
signs and symptoms related PsA 
Core Domain Set13 in PF-06700841 
treated subjects.
Assessed at all treatment timepoints:
•
The proportion of subjects achieving an ACR20 response at all 
treatment timepoints (other than Week 16), and proportion of subjects
achieving an ACR50 and ACR70 response;
•
Change from baseline in the ACR response criteria components 
(Tender/painful joint count, Swollen joint count, Patient’s Assessment 
of Arthritis Pain, Patient’s Global Assessment of Arthritis, Physician’s 
Global Assessment of Arthritis, Health Assessment Questionnaire 
[HAQ] disability index [DI], and hsCRP);
•
The proportion of subjects achieving a Psoriasis Area and Severity 
Index 75/90/100 (PASI75/90/100) response;
•
Change from baseline in the enthesitis score (using the 
Spondyloarthritis Research Consortium of Canada [SPARCC] 
Enthesitis Index and Leeds Enthesitis Index);
•
Change from baseline in the Dactylitis Severity Score;
•
Change from baseline in the Nail Psoriasis Severity Index (NAPSI) 
Score.
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•
To evaluate the improvement in 
patient reported outcome measures 
related PsA Core Domain Set13 in 
PF-06700841 treated subjects.
Assessed at all treatment timepoints:
•
Change from baseline in the Patient’s Global Joint and Skin 
Assessment-Visual Analog Scale (PGJS-VAS); 
•
Change from baseline in the Functional Assessment of Chronic Illness 
Therapy-Fatigue (FACIT-Fatigue);
Assessed at all treatment timepoints except Week 2:
•
Change from baseline in the Short-Form-36 Health Survey (SF-36) 
Version 2, Acute.
•
To evaluate the improvement in 
additional composite outcome 
measures in PF-06700841 treated 
subjects.
Assessed at all treatment timepoints except Week 2:
•
The proportion of subjects achieving Minimal Disease Activity (MDA) 
and Very Low Disease Activity (VLDA) response;
•
Change from baseline in the Disease Activity Index for Reactive 
Arthritis/PsA (DAREA/DAPSA);
•
The proportion of subjects achieving the Psoriatic Arthritis Response 
Criteria (PsARC); 
•
Change from baseline in the Psoriatic Arthritis Disease Activity Score 
(PASDAS).
•
To evaluate the safety and 
tolerability of PF-06700841.
•
Incidence of adverse events (AEs), serious adverse events (SAEs) and 
serious infectious events (SIEs), withdrawals due to AEs and SAEs, 
and laboratory abnormalities, changes in vital signs, and 
electrocardiogram (ECG) findings throughout the study.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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3. STUDY DESIGN
This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging, parallel 
treatment group, efficacy and safety study designed to characterize the dose response of 
PF-06700841 in subjects with active PsA.  A total of approximately 196 subjects will be 
randomized in a 4:4:1:1:2:2 ratio to one of the six parallel treatment sequences as shown 
below. The primary efficacy endpoint is the ACR20 response rate at Week 16.  For the 
treatment comparison of each of three active treatment regimens (60 mg QD, 30 mg QD and 
10 mg QD) versus placebo in the primary endpoint, this results in a 2:2:1:2 allocation ratio 
(in the order of 60 mg QD, 30 mg QD, 10 mg QD and placebo). 
A schematic of the study design is shown below:
Figure 1.
Schematic of Study Design
The study consists of a screening period of up to 5 weeks, a double-blind treatment period of 
52 weeks (ie, one year), including a placebo controlled phase from Day 1 to Week 16 visits 
and an extended active treatment phase from Week 17 through Week 52, and a safety 
follow-up period of 4 weeks from last dose of study drug to last study visit.  The total 
duration of study subject participation will be approximately 61 weeks, including the 
screening period and follow-up period.
C
C
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All eligible subjects must have active PsA despite previous or current treatment with 
nonsteroidal anti-inflammatory drugs (NSAIDs), and/or non-biologic disease-modifying 
antirheumatic drugs (DMARDs), or apremilast.  Some subjects (up to 30% of study 
population) may also have been previously treated with no more than one TNF inhibitor 
(TNFi).  Randomization will be stratified by prior TNFi exposure.
All subjects will randomly be assigned to one of the six treatment sequences (A-F) shown in 
Table 1.  Starting after the Week 16 visit, subjects receiving the 60 mg QD dose 
(sequence A) or the 30 mg QD dose (sequence B) will continue on their initial dose; while all 
other subjects, including those from the 10 mg QD dose arm (sequences C and D) and 
placebo arm (sequences E and F), will start to randomly receive either the 60 mg QD dose or 
30 mg QD dose until Week 52, as predetermined at randomization.  All subjects will receive 
blinded dosing throughout the 52 weeks study treatment period in order to maintain the study 
blind.
Table 1.
Treatment Sequence
Treatment 
Sequence
Treatment
Subject Size
A
PF-06700841 60 mg QD
56
B
PF-06700841 30 mg QD
56
C1
PF-06700841 10 mg QD first & advance to 60 mg QD after the 
Week 16 visit
14
D2
PF-06700841 10 mg QD first & advance to 30 mg QD after the 
Week 16 visit
14
E1
Placebo QD first & advance to PF-06700841 60 mg QD after 
the Week 16 visit
28
F2
Placebo QD first & advance to PF-06700841 30 mg QD after 
the Week 16 visit
28
1.
Starting after the Week 16 visit, subjects randomized to treatment sequences C or E will receive 
PF-06700841 60 mg QD in a blinded fashion for the remainder of the study.
2.
Starting after the Week 16 visit, subjects randomized to treatment sequences D or F will receive 
PF-06700841 30 mg QD in a blinded fashion for the remainder of the study.
An interim analysis may be performed for business reasons and planning for future studies 
when approximately 118 (60%) subjects have completed or have the opportunity to complete 
Week 16 of the study. Safety and efficacy data may be reviewed by an Internal Review 
Committee (IRC).  Members of the study team will not be part of the IRC.
4. SUBJECT ELIGIBILITY CRITERIA
This study can fulfill its objectives only if appropriate subjects are enrolled.  The following 
eligibility criteria are designed to select subjects for whom participation in the study is 
considered appropriate.  All relevant medical and nonmedical conditions should be taken into 
consideration when deciding whether a particular subject is suitable for this protocol. 
Subject eligibility should be reviewed and documented by an appropriate member of the 
investigator’s study team before subjects are included in the study. 


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4.1. Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the 
study:
1. Evidence of a personally signed and dated informed consent document indicating that 
the subject has been informed of all pertinent aspects of the study.
2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and 
other study procedures.
3. Male or female subjects between 18-75 years of age, inclusive, at time of informed 
consent.
4. Male subjects able to father children and female subjects of childbearing potential 
must agree to use two effective methods (one of which is highly effective method) of 
contraception throughout the study and for at least 28 days after the last dose of 
investigational product. 
Female subjects of nonchildbearing potential must meet at least 1 of the following 
criteria:

Achieved postmenopausal status, defined as follows: cessation of regular menses 
for at least 12 consecutive months with no alternative pathological or 
physiological cause; status may be confirmed with a serum follicle-stimulating 
hormone (FSH) level confirming the postmenopausal state;

Have undergone a documented hysterectomy and/or bilateral oophorectomy; 

Have medically confirmed ovarian failure. 
All other female subjects (including female subjects with tubal ligations) are 
considered to be of childbearing potential. 
Disease under study
5. The subject must have signs and symptoms consistent with the diagnosis of PsA for at 
least 6 months and fulfills CASPAR Criteria at Screening. 
6. To meet the CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria,18 a
subject must have inflammatory articular disease (joint, spine, or entheseal) with at 
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a.
Evidence of current psoriasis, a personal history of psoriasis, or a family history 
of psoriasis.  Current psoriasis is defined as psoriatic skin or scalp disease present 
today as judged by a rheumatologist or dermatologist.† A personal history of 
psoriasis is defined as a history of psoriasis that may be obtained from a patient, 
family physician, dermatologist, rheumatologist, or other qualified health care 
provider.  A family history of psoriasis is defined as a history of psoriasis in a 
first- or second-degree relative according to patient report. 
b. Typical psoriatic nail dystrophy including onycholysis, pitting, and hyperkeratosis 
observed on current physical examination. 
c.
A negative test result for the presence of rheumatoid factor by any method except 
latex but preferably by enzyme-linked immunosorbent assay or nephelometry, 
according to the local laboratory reference range. 
d. Either current dactylitis, defined as swelling of an entire digit, or a history of 
dactylitis recorded by a rheumatologist. 
e.
Radiographic evidence of juxtaarticular new bone formation, appearing as 
ill-defined ossification near joint margins (but excluding osteophyte formation) on 
plain radiographs of the hand or foot. 
†Current psoriasis is assigned a score of 2; all other features are assigned a score of 1.
7. The subject must have evidence of active arthritis as defined by having at least 
3 tender/painful joints on motion (out of 68 joints assessed) and at least 3 swollen 
joints (out of 66 joints assessed) at both Screening and Baseline (Randomization). 
8. The subject must have active plaque psoriasis, with at least one psoriatic plaque or 
nail changes consistent with psoriasis, at both Screening and Baseline 
(Randomization) which has been diagnosed or confirmed by a dermatologist or a 
sponsor-approved rheumatologist.
9. Rheumatoid factor (RF), cyclic citrullinated peptide (CCP) antibodies negative.
10. Subject must have active PsA despite previous or current nonsteroidal 
anti-inflammatory drug (NSAID) treatment of at least 4 weeks or intolerance, and/or 
non-biologic disease-modifying antirheumatic drugs (DMARD) treatment of at least 
3 months or intolerance. 
Prior and concomitant medication
11. Subjects who are on any non-biologic DMARD other than methotrexate, leflunomide 
or sulfasalazine must discontinue the non-biologic DMARD at least 28 days prior to 
randomization.  Ongoing treatment with a single non-biologic DMARD (limited to 
methotrexate, leflunomide or sulfasalazine) during the study is allowed but is not 
required, providing the following criteria are met:


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
Methotrexate: Maximum dose of 25 mg/week.  Minimum duration of therapy
3 months and dose stable for 4 weeks prior to first dose of study drug, and should 
remain stable throughout the course of the study.  Subjects on methotrexate 
should be on an adequate and stable dose of folate supplementation (not less than 
5 mg weekly based on folic acid, unless such doses would violate the local label 
guidelines or standard of care) for at least 4 weeks prior to the first dose of study 
drug.  Subject must not have had previous serious toxicity while on methotrexate 
and not be expected to require evaluation for possible methotrexate toxicity 
(eg, require a liver biopsy for methotrexate toxicity) during the study. 

Sulfasalazine: Maximum dose of 3 gm/day.  Minimum duration of therapy 
2 months and dose stable for 4 weeks prior to first dose of study drug, and should 
remain stable throughout the course of the study.

Leflunomide: Maximum dose of 20 mg/day.  Minimum duration of therapy
3 months and dose stable for 4 weeks prior to first dose of study drug, and should 
remain stable throughout the course of the study.
For subjects who plan to continue receiving the aforementioned permitted concomitant 
non-biologic DMARD treatment during the study, all local standard-of-care practices for 
the administration of non-biologic DMARD therapy, including laboratory testing, 
contraceptive requirements, follow-up care and contraindications should be performed 
according to local standards of care throughout the study. 
12. Subjects who have received an approved TNF inhibiting biologic agent that was 
administered in accordance with its labeling recommendations must have experienced 
an inadequate response due to lack of efficacy and/or intolerance as follows: 

An inadequate response to TNF inhibitor treatment due to lack of efficacy, and 
prior treatment according to local label and after minimum treatment duration of 
at least 3 months treatment for adalimumab (Humiraor biosimilars), etanercept 
(Enbrelor biosimilars), and certolizumab (Cimzia), or at least 3 injections of 
golimumab (Simponiand Simponi Aria), or at least 4 infusions of infliximab 
(Remicadeor biosimilars). 

An inadequate response to TNF inhibitor treatment due to intolerance is defined 
as a treatment-related adverse event (eg, infusion/injection reactions, infections, 
laboratory test changes, etc).
Subjects could have failed no more than one TNF inhibiting biologic agents that were 
administered in accordance with its labeling recommendations and was inadequately 
effective and/or not tolerated.


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13. Subjects must not be receiving TNF inhibitors during the study.  Subjects on TNF 
inhibitors must discontinue and require washout according to the following criteria: 

Adalimumab (Humiraor biosimilars), certolizumab (Cimzia), golimumab
(Simponiand Simponi Aria): Discontinued at least 10 weeks prior to first dose 
of study drug;

Infliximab (Remicadeor biosimilars): Discontinued at least 8 weeks prior to the 
first dose of study drug;

Etanercept (Enbrelor biosimilars): Discontinued at least 4 weeks prior to the 
first dose of study drug.
14. Subjects who are already taking nonsteroidal anti-inflammatory drugs (NSAIDs) or 
cyclooxygenase-2 (COX-2) inhibitors may participate in the study provided that the 
dose is stable for two weeks prior to first dose of study drug, and should remain stable 
throughout the course of the study. 
15. Subjects who are already taking oral corticosteroids (but not injectable) may 
participate in the study provided that they are on a stable dose of 10 mg/day of 
prednisone or equivalent for 4 weeks prior to first dose of study drug, and the dose 
should remain stable throughout the course of the study. 
4.2. Exclusion Criteria
Subjects with any of the following characteristics/conditions will not be included in the 
study:
1. Investigator site staff members directly involved in the conduct of the study and their 
family members, site staff members otherwise supervised by the investigator, or 
subjects who are Pfizer employees, including their family members, directly involved 
in the conduct of the study.
2. Participation in other interventional studies within 4 weeks or 5 half-lives, if known, 
whichever is longer, prior to study entry and/or during study participation.  
Participation in any observational studies during study participation.  Note any 
investigational or experimental therapy or procedure for psoriasis, PsA or 
rheumatoid arthritis must be discontinued for at least 12 weeks prior to first dose of 
study drug.
3. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and 
female subjects of childbearing potential who are unwilling or unable to use two 
effective methods (one of which is highly effective) of contraception as outlined in 
this protocol for the duration of the study and for at least 28 days after the last dose of 
investigational product.  Women of childbearing potential must test negative for 
pregnancy prior to enrollment in this study. 


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4. Other acute or chronic medical or psychiatric condition including recent (within the 
past year) or active suicidal ideation or behavior or laboratory abnormality that may 
increase the risk associated with study participation or investigational product 
administration or may interfere with the interpretation of study results and, in the 
judgment of the investigator, would make the subject inappropriate for entry into this 
study.
5. Subjects with ANY of the following abnormalities in clinical laboratory tests at 
Screening, as assessed by the study-specific laboratory and confirmed by a single 
repeat, if deemed necessary: 

Hemoglobin <10 g/dL (<100 g/L) or hematocrit <30%; 

White blood cell count <3.0 x 109/L (<3000 mm3); 

Absolute neutrophil count <1.5 x 109/L (<1500 mm3); 

Absolute lymphocyte count of <1.0 x 109/L (<1000/mm3);

Platelet count <100 x 109/L (<100,000/mm3);

eGFR<60 mL/min/1.73 m2 based on the age appropriate calculation;

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values 
>=2 times the ULN; 

Total bilirubin >=1.5 times the ULN; subjects with a history of Gilbert's 
syndrome may have a direct bilirubin measured and would be eligible for this 
study provided the direct bilirubin is <ULN;

Creatine kinase (CK) >3 times the ULN and positive urine myoglobin.
6. Current or recent history of uncontrolled renal, hepatic, hematological, 
gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic 
disease.  Known history of pulmonary embolism or recurrent deep vein thrombosis 
(DVT).
7. History of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV) 
related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and 
symptoms suggestive of current lymphatic disease.
Infection related exclusion criteria
8. History of infection requiring hospitalization, parenteral antimicrobial therapy, or as 
otherwise judged clinically significant by the investigator, within the 6 months prior 
to the first dose of study medication; or history of infection requiring oral 
antimicrobial therapy within 2 weeks prior to the first dose of study medication.  


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History of an infected joint prosthesis at any time, with the prosthesis still in situ.  
Any known current chronic infection or recurrent infection.
9. History of disseminated herpes zoster or disseminated herpes simplex, or a recurrent 
(more than one episode of) localized, dermatomal herpes zoster.
10. Known infection with hepatitis B viruses.  All subjects will undergo testing for 
Hepatitis B Surface Antigen (HBsAg) and Hepatitis B Core Antibody (HBcAb).  
Subjects who are HBsAg positive are not eligible for the study.  Subjects who are 
HBsAg negative and HBcAb positive will be reflex tested for Hepatitis B Surface 
Antibody (HBsAb) and if HBsAb is positive, may be enrolled in the study; if HBsAb 
is negative, the subject is not eligible for the study. 
11. Known infection with hepatitis C viruses.  Subjects who are hepatitis C antibody 
(HCV Ab) positive require further testing with HCV RNA PCR and are allowed to 
enroll if negative.
12. Known infection with human immunodeficiency virus (HIV) or positive HIV 
serology at screening.
13. Infected with Mycobacterium tuberculosis (TB) as defined by the following: 
a.
A positive Interferon Gamma Release Assay (IGRA) test performed at Screening 
or within the 12 weeks prior to Day 1 is exclusionary; a negative test is required 
for eligibility (except adequately treated latent or active TB infection as defined 
below).  The following are acceptable IGRA assays: QuantiFERON®-TB Gold 
Plus test, QuantiFERON- TB Gold test (QFT-G), QuantiFERON- TB Gold 
In-Tube test (QFT-GIT), and T-SPOTTB test (T-Spot).

If the results of the IGRA are indeterminate, the test may be repeated, and if a 
negative result is obtained, enrollment may proceed.  A positive test on repeat 
is exclusionary.

Subjects with repeat indeterminate IGRA results may be enrolled after 
consultation with pulmonary or infectious disease specialist that determines 
low risk of infection (ie, subject would be acceptable for immunosuppressant
treatment without additional action).

Subjects who test positive for QFT-G/QFT-GIT test, but in the opinion of the 
Investigator are at low risk of TB infection may be referred to pulmonary or 
infectious disease specialist for consultation and potential IGRA test repeated 
once.  Subjects will be eligible if the repeat test is negative before the 
randomization.


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
If a subject has previously received an adequate course of therapy for either 
latent (9 months of isoniazid in a locale where rates of primary multi-drug 
resistant TB infection are <5% or an acceptable alternative regimen) or active 
(acceptable multi-drug regimen) TB infection, no IGRA test need be obtained, 
but a chest radiograph must still be obtained if not done so within the prior 
12 weeks.
b. Chest radiograph taken at screening with changes suggestive of active TB 
infection, unless previously performed normal and documented chest radiograph 
within 12 weeks prior to Screening.
c.
A history of either untreated or inadequately treated latent or active TB infection.
d. A subject who is currently being treated for active or latent TB infection is to be 
excluded.
14. Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to 
the first dose of study drug, or expects to be vaccinated with these vaccines during 
study treatment, or within the 6 weeks following the last dose of study drug.  (For 
further information regarding avoidance of household contacts who may be 
vaccinated see Section 5.10).  Recombinant subunit vaccines (eg, Shingrix) is 
permitted and it is preferably that the last dose is administered at least 4 weeks prior 
to Day 1.
15. A subject with known immunodeficiency disorder or a first degree relative with a 
hereditary immunodeficiency.
Disease under study related exclusion criteria
16. History of any autoimmune rheumatic disease other than PsA (including systemic 
lupus erythematosis, mixed connective tissue disease, scleroderma, polymyositis) or 
known diagnosis of fibromyalgia, without approval by sponsor.  Also excluded are 
subjects with prior history of, or current, rheumatic inflammatory disease other than 
PsA (eg, gout, reactive arthritis, chronic Lyme disease) without approval by sponsor 
clinician.
17. Currently have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, 
with the exception of nail psoriasis, which is allowed.  Have current drug-induced 
psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta 
blockers, calcium channel blockers, antimalarial drugs or lithium.
18. Subjects with evidence of skin conditions (eg, eczema) at the time of the screening or 
baseline visit that would interfere with evaluation of psoriasis.
19. Functional Class IV as defined by the American College of Rheumatology revised 
criteria for classification of functional status in rheumatoid arthritis, ie, limited in 
ability to perform usual self-care, vocational, and avocational activities. 


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Concomitant medication related exclusion criteria
20. Cannot discontinue systemic therapies and/or topical therapies for the treatment of 
psoriasis and cannot discontinue phototherapy (UVB or Psoralens + UVA 
phototherapy [PUVA]). 
Subjects are to discontinue active psoriasis treatments prior to being enrolled in the 
study.

Biologics: All biologic agents not otherwise mentioned in this Protocol must be 
discontinued for a minimum of 6 months prior to first dose of study drug.

Topical treatments that could affect psoriasis, eg, corticosteroids, tars, 
keratolytics, anthralin, vitamin D analogs, and retinoids must be discontinued at 
least 2 weeks prior to first dose of study drug.  Exceptions- the following topical 
treatments are allowed: non-medicated emollients for use over the whole body; 
topical steroids including hydrocortisone and hydrocortisone acetate 1% for the 
palms, soles, face and intertriginous areas only; tar and salicylic acid preparations 
for the scalp only and shampoos free of corticosteroid for the scalp only.

UVB (narrowband or broadband) phototherapy must be discontinued at least 
2 weeks prior to first dose of study drug.  Psoralens + UVA phototherapy (PUVA) 
must be discontinued at least 4 weeks prior to first dose of study drug.
21. Subjects who have undergone treatment with injectable corticosteroids 
(eg, intraarticular, intramuscular or intravenous) within 4 weeks prior to the first dose 
of study drug, or may require injectable corticosteroids during the study (except 
intra-articular corticosteroids may be given as rescue medication; See Appendix 3,
Rescue Therapy).
22. Subjects who have undergone treatment with any IL-17 inhibitor, IL-12/23 inhibitor, 
or IL-23 inhibitor, including but not limited to secukinumab (Cosentyx), ixekizumab 
(Taltz), ustekinumab (Stelara), brodalumab (Siliq), guselkumab (Tremfya), 
risankizumab, bimekizumab, and tildrakizumab. 
23. Subjects who have undergone treatment with any Janus kinase (Jak) inhibitors, 
(including but not limited to tofacitinib [Xeljanz], baricitinib [Olumiant], 
upadacitinib, peficitinib, filgotinib).
24. Subjects who have undergone treatment with apremilast (Otezla) within 4 weeks of 
first dose of study drug. 
25. Subjects who have undergone treatment with abatacept (Orencia) within 10 weeks 
prior to first dose of study drug. 


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26. Subjects currently taking high potency opioid analgesics (Appendix 2, Prohibited 
Prior and Concomitant Medications).
27. Any prior treatment with non B cell-specific lymphocyte depleting agents/therapies 
(eg, alemtuzumab [Lemtrada, CamPath], alkylating agents [eg, cyclophosphamide 
or chlorambucil], total lymphoid irradiation, etc); subjects who have received 
rituximab or other selective B-lymphocyte depleting agents (including experimental 
agents) within 6 months of first dose of study drug or 5 half-lives (if known), 
whichever is longer, or until lymphocyte count returns to normal, whichever is 
longer. 
28. Have previously been treated with efalizumab (Raptiva).
29. Require treatment with prohibited concomitant medication(s) (Appendix 2, Prohibited 
Prior and Concomitant Medications) or have received a prohibited concomitant 
medication within 7 days or 5 half-lives (whichever is longer) prior to first dose of 
study drug.
Other exclusionary conditions
30. A subject with any condition possibly affecting oral drug absorption, eg, gastrectomy, 
clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery 
such as gastric bypass.  Procedures such as gastric banding, that simply divide the 
stomach into separate chambers, are NOT exclusionary.
31. History of alcohol or drug abuse in investigator’s opinion unless in full remission for 
greater than 12 months prior to first dose of study medication.
32. Screening 12-lead electrocardiogram (ECG) that demonstrates clinically significant 
abnormalities requiring treatment (eg, acute myocardial infarction, serious tachy- or 
brady-arrhythmias) or that are indicative of serious underlying heart disease 
(eg, cardiomyopathy, major congenital heart disease, low voltage in all leads, 
Wolff-Parkinson-White syndrome) and other clinically relevant abnormalities which 
may affect subject safety or interpretation of study results.  Specifically, subject with 
screening or Day 1/Baseline QTcF >450 milliseconds (msec) should be excluded.  If 
QTcF exceeds 450 msec, the ECG should be repeated two more times and the 
average of the three QTcF should be used to determine the subject eligibility.
33. A history of additional risk factors for torsade de pointes (TdP) (eg, heart failure 
[New York Heart Association status of class III or IV], hypokalemia, family history 
of Long QT Syndrome).
34. Use of concomitant medications that prolong the QT interval.
35. A subject with a malignancy or history of malignancy, with the exception of 
adequately treated or excised non metastatic basal cell or squamous cell cancer of the 
skin or cervical carcinoma in situ with no evidence of recurrence.


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36. Significant trauma or surgery procedure within 1 month prior to first dose of study 
medication, or any planned elective surgery during the study period.
37. A subject who, in the opinion of the investigator or Pfizer (or designee), will be 
uncooperative or unable to comply with study procedures. 
4.3. Randomization Criteria 
A subject who has signed an informed consent document to participate in the study, has 
undergone all screening procedures, and meets all Subject Eligibility Criteria for 
participation in the study at the baseline visit, may be randomized into this study.  Subjects 
will be randomized in a 4:4:1:1:2:2 ratio to one of the six parallel treatment sequences in 
Table 1.  Randomization will be stratified by prior TNFi exposure.  A centralized 
computer-generated randomization schedule will be used to assign subjects to the treatment 
sequences.  Subjects will be assigned a subject identification number in the order of their 
screening for the study.  The identifying number will be retained throughout the study.
4.4. Lifestyle Requirements 
4.4.1. Contraception
In this study, fertile male subjects and female subjects who are of childbearing potential as 
applicable to the study will receive PF-06700841, which has been associated with 
demonstrated teratogenicity/fetotoxicity in animals (more details in the IB).  Subjects who 
are, in the opinion of the investigator, sexually active and at risk for pregnancy with their 
partner(s) must agree to use 2 methods of effective contraception (one must be highly 
effective contraception) throughout the study and for at least 28 days after the last dose of 
investigational product.  The investigator or his or her designee, in consultation with the 
subject, will confirm that the subject has selected 2 appropriate methods of contraception for 
the individual subject and his/her partner(s) from the list of permitted contraception methods 
(see below) and will confirm that the subject has been instructed in their consistent and 
correct use.  At time points indicated in the Schedule of Activities, the investigator or 
designee will inform the subject of the need to use 2 effective methods of contraception (one 
must be highly effective contraception) consistently and correctly and document the 
conversation, and the subject’s affirmation, in the subject’s chart.  In addition, the 
investigator or designee will instruct the subject to call immediately if 1 or both of the 
selected contraception methods is discontinued or if pregnancy is known or suspected in the 
subject or partner.
Highly effective methods of contraception are those that, alone or in combination, result in a 
failure rate of less than 1% per year when used consistently and correctly (ie, perfect use) and 
include the following:
1. Established use of hormonal methods of contraception associated with inhibition of 
ovulation (eg, oral, inserted, injected, implanted, transdermal), provided the subject or 
male subject’s female partner plans to remain on the same treatment throughout the 
entire study and has been using that hormonal contraceptive for an adequate period of 
time to ensure effectiveness.


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2. Correctly placed copper-containing intrauterine device (IUD).
3. Male sterilization with absence of sperm in the postvasectomy ejaculate.
4. Bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusive procedure 
(provided that occlusion has been confirmed in accordance with the device’s label).
Examples of effective, but not highly effective methods of contraception can be found in 
Appendix 8.
Male subjects should refrain from donating sperm during the study and for at least 90 days 
after the last administration of the investigational product.
4.4.2. Fasting Visit Requirements
On visit days when fasting lipid panels are scheduled to be collected, all subjects should 
refrain from all food and liquids (water and medications permitted, if appropriate) for at least 
8 hours prior to scheduled safety laboratory tests.  Visits that require fasting are indicated in 
the Schedule of Activities.
4.4.3. Other Requirements
In order to participate in the study, subjects must be made aware of the following life style
guidelines and restrictions that apply during and after the study period.  Details of these life
style guidelines are provided in the sections as noted.

Agree to avoid strenuous exercise during the study, especially within one week prior 
to the scheduled study visits and maintain adequate hydration, if possible.

On study visit days, do not smoke or ingest caffeine (eg, tea, coffee, some soft 
drinks/colas/energy drinks and power bars) during the 30 minutes prior to blood
pressure and pulse (heart) rate measurements.

Refrain from consumption of grapefruit or grapefruit juice or citrus fruits eg, Seville 
oranges, pomelos within 7 days prior to the first dose of study medication until the 
end of treatment (Week 52).

On study visit days, showering or bathing is permitted prior to attending the study 
visit, but do not moisturize.

As needed, subjects may use the permitted psoriasis treatments as listed in 
Section 5.8.1 for the specified body sites described.  On clinic visit days, do not use 
any of these treatments until after the clinic visit is completed.

On study visit days, take prescribed permitted concomitant medication, as needed, 
prior to the study visit, if it can be administered with water only.


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
Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or 
other ultraviolet light sources during the study.

Discontinue and avoid using certain medications and treatments used to treat PsA or 
psoriasis (see Section 5 and Appendix 2).  Discontinue and avoid using certain other 
prohibited medications and treatments (see Section 5 and Appendix 2) not used to 
treat PsA or psoriasis.  For a medical condition where it is important for the subject’s 
safety to continue using the prohibited drug, and where there is no study-permitted 
alternative, the subject must not participate in this study.

Contact the study site investigator if there are any changes or additions to 
concomitant medications.

Avoid having elective surgery.

The subject should continue all non-pharmacological therapies, such as physical 
therapy, as indicated.  However, the subject should avoid changing the type or 
intensity of therapy or initiating new therapy until after Week 16 visit, but preferably 
after Week 52 visit.
4.5. Sponsor’s Qualified Medical Personnel
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the Study Binder.
To facilitate access to appropriately qualified medical personnel on study-related medical 
questions or problems, subjects are provided with a contact card.  The contact card contains, 
at a minimum, protocol and investigational product identifiers, subject study numbers, 
contact information for the investigator site, and contact details for a contact center in the 
event that the investigator site staff cannot be reached to provide advice on a medical 
question or problem originating from another healthcare professional not involved in the 
subject’s participation in the study.  The contact number can also be used by investigator 
staff if they are seeking advice on medical questions or problems; however, it should be used 
only in the event that the established communication pathways between the investigator site 
and the study team are not available.  It is therefore intended to augment, but not replace, the 
established communication pathways between the investigator site and the study team for 
advice on medical questions or problems that may arise during the study.  The contact 
number is not intended for use by the subject directly, and if a subject calls that number, he 
or she will be directed back to the investigator site.
5. STUDY TREATMENTS
For the purposes of this study, and per International Conference on Harmonisation (ICH) 
guidelines, investigational product is defined as a pharmaceutical form of an active 
ingredient or placebo being tested or used as a reference/comparator in a clinical trial, 
including a product with a marketing authorization when used or assembled (formulated or 
packaged) in a way different from the approved form, or when used for an unapproved 
indication, or when used to gain further information about an approved use (ICH E6 1.33). 


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For this study, the investigational product is PF-06700841. 
5.1. Allocation to Treatment
Subjects will be randomized in a 4:4:1:1:2:2 ratio to one of the six parallel treatment 
sequences in Table 1.  Allocation of subjects to treatment groups will proceed through the 
use of an interactive response technology (IRT) system (interactive Web-based response 
[IWR]).  The site personnel (study coordinator or specified designee) will be required to 
enter or select information including but not limited to the user’s identification (ID) and 
password, the protocol number, and the subject number.  The site personnel will then be 
provided with a treatment assignment, randomization number, and dispensable unit (DU) or 
container number when investigational product is being supplied via the IRT system.  The 
IRT system will provide a confirmation report containing the subject number, randomization 
number, and DU or container number assigned.  The confirmation report must be stored in 
the site’s files. 
The study-specific IRT reference manual will provide the contact information and further 
details on the use of the IRT system. 
5.2. Breaking the Blind
The study will be subject and investigator blinded.  At the initiation of the study, the 
investigator site will be instructed on the method for breaking the blind.  The method will be 
an electronic process.  Blinding codes should be broken only in exceptional circumstances 
when knowledge of the actual treatment code is absolutely essential for further management 
of the subject.  Investigators are encouraged (but not required) to discuss with a member of 
the study team if they believe that unblinding is necessary.  When the blinding code is 
broken, the reason must be fully documented and entered on the case report form (CRF).
At all times, treatment and randomization information will be kept confidential and will not 
be released to the investigator/study stuff until the conclusion of the study.
5.3. Subject Compliance
For self-administration of study medication at home, compliance will be captured and 
completed by the subject.
Subject compliance with dosing administration will be verified by accounting of returned 
study medication at each clinic visit.  When study medication is administered at the research 
facility, it will be administered under the supervision of study personnel.
Compliance of the study drug will be monitored by the accounting of unused medication 
returned by the subject and will be documented.  Subjects will be directed to bring any used 
and unused blister cards to each visit after randomization.  The number of tablets dispensed 
minus the number of tablets returned will be used to calculate the number of tablets taken and 
compliance.


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
Subjects who demonstrate <80% compliance should be counseled by the investigator 
or designee and ensure steps are taken to improve compliance.  Subjects who are 
<80% compliant with dosage regimen for any two consecutive visit periods should be 
withdrawn from the study.

If the subject is over-compliant (>120%) with study drug (intentional or accidental) 
the investigator or designee is to counsel the subject and ensure correct understanding 
of the study drug dosing regimen.  The investigator should contact the Pfizer Study 
Clinician promptly with any over-compliance that may potentially impact the safe use 
of study drug or that may result in a serious adverse event (SAE; See Section 8 for 
SAE reporting).
5.4. Investigational Product Supplies
5.4.1. Dosage Form(s) and Packaging
Blinded PF-06700841 tablets and matching placebo will be provided as tablets for oral 
administration.  The PF-06700841, 5 mg and 25 mg tablets and their matching placebos will 
be supplied in blisters and labeled according to local regulatory requirements.
5.4.2. Preparation and Dispensing
The investigational product will be dispensed using an IRT drug management system at each 
visit from Day 1 to Week 44.  A qualified staff member will dispense the investigational 
product via unique container numbers in the blister cards provided, in quantities appropriate 
for the study visit schedule.  The subject/caregiver should be instructed to maintain the 
product in the blister cards provided throughout the course of dosing and return the blister 
cards to the site at the next study visit. 
5.5. Administration
Subjects will receive investigational product (IP) as outpatients.  PF-06700841 tablets and 
matching placebo for oral administration will be dispensed in blisters.  Subjects will be 
provided dosing instructions.
All subjects, regardless of assigned treatment regimen will receive blinded QD dosing 
throughout the study treatment period to maintain the study blind.
Sites will be trained on how subjects should take tablets at home through an IP manual and/or 
other vehicle(s). Sites are responsible for communicating this information.
Subjects should take the medication orally for 52 weeks from study Days 1 through Week 52 
during the trial; Subjects will be encouraged to take the medication in the morning whenever 
possible; Subjects should swallow the tablets with ambient temperature water to a total 
volume of approximately 240 mL; Subjects will swallow the investigational product whole, 
and will not manipulate or chew the medication prior to swallowing; IP may be taken with or 
without food; however, for the Week 2 study visit day only, subjects are to be instructed to 
refrain from dosing at home and are to bring the investigational product with them, and are to 


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take the dose in the clinic from their previous blister card and dose from the newly dispensed 
blister card on the next day at home.
If a dose is missed and the interval to the next dose is less than 8 hours, the missed dose 
should not be administered. 
5.6. Investigational Product Storage 
The investigator or an approved representative, eg, pharmacist, will ensure that all 
investigational products are stored in a secured area with controlled access under required 
storage conditions and in accordance with applicable regulatory requirements.
Investigational products should be stored in their original containers and in accordance with 
the labels. 
Any storage conditions stated in the SRSD will be superseded by the storage conditions 
stated on the product label.
Site systems must be capable of measuring and documenting (for example, via a log), at a
minimum, daily minimum and maximum temperatures for all site storage locations (as 
applicable, including frozen, refrigerated, and/or room-temperature products).  This should 
be captured from the time of investigational product receipt throughout the study.  Even for 
continuous-monitoring systems, a log or site procedure that ensures active evaluation for 
excursions should be available.  The intent is to ensure that the minimum and maximum 
temperature is checked each business day to confirm that no excursion occurred since the last 
evaluation and to provide the site with the capability to store or view the minimum/maximum 
temperature for all non-working days upon return to normal operations.  The operation of the 
temperature monitoring device and storage unit (for example, refrigerator), as applicable, 
should be regularly inspected to ensure they are maintained in working order. 
Any excursions from the product label storage conditions should be reported to Pfizer upon 
discovery.  The site should actively pursue options for returning the product to the storage 
conditions described in the labeling, as soon as possible.  Deviations from the storage 
requirements, including any actions taken, must be documented and reported to Pfizer. 
Once an excursion is identified, the investigational product must be quarantined and not used 
until Pfizer provides permission to use the investigational product.  It will not be considered a 
protocol deviation if Pfizer approves the use of the investigational product after the 
temperature excursion.  Use of the investigational product prior to Pfizer approval will be 
considered a protocol deviation. Specific details regarding information the site should report 
for each excursion will be provided to the site.
Receipt of materials, door opening and closing, and other routine handling operations where 
the products are briefly out of the temperature range described in the labeling are not 
considered excursions.


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Site staff will instruct subjects on the proper storage requirements for take home 
investigational products.
5.7. Investigational Product Accountability 
The investigator site must maintain adequate records documenting the receipt, use, loss, or 
other disposition of the investigational product supplies.  All investigational products will be 
accounted for using a drug accountability form/record.  All blister cards of study drug must 
be returned to the investigator by the subject at every applicable visit and at the end of the 
trial. 
5.7.1. Destruction of Investigational Product Supplies 
The sponsor or designee will provide guidance on the destruction of unused investigational 
product (eg, at the site).  If destruction is authorized to take place at the investigator site, the 
investigator must ensure that the materials are destroyed in compliance with applicable 
environmental regulations, institutional policy, and any special instructions provided by 
Pfizer, and all destruction must be adequately documented.
5.8. Concomitant Treatments
It is important to be aware of, and document, all concomitant treatments including: 
prescription, non-prescription (ie, over-the-counter) and herbal medications in the Case 
Report Form.
A subject who is receiving an allowed concomitant medication for any reason must be on a 
locally-approved medication and dose that is considered standard-of-care for the treated 
indication, and this must be documented in the Case Report Form.  Subjects are not allowed 
on any other investigational drug during the study. 
It is recommended that unless otherwise noted in this protocol, subjects avoid changing 
non-prohibited prescription or non-prescription drugs, vitamins, and dietary supplements 
within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication 
and throughout the study. 
Treatments that are taken in the Screening period (after informed consent is obtained and 
before the first dose of study drug) will be documented as prior treatments.  Treatments taken 
after the first dose of study drug has been administered will be documented as concomitant 
treatments.  All concomitant treatments taken during the study must be recorded in the study 
records with indication, route, dose, frequency and start/stop dates of administration.  
Subjects will be queried about concomitant treatments at each study visit.
Minimum guidelines for folate supplementation during study: Subjects on methotrexate must 
receive folate supplementation according to local methotrexate label guidelines and standard 
of care.  A minimum of 5 mg weekly based on folic acid should be given unless local 
guidelines or standard of care state otherwise.


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5.8.1. Permitted Background Pain or Other Psoriatic Arthritis Therapy
Subjects taking permitted traditional non-biologic DMARDs (eg, methotrexate 
(25 mg/week), sulfasalazine (3 gm/day), leflunomide (20 mg/day)), nonsteroidal 
anti-inflammatory drugs (NSAIDs) including selective cyclooxygenase-2 inhibitors 
(COX-2 inhibitors), acetaminophen/paracetamol, and/or corticosteroids (10 mg prednisone 
mg/day) should remain on the same dose regimen throughout the study except if adjustment 
is needed to protect the subject’s safety (See Appendix 5, Oral Corticosteroid Equivalents). 
Daily dosage of NSAIDs/COX-2 inhibitors, corticosteroids, permitted opioids and 
acetaminophen/paracetamol must not be modified within the 24 hours prior to any study 
visit, except if adjustment is needed to protect a subject’s safety.
As needed (PRN) dosage of NSAIDs/COX-2 inhibitors, permitted opioids, or 
paracetamol/acetaminophen within the 2 weeks before randomization can continue after 
randomization, however, subject have to refrain from any intake within the 24 hours prior to 
any study visit.
The total daily dose of acetaminophen may not exceed 2.6 grams per day, and the total daily 
dose of opioid may not exceed the potency equivalent of 30 mg of orally-administered 
morphine (See Appendix 4, Maximum Allowed Total Daily Dose of Opioid Analgesics).
Intravenous or intramuscular corticosteroids are not allowed during this study either as a 
stable concomitant medication or as rescue medication. 
Concomitant psoriasis therapies are not permitted during the study, with the exception of:
Table 2.
Permitted Topical Concomitant Psoriasis Treatment
Body Region
Permitted Topical Treatments
Palms, soles, face, and intertriginous 
areas
Hydrocortisone 1% and hydrocortisone acetate 1% are the only 
topical corticosteroids permitted
Scalp
Tar preparations
Salicylic acid preparations, Shampoos free of corticosteroids
All body regions
Study supplied non-medicated emollient, Cetaphilmoisturizing 
cream
5.8.2. Prohibited Concomitant Medications
Prohibited drugs must be discontinued according to protocol guidelines; a list of prohibited 
drugs with specific discontinuation recommendations is listed in Appendix (See Appendix 2,
Prohibited Prior and Concomitant Medications). 
Subjects taking certain medications for PsA, and deriving inadequate benefit from them, may 
enter the study after a sufficient washout period for that medication.  Subjects receiving 
certain medications for psoriasis may enter the study after a sufficient washout period for that 
medication.  All biologic DMARDs are prohibited.  Non-biologic DMARD other than 
methotrexate, leflunomide or sulfasalazine are prohibited.  Injectable corticosteroids are 


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prohibited except for use as rescue medication (Appendix 3, Rescue Therapy).  High potency
opioid analgesics (eg, methadone, hydromorphone, buprenorphine, and fentanyl) are 
prohibited. 
5.8.3. Dietary Supplements
For the purposes of this protocol, dietary supplements are defined as vitamins, minerals, 
purified food substances, and herbals with pharmaceutical properties. 
Vitamins, minerals and purified food substances are allowed in amounts not known to be 
associated with adverse effects (such as hypervitaminosis).  Herbals with pharmaceutical 
properties are allowed only if there is acceptable evidence of no significant CYP3A 
inhibition or induction.  Otherwise, herbals with pharmaceutical properties must be 
discontinued for at least 4 weeks prior to first dose of study drug, unless there is sufficient 
data available regarding the duration of an herbal medication’s 
  All 
other prohibited drugs require at least a 7 day or 5 half-life (whichever is longer) washout 
period prior to the first dose of study treatment.
Glucosamine sulfate and chondroitin sulfate are allowed in the study but should be stably 
dosed beginning at least 1 week prior to first dose of study medicine.
5.9. Rescue Medications
The only medications that are allowed for rescue are listed and detailed in Appendix 
(Appendix 3, Rescue Therapy).  Briefly, acetaminophen/paracetamol (dosed no more than 
2.6 gm/day) and/or opioid (not exceeding the potency equivalent of 30 mg of 
orally-administered morphine) are allowable as rescue medication throughout the study if 
dosed for no more than 10 consecutive days (See Section 5.8.1 for stable background usage 
of acetaminophen/paracetamol and permitted opioids). 
•
Subjects who require rescue for more than 10 consecutive days should be 
discontinued from the study.
•
Subjects must not be dosed with rescue medication on the preceding day or the same 
day of a study visit (including Day 1/Randomization, Week 16 and any study visit 
where efficacy assessments are being collected), except if adjustment is needed 
because subject is experiencing intolerable pain. 
•
Baseline stable use acetaminophen/paracetamol or opioids should NOT be 
discontinued in advance of study visits.
In addition, intra-articular corticosteroids or hyaluronate sodium will be allowed as rescue 
medication and may be given at or after the Week 16 visit only.  If performed at the Week 16 
visit, intra-articular injections must be given after all assessments are completed.  Injected 
joints will also be considered as having their pre-injection status (swollen and/or 
painful/tender) and should not be counted for the remainder of the trial.
CCI


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5.10. Vaccination
Vaccination with live virus, attenuated live virus, or any live viral components is prohibited
within the 6 weeks prior to the first dose of study drug, during the study, and for 6 weeks
after the last dose of investigational product.  Similarly, current routine household contact
with individuals who have been vaccinated with live vaccine components should be avoided
during treatment and for 6 weeks following completion of treatment.  Such vaccines include 
but are not limited to: FluMist(intranasal influenza vaccine), attenuated rotavirus vaccine, 
varicella (chickenpox) vaccine, attenuated typhoid fever vaccine, oral polio vaccine, MMR 
(measles, mumps, rubella) vaccine and vaccinia (smallpox) vaccine.  Following vaccination 
with live component vaccines, the virus may be shed in bodily fluids, including stool, and 
there is a potential risk that the virus may be transmitted.
Recombinant subunit vaccines (eg, Shingrix) is permitted and it is preferably that the last 
dose is administered at least 4 weeks prior to Day 1.
6. STUDY PROCEDURES 
6.1. Screening
Subjects will be screened within 35 days prior to administration of study medication to 
confirm that they meet the entrance criteria for the study.
The study investigator or a sub-investigator will discuss with each subject the nature of the 
study, its requirements, and its restrictions.  Written informed consent must be obtained prior 
to performance of any protocol-specific procedures. 
The following procedures will be performed during Screening:

Obtain written Informed Consent;

Register Subject Using IRT System;

Demography; 

Contraception Check: Male subjects able to father children and female subjects of 
childbearing potential must agree to use two effective methods (one of which is 
highly effective method) of contraception throughout the study and for at least 
28 days after the last dose of assigned treatment.  Appropriate contraception must be 
commenced from Screening;

Confirmation of PsA diagnosis: The subject must have a diagnosis of PsA based upon 
the CASPAR Criteria.  PsA disease subtype will be documented in CRF;

Tender/Painful Joint Count (68), Swollen Joint Count (66): Subject must have 
evidence of active arthritis as defined by having at least 3 tender/painful joints on 
motion (out of 68 joints assessed) and at least 3 swollen joints (out of 66 joints 
assessed) at both Screening and Baseline (Randomization);


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
Dermatological Assessment of active plaque psoriasis;

Prior and Concomitant treatments: Include a complete history of all DMARDs ever 
taken with reasons for discontinuation (those taken during the 1 year prior to the first 
dose of study drug should include dose and duration of treatment).  In addition to 
DMARD, complete history of steroid (oral/injectable/topical) and NSAIDs.  History 
of all other drugs (including nonprescription drugs, vitamins, and dietary 
supplements), taken within 4 weeks prior to screening procedures;

Medical history: Include history of infection such as zoster.  The medical history 
should also include smoking status; average weekly alcohol consumption and family 
history of disease including premature coronary heart disease (CHD).  Premature 
coronary heart disease is defined as CHD in a male first-degree relative first observed 
at <55 years or CHD in female first-degree relative first observed at <65 years;

Vital signs: Sitting blood pressure, pulse rate and temperature;

Complete Physical Examination (including height): Height (at Screening Visit only), 
weight; general appearance, skin (presence of rash), HEENT (head, eyes, ears, nose 
and throat), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, 
rubs), lower extremities (presence of peripheral edema), abdomen (palpation and 
auscultation), neurologic (mental status, station, gait, reflexes, motor and sensory 
function, coordination) and lymph nodes; 

Perform a single 12-lead ECG (read locally and centrally): If QTcF exceeds 450 ms, 
the ECG should be repeated two more times and the average of the three QTcF 
should be used to determine the subject eligibility;

Chest radiograph.  Chest X-ray or other appropriate diagnostic imaging (ie, CT or 
MRI) may be performed up to 12 weeks prior to Screening Visit.  Official reading (by 
radiologist or pulmonologist per local standard of care) must be located in the source 
documentation;

Central laboratory testing: Serum FSH or Serum Pregnancy test; Hematology, 
Chemistry, Rheumatoid Factor (RF), Cyclic Citrullinated Peptide (CCP) Antibodies, 
Urinalysis, High-Sensitivity C-Reactive Protein (hsCRP), HIV Testing, HBsAg, 
HBcAb, HBsAb and HCV Ab and HCV RNA PCR if HCV Ab is positive, 
Tuberculosis Tests, Urine Myoglobin.  Specifically:

Serum Follicle stimulating hormone (FSH) test to be performed at Screening to 
confirm postmenopausal status in female subjects who have been amenorrheic for 
at least 12 consecutive months;

Serum Pregnancy test is required for all Women of Childbearing Potential;


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
Tuberculosis Tests: QuantiFERON-Gold (QFT-G) or other Interferon Gamma 
Release Assay (IGRA) test: Must be performed unless previously tested and 
documented within 12 weeks prior to Day 1/Randomization OR unless subject 
has previously received an adequate course of therapy for either latent or active 
TB infection;

Screening laboratory tests with abnormal results may be repeated once to confirm 
abnormal results; the last value will be used to determine eligibility.  If results 
return to normal within the 5-week screening period, the subject may enter the 
study;

Review all Inclusion and Exclusion criteria;

Assess for occurrence of Adverse Events: The reporting period starts with the signing 
of the informed consent. 
Sites will be permitted to re-screen subjects (with a new screening number) who initially do 
not meet eligibility criteria once.  Subjects may not be rescreened unless approved by the 
sponsor.  Rescreening of subjects will be allowed in a limited number of circumstances as 
determined by the Pfizer study clinician (eg, subject requires washout of prohibited 
medications, requires antimicrobial therapy within 2 weeks prior to the first dose of study 
medication, requires emergency surgery) and should be confirmed with the Pfizer study 
clinician when rescreening can occur. 
6.2. Study Period
Subjects who have met all the inclusion criteria and have no exclusion criteria present may 
participate in the study.
Subjects should complete the patient reported outcome (PRO) questionnaires at the clinic 
prior to any other study procedures.  This sequence of study procedures will reduce the risk 
of inadvertently introducing bias in a subject’s responses through study staff interactions.  In 
the unlikely event that a PRO questionnaire(s) is not able to be administered by the study site 
staff and completed by the subject at the clinic visit, the PRO questionnaire(s) should not be 
administered.
All rheumatological and dermatological assessments will be performed by qualified, trained 
assessors who are blinded to the subject’s safety data, previous efficacy data and treatment 
randomization.  Assessors performing efficacy assessments are not required to be blinded 
prior to treatment randomization, ie at Screening and Baseline visits.  To ensure consistency 
and reduce intra-individual variability, the same qualified assessor should score all 
evaluations for a particular assessment for a given subject throughout the study (See 
Section 7.6 Rater (Assessor) Qualifications). 


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6.2.1. Baseline Day 1 
Subjects are required to fast for at least 8 hours prior to the visit.
All Patient Reported Outcomes (PROs) should be completed prior to any other study 
procedures.
•
These PROs include the following:
•
Patient’s Assessment of Arthritis Pain; 
•
Patient’s Global Assessment of Arthritis; 
•
Health Assessment Questionnaire (HAQ) disability index (DI);
•
Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS);
 
•
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue); 
•
Short-Form-36 Health Survey (SF-36) Version 2, Acute;
 
All clinical rheumatological and dermatological assessments will be performed by qualified, 
trained assessors:
•
Clinical Rheumatology Assessments by qualified, trained assessors:
•
Tender/painful joint counts (68) and Swollen joint counts (66): Subject must have 
evidence of active arthritis as defined by having at least 3 tender/painful joints on 
motion (out of 68 joints assessed) and at least 3 swollen joints (out of 66 joints 
assessed) at both Screening and Baseline (Randomization);
•
Physician’s Global Assessment of Arthritis;
•
Physician’s Global Assessment of Psoriatic Arthritis;
•
Dactylitis Assessment;
•
Enthesitis Assessment (Spondyloarthritis Research Consortium of Canada 
[SPARCC]), Leeds Enthesitis Index).
C
C
C
C
I
C
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C
C


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•
Clinical Dermatology Assessments by qualified, trained assessors:
•
Evaluation of Plaque Psoriasis;
•
Psoriasis Area and Severity Index (PASI);
•
Body Surface Area (BSA);
•
Nail Psoriasis Severity Index (NAPSI).
Other clinical assessment procedures that will be performed prior to randomization and the 
first dose of study drug on Day 1 for baseline include: 
•
Contraception Check: Male subjects able to father children and female subjects of 
childbearing potential must agree to use two effective methods (one of which is 
highly effective method) of contraception throughout the study and for at least 
28 days after the last dose of assigned treatment;
•
Medical History: Review any changes in the medical history (any AEs happened 
before the first dosing of Investigational Product should be reflected on the medical 
history);
•
Complete Physical Examination: Weight, general appearance, skin (presence of rash), 
HEENT (head, eyes, ears, nose and throat), lungs (auscultation), heart (auscultation 
for presence of murmurs, gallops, rubs), lower extremities (presence of peripheral 
edema), abdomen (palpation and auscultation), neurologic (mental status, station, 
gait, reflexes, motor and sensory function, coordination) and lymph nodes;
•
Perform 12-lead ECG in triplicate approximately 2-4 minutes apart (read locally and
centrally): The average of three ECG measurements will serve as baseline value. If 
baseline QTcF exceeds 450 ms, subjects should be excluded;
•
Vital signs: Sitting blood pressure, pulse rate and temperature;
•
Urine Pregnancy Tests (conducted at study site) must be performed prior to dosing 
with the investigational product for female subjects of childbearing potential. Two 
negative pregnancy tests are required before receiving investigational product 
(1 negative Serum Pregnancy Test at Screening and 1 negative Urine Pregnancy Tests 
at the Baseline Day 1 visit);
•
Central laboratory testing: Hematology, Chemistry, Fasting Lipid Panel, Serum 
Cystatin C, Urinalysis, Urine Myoglobin, High-Sensitivity C-Reactive Protein 
(hsCRP), FACS-TBNK, and Viral Surveillance (EBV, CMV, HSV1, HSV2, and 
VZV);
C
C


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•
Collect banked biospecimen (Prep D1, Prep R1, Prep B2.5 and Prep B1.5);
•
Review of prior and concomitant treatment; 
•
Review of rescue medication;
•
Inclusion/Exclusion review. 
If the subject is eligible for continued participation:
•
Randomization; 
•
Investigational Product Dispensing and Administration;
•
Monitoring of adverse events; 
•
Subjects are to be instructed not to take the study medication prior to coming to the 
clinic at the next (Week 2) visit but to bring the study medication with them to the 
visit.
6.2.2. Week 2 Visit
There is a ±3 day window for this visit.
 
All Patient Reported Outcomes (PROs) should be completed prior to any other study 
procedures.
•
These PRO include the following:
•
Patient’s Assessment of Arthritis Pain; 
•
Patient’s Global Assessment of Arthritis; 
•
Health Assessment Questionnaire (HAQ) disability index (DI);
•
Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS);
 
•
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue); 
 
CCI
C
C
C
C
I


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All clinical rheumatological and dermatological assessments will be performed by blinded, 
qualified, trained assessors.
•
Clinical Rheumatology Assessments by blinded assessor:
•
Tender/painful joint counts (68) and Swollen joint counts (66); 
•
Physician’s Global Assessment of Arthritis;
•
Physician’s Global Assessment of Psoriatic Arthritis;
•
Dactylitis Assessment;
•
Enthesitis Assessment (Spondyloarthritis Research Consortium of Canada 
[SPARCC]), Leeds Enthesitis Index).
•
Clinical Dermatology Assessments by blinded assessor:
•
Psoriasis Area and Severity Index (PASI);
•
Body Surface Area (BSA);
•
Nail Psoriasis Severity Index (NAPSI).
Other clinical assessment procedures that will be performed include: 
•
Contraception Check: Male subjects able to father children and female subjects of 
childbearing potential must agree to use two effective methods (one of which is 
highly effective method) of contraception throughout the study and for at least 
28 days after the last dose of assigned treatment;
•
Targeted Physical Examination should include skin, heart, lungs, and abdomen and 
examination of body systems where there are symptom complaints by the subject;
•
Perform a single 12 lead ECG (read locally and centrally): At Week 2 visit only, ECG
will be collected between 2-4 hours post-dose.
•
Vital signs: Sitting blood pressure, pulse rate and temperature;
•
Urine Pregnancy Tests (conducted at study site) must be performed for female 
subjects of childbearing potential;
C
C
I
C
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•
Central laboratory testing: Hematology, Chemistry, Serum Cystatin C, Urinalysis, 
High-Sensitivity C-Reactive Protein (hsCRP), FACS-TBNK;
•
Collect banked biospecimen (Prep R1, Prep B2.5 and Prep B1.5);
 
 
•
Review of concomitant treatment; 
•
Review of rescue medication;
•
Monitoring of adverse events; 
•
Investigational Product Accountability.
If the subject is eligible for continued participation: 
•
Investigational Product Dispensing.
6.2.3. Week 4, 8, 12, 16 Visit
There is a ±3 day window for the Week 4 Visit, and ±7 day window for the rest of the Visits.
Subjects are required to fast for at least 8 hours prior to the Week 8 and Week 16 visits only. 
All Patient Reported Outcomes (PROs) should be completed prior to any other study 
procedures.
•
These PROs include the following:
•
Patient’s Assessment of Arthritis Pain; 
•
Patient’s Global Assessment of Arthritis; 
•
Health Assessment Questionnaire (HAQ) disability index (DI);
•
Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS);
•
 
•
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue); 
•
Short-Form-36 Health Survey (SF-36) Version 2, Acute;
 
C
C
I
CCI
C
C
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All clinical rheumatological and dermatological assessments will be performed by qualified, 
trained assessors.
•
Clinical Rheumatology Assessments by blinded assessor:
•
Tender/painful joint counts (68) and Swollen joint counts (66); 
•
Physician’s Global Assessment of Arthritis;
•
Physician’s Global Assessment of Psoriatic Arthritis;
•
Dactylitis Assessment;
•
Enthesitis Assessment (Spondyloarthritis Research Consortium of Canada 
[SPARCC]), Leeds Enthesitis Index).
•
Clinical Dermatology Assessments by blinded assessor:
•
Psoriasis Area and Severity Index (PASI);
•
Body Surface Area (BSA);
•
Nail Psoriasis Severity Index (NAPSI).
Other clinical assessment procedures that will be performed include: 
•
Contraception Check: Male subjects able to father children and female subjects of 
childbearing potential must agree to use two effective methods (one of which is 
highly effective method) of contraception throughout the study and for at least 
28 days after the last dose of assigned treatment;
•
Complete Physical Examination (Week 16 Visit only): Weight, general appearance, 
skin (presence of rash), HEENT (head, eyes, ears, nose and throat), lungs 
(auscultation), heart (auscultation for presence of murmurs, gallops, rubs), lower 
extremities (presence of peripheral edema), abdomen (palpation and auscultation), 
neurologic (mental status, station, gait, reflexes, motor and sensory function, 
coordination) and lymph nodes;
•
Targeted Physical Examination (Week 4, 8, 12 Visits only) should include skin, heart, 
lungs, and abdomen and examination of body systems where there are symptom 
complaints by the subject;
C
C
C
C
C
C


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•
Perform a single 12-lead ECG (read locally and centrally; Week 16 only); 
•
Vital signs: Sitting blood pressure, pulse rate and temperature;
•
Urine Pregnancy Tests (conducted at study site) must be performed for female 
subjects of childbearing potential;
•
Central laboratory testing: Hematology, Chemistry, Fasting Lipid Panel (Week 8 and 
Week 16 visits only), Serum Cystatin C, Urinalysis, High-Sensitivity C-Reactive 
Protein (hsCRP), FACS-TBNK;
•
Collect banked biospecimen (Prep R1, Prep B2.5 and Prep B1.5) at Week 4, 16 only;
•
Review of concomitant treatment;
•
Review of rescue medication;
•
Monitoring of adverse events; 
•
Investigational Product Accountability.
If the subject is eligible for continued participation: 
•
Investigational Product Dispensing.
6.2.4. Week 20, 28, 36, 44 Visit
There is a ±7 day window for these Visits.
Subjects are required to fast for at least 8 hours prior to the Week 28, 36, 44 visits. 
All Patient Reported Outcomes (PROs) should be completed prior to any other study 
procedures.
•
These PROs include the following:
•
Patient’s Assessment of Arthritis Pain; 
•
Patient’s Global Assessment of Arthritis; 
•
Health Assessment Questionnaire (HAQ) disability index (DI);
•
Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS);
 
C
C
C
C


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•
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue); 
•
Short-Form-36 Health Survey (SF-36) Version 2, Acute;
 
All clinical rheumatological and dermatological assessments will be performed by qualified, 
trained assessors.
•
Clinical Rheumatology Assessments by blinded assessor:
•
Tender/painful joint counts (68) and Swollen joint counts (66); 
•
Physician’s Global Assessment of Arthritis;
•
Physician’s Global Assessment of Psoriatic Arthritis;
•
Dactylitis Assessment;
•
Enthesitis Assessment (Spondyloarthritis Research Consortium of Canada 
[SPARCC]), Leeds Enthesitis Index).
•
Clinical Dermatology Assessments by blinded assessor:
•
Psoriasis Area and Severity Index (PASI);
•
Body Surface Area (BSA);
•
Nail Psoriasis Severity Index (NAPSI).
Other clinical assessment procedures that will be performed include: 
•
Contraception Check: Male subjects able to father children and female subjects of 
childbearing potential must agree to use two effective methods (one of which is 
highly effective method) of contraception throughout the study and for at least 
28 days after the last dose of assigned treatment;
•
Targeted Physical Examination should include skin, heart, lungs, and abdomen and 
examination of body systems where there are symptom complaints by the subject;
•
Perform a single 12 lead ECG (read locally and centrally); 
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•
Vital signs: Sitting blood pressure, pulse rate and temperature; 
•
Urine Pregnancy Tests (conducted at study site) must be performed for female 
subjects of childbearing potential;
•
Central laboratory testing: Hematology, Chemistry, Fasting Lipid Panel (Week 28, 
36, 44 visits only), Serum Cystatin C, Urinalysis, High-Sensitivity C-Reactive Protein 
(hsCRP), FACS-TBNK;
•
Review of concomitant treatment;
•
Review of rescue medication;
•
Monitoring of adverse events; 
•
Investigational Product Accountability.
If the subject is eligible for continued participation: 
•
Investigational Product Dispensing.
6.2.5. Week 52 Visit or Early Termination Visit
There is a ±7 day window for the Week 52 Visit.
Subjects are required to fast for at least 8 hours prior to the visit. 
All Patient Reported Outcomes (PROs) should be completed prior to any other study 
procedures.
•
These PROs include the following:
•
Patient’s Assessment of Arthritis Pain; 
•
Patient’s Global Assessment of Arthritis; 
•
Health Assessment Questionnaire (HAQ) disability index (DI);
•
Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS);
 
•
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue); 
•
Short-Form-36 Health Survey (SF-36) Version 2, Acute;
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All clinical rheumatological and dermatological assessments will be performed by qualified, 
trained assessors.
•
Clinical Rheumatology Assessments by blinded assessor:
•
Tender/painful joint counts (68) and Swollen joint counts (66); 
•
Physician’s Global Assessment of Arthritis;
•
Physician’s Global Assessment of Psoriatic Arthritis;
•
Dactylitis Assessment;
•
Enthesitis Assessment (Spondyloarthritis Research Consortium of Canada 
[SPARCC]), Leeds Enthesitis Index).
•
Clinical Dermatology Assessments by blinded assessor:
•
Psoriasis Area and Severity Index (PASI);
•
Body Surface Area (BSA);
•
Nail Psoriasis Severity Index (NAPSI).
Other clinical assessment procedures that will be performed include: 
•
Contraception Check: Male subjects able to father children and female subjects of 
childbearing potential must agree to use two effective methods (one of which is 
highly effective method) of contraception throughout the study and for at least 
28 days after the last dose of assigned treatment;
•
Complete Physical Examination: Weight, general appearance, skin (presence of rash), 
HEENT (head, eyes, ears, nose and throat), lungs (auscultation), heart (auscultation 
for presence of murmurs, gallops, rubs), lower extremities (presence of peripheral 
edema), abdomen (palpation and auscultation), neurologic (mental status, station, 
gait, reflexes, motor and sensory function, coordination) and lymph nodes;
•
Perform a single 12-lead ECG (read locally and centrally);
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•
Vital signs: Sitting blood pressure, pulse rate and temperature; 
•
Urine Pregnancy Tests (conducted at study site) must be performed for female 
subjects of childbearing potential;
•
Central laboratory testing: Hematology, Chemistry, Fasting Lipid Panel, Serum
Cystatin C, Urinalysis, High-Sensitivity C-Reactive Protein (hsCRP), FACS-TBNK;
•
Collect banked biospecimen (Prep R1, Prep B2.5 and Prep B1.5);
•
Review of concomitant treatment;
•
Review of rescue medication;
•
Monitoring of adverse events; 
•
Investigational Product Accountability.
6.2.6. Follow-up Visit
A Follow-up Visit will be completed 4 weeks after the last administration of the 
investigational product for all subjects who complete the Week 52 Visit or Early Termination 
Visit. 
There is a +7 days window for the Follow-up Visit.
Subjects are required to fast for at least 8 hours prior to the visit. 
The following procedures will be performed:
•
Contraception Check: Male subjects able to father children and female subjects of 
childbearing potential must agree to use two effective methods (one of which is 
highly effective method) of contraception throughout the study and for at least 
28 days after the last dose of assigned treatment;
•
Targeted Physical Examination should include skin, heart, lungs, and abdomen and 
examination of body systems where there are symptom complaints by the subject;
•
Vital signs: Sitting blood pressure, pulse rate and temperature; 
•
Urine Pregnancy Tests (conducted at study site) must be performed for female 
subjects of childbearing potential;
•
Central laboratory testing: Hematology, Chemistry, Fasting Lipid Panel, Serum 
Cystatin C, Urinalysis;
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
Review of concomitant treatment;

Monitoring of adverse events.
If clinical significant abnormalities in hematology or chemistry laboratory testing results are 
still observed at the follow-up visit, the subject must continue to be followed until the 
laboratory abnormality stabilizes or returns to baseline levels.
In the event that a Follow-up Visit is not possible, at the bare minimum, a follow-up phone 
contact must be completed 4 weeks (+7 days window) after the last administration of the 
investigational product to capture any potential adverse events (see the Time Period for 
Collecting AE/SAE Information section) and to confirm appropriate contraception usage (see 
the Contraception section). 
Any subject meeting discontinuation criteria for adverse events, laboratory, or ECG 
(Appendix 6, Discontinuation Criteria) must enter into the Follow up Period with additional 
follow up visit occurring 1 week after their last dose or Early Termination Visit whenever 
possible, and follow up until any clinically relevant abnormalities or adverse events have 
resolved, returned to a baseline state, or are deemed clinically stable.  The only exception to 
this is when a subject specifically withdraws consent for any further contact with him or her.
6.3. Subject Withdrawal 
Subjects may withdraw from the study at any time at their own request, or they may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety (see also the 
Withdrawal From the Study Due to Adverse Events section) or behavioral reasons, or the 
inability of the subject to comply with the protocol-required schedule of study visits or 
procedures at a given study site. 
The investigator should inquire about the reason for withdrawal, request that the subject 
return all unused investigational product(s), request that the subject return for a final visit, if 
applicable, and follow up with the subject regarding any unresolved adverse events (AEs).
The investigator may withdraw/early terminate a subject from the study treatment based on 
the Discontinuation Criteria described in Appendix 6, Discontinuation Criteria.  An Early 
Termination Visit and subsequent Follow-up Visit should be completed in the case where a 
subject is withdrawn from the study treatment by the investigator.
Withdrawal of consent:
If the subject withdraws from the study, and also withdraws consent for disclosure of future 
information, no further evaluations should be performed, and no additional data should be 
collected.  The sponsor may retain and continue to use any data collected before such 
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Subjects who request to discontinue receipt of study treatment will remain in the study and 
must continue to be followed for protocol specified follow-up procedures, ie, Early 
Termination Visit and Follow-up Visit as specified in Section 6.2.  The only exception to this 
is when a subject specifically withdraws consent for any further contact with him or her or 
persons previously authorized by the subject to provide this information.  Subjects should 
notify the investigator in writing of the decision to withdraw consent from future follow-up, 
whenever possible. 
The withdrawal of consent should be explained in detail in the medical records by the 
investigator, as to whether the withdrawal is only from further receipt of investigational 
product or also from study procedures and/or posttreatment study follow-up, and entered on 
the appropriate CRF page. 
Withdrawal due to adverse event should be distinguished from withdrawal due to insufficient 
response according to the definition of adverse event noted in Protocol Section 8 ADVERSE 
EVENT REPORTING.  Withdrawal due to a subject being no longer willing to participate in 
the study should be distinguished from withdrawal due to “lost to follow-up”.
Lost to follow-up (LTFU): 
If a subject does not return for a scheduled visit, every effort should be made to contact the 
subject who is potentially LTFU.  In any circumstance, every effort should be made to 
document subject outcome, if possible. 
All reasonable efforts must be made to locate subjects to determine and report their ongoing 
status.  This includes follow-up with persons authorized by the subject as noted above.  Lost 
to follow-up is defined by the inability to reach the subject after a minimum of 2 documented 
phone calls, faxes, or e-mails as well as lack of response by the subject to 1 registered mail 
letter.  A subject should not be considered a withdrawal due to LTFU until at least 3 attempts 
to contact the subject by multiple methods have been unsuccessful.  All methods of 
attempted contact with the subject must be clearly documented (dated and initialed) in the 
subject’s source documents and recorded on appropriate case report form (CRF) page. 
If it is determined that the subject has died, the site will use locally permissible methods to 
obtain the date and cause of death.  If the investigator’s use of a third-party representative to 
assist in the follow-up portion of the study has been included in the subject’s informed 
consent, then the investigator may use a sponsor-retained third-party representative to assist 
site staff with obtaining the subject’s contact information or other public vital status data 
necessary to complete the follow-up portion of the study.  The site staff and representative 
will consult publicly available sources, such as public health registries and databases, in 
order to obtain updated contact information.  If, after all attempts, the subject remains lost to 
follow-up, then the last-known-alive date as determined by the investigator should be 
reported and documented in the subject’s medical records. 
All potential LTFU subjects must be discussed with the Pfizer study team or designee prior 
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7. ASSESSMENTS
Every effort should be made to ensure that the protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside of the control of the investigator that may make it unfeasible to 
perform the test.  In these cases the investigator will take all steps necessary to ensure the 
safety and well-being of the subject.  When a protocol-required test cannot be performed, the 
investigator will document the reason for this and any corrective and preventive actions that 
he or she has taken to ensure that normal processes are adhered to as soon as possible.  The 
study team will be informed of these incidents in a timely manner.
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study.
7.1. Efficacy Assessments
7.1.1. Clinical Rheumatology Assessments
All rheumatological evaluations will be performed by qualified, trained, independent blinded 
assessors who are blinded to the subject’s safety data, previous efficacy data and treatment 
randomization.  To ensure consistency and reduce intra-individual variability, the same 
qualified assessor should score all evaluations for a given assessment for a given subject 
throughout the study.
7.1.1.1. Tender/Painful and Swollen Joint Count
Tender/Painful and swollen joints will be assessed by a blinded assessor to determine the 
number of joints that are considered tender/painful and/or swollen using the following scale: 
Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints).  
Artificial joints will not be assessed.  Injected joints will be counted according to their 
pre-injection status for the remainder of the study.
The sixty-eight (68) joints to be assessed for tenderness are:19

Upper Body: 2 temporomandibular, 2 sternoclavicular, 2 acromioclavicular;

Upper Extremity: 2 shoulder, 2 elbow, 2 wrist (includes radiocarpal, carpal and 
carpometacarpal considered as one unit), 10 metacarpophalangeals (MCP I, II, III, IV, 
V), 2 thumb interphalangeal (IP), 8 proximal interphalangeals (PIP II, III, IV, V), 
8 distal interphalangeals (DIP II, III, IV, V);

Lower Extremity: 2 hip, 2 knee, 2 ankle, 2 tarsus (includes subtalar, transverse tarsal 
and tarsometatarsal considered as one unit), 10 metatarsophalangeals (MTP I, II, III, 
IV, V), 2 great toe interphalangeal (IP), 8 proximal and distal interphalangeals 
combined (PIP II, III, IV, V).
The sixty-six (66) joints to be assessed for swelling are the same as those listed above for 
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The 28 joints to be assessed for tenderness and/or swelling are: 2 shoulders, 2 elbows, 
2 wrists, 10 metacarpophalangeal joints (MCP), 10 proximal interphalangeal joints (PIP), and 
2 knees.  The 28 joints count will be calculated by sponsor from the 68/66 tender/swollen 
joint count assessed as described above.
7.1.1.2. Physician’s Global Assessment of Arthritis
The blinded assessor will assess how the subject’s overall arthritis appears at the time of the 
visit.  This is an evaluation based on the subject’s disease signs, functional capacity and 
physical examination, and should be independent of the Patient’s Global Assessment of 
Arthritis.  The investigator’s response will be recorded using a 100 mm visual analog scale 
(VAS).
THE PATIENT’S ARTHRITIS AT THIS TIME IS:
(PLEASE MAKE AN X MARK ON THE LINE BELOW.)
Very Good ______________________________________________________ Very Poor
[Note: Scale will be 100 mm in length]
7.1.1.3. Physician’s Global Assessment of Psoriatic Arthritis
The blinded investigator or qualified assessor will assess how the subject’s overall PsA 
appears at the time of the visit.  This may include any element of the disease that is related to 
their PsA and may include arthritis, psoriasis, enthesitis, dactylitis or spondylitis.  The 
investigator’s response will be recorded using a 100 mm visual analog scale (VAS).
THE PATIENT’S OVERALL PSORIATIC ARTHRITIS AT THIS TIME IS:
(PLEASE MAKE AN X MARK ON THE LINE BELOW.)
Not active at all ___________________________________________Extremely active
[Note: Scale will be 100 mm in length]
7.1.1.4. Dactylitis Assessment
The number of digits in hands and feet with dactylitis will be evaluated by a blinded assessor.  
In addition, dactylitis severity will be scored based upon digit tenderness using a scale of 
0-3, where 0 = no tenderness and 3 = extreme tenderness, in each digit of the hands and feet.  
The range of total dactylitis scores for a subject would be 0-60.
7.1.1.5. Enthesitis Assessment (Spondyloarthritis Research Consortium of Canada 
[SPARCC]), Leeds Enthesitis Index)
Number of sites with enthesitis will be evaluated by a blinded assessor using the 
Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index20 and Leeds 
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The SPARCC Enthesitis Index examines tenderness at sixteen sites: medial epicondyle 
humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of 
humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar 
ligament insertion into inferior pole of patella or tibial tubercle (considered 1 site for scoring 
purposes), Achilles tendon insertion into calcaneum and plantar fascia insertion into 
calcaneum.  Each site is classified on a dichotomous basis as either tender (score=1) or not 
tender (score=0).  The SPARCC Enthesitis Index scores range from 0-16, with higher scores 
indicating higher disease activity.20
The Leeds Enthesitis Index (LEI) examines tenderness at six sites: lateral epicondyle 
humerus, medial femoral condyle and Achilles tendon insertion.  Each site is assessed as 
either tender (score=1) or not tender (score=0).  The LEI scores range from 0-6, with higher 
scores indicating higher disease activity.21
7.1.2. Clinical Dermatology Assessments
All dermatological evaluations will be performed by qualified, trained, independent blinded 
assessors who are blinded to the subject’s safety data, previous efficacy data and treatment 
randomization.  To ensure consistency and reduce intra-individual variability, the same 
qualified assessor should score all evaluations for a given assessment for a given subject 
throughout the study.
7.1.2.1. Evaluation of Plaque Psoriasis
Subject must have active plaque psoriasis, with at least one psoriatic plaque or nail changes 
consistent with psoriasis, at both Screening and Baseline (Day 1/Randomization) which has 
been diagnosed or confirmed by a dermatologist or a sponsor-approved rheumatologist.
 
 
 
 
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7.1.2.3. Body Surface Area (BSA)
Assessment of body surface area involved in psoriasis is performed separately for four body 
regions: head (including neck), upper limbs, trunk (including axillae and groin), and lower 
limbs (including buttocks). 
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The percent BSA with psoriasis is estimated by means of the handprint method,22 where the 
full palmar hand of the subject (ie, the subject’s fully extended palm, fingers and thumb 
together) represents approximately 1% of the total BSA and a set percentage of each body 
region:

1 handprint corresponds to approximately 10% of the head (including neck);

1 handprint corresponds to approximately 5% of the upper limbs;

1 handprint corresponds to approximately 3.3% of the trunk (including axillae and 
groin);

1 handprint corresponds to approximately 2.5% of the lower limbs (including 
buttocks).
The extent (%) to which each of the four body regions is affected by psoriasis is captured on 
the CRF (to 2 decimal places, as necessary). 
A weighting factor is applied to each of the four body regions in calculation of the total BSA 
affected: head x0.1; upper limbs x0.2; trunk x0.3; lower limbs x0.4, as the four body regions 
correspond to approximately 10%, 20%, 30% and 40% of the total BSA, respectively.  The 
sum of the weighted percent involvement obtained for each of the four body areas is the 
grand total BSA with psoriasis, as described in the following equation:
BSA (%) =
0.1Sh + 0.2Su + 0.3St + 0.4Sl
where S = body region surface area with psoriasis; h = head; u = upper limbs; t = trunk; l = lower limbs.
7.1.2.4. Psoriasis Area and Severity Index (PASI)
PASI assessment must be performed for PsA subject with Baseline psoriasis affecting 
3% Body Surface Area (BSA).
The Psoriasis Area and Severity Index quantifies the severity of a subject’s psoriasis based 
on both lesion severity and the percentage of body surface area affected.23
Assessments of lesion Severity Score and Area Score are performed separately for each of 
the four body regions: head (including neck), upper limbs, trunk (including axillae and 
groin), and lower limbs (including buttocks). 

Severity Score: the basic characteristics of psoriatic lesions – erythema (E), 
induration (I) and scaling (S) – provide a means for assessing the severity of lesions.  
In each body region, the severity of each sign is rated according to a 5-point scale: 
0, no involvement; 1, slight; 2, moderate; 3, marked; 4, very marked. 


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
Area Score (A): the extent (%) to which each of the four body regions is involved 
with psoriasis is categorized using a non-linear scaling method to a numerical Area 
Score according to the following scoring criteria: 0, no involvement; 1, >0 to 9%; 
2, 10 to 29%; 3, 30 to 49%; 4, 50 to 69%; 5, 70 to 89%; 6, 90 to 100% (percentage of 
body region, not whole body; estimated by the handprint method, ie, one handprint 
corresponds to approximately 10% of the head, or 5% of the upper limbs, or 3.3% of 
the trunk, or 2.5% of the lower limbs, as detailed in Section 7.1.2.3).
Calculating PASI
In each body region, the sum of the lesion Severity Scores for erythema, induration and 
scaling is multiplied by the Area Score which represents the percentage of this area involved 
by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower 
limbs 0.4).  The sum of the numbers obtained for each of the four body region is the PASI.
PASI= 0.1Ah(Eh+Ih+Sh) + 0.2Au(Eu+Iu+Su) + 0.3At(Et+It+St) + 0.4Al(El+Il+Sl)
where h = head and neck; u = upper limbs; t = trunk, l = lower limbs; A = Area Score; E = erythema;
I =induration; S = scaling.
The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores 
representing greater severity of psoriasis.
Table 5.
Component Scoring Criteria for the Psoriasis Area and Severity Index 
(PASI)
Component Score
Description
Erythema (E)
0
No involvement
None; may have residual hyperpigmentation
1
Slight
Pink or light red
2
Moderate
Darker pink-red
3
Marked
Red
4
Very Marked
Extremely red, “beefy” red
Induration (I)
0
No involvement
None
1
Slight
Minimal elevation relative to normal surrounding skin
2
Moderate
Easily palpable with rounded edges
3
Marked
Elevated with hard, sharp borders
4
Very Marked
Very elevated with very hard, sharp borders
Scaling (S)
0
No involvement
None
1
Slight
Mainly fine scale, some lesion partially covered
2
Moderate
Coarser thin scale, most lesions partially covered
3
Marked
Coarser thick scale, nearly all lesions covered, rough
4
Very Marked
Very thick scale, all lesions covered, very rough


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7.1.2.5. Nail Psoriasis Severity Index (NAPSI)
A target finger nail will be evaluated by the blinded assessor using the NAPSI scale.24  At the
baseline visit, the worst case fingernail should be chosen and the same nail evaluated
consistently through the entire study.  Each quadrant of the target nail is graded for nail
matrix psoriasis (including any of the following parameters: pitting, leukonychia, red spots in
lunula, nail plate crumbling) and nail bed psoriasis (including any of the following
parameters: onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, nail 
bed hyperkeratosis), giving that 1 target nail a score of 0-8.
7.1.3. Patient Report Outcomes (PROs)
All questionnaires should be completed by subjects prior to any procedures being performed 
at the study visit.  Forms should be checked by site staff for completeness.  In the unlikely 
event that a PRO questionnaire(s) is not able to be administered by study site staff and 
completed by the subject as directed at the clinic visit, the PRO questionnaire(s) should not 
be administered.  PRO questionnaires should also be reviewed for potential adverse events.  
The total completion time for all the PRO questionnaires is approximately 30 minutes.
7.1.3.1. Patient’s Assessment of Arthritis Pain
Subjects will assess the severity of their arthritis pain using a 100 mm visual analog scale
(VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which
corresponds to the magnitude of their pain.
MY PAIN AT THIS TIME IS:
(PLEASE MAKE AN X MARK ON THE LINE BELOW)
No Pain ________________________________________________________ Most Severe 
Pain
[Note: Scale will be 100 mm in length]
7.1.3.2. Patient’s Global Assessment of Arthritis
Subjects will answer the following question, “Considering all the ways your arthritis affects 
you, how are you feeling today?” The subject’s response will be recorded using a 100 mm 
visual analog scale (VAS).
CONSIDERING ALL THE WAYS YOUR ARTHRITIS AFFECTS YOU, HOW ARE YOU 
FEELING TODAY?
(PLEASE MAKE AN X MARK ON THE LINE BELOW)
Very Well ______________________________________________________ Very Poorly
[Note: Scale will be 100 mm in length]


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7.1.3.3. Health Assessment Questionnaire (HAQ) Disability Index (DI)
The HAQ-DI assesses the degree of difficulty a subject has experienced during the past week 
in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, 
hygiene, reach, grip, and other activities.25  Each activity category consists of 2-3 items.  For 
each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 
0 representing “no difficulty,” 1 as “some difficulty,” 2 as “much difficulty,” and 3 as 
“unable to do”.  Any activity that requires assistance from another individual or requires the 
use of an assistive device adjusts to a minimum score of 2 to represent a more limited 
functional status.  It can be completed in approximately 5 minutes.
7.1.3.4. Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS)
Subject’s perception of disease will be assessed using a 100 mm visual analog scale (VAS) 
by placing a mark on the scale between 0 (excellent) and 100 (poor).  The rating corresponds 
to the way in which the subject felt over the past week in terms of how they were affected by 
their: 1) psoriasis and arthritis (global, PGA); 2) arthritis only (PJA) and 3) psoriasis only 
(PSA).26
•
Global (PGA)
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
•
Joints (PJA)
In all the ways your ARTHRITIS affects you, how would you rate the way in which you felt 
over the past week?
Excellent ________________________________________________ Poor
•
Skin (PSA)
In all the ways your PSORIASIS affects you, how would you rate the way in which you felt 
over the past week?
Excellent _________________________________________________ Poor
[Note: Scale will be 100 mm in length]
 
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7.1.3.6. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue; a 
13-item FACIT Fatigue Scale)
The FACIT-Fatigue Scale is a patient completed questionnaire consisting of 13 items that 
assess fatigue.28  Subjects respond to each item on a 5-point scale based on their experience 
of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 
4 = very much).  Instrument scoring yields a range from 0 to 52 (negatively worded items 
were reversed during analysis), with higher scores representing better subject status (less 
fatigue).  It can be completed in 5 minutes.
7.1.3.7. Short-Form-36 Health Survey (SF-36) Version 2, Acute
The SF-36 v2 (Acute)29 is a 36-item generic health status measure.  It measures 8 general 
health domains: physical functioning, role limitations due to physical health, bodily pain, 
general health perceptions, vitality, social functioning, role limitations due to emotional 
problems, and mental health.  These domains can also be summarized as physical and mental 
component scores.  It can be completed in 5 to 10 minutes.
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
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7.1.4. Composite Efficacy Endpoints
7.1.4.1. American College of Rheumatology (ACR) response criteria
The American College of Rheumatology’s definition for calculating improvement in 
rheumatoid arthritis (ACR20) is calculated as a 20% improvement in tender and swollen 
joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: patient 
and physician global assessments, pain, disability, and an acute-phase reactant.33  Similarly, 
ACR50, 70 and 90 are calculated with the respective percent improvement. 
The specific components of the ACR Assessments that will be used in this study are:

Tender/painful joint Count (68);

Swollen Joint Count (66);

Patient’s Assessment of Arthritis Pain (VAS);

Patient’s Global Assessment of Arthritis (VAS);

Physician’s Global Assessment of Arthritis (VAS);

C-Reactive Protein (CRP);

Health Assessment Questionnaire – Disability Index (HAQ-DI).
This efficacy measurement will be calculated at every study visit during the treatment period.
7.1.4.2. Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA) Score
A psoriatic arthritis patient is defined as having Minimal Disease Activity (MDA)34 when the 
subject meets 5 of the 7 following criteria: 1) Tender/painful joint count 1; 2) swollen joint 
count 1; 3) PASI score 1 or BSA 3%; 4) Patient’s Assessment of Arthritis Pain (VAS) 
15; 5) Patient’s Global Assessment of Arthritis (VAS) 20; 6) HAQ-DI score 
0.5; 7) tender entheseal points (using Leed’s Enthesitis Index) 1.  A patient is in Very Low 
Disease Activity (VLDA) when all seven criteria are met.2  The MDA and VLDA will be 
calculated at every study visit during the treatment period except Week 2 visit.
7.1.4.3. Disease Activity Index for Reactive Arthritis/Psoriatic Arthritis
(DAREA/DAPSA)
DAREA/DAPSA is a composite instrument to assess peripheral joint involvement that is
based upon numerical summation of 5 variables of disease activity: tender/painful joint 
count + swollen joint count (using SJC66/TJC68 assessments), Patient’s Global Assessment 
of Arthritis (PtGA), Patient’s Assessment of Arthritis Pain (PAIN) and CRP (in mg/dL).  
Since DAREA reflects domains found important in PsA, it has been proposed to serve as a 
Disease Activity Index for Psoriatic Arthritis (DAPSA). DAREA/DAPSA is calculated as 
follows:
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DAREA/DAPSA will be calculated at every study visit during the treatment period except 
Week 2 visit.
7.1.4.4. Disease Activity Score-28 (DAS28)
The Disease Activity Score-28 (DAS28)35 is a derived measurement with differential 
weighting given to each component.  DAS28 (CRP) will be calculated from measurements 
made at study visits.  The components of the DAS28 (CRP) arthritis assessment are: 
Tender/Painful Joint Count (28), Swollen Joint Count (28), and C-Reactive Protein (CRP).  
DAS28 will be calculated at every study visit during the treatment period.
7.1.4.5. Psoriatic Arthritis Response Criteria (PsARC)
The PsARC consists of 4 measurements:36,37 Tender/painful joint count (68), Swollen joint 
count (66), Physician’s Global Assessment of Arthritis (VAS), and Patient’s Global
Assessment of Arthritis (VAS).  The same tender/painful joint count and swollen joint count 
used for ACR response criteria will be applied to the PsARC.  In order to be a ‘PsARC 
responder’, subjects must achieve improvement in 2 of 4 measures, one of which must be
joint pain or swelling, without worsening in any measure.  PsARC will be calculated at every
study visit during the treatment period except Week 2 visit.
 
 
 
 
 
7.1.4.7. Psoriatic Arthritis Disease Activity Score (PASDAS)
PASDAS is a composite PsA disease activity score that includes the following components: 
Patient’s Global Joint and Skin Assessment (VAS), Physician’s Global Assessment of 
Psoriatic Arthritis (VAS), swollen and Tender/painful joint counts (66/68), Leeds Enthesitis 
Index score, tender dactylitic digit score, physical component summary (PCS) score of SF-36 
and CRP.  PASDAS will be calculated at every study visit during the treatment period except 
Week 2 visit.
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7.2. Safety Assessments
Safety will be assessed by the spontaneous reporting of adverse events (AEs), physical 
examinations and clinical laboratory results in all subjects who receive at least one dose of 
study drug.  Investigators and Pfizer clinicians will review individual subject data throughout 
the conduct of the study to ensure the subjects’ well-being.
7.2.1. Laboratory
The following safety laboratory tests will be performed at times defined in the Schedule of 
Activities section of this protocol.  Additional laboratory results may be reported on these 
samples as a result of the method of analysis or the type of analyzer used by the clinical 
laboratory; or as derived from calculated values.  These additional tests would not require 
additional collection of blood. 
Unscheduled clinical laboratory measurements may be obtained at any time during the study 
to assess any perceived safety concerns (for laboratory abnormalities require prompt 
re-testing, see Appendix 7, Laboratory Abnormalities Require Re-Testing).
Laboratory Tests
Hematology
Chemistry
Urinalysise
Other
Hemoglobin
Hematocrit
RBC count and indices
(MCH, MCHC, MCV, RBC 
Morphology)
Reticulocytes count 
WBC count with differential
Neutrophils (%, Abs)
Eosinophils (%, Abs)
Monocytes (%, Abs)
Basophils (%, Abs)
Lymphocytes (%, Abs)
Platelet count
Activated Partial
Thromboplastin Time
(APTT), Prothrombin
Time/International
Normalized Ratio
(PT/INR)
BUN/urea
Creatinine
Cystatin C
Glucose
Calcium
Sodium
Potassium
Chloride
Total CO2 (Bicarbonate)
Albumin
Total protein
Alanine transaminase (ALT)
Aspartate transaminase (AST)
Total Bilirubin
Direct bilirubina
Alkaline phosphatase
Uric acid
Creatine kinase (CK)
CK fractionationb
Total Cholesterolc
Triglyceridesc
HDLc
LDLc
Rheumatoid Factor (RF)d
Cyclic Citrullinated Peptide 
(CCP) Antibodiesd
pH
Glucose (qual)
Protein (qual)
Blood (qual)
Ketones
Nitrites
Leukocyte esterase
Urobilinogen
Urine bilirubin
Microscopy and/or 
culturef
FSHd,g
Pregnancy test (β-hCG)h
Hepatitis B, C and HIVd
QFT-G or other IGRAd
hsCRPi
FACS-TBNK
Viral Surveillance (EBV,
CMV, HSV1, HSV2,
VZV)j
Skin swabs for
herpetiform rashj
Urine Myoglobink
a.
Only if total bilirubin is elevated.
b.
Only if CK is elevated.
c.
Fasting (water only), 8 hours prior to collection.
d.
At screening only.
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e.
Dipstick in all cases.
f.
Only if urine dipstick is positive for blood, protein, nitrites or leukocyte esterase.  Urine culture is 
performed if urinalysis is positive for nitrite and/or leukocyte esterase or if clinically indicated.
g.
For confirmation of postmenopausal status only, in females who are amenorrheic for at least 12 consecutive 
months. 
h.
Pregnancy tests (serum/urine) for females of childbearing potential.  Serum pregnancy test must be 
performed at Screening.
i.
Blood samples will be collected at each visit for analysis of CRP using an assay analyzed by the central 
laboratory.  The investigator and sponsor will be kept blinded to the results of this test at all visits except 
the Screening Visit.
j.
When required in cases of suspected herpetiform rash (eg, suspected herpes zoster and herpes simplex) a 
skin swab and additional blood viral surveillance sample will be collected. Blood viral surveillance sample 
will also be collected at Baseline Day 1.
k.
At Screening, Baseline Day 1/Randomization and in case of CK >3x ULN.
7.2.2. Pregnancy Testing
All pregnancy tests used in this study, either urine or serum, must have a sensitivity of at
least 25 mIU/mL and must be performed by a certified laboratory.
For female subjects of childbearing potential, 2 negative pregnancy tests are required before 
receiving investigational product/study treatment(s) (1 negative serum pregnancy test at 
screening and 1 negative urine pregnancy test at the baseline visit immediately before 
investigational product/study treatment administration).  Following a negative pregnancy test 
result at screening, appropriate contraception must be commenced and the second negative 
pregnancy test result will then be required at the baseline visit and within 5 days after the first 
day of the menstrual period (counting the first day of the menstrual period as Day 1) before 
the subject may receive the investigational product/study treatment.  In the absence of regular 
menstrual bleeding, the study candidate should have used 2 forms of contraception for at 
least 1 month before the second pregnancy test. 
Pregnancy tests will also be repeated at every visit and at the end of the study to confirm that
the subject has not become pregnant during the study. Pregnancy tests will also be done 
whenever 1 menstrual cycle is missed during the active treatment period and when potential 
pregnancy is otherwise suspected, and may be repeated if requested by institutional review
boards (IRBs)/ethics committees (ECs) or if required by local regulations.  In the case of a 
positive confirmed pregnancy, the subject will be withdrawn from administration of 
investigational product and from the study.
7.2.3. Serum Creatinine, Serum Cystatin C and Estimated Glomerular Filtration Rate 
(eGFR)
Serum creatinine is the best known standard test for monitoring renal function.  However, 
serum creatinine based estimates of glomerular filtration rate (eGFR) may be affected by 
factors other than renal function, including chronic and acute illness.  Cystatin C is a test that 
can be used either as an adjunct to or a replacement for serum creatinine.  The most reliable 
estimates of glomerular filtration rate (GFR) use both test results.39


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Cystatin C is a low molecular weight protein that is used as an alternative to serum creatinine 
for monitoring of renal function.  It seems to correlate more closely with GFR than does 
serum creatinine concentration and may be a more sensitive detector of early renal 
dysfunction.  While use of cystatin C has been limited, its independence of demographic 
factors (eg, race) has made it an interesting means of determining changes in renal function 
in clinical settings and it is included in the 2012 Kidney Disease: Improving Global 
Outcomes (KDIGO) guidelines.40  Estimated GFR may be calculated via the 2012 Chronic 
Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine, cystatin C, and 
creatinine-cystatin C equations.41
Serum creatinine will be measured as part of serum chemistry at times specified in the 
Schedule of Activities section of the protocol and serum creatinine based eGFR will be 
calculated.  Creatinine elevations above the ULN will be followed until resolution or 
baseline. 
Serum cystatin C will be measured at times specified in the Schedule of Activities section of 
the protocol and cystatin C based eGFR will be calculated. 
The eGFR will be calculated using the 2 sets of equations developed by the CKD-EPI, which 
utilize serum creatinine (SCr) and serum cystatin C respectively.41,42

The CKD-EPI creatinine equation (2009) expressed as a single equation:41
141 x min(SCr/κ, 1)a x max(SCr/κ, 1)-1.209 × 0.993Age [x 1.018 if female] [x 1.159 if 
black], where SCr is serum creatinine, κ is 0.7 for females and 0.9 for males, is 
-0.329 for females and -0.411 for males, min is the minimum of SCr/κ or 1, and 
max is the maximum of SCr/κ or 1.

The CKD-EPI cystatin C equation (2012) expressed as a single equation:41
133 x min(Scys/0.8, 1)-0.499 x max (Scys/0.8, 1)-1.328 × 0.996Age [× 0.932 if female], 
where Scys is serum cystatin C, min indicates the minimum of SCr/κ or 1, and 
max indicates the maximum of Scys/κ or 1.
7.2.4. Tuberculosis Testing 
Interferon-Gamma Release Assays (IGRAs) are blood tests for TB infection.  Subjects may 
be screened for TB using an IGRA per local guidelines.  IGRA will be tested at Screening or 
within 12 weeks prior to Day 1.  The following are acceptable IGRA assays:
QuantiFERON®-TB Gold Plus test, QuantiFERON-TB Gold test (QFT-G), 
QuantiFERON-TB Gold In-Tube test (QFT-GIT), and T-SPOTTB test (T-Spot).  Site 
personnel should follow the processing and analyses steps based on the assay chosen.  Ensure 
incubation steps are followed as appropriate.
An IGRA is preferred for subjects with a prior Bacillus Calmette-Guerin (BCG) vaccination, 
but may be used for any subject.  Documentation of IGRA product used and the test result 
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If the results of the IGRA are indeterminate, the test may be repeated, and if a negative result 
is obtained, enrollment may proceed.  A positive test on repeat is exclusionary.
Subjects with repeat indeterminate IGRA results may be enrolled after consultation with 
pulmonary or infectious disease specialist that determines low risk of infection (ie, subject 
would be acceptable for immunosuppressant (eg, anti-TNF) treatment without additional 
action).
Subjects who test positive for QFT-G/QFT-GIT test, but in the opinion of the PI are at low 
risk of TB infection may be referred to pulmonary or infectious disease specialist for 
consultation and potential IGRA test repeated once.  Subjects will be eligible if the repeat test 
is negative before the randomization.
Refer to lab manual for any additional processing information and shipping instructions.
7.2.5. Herpetiform Skin Rash Surveillance
For any occurrence of a suspected herpetiform rash (eg, herpes zoster and herpes simplex), 
additional specimens for viral DNA analysis will be obtained for confirmation.  An 
additional blood viral surveillance sample will be collected for the analysis of viral load for 
the relevant viruses.  A swab of the affected area will also be collected and sent for the 
analysis of viral load for HSV1, HSV2, and VZV.  Details for these collections will be 
provided in the laboratory manual.
7.2.6. Medical History, Physical Examination, Height and Weight
Medical history will include history of drug, alcohol and tobacco use. Medical history 
includes herpes zoster details.  Medical history also includes collection of details on 
(i) Family history of diabetes mellitus, hypertension, and premature coronary heart disease 
(CHD), where premature CHD is defined as (a) CHD in a male first degree relative <55 years 
of age, or (b) CHD in a female first degree relative <65 years of age, (ii) Any prior 
rheumatologist confirmed diagnosis of rheumatoid arthritis, (iii) Any prior diagnosis of dry 
eye disease/syndrome, and (iv) Any previous history of liver biopsy.  Smoking status and 
average weekly alcohol consumption (units/week) will also be collected, where a unit 
contains 12 g of pure alcohol, an amount equivalent to that contained in 5 oz (a glass) of 
wine, 12 oz of beer, or 1.5 oz of 90 proof of spirits.  Medical History will be collected at the 
Screening visit, and reviewed at Baseline Day 1 visit of any changes (any AEs happened 
before the first dosing should be reflected on the medical history).
Complete physical examinations must be performed by the investigator, sub-investigator, or 
a qualified healthcare professional per local guidelines.  A complete physical examination 
will include height (at Screening Visit only), weight, general appearance, skin (presence of 
rash), HEENT (head, eyes, ears, nose and throat), lungs (auscultation), heart (auscultation for 
presence of murmurs, gallops, rubs), lower extremities (presence of peripheral edema), 
abdomen (palpation and auscultation), neurologic (mental status, station, gait, reflexes, motor 
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Targeted physical examinations must be performed by the investigator, sub-investigator, or a 
qualified healthcare professional per local guidelines.  Targeted physical examination 
consists of skin, heart, lungs, abdomen, and examination of body systems where there are 
symptom complaints by the subject.
Complete and Targeted physical examinations are performed at specified time points (see
Schedule of Activities).
Height and weight will be measured without the subject wearing shoes.
7.2.7. Vital Sign Measurements (Blood pressure, pulse rate, and temperature)
Single sitting blood pressure (BP), pulse rate, and temperature will be measured at times
specified in the Schedule of Activities.  Additional collection times or changes to collection 
times will be permitted, as necessary to ensure appropriate collection of safety data.
Sitting blood pressure will be measured with the subject’s arm supported at the level of the 
heart, and recorded to the nearest mm Hg.  It is preferred that the same arm (preferably the 
dominant arm) be used throughout the study.  All blood pressure in this study will be 
measured with the subject in the sitting position after resting for at least 5 minutes.  The same 
size BP cuff, which has been properly sized and calibrated, should be used to measure BP 
each time. 
When the timing of the vital sign measurements coincides with a blood collection, it is 
preferred that vital signs be obtained prior to the nominal time of blood collection.
It is preferred that body temperature be collected using tympanic, oral, or axillary methods 
and that the same method be used consistently throughout the study.
7.2.8. Electrocardiogram
Twelve (12) lead ECGs should be collected at times specified in the Schedule of Activities.  
Additional ECG may be performed upon request by the sponsor clinician.
At the Screening Visit, a single ECG will be collected. Subjects with screening QTcF 
>450 milliseconds (msec) should be excluded.  If the QTcF exceeds 450 msec, the ECG 
should be repeated two more times and the average of the three QTcF should be used to 
determine the subject eligibility. On Day 1 only, triplicate ECGs will be obtained
approximately 2-4 minutes apart, and the average of the triplicate ECG measurements will 
serve as each subject’s baseline value. At the Week 2 visit only, a single ECG will be 
collected between 2-4 hours postdose. At all the other visits specified, a single ECG will be 
collected pre-dose or post-dose.
All scheduled ECGs should be performed after the subject has rested quietly for at least 
10 minutes in a supine position.  When the timing of these measurements coincides with a 
blood collection, the ECG should be obtained prior to the nominal time of the blood 
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ECGs will be read and interpreted locally and centrally.  Locally read ECG parameters (heart 
rate, QT, QTcF, PR and QRS intervals) should also be recorded on the Case Report Form 
(CRF). A copy of the ECG should be available as source documents for review. 
To ensure safety of the subjects, a qualified individual (eg, sub-investigator) at the 
investigator site will make comparisons to baseline measurements taken at Day 1. 
In some cases, it may be appropriate to repeat abnormal ECGs to rule out improper lead 
placement as contributing to the ECG abnormality.  It is important that leads are placed in the 
same positions each time in order to achieve precise ECG recordings. If a machine-read QTc
value is prolonged, repeat measurements may not be necessary if a qualified physician’s 
interpretation determines that the QTc values are in the acceptable range.
7.2.9. Chest Radiograph
Chest x-ray (posterior-anterior and lateral views are recommended however local guidelines 
should be followed) or other appropriate diagnostic image (ie, computed tomography [CT] or 
magnetic resonance imaging [MRI]) with no current evidence of untreated latent or active 
TB infection or evidence of currently active TB, general infections, heart failure or 
malignancy taken at screening or within the 12 weeks prior to Screening and read by a 
qualified radiologist.  Documentation of the official reading must be located and available in 
the source documentation.
7.2.10. Events for Adjudication/Review Committee Submission
The identification of events requiring submission to external adjudication committees for 
review will be made by the study site and communicated to Pfizer or designee.  Events 
requiring review, including opportunistic infections, malignancy and cardiovascular events 
may also be identified by the Pfizer Study Team or designee during the blinded review of 
subject data listings or by site monitors during routine monitoring of subject’s study records. 
The Pfizer Study Team or designee will notify the study site of any events should they be 
identified.
The Pfizer Study Team or designee will provide a listing of specific documents needed to 
support event adjudication by the Adjudication/Review Committees. Obtaining and 
submitting the documentation will be the responsibility of the study site.  Event 
documentation will vary with the event requiring adjudication and may include (but not be 
limited to): hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic 
tests, pathology reports, autopsy reports and death certificate information, as applicable.
 
 
 
 
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7.3.1. High-Sensitivity C-Reactive Protein (hsCRP)
Blood samples for determination of hsCRP will be obtained at the times specified in the
Schedule of Activities.
Instructions and supplies for collection, processing, and shipment of samples will be supplied 
under separate cover by Pfizer, the designated laboratory vendor, and the vendor laboratory 
manual.
 
 
 
7.3.3. Viral Surveillance
Blood sample for the analysis of CMV (cytomegalovirus), EBV, HSV-1, HSV-2 and VZV 
(varicella zoster virus) will be collected according to the times outlined in the Schedule of 
Activities.  Additional sample collection instructions will be provided in the lab manual.
Note: Due to long turnaround time, the retrospective nature of these labs might make their 
reporting time quite delayed.
In addition to time points specified, a plasma sample for viral surveillance sample will also 
be taken at the time of an adverse event, as clinically appropriate.
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7.6. Rater (Assessor) Qualifications 
For specific rating assessments, only qualified raters will be allowed to evaluate and/or rate 
subjects in this study.  The minimum qualifications a rater must meet for each study rating 
assessment will be outlined in the Assessor Qualification Requirements provided to each 
participating site.  The level of experience with the target population, specific scale 
experience (or equivalent), and certification required (if applicable) will be listed and used to 
determine whether a rater is approved for a given assessment.  Proposed raters who do not 
meet specific criteria but who may be qualified based on unique circumstances may be 
individually reviewed by the study clinical team to determine whether or not a waiver may be
issued.  The rater must become certified to perform selected study assessments before he or 
she can participate in the conduct of the study.  For specifically defined assessments, rater 
training and standardization exercises may be conducted, and written and signed 
documentation will be provided by the site for each rater’s certification.  In return, each site 
will be provided written and signed documentation outlining each rater’s certification for 
specific study assessments.  Recertification may be required at periodic intervals during the 
study.  The raters who administer specific study assessments will be documented in a 
centralized location and all site staff who administer ratings will be verified in the site study 
documentation during the conduct of the study.
Individuals who perform the Physician’s Global Assessment of Arthritis and Physician’s 
Global Assessment of PsA must be a physician or other healthcare professional who is 
competent to perform the assessments.  Individuals who perform Physician’s Global 
Assessment of Psoriasis will be similarly qualified, however, with previous psoriasis clinical 
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experience.  The following procedures require a health care professional who is competent to 
perform the assessments: Tender/painful joint count; swollen joint count; assessment of 
dactylitis; assessment of enthesitis; PASI, BSA; NAPSI.
Completion of the study “Delegation Log” (including date of training completion) for the 
assessors will constitute verification that the individual is competent to conduct these 
assessments.
8. ADVERSE EVENT REPORTING
8.1. Requirements
The table below summarizes the requirements for recording safety events on the CRF and for 
reporting safety events on the Clinical Trial (CT) Serious Adverse Event (SAE) Report Form 
to Pfizer Safety.  These requirements are delineated for 3 types of events: (1) SAEs; 
(2) non-serious adverse events (AEs); and (3) exposure to the investigational product under 
study during pregnancy or breastfeeding, and occupational exposure. 
Safety Event
Recorded on the CRF
Reported on the CT SAE 
Report Form to Pfizer Safety 
Within 24 Hours of 
Awareness
SAE
All
All
Non-serious AE
All
None
Exposure to the 
investigational product 
under study during 
pregnancy or breastfeeding, 
and occupational exposure
All (regardless of whether 
associated with an AE), except 
occupational exposure
Exposure during pregnancy, 
exposure via breastfeeding, 
occupational exposure 
(regardless of whether 
associated with an AE)
All observed or volunteered events regardless of treatment group or suspected causal 
relationship to the investigational product(s) will be reported as described in the following 
paragraphs.
Events listed in the table above that require reporting to Pfizer Safety on the CT SAE Report 
Form within 24 hours of awareness of the event by the investigator are to be reported 
regardless of whether the event is determined by the investigator to be related to an
investigational product under study.  In particular, if the SAE is fatal or life-threatening, 
notification to Pfizer Safety must be made immediately, irrespective of the extent of available 
event information.  This time frame also applies to additional new (follow-up) information on 
previously forwarded reports.  In the rare situation that the investigator does not become 
immediately aware of the occurrence of an event, the investigator must report the event 
within 24 hours after learning of it and document the time of his/her first awareness of the 
event.
For each event, the investigator must pursue and obtain adequate information both to 
determine the outcome and to assess whether it meets the criteria for classification as an SAE 
(see the Serious Adverse Events section below).  In addition, the investigator may be 
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This information is more detailed than that recorded on the CRF.  In general, this will include 
a description of the event in sufficient detail to allow for a complete medical assessment of 
the case and independent determination of possible causality.  Any information relevant to 
the event, such as concomitant medications and illnesses, must be provided.  In the case of a 
subject death, a summary of available autopsy findings must be submitted as soon as possible 
to Pfizer Safety.  Any pertinent additional information must be reported on the CT SAE 
Report Form; additional source documents (eg, medical records, CRF, laboratory data) are to 
be sent to Pfizer Safety ONLY upon request.
As part of ongoing safety reviews conducted by the sponsor, any non-serious AE that is 
determined by the sponsor to be serious will be reported by the sponsor as an SAE.  To assist 
in the determination of case seriousness, further information may be requested from the 
investigator to provide clarity and understanding of the event in the context of the clinical 
study.
8.1.1. Additional Details on Recording Adverse Events on the CRF
All events detailed in the table above will be recorded on the AE page(s) of the CRF.  It 
should be noted that the CT SAE Report Form for reporting of SAE information is not the 
same as the AE page of the CRF.  When the same data are collected, the forms must be 
completed in a consistent manner.  AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE Report 
Form for reporting of SAE information.
8.1.2. Eliciting Adverse Event Information
The investigator is to record on the CRF all directly observed AEs and all AEs spontaneously 
reported by the study subject.  In addition, each study subject will be questioned about the 
occurrence of AEs in a non-leading manner.
8.1.3. Withdrawal from the Study Due to Adverse Events (see also the Subject 
Withdrawal section)
Withdrawal due to AEs should be distinguished from withdrawal due to other causes,
according to the definition of AE noted below, and recorded on the CRF. 
When a subject withdraws from the study because of an SAE, the SAE must be recorded on 
the CRF and reported, as appropriate, on the CT SAE Report Form, in accordance with the 
Requirements section above.
8.1.4. Time Period for Collecting AE/SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each subject begins from the time the subject provides informed consent, which 
is obtained before the subject’s participation in the study (ie, before undergoing any 
study-related procedure and/or receiving investigational product), through and including a 
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For subjects who are screen failures, the active collection period ends when screen failure 
status is determined.
8.1.4.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a subject during the active collection period are reported to Pfizer 
Safety on the CT SAE Report Form.
SAEs occurring in a subject after the active collection period has ended are reported to Pfizer 
Safety if the investigator becomes aware of them; at a minimum, all SAEs that the 
investigator believes have at least a reasonable possibility of being related to investigational 
product must be reported to Pfizer Safety.
Follow up by the investigator continues throughout and after the active collection period and 
until the event or its sequelae resolve or stabilize at a level acceptable to the investigator, and 
Pfizer concurs with that assessment.
8.1.4.2. Recording Non-serious AEs and SAEs on the CRF
During the active collection period, both non-serious AEs and SAEs are recorded on the 
CRF.
Follow-up by the investigator may be required until the event or its sequelae resolve or 
stabilize at a level acceptable to the investigator, and Pfizer concurs with that assessment.
8.1.5. Causality Assessment
The investigator’s assessment of causality must be provided for all AEs (serious and 
non-serious); the investigator must record the causal relationship on the CRF, and report such 
an assessment in accordance with the SAE reporting requirements, if applicable.  An 
investigator’s causality assessment is the determination of whether there exists a reasonable 
possibility that the investigational product caused or contributed to an AE; generally the facts 
(evidence) or arguments to suggest a causal relationship should be provided.  If the 
investigator does not know whether or not the investigational product caused the event, then 
the event will be handled as “related to investigational product” for reporting purposes, as 
defined by the sponsor.  If the investigator's causality assessment is “unknown but not 
related” to investigational product, this should be clearly documented on study records. 
In addition, if the investigator determines that an SAE is associated with study procedures, 
the investigator must record this causal relationship in the source documents and CRF, and 
report such an assessment in the dedicated section of the CT SAE Report Form and in 
accordance with the SAE reporting requirements.
8.1.6. Sponsor’s Reporting Requirements to Regulatory Authorities
AE reporting, including suspected unexpected serious adverse reactions, will be carried out
in accordance with applicable local regulations.


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8.2. Definitions
8.2.1. Adverse Events
An AE is any untoward medical occurrence in a study subject administered a product or 
medical device; the event need not necessarily have a causal relationship with the treatment 
or usage.  Examples of AEs include, but are not limited to: 

Abnormal test findings;

Clinically significant signs and symptoms;

Changes in physical examination findings;

Hypersensitivity;

Progression/worsening of underlying disease;

Drug abuse;

Drug dependency.
Additionally, AEs may include signs and symptoms resulting from:

Drug overdose;

Drug withdrawal;

Drug misuse; 

Drug interactions;

Extravasation;

Exposure during pregnancy (EDP);

Exposure via breastfeeding;

Medication error;

Occupational exposure.
8.2.2. Abnormal Test Findings
Abnormal objective test findings should be recorded as AEs when any of the following 
conditions are met: 

Test result is associated with accompanying symptoms; and/or

Test result requires additional diagnostic testing or medical/surgical intervention; 
and/or


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
Test result leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional concomitant 
drug treatment, or other therapy; and/or

Test result is considered to be an AE by the investigator or sponsor.
Merely repeating an abnormal test, in the absence of any of the above conditions, does not 
constitute an AE.  Any abnormal test result that is determined to be an error does not require 
recording as an AE.
8.2.3. Serious Adverse Events
A serious adverse event is any untoward medical occurrence at any dose that:

Results in death;

Is life-threatening (immediate risk of death);

Requires inpatient hospitalization or prolongation of existing hospitalization;

Results in persistent or significant disability/incapacity (substantial disruption of the 
ability to conduct normal life functions);

Results in congenital anomaly/birth defect.
Or that is considered to be:

An important medical event.
Medical and scientific judgment is exercised in determining whether an event is an important 
medical event.  An important medical event may not be immediately life-threatening and/or 
result in death or hospitalization.  However, if it is determined that the event may jeopardize 
the subject or may require intervention to prevent one of the other AE outcomes, the 
important medical event should be reported as serious.
Examples of such events are intensive treatment in an emergency room or at home for 
allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; 
or development of drug dependency or drug abuse.
8.2.4. Hospitalization
Hospitalization is defined as any initial admission (even less than 24 hours) in a hospital or 
equivalent healthcare facility, or any prolongation of an existing admission.  Admission also 
includes transfer within the hospital to an acute/intensive care unit (eg, from the psychiatric 
wing to a medical floor, medical floor to a coronary care unit, or neurological floor to a 
tuberculosis unit).  An emergency room visit does not necessarily constitute a hospitalization;
however, the event leading to the emergency room visit is assessed for medical importance.


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Hospitalization does not include the following:

Rehabilitation facilities;

Hospice facilities;

Respite care (eg, caregiver relief);

Skilled nursing facilities;

Nursing homes;

Same-day surgeries (as outpatient/same-day/ambulatory procedures).
Hospitalization or prolongation of hospitalization in the absence of a precipitating clinical 
AE is not in itself an SAE.  Examples include:

Admission for treatment of a preexisting condition not associated with the 
development of a new AE or with a worsening of the preexisting condition (eg, for 
workup of a persistent pretreatment laboratory abnormality);

Social admission (eg, subject has no place to sleep);

Administrative admission (eg, for yearly physical examination);

Protocol-specified admission during a study (eg, for a procedure required by the study 
protocol);

Optional admission not associated with a precipitating clinical AE (eg, for elective 
cosmetic surgery);

Hospitalization for observation without a medical AE;

Preplanned treatments or surgical procedures.  These should be noted in the baseline 
documentation for the entire protocol and/or for the individual subject.
Diagnostic and therapeutic noninvasive and invasive procedures, such as surgery, should not 
be reported as SAEs.  However, the medical condition for which the procedure was 
performed should be reported if it meets the definition of an SAE.  For example, an acute 
appendicitis that begins during the reporting period should be reported if the SAE 
requirements are met, and the resulting appendectomy should be recorded as treatment of the 
AE.


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8.3. Severity Assessment
If required on the AE page of the CRF, the investigator will use the adjectives MILD, 
MODERATE, or SEVERE to describe the maximum intensity of the AE.  For purposes of 
consistency, these intensity grades are defined as follows:
MILD
Does not interfere with subject's usual function.
MODERATE
Interferes to some extent with subject's usual function.
SEVERE
Interferes significantly with subject's usual function.
Note the distinction between the severity and the seriousness of an AE.  A severe event is not 
necessarily an SAE.  For example, a headache may be severe (interferes significantly with 
the subject's usual function) but would not be classified as serious unless it met one of the 
criteria for SAEs, listed above.
8.4. Special Situations
8.4.1. Protocol-Specified Serious Adverse Events
There are no protocol-specified SAEs in this study.  All SAEs will be reported to Pfizer 
Safety by the investigator as described in previous sections, and will be handled as SAEs in 
the safety database. 
8.4.2. Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury, but adapt 
are termed “adaptors.”  In some subjects, transaminase elevations are a harbinger of a more 
serious potential outcome.  These subjects fail to adapt and therefore are "susceptible" to 
progressive and serious liver injury, commonly referred to as drug-induced liver injury 
(DILI).  Subjects who experience a transaminase elevation above 3 times the upper limit of
normal (× ULN) should be monitored more frequently to determine if they are an “adaptor” 
or are “susceptible.”
In the majority of DILI cases, elevations in aspartate aminotransferase (AST) and/or alanine 
aminotransferase (ALT) precede total bilirubin (TBili) elevations (>2 × ULN) by several 
days or weeks.  The increase in TBili typically occurs while AST/ALT is/are still elevated 
above 3 × ULN (ie, AST/ALT and TBili values will be elevated within the same lab sample).  
In rare instances, by the time TBili elevations are detected, AST/ALT values might have 
decreased.  This occurrence is still regarded as a potential DILI.  Therefore, abnormal 
elevations in either AST OR ALT in addition to TBili that meet the criteria outlined below 
are considered potential DILI (assessed per Hy’s law criteria) cases and should always be 
considered important medical events, even before all other possible causes of liver injury 
have been excluded.


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The threshold of laboratory abnormalities for a potential DILI case depends on the subject’s 
individual baseline values and underlying conditions.  Subjects who present with the 
following laboratory abnormalities should be evaluated further as potential DILI
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory
values:

Subjects with AST/ALT and TBili baseline values within the normal range who 
subsequently present with AST OR ALT values >3 × ULN AND a TBili value 
>2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available;

For subjects with baseline AST OR ALT OR TBili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed, 
depending on which values are above the ULN at baseline:

Preexisting AST or ALT baseline values above the normal range: AST or ALT 
values >2 times the baseline values AND >3 × ULN; or >8 × ULN (whichever is 
smaller);

Preexisting values of TBili above the normal range: TBili level increased from 
baseline value by an amount of at least 1 × ULN or if the value reaches 
>3 × ULN (whichever is smaller).
Rises in AST/ALT and TBili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor. 
The subject should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results.  This evaluation should 
include laboratory tests, detailed history, and physical assessment. 
In addition to repeating measurements of AST and ALT and TBili, laboratory tests should 
include albumin, creatine kinase (CK), direct and indirect bilirubin, gamma-glutamyl 
transferase (GGT), prothrombin time (PT)/international normalized ratio (INR), total bile 
acids, alkaline phosphatase and acetaminophen drug and/or protein adduct levels.  
Consideration should also be given to drawing a separate tube of clotted blood and an 
anticoagulated tube of blood for further testing, as needed, for further contemporaneous 
analyses at the time of the recognized initial abnormalities to determine etiology.  A detailed 
history, including relevant information, such as review of ethanol, acetaminophen (either by 
itself or as a coformulated product in prescription or over-the-counter medications), 
recreational drug, supplement (herbal) use and consumption, family history, sexual history, 
travel history, history of contact with a jaundiced person, surgery, blood transfusion, history 
of liver or allergic disease, and potential occupational exposure to chemicals, should be 
collected.  Further testing for acute hepatitis A, B, C, D, and E infection and liver imaging 
(eg, biliary tract) may be warranted. 


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All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
TBili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the liver function test (LFT) abnormalities has yet been found.  Such 
potential DILI (Hy’s law) cases are to be reported as SAEs, irrespective of availability 
of all the results of the investigations performed to determine etiology of the LFT 
abnormalities.
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.
8.4.3. Potential Cases of Decreased eGFR
In First in Human (FIH) study B7931001, serum creatinine elevation was reported across 
dose levels in healthy volunteer and psoriasis patients.  The proposed mechanism for the 
observed serum creatinine increases in study B7931001 is inhibition of creatinine transport in 
the kidney (ie, transporter-mediated rather than direct nephrotoxicity).
All subjects will have serum creatinine based and serum cystatin-C based eGFR calculated at 
baseline upon entry into the study.
Abnormal values in serum creatinine concurrent with absence of increase in blood urea
nitrogen (BUN) that meet the below criteria, in the absence of other causes of kidney injury,
are considered potential cases of acute kidney injury and should be considered important 
medical events.
If an individual subject demonstrates a CONCOMITANT serum creatinine based AND
serum cystatin C based eGFR decline of 30% compared to the subject’s baseline eGFR, 
then the subject should not be further dosed and adequate, immediate, supportive measures 
including immediate evaluation by a nephrologist (preferably within 24 hours) with
appropriate management and treatment as clinically indicated.  Results should be repeated 
as indicated by the nephrologist or weekly at a minimum until the eGFR returns to baseline 
15% or the renal parameters are deemed to be stable by the nephrologist and/or PI.
If the subject cannot be seen by a nephrologist within 24 hours (as described above), 
then the subject should be sent to a local emergency room for evaluation and treatment 
as clinically indicated.
Subjects should return to the investigational site and be evaluated as soon as possible,
preferably within 24-48 hours from awareness of the abnormal eGFR result 
(CONCOMITANT serum creatinine based AND serum cystatin C based eGFR decline of 
30% compared to the subject’s baseline eGFR) for a safety follow-up visit.  This evaluation 
should include laboratory tests, detailed history, and physical assessment.  In addition to 
repeating serum creatinine and serum cystatin C, laboratory tests should also include: serum 
BUN, serum CK, serum electrolytes (including at a minimum potassium, sodium, 
phosphate/phosphorus, calcium), in addition to urine dipstick, urine microscopic 
examination, and urinary indices.  All cases confirmed on repeat testing as meeting the 
laboratory criteria for acute kidney injury, with no other cause(s) of laboratory abnormalities 


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identified should be considered as potential cases of drug-induced kidney injury irrespective 
of availability of all the results of the investigations performed to determine etiology of the 
abnormal serum creatinine.
All relevant test results will be forwarded to Pfizer for review immediately upon receipt by 
the PI.
This requirement applies to all subjects.
8.4.4. Infections
All treated infections occurring during the study, including, but not limited to, respiratory
infections, cutaneous infections, urinary tract infections and episodes of suspicious or febrile 
diarrhea, should be cultured and any identified organisms noted in the Case Report Form.  
Infections should be classified as either serious infections or treated infections, as defined
below.
8.4.4.1. Serious Infections
A serious infection is any infection that requires hospitalization for treatment or requires
parenteral antimicrobial therapy or meets other criteria that require it to be classified as a
serious adverse event.  A subject who experiences a serious infection should be discontinued
from the study and the serious adverse event should be listed as the reason for
discontinuation in the Case Report Form.  Appropriate laboratory investigations, including
but not limited to cultures should be performed to establish the etiology of any serious
infection.  All adverse events, including serious adverse events, should be reported as
described in Section 8 on ADVERSE EVENT REPORTING.
8.4.4.2. Treated Infections
A treated infection is any infection that requires antimicrobial therapy by any route of
administration or any surgical intervention (eg, incision and drainage).  Subjects who
experience infections that require treatment can have their blinded study drug temporarily
discontinued during antimicrobial therapy in consultation with the sponsor. This information
should be noted in the Case Report Form.
8.4.5. Exposure to the Investigational Product during Pregnancy or Breastfeeding, and 
Occupational Exposure
Exposure to the investigational product under study during pregnancy or breastfeeding and 
occupational exposure are reportable to Pfizer Safety within 24 hours of investigator 
awareness.


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8.4.5.1. Exposure During Pregnancy
For both unapproved/unlicensed products and for marketed products, an exposure during 
pregnancy (EDP) occurs if:

A female becomes, or is found to be, pregnant either while receiving or having been 
exposed (eg, because of treatment or environmental exposure) to the investigational 
product; or the female becomes or is found to be pregnant after discontinuing and/or 
being exposed to the investigational product;

An example of environmental exposure would be a case involving direct contact 
with a Pfizer product in a pregnant woman (eg, a nurse reports that she is pregnant 
and has been exposed to chemotherapeutic products).

A male has been exposed (eg, because of treatment or environmental exposure) to the 
investigational product prior to or around the time of conception and/or is exposed 
during his partner’s pregnancy. 
If a subject or subject’s partner becomes or is found to be pregnant during the subject’s 
treatment with the investigational product, the investigator must report this information to 
Pfizer Safety on the CT SAE Report Form and an EDP supplemental form, regardless of 
whether an SAE has occurred.  In addition, the investigator must submit information 
regarding environmental exposure to a Pfizer product in a pregnant woman (eg, a subject 
reports that she is pregnant and has been exposed to a cytotoxic product by inhalation or 
spillage) to Pfizer Safety using the EDP supplemental form.  This must be done irrespective 
of whether an AE has occurred and within 24 hours of awareness of the exposure.  The 
information submitted should include the anticipated date of delivery (see below for 
information related to termination of pregnancy).
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome.  The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP supplemental form.  In the case of a live birth, the structural
integrity of the neonate can be assessed at the time of birth.  In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
pre-procedure test findings are conclusive for a congenital anomaly and the findings are 
reported).
If the outcome of the pregnancy meets the criteria for an SAE (ie, ectopic pregnancy, 
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly [in a
live-born baby, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the 
investigator should follow the procedures for reporting SAEs.


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Additional information about pregnancy outcomes that are reported to Pfizer Safety as SAEs 
follows: 

Spontaneous abortion includes miscarriage and missed abortion;

Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs.  In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to the investigational product.
Additional information regarding the EDP may be requested by the sponsor.  Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays).  In the case of paternal exposure, the 
investigator will provide the subject with the Pregnant Partner Release of Information Form 
to deliver to his partner.  The investigator must document in the source documents that the 
subject was given the Pregnant Partner Release of Information Form to provide to his 
partner.
A special safety concern (SSC), fetal cleft lip, was reported in the B7931004 (investigating 
PF-06700841 to treat psoriasis) trial affecting a singleton pregnancy of a subject on 
concomitant medications including an herbal supplement which carried a pregnancy warning.
8.4.5.2. Exposure During Breastfeeding
Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of 
an associated SAE, to Pfizer Safety within 24 hours of the investigator’s awareness, using the 
CT SAE Report Form.  An exposure during breastfeeding report is not created when a Pfizer 
drug specifically approved for use in breastfeeding women (eg, vitamins) is administered in 
accord with authorized use.  However, if the infant experiences an SAE associated with such 
a drug’s administration, the SAE is reported together with the exposure during breastfeeding.
8.4.5.3. Occupational Exposure
An occupational exposure occurs when, during the performance of job duties, a person 
(whether a healthcare professional or otherwise) gets in unplanned direct contact with the 
product, which may or may not lead to the occurrence of an AE.
An occupational exposure is reported to Pfizer Safety within 24 hours of the investigator’s 
awareness, using the CT SAE Report Form, regardless of whether there is an associated 
SAE.  Since the information does not pertain to a subject enrolled in the study, the 
information is not recorded on a CRF; however, a copy of the completed CT SAE Report 
Form is maintained in the investigator site file.


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8.4.6. Medication Errors 
Other exposures to the investigational product under study may occur in clinical trial settings, 
such as medication errors.
Safety Event
Recorded on the CRF
Reported on the CT SAE Report 
Form to Pfizer Safety Within 
24 Hours of Awareness
Medication errors
All (regardless of whether 
associated with an AE)
Only if associated with an SAE
8.4.6.1. Medication Errors
Medication errors may result from the administration or consumption of the investigational 
product by the wrong subject, or at the wrong time, or at the wrong dosage strength. 
Medication errors include:

Medication errors involving subject exposure to the investigational product;

Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the participating subject.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
In the event of a medication dosing error, the sponsor should be notified immediately.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and non-serious, are recorded on an AE page of the 
CRF.
Medication errors should be reported to Pfizer Safety within 24 hours on a CT SAE Report 
Form only when associated with an SAE.
9. DATA ANALYSIS/STATISTICAL METHODS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in a statistical analysis plan (SAP), which will be 
maintained by the sponsor.  The SAP may modify what is outlined in the protocol where 
appropriate; however, any major modifications of the primary endpoint definitions or their 
analyses will also be reflected in a protocol amendment. The SAP will be finalized prior to 
the study unblinding. 


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9.1. Sample Size Determination
The primary endpoint in this study is the ACR20 response rate at Week 16.  Assuming an
ACR20 response rate of 25% for the placebo group and 1-sided type-I error rate of 5% and 
using the normal approximation method, the study will have over 90% power under a sample 
size of 50 per arm and 80% power under a sample size of 25 per arm, to detect a treatment 
difference of 30% or greater without multiplicity adjustment.  With the 2:2:1:2 allocation 
ratio (in the order of 60 mg QD, 30 mg QD, 10 mg QD and placebo), and accounting for a 
10% chance of drop out, approximately a total of 196 subjects will be enrolled in this study, 
with 56 subjects per treatment group (with the exception of 28 subjects for the 10 mg QD 
treatment group).  Each of three PF-06700841 dose regimens (60 mg QD, 30 mg QD and 
10 mg QD) will be compared with placebo for the primary endpoint.  Simulations were 
conducted for multiple testing against placebo using the Dunnett’s testing procedure for 
various dose-response profiles.  Assuming a placebo ACR20 response rate of 20-25% and 
30-35% placebo-adjusted effect for the best active dose arm and an overall one-sided 
type-I error rate of 5%, the study will have over 85% power to show a statistically significant 
effect from placebo. 
9.2. Efficacy Analysis
9.2.1. Analysis of the Primary Endpoint 
The primary endpoint is the ACR20 response rate at Week 16. Statistical analyses will be 
performed when all randomized subjects have completed Week 16 visit or have the 
opportunity to complete the Week 16 visit. The primary efficacy analysis population will 
include all randomized subjects who receive at least one dose of study medication. Each of 
the three PF-06700841 dose regimens (60 mg QD, 30 mg QD and 10 mg QD) will be 
compared with placebo.  The normal approximation for the treatment difference in the 
ACR20 response rate at Week 16 will be used to test superiority of each PF-06700841 dose 
regimen against placebo. In order to control for the type-I error, the Dunnett’s method will 
be used for the primary endpoint of ACR20 response rate at Week 16 to adjust for 
multiplicity and serve as a gatekeeper for further testing of secondary endpoints.  
Specifically, if any PF-06700841 dose regimen is superior to placebo under the Dunnett’s 
test, selected secondary endpoints at Week 16 for that dose regimen will be formally tested 
for superiority against placebo hierarchically in the order of PASI75 ACR50 PASI90
PASI100 HAQ-DI.  This testing strategy will control the family-wise type-I error rate 
at an overall 1-sided 5% level.
Treatment differences between each PF-06700841 dose regimen and placebo in the 
ACR20 response rate at Week 16 will be summarized by point estimates and two-sided 
90% confidence intervals using the normal approximation method.  To adjust for the effect of 
prior TNFi exposure, treatment differences in the primary endpoint will aslo be summarized 
using the Cochran-Mantel-Haenszel method.
Missing values due to subject dropouts from the study for any reason (eg, lack of efficacy or 
adverse event) will be handled by non-responder imputation for the primary analyses.  
Tipping-point analyses may be performed to assess the robustness of the results when 
necessary.


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9.2.2. Analysis of Secondary Endpoints
Secondary endpoints include ACR endpoints (ACR20 at visits other than Week 16, 
ACR50 and ACR70 and PASI endpoints (PASI75, PASI90 and PASI100).  The ACR50 and 
PASI75/90/100 endpoints at Week 16 will be formally tested in the testing strategy described 
in Section 9.2.1.  Similar to the primary endpoint, the normal approximation method for the 
treatment differences in these binary endpoints will be used to test superiority of 
PF-06700841 against placebo.  Regardless of formal testing results, treatment differences 
between each PF-06700841 dose regimen and placebo in these secondary endpoints will be 
summarized using descriptive statistics (ie, point estimates and two-sided 90% confidence 
intervals).  Specifically, point estimates for the treatment differences between each 
PF-06700841 and placebo in all ACR and PASI endpoints and two-sided 90% confidence 
intervals will be generated for all visits at or prior to Week 16 using normal approximation, 
and Cochran-Mantel-Haenszel method adjusting for prior TNFi exposure when appropriate.  
For visits after Week 16, ACR and PASI response rates will be summarized using descriptive 
statistics by study visit and by treatment sequences, or combined when appropriate.  Other 
analyses, including landmark logistic regression and/or generalized linear mixed model for 
longitudinal binary endpoints, may also be performed.  Details will be documented in the 
SAP. 
The change from baseline in the HAQ-DI score will be analyzed using a repeated measure 
model that includes fixed effects of treatment group, study visit (at or prior to Week 16), 
treatment by visit interaction, prior TNFi exposure and baseline HAQ-DI score, with an 
unstructured variance-covariance matrix.  Details of missing data imputation method will be 
documented in the SAP. HAQ-DI score at visits post Week 16 will be summarized 
descriptively by study visit and by treatment sequences, or combined when appropriate.  
Other longitudinal secondary continuous endpoints will be analyzed similarly. 
 
 
 
9.4. Analysis of Other Endpoints
Details of analysis methods for all other endpoints will be documented in the SAP.  Binary 
endpoints will be summarized using normal approximation method, and 
Cochran-Mantel-Haenszel method adjusting for prior TNFi exposure when appropriate.
Longitudinal continuous endpoints will be analyzed in a repeated measure model similar to 
the model for HAQ-DI.  For all of these endpoints, descriptive statistics will be provided by 
study visit and treatment sequence, or combined when appropriate. 
CCI


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9.6. Safety Analysis
All subjects who receive study medication (safety population) will be included in the safety 
analyses.  All safety data will be summarized descriptively through appropriate data 
tabulations, descriptive statistics, and graphical presentations.  These include, but not limited 
to:
•
Incidence and severity of adverse events;
•
Summary of absolute vital signs and vital signs change from baseline;
•
Summary of absolute values and changes from baseline in ECG signals;
•
Serious infections, defined as infection (viral, bacterial, and fungal) requiring 
hospitalization or parenteral antimicrobials;
CCI
CCI


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
Any safety events that trigger withdrawals of a subject;

Safety laboratory tests.
Details will be provided in statistical analysis plan. 
9.7. Interim Analysis 
An administrative interim analysis may be performed when approximately 60% of subjects 
have completed Week 16 visit or have the opportunity to complete the Week 16 visit.  If 
performed, this interim analysis would be conducted by an unblinded team independent of 
this study team and the safety and efficacy results from the interim analysis may be reviewed 
by an Internal Review Committee (IRC).  No members of the study team will be part of the 
IRC. The interim analysis, if performed, will not be used to drive any decisions for the 
current study; however it may be used for internal business decisions regarding future study
planning.
During the interim analysis, some members of the study team may be unblinded and replaced 
with blinded colleagues.  The subjects, investigators, and individuals from the sponsor (or 
designee) who interact with the investigators and monitor safety will continue to be blinded 
to individual study treatments throughout the follow up period of the study.
Before any interim analysis is conducted, the details of the objectives, decision criteria, 
dissemination plan, and method of maintaining the study blind as per Pfizer’s standard 
operating procedures (SOPs) will be documented and approved in an internal review 
committee (IRC) charter.  In addition, the analysis details must be documented and approved 
in an interim analysis SAP or final SAP.
9.8. Data Monitoring Committee 
This study will use an Internal Review Committee (IRC). 
The IRC will be responsible for ongoing monitoring of the safety of subjects in the study 
according to the IRC charter.  The IRC will review accumulating unblinded safety data and 
may propose changes to the protocol as needed to ensure subject safety.  The IRC may also 
review results of the interim analyses as described in Section 9.7.
The recommendations made by the IRC to alter the design and/or conduct of the study will 
be forwarded to the sponsor executive team for final decision.  Pfizer will forward such 
decisions, which may include summaries of aggregate analyses of endpoint events and of 
safety data that are not endpoints, to regulatory authorities, as appropriate.  Details will be 
documented in the IRC charter.


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9.9. Safety Adjudication Committees
To help assess the specific, complex safety events related to malignancies, cardiovascular 
events, and opportunistic infection in this study, Safety Adjudication Committees, consisting 
of external clinical experts in each of the relevant clinical areas, will be set up to harmonize 
and standardize assessments. Members of the safety event adjudication committees will be 
blinded to treatment assignment in order to allow for unbiased assessments. Further 
information about these committees can be found in the respective charters, including 
specific descriptions of the scope of their responsibilities, plans where communication 
timelines are defined, and the processes and definitions used to review and assess specific 
safety events. Other safety events for adjudication may be identified and included in the 
remit of the Safety Adjudication Committees as appropriate.  
10. QUALITY CONTROL AND QUALITY ASSURANCE
Pfizer or its agent will conduct periodic monitoring visits during study conduct to ensure that 
the protocol and Good Clinical Practices (GCPs) are being followed.  The monitors may 
review source documents to confirm that the data recorded on CRFs are accurate.  The 
investigator and institution will allow Pfizer monitors/auditors or its agents and appropriate 
regulatory authorities direct access to source documents to perform this verification.  This 
verification may also occur after study completion.
During study conduct and/or after study completion, the investigator site may be subject to 
review by the IRB/EC, and/or to quality assurance audits performed by Pfizer, or companies 
working with or on behalf of Pfizer, and/or to inspection by appropriate regulatory 
authorities.
The investigator(s) will notify Pfizer or its agents immediately of any regulatory inspection 
notification in relation to the study.  Furthermore, the investigator will cooperate with Pfizer 
or its agents to prepare the investigator site for the inspection and will allow Pfizer or its 
agent, whenever feasible, to be present during the inspection.  The investigator site and 
investigator will promptly resolve any discrepancies that are identified between the study 
data and the subject's medical records.  The investigator will promptly provide copies of the 
inspection findings to Pfizer or its agent.  Before response submission to the regulatory 
authorities, the investigator will provide Pfizer or its agents with an opportunity to review 
and comment on responses to any such findings.
It is important that the investigator(s) and their relevant personnel are available during the 
monitoring visits and possible audits or inspections and that sufficient time is devoted to the 
process.


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11. DATA HANDLING AND RECORD KEEPING
11.1. Case Report Forms/Electronic Data Record
As used in this protocol, the term CRF should be understood to refer to either a paper form or 
an electronic data record or both, depending on the data collection method used in this study.
A CRF is required and should be completed for each included subject.  The completed 
original CRFs are the sole property of Pfizer and should not be made available in any form to 
third parties, except for authorized representatives of Pfizer or appropriate regulatory 
authorities, without written permission from Pfizer.  The investigator shall ensure that the 
CRFs are securely stored at the study site in encrypted electronic and/or paper form and will 
be password protected or secured in a locked room to prevent access by unauthorized third 
parties.
The investigator has ultimate responsibility for the collection and reporting of all clinical, 
safety, and laboratory data entered on the CRFs and any other data collection forms (source 
documents) and ensuring that they are accurate, authentic/original, attributable, complete, 
consistent, legible, timely (contemporaneous), enduring, and available when required.  The 
CRFs must be signed by the investigator or by an authorized staff member to attest that the
data contained on the CRFs are true.  Any corrections to entries made in the CRFs or source 
documents must be dated, initialed, and explained (if necessary) and should not obscure the 
original entry. 
In most cases, the source documents are the hospital or the physician subject chart.  In these 
cases, data collected on the CRFs must match the data in those charts. 
In some cases, the CRF may also serve as the source document.  In these cases, a document 
should be available at the investigator site and at Pfizer that clearly identifies those data that 
will be recorded on the CRF, and for which the CRF will stand as the source document.
11.2. Record Retention
To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, the 
investigator agrees to keep records, including the identity of all participating subjects 
(sufficient information to link records, eg, CRFs and hospital records), all original signed 
informed consent documents, copies of all CRFs, safety reporting forms, source documents,
and detailed records of treatment disposition, and adequate documentation of relevant 
correspondence (eg, letters, meeting minutes, and telephone call reports).  The records should 
be retained by the investigator according to the ICH guidelines, according to local 
regulations, or as specified in the clinical study agreement (CSA), whichever is longer.  The 
investigator must ensure that the records continue to be stored securely for so long as they are 
retained.
If the investigator becomes unable for any reason to continue to retain study records for the 
required period (eg, retirement, relocation), Pfizer should be prospectively notified.  The 
study records must be transferred to a designee acceptable to Pfizer, such as another 
investigator, another institution, or an independent third party arranged by Pfizer. 


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Investigator records must be kept for a minimum of 15 years after completion or 
discontinuation of the study or for longer if required by applicable local regulations. 
The investigator must obtain Pfizer's written permission before disposing of any records, 
even if retention requirements have been met.
12. ETHICS
12.1. Institutional Review Board/Ethics Committee
It is the responsibility of the investigator to have prospective approval of the study protocol,
protocol amendments, informed consent documents, and other relevant documents, 
eg, recruitment advertisements, if applicable, from the IRB/EC.  All correspondence with the 
IRB/EC should be retained in the investigator file.  Copies of IRB/EC approvals should be 
forwarded to Pfizer.
The only circumstance in which an amendment may be initiated prior to IRB/EC approval is 
where the change is necessary to eliminate apparent immediate hazards to the subjects.  In 
that event, the investigator must notify the IRB/EC and Pfizer in writing immediately after 
the implementation.
12.2. Ethical Conduct of the Study
The study will be conducted in accordance with the protocol, legal and regulatory 
requirements, and the general principles set forth in the International Ethical Guidelines for 
Biomedical Research Involving Human Subjects (Council for International Organizations of 
Medical Sciences 2002), ICH Guideline for Good Clinical Practice, and the Declaration of 
Helsinki.
12.3. Subject Information and Consent
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of subject personal data.  Such 
measures will include omitting subject names or other directly identifiable data in any 
reports, publications, or other disclosures, except where required by applicable law. 
The personal data will be stored at the study site in encrypted electronic and/or paper form 
and will be password protected or secured in a locked room to ensure that only authorized 
study staff have access.  The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster.  In the event of a potential personal data breach, the study site shall be responsible 
for determining whether a personal data breach has in fact occurred and, if so, providing 
breach notifications as required by law.
To protect the rights and freedoms of natural persons with regard to the processing of 
personal data, when study data are compiled for transfer to Pfizer and other authorized 
parties, subject name will be removed, and will be replaced by a single, specific, numerical 
code based on a numbering system defined by Pfizer.  All other identifiable data transferred 
to Pfizer or other authorized parties will be identified by this single, subject-specific code. 


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The investigator site will maintain a confidential list of subjects who participated in the 
study, linking each subject’s numerical code to his or her actual identity.  In case of data 
transfer, Pfizer will maintain high standards of confidentiality and protection of subjects’ 
personal data consistent with the Clinical Study Agreement and applicable privacy laws.
The informed consent documents and any subject recruitment materials must be in 
compliance with ICH GCP, local regulatory requirements, and legal requirements, including 
applicable privacy laws.
The informed consent documents used during the informed consent process and any subject 
recruitment materials must be reviewed and approved by Pfizer, approved by the IRB/EC 
before use, and available for inspection. 
The investigator must ensure that each study subject is fully informed about the nature and 
objectives of the study, the sharing of data relating to the study and possible risks associated 
with participation, including the risks associated with the processing of the subject’s personal 
data.  The investigator further must ensure that each study subject is fully informed about his 
or her right to access and correct his or her personal data and to withdraw consent for the 
processing of his or her personal data. 
The investigator, or a person designated by the investigator, will obtain written informed 
consent from each subject before any study-specific activity is performed.  The investigator 
will retain the original of each subject's signed consent document.
12.4. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the investigational 
product, Pfizer should be informed immediately.
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study subjects against any immediate hazard, and of 
any serious breaches of this protocol or of ICH GCP that the investigator becomes aware of.
13. DEFINITION OF END OF TRIAL
13.1. End of Trial in All Participating Countries 
End of trial in all participating countries is defined as last subject last visit (LSLV).
14. SPONSOR DISCONTINUATION CRITERIA
Premature termination of this study may occur because of a regulatory authority decision, 
change in opinion of the IRB/EC, or investigational product safety problems, or at the 
discretion of Pfizer.  In addition, Pfizer retains the right to discontinue development of 
PF-06700841 at any time.


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If a study is prematurely terminated, Pfizer will promptly notify the investigator.  After 
notification, the investigator must contact all participating subjects and the hospital pharmacy 
(if applicable) within 7 business days.  As directed by Pfizer, all study materials must be 
collected and all CRFs completed to the greatest extent possible.
15. PUBLICATION OF STUDY RESULTS
15.1. Communication of Results by Pfizer
Pfizer fulfills its commitment to publicly disclose clinical trial results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the European Clinical Trials 
Database (EudraCT), and/or www.pfizer.com, and other public registries in accordance with 
applicable local laws/regulations. 
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.
www.clinicaltrials.gov
Pfizer posts clinical trial US Basic Results on www.clinicaltrials.gov for Pfizer-sponsored 
interventional studies (conducted in patients) that evaluate the safety and/or efficacy of a 
Pfizer product, regardless of the geographical location in which the study is conducted.  US 
Basic Results are submitted for posting within 1 year of the primary completion date (PCD) 
for studies in adult populations or within 6 months of the PCD for studies in pediatric 
populations.
PCD is defined as the date that the final subject was examined or received an intervention for 
the purposes of final collection of data for the primary outcome, whether the clinical study 
concluded according to the prespecified protocol or was terminated.
EudraCT
Pfizer posts European Union (EU) Basic Results on EudraCT for all Pfizer-sponsored 
interventional studies that are in scope of EU requirements.  EU Basic Results are submitted 
for posting within 1 year of the PCD for studies in adult populations or within 6 months of 
the PCD for studies in pediatric populations.
www.pfizer.com
Pfizer posts Public Disclosure Synopses (clinical study report synopses in which any data 
that could be used to identify individual patients has been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the US Basic Results document is 
posted to www.clinicaltrials.gov.


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15.2. Publications by Investigators
Pfizer supports the exercise of academic freedom and has no objection to publication by the 
principal investigator (PI) of the results of the study based on information collected or 
generated by the PI, whether or not the results are favorable to the Pfizer product.  However, 
to ensure against inadvertent disclosure of confidential information or unprotected 
inventions, the investigator will provide Pfizer an opportunity to review any proposed 
publication or other type of disclosure of the results of the study (collectively, “publication”) 
before it is submitted or otherwise disclosed.
The investigator will provide any publication to Pfizer at least 30 days before it is submitted 
for publication or otherwise disclosed.  If any patent action is required to protect intellectual 
property rights, the investigator agrees to delay the disclosure for a period not to exceed an 
additional 60 days.
The investigator will, on request, remove any previously undisclosed confidential 
information before disclosure, except for any study- or Pfizer product-related information 
necessary to the appropriate scientific presentation or understanding of the study results.
If the study is part of a multicenter study, the investigator agrees that the first publication is 
to be a joint publication covering all investigator sites, and that any subsequent publications 
by the PI will reference that primary publication.  However, if a joint manuscript has not 
been submitted for publication within 12 months of completion or termination of the study at 
all participating sites, the investigator is free to publish separately, subject to the other 
requirements of this section.
For all publications relating to the study, the institution will comply with recognized ethical 
standards concerning publications and authorship, including Section II - “Ethical 
Considerations in the Conduct and Reporting of Research” of the Uniform Requirements for 
Manuscripts Submitted to Biomedical Journals, http://www.icmje.org/index.html#authorship, 
established by the International Committee of Medical Journal Editors.
Publication of study results is also provided for in the CSA between Pfizer and the 
institution.  In this section entitled Publications by Investigators, the defined terms shall have 
the meanings given to them in the CSA.
If there is any conflict between the CSA and any attachments to it, the terms of the CSA 
control.  If there is any conflict between this protocol and the CSA, this protocol will control 
as to any issue regarding treatment of study subjects, and the CSA will control as to all other 
issues.


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Appendix 1. Abbreviations 
This following is a list of abbreviations that may be used in the protocol. 
Abbreviation
Term
Ab
Antibody
AC
Adjudication Committee
ACR
American College of Rheumatology
ADME
Absorption, Distribution, Metabolism, Excretion
AE
Adverse Event
ALT
Alanine Aminotransferase
Anti-CCP
Anti-Cyclic Citrullinated Protein Antibody
AST
Aspartate Aminotransferase
AUC
Area under concentration-time curve
BA
Bioavailability
BCG
Bacillus Calmette-Guerin
BCRP
Breast Cancer Resistance Protein
BID
Twice daily
BP
Blood Pressure
BSA
Body Surface Area
BUN
Blood Urea Nitrogen
CASPAR
Classification Criteria for Psoriatic Arthritis
CCP
Cyclic Citrullinated Peptide
CD
Cluster Of Differentiation; Crohn’s Disease
CFB
Change From Baseline
CHD
Coronary Heart Disease
CI
Confidence Interval
CK
Creatine Kinase
CKD-EPI
Chronic Kidney Disease Epidemiology Collaboration
Cmax
Maximum Observed Concentration
CMV
Cytomegalovirus
COX-2
Cyclooxygenase-2
CRF
Case Report Form
CRP
C-reactive Protein
CSA
Clinical Study Agreement
CSR
Clinical Study Report
CT
Computed Tomography
CTCAE
Common Terminology Criteria for Adverse Events
CYP
Cytochrome P
DAPSA
Disease Activity Index for Psoriatic Arthritis
DAREA
Disease Activity Index for Reactive Arthritis
DAS28
Disease Activity Score-28
DILI
Drug-induced liver injury
CCI


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Abbreviation
Term
DIP
Distal Interphalangeal
DMARDs
Disease-Modifying Anti-Rheumatic Drugs
DMC
Data Monitoring Committee
DNA
Deoxyribonucleic Acid
DU
Dispensable Unit
DVT
Deep Vein Thrombosis
EBV
Epstein Barr Virus
EC
Ethics Committee
ECG
Electrocardiogram
EDP
Exposure During Pregnancy
EFD
Embryo-Fetal Development
eGFR
Estimated Glomerular Filtration Rate
EPO
Erythroprotein
EU
European Union
EudraCT
European Clinical Trials Database
EULAR
European League Against Rheumatism
FACIT-Fatigue
Functional Assessment of Chronic Illness Therapy-Fatigue
FACS
Fluorescence Activated Cell Sorting
FDA
Food And Drug Administration
FIH
First In Human
FSH
Follicle-Stimulating Hormone
GCP
Good Clinical Practice
GFR
Glomerular Filtration Rate
GGT
Gamma-Glutamyl Transferase
gm
Gram
GM-CSF
Granulocyte-Macrophage Colony-Stimulating Factor
GRAPPA
Group For Research And Assessment Of Psoriasis and Psoriatic 
Arthritis
HAQ-DI
Health Assessment Questionnaire-Disability Index
HBcAb
Hepatitis B Core Antibody
HBsAb
Hepatitis B Surface Antibody
HBsAg
Hepatitis B Surface Antigen
HCG
Human Chorionic Gonadotrophin
HCV Ab
Hepatitis C Antibody
HDL
High Density Lipoprotein
HEENT
Head, Eyes, Ears, Nose, Throat
HIV
Human Immunodeficiency Virus
HRQL
Health-Related Quality Of Life
HSV
Herpes Simplex Virus
IB
Investigator's Brochure
IC50
Half maximal inhibitory concentration
ICF
Informed Consent Form
CCI


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Abbreviation
Term
ICH
International Conference On Harmonisation
ID
Identification
IFN
Interferon
IGRA
Interferon-Gamma Release Assay
IL
Interleukin
IND
Investigational New Drug Application
INR
International Normalized Ratio
IP
Investigational Product; Interphalangeal
IRB
Institutional Review Board
IRC
Internal Review Committee
IRT
Interactive Response Technology
IUD
Intrauterine Device
IV
Intravenous
IWR
Interactive Web Response
JAK
Janus kinase
KDIGO
Kidney Disease: Improving Global Outcomes
K2EDTA
Dipotassium Ethylenediaminetetraacetic Acid
LAM
Lactational Amenorrhoea Method
LDL
Low Density Lipoprotein
LEI
Leeds Enthesitis Index
LFT
Liver Function Test
LSLV
Last Subject Last Visit 
LTFU
Lost To Follow-Up
MATE
Multidrug And Toxin Extrusion Protein
MCP
Metacarpophalangeal
MDA
Minimal Disease Activity
MDR
Multidrug Resistance Protein
mg
Milligrams
MRI
Magnetic Resonance Imaging
mRNA
Messenger Ribonucleic Acid
msec
Millisecond
MTX
Methotrexate
N/A
Not Applicable
NAPSI
Nail Psoriasis Severity Score
NK
Natural Killer
NOAEL
No Observed Adverse Effect Level
NSAID
Nonsteroidal Anti-Inflammatory Drug
OAT
Organic Anion Transporter
OATP
Organic Anion Transporting Polypeptide
OCT
Organic Cation Transporter
PASDAS
Psoriatic Arthritis Disease Activity Score
PASI
Psoriasis Area Severity Index
CC
I


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Abbreviation
Term
PCD
Primary Completion Date
PCR
Polymerase Chain Reaction
PCS
Physical Component Summary
PD
Pharmacodynamics
PE
Pulmonary Embolism
P-gp
P-glycoprotein
PGJS
Patient’s Global Joint and Skin Assessment
PGx
Pharmacogenomics
PI
Principal Investigator
PIP
Proximal Interphalangeal
PRN
As Needed
PRO
Patient Reported Outcome
PsA
Psoriatic Arthritis
PsARC
Psoriatic Arthritis Response Criteria
PsO
Psoriasis
PT
Prothrombin Time
PUVA
Psoralens + UVA phototherapy
QD
Quaque die (once daily)
QFT-G
QuantiFERON®-TB Gold test
QFT-GIT
QuantiFERON®-TB Gold In-Tube test
QTc
Corrected QT
QTcF
Corrected QT (Fridericia method)
OMERACT
Outcome Measures in Rheumatology 
RBC
Red Blood Cell
RF
Rheumatoid Factor
RNA
Ribonucleic Acid
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SC
Subcutaneous
SCr
Serum Creatinine
SF-36
36-Item Short-Form Health Survey
SJC
Swollen Joint Count
SLE
Systemic Lupus Erythematosus
SOP
Standard Operating Procedure
SPARCC
Spondyloarthritis Research Consortium of Canada
SRSD
Single Reference Safety Document
SSC
Special Safety Concern
STAT
Signal Transducer And Activator Of Transcription
SUSAR
Suspected Unexpected Serious Adverse Reaction
CCI
CC
I
CCI
CCI


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Abbreviation
Term
t1/2
Terminal Phase Half-Life
TB
Tuberculosis
TBili
Total Bilirubin
TBNK
T Cell, B Cell And Natural Killer Cell
TdP
Torsade De Pointes
TEAE
Treatment Emergent Adverse Event
TIA
Transient Ischemic Attack
TJC
Tender/Painful Joint Count
Tmax
Time to first occurrence of Cmax
TNF
Tumour Necrosis Factor
TNFi
Tumour Necrosis Factor Inhibitor
T-Spot
T-SPOT® TB test
TYK2
Tyrosine kinase 2
ULN
Upper Limit Of Normal
US
United States
UVB
Ultraviolet B
VAS
Visual Analog Scale
VLDA
Very Low Disease Activity
VZV
Varicella-Zoster Virus
WBC
White Blood Cell


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Appendix 2. Prohibited Prior and Concomitant Medications
Prohibited medication and washout time prior to first dose of study drug (if applicable).
Prohibited Medication
Discontinuation 
and/or washout time 
prior to first dose of 
study drug
Note
Adalimumab (Humiraor biosimilars), 
Certolizumab (Cimzia), Golimumab 
(Simponiand Simponi Aria)
10 weeks
Infliximab (Remicadeor biosimilars)
8 weeks
Etanercept (Enbrelor biosimilars)
4 weeks
Abatacept (Orencia)
10 weeks
Rituximab or other selective 
B-lymphocyte depleting agents 
(including experimental agents)
6 months or 
5 half-lives (if 
known), whichever is
longer, or until 
lymphocyte count 
returns to normal, 
whichever is longer
Any IL-17 inhibitor, IL-12/23 inhibitor, 
or IL-23 inhibitor, including but not 
limited to secukinumab (Cosentyx), 
ixekizumab (Taltz), ustekinumab 
(Stelara), brodalumab (Siliq),
guselkumab (Tremfya), risankizumab,
bimekizumab, and tildrakizumab
Subject is not eligible 
(Exclusion Criterion 
#22).
Non B cell-specific lymphocyte depleting 
agents/therapies (eg, alemtuzumab 
[Lemtradaor CamPath]), alkylating 
agents (eg, cyclophosphamide or 
chlorambucil), total lymphoid irradiation, 
etc.
Subject is not eligible 
(Exclusion Criterion 
#27).
Efalizumab (Raptiva)
Subject is not eligible 
(Exclusion Criterion 
#28).
Cumulatively 2 or more TNF inhibiting 
biologic agents
Subject is not eligible 
(Inclusion Criterion 
#12).
Other biologic agents
6 month unless 
otherwise specified in 
this table


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Prohibited Medication
Discontinuation 
and/or washout time 
prior to first dose of 
study drug
Note
Any Janus kinase (Jak) inhibitors, 
including but not limited to tofacitinib 
(Xeljanz), baricitinib (Olumiant), 
upadacitinib, peficitinib, filgotinib
Subject is not eligible 
(Exclusion Criterion 
#23).
Apremilast (Otezla) 
4 weeks
Non-biologic DMARD other than 
methotrexate, leflunomide or 
sulfasalazine, including but not limited to 
hydroxychloroquine, azathioprine, 
cyclosporine, mizoribine, tacrolimus and 
tetracycline (used as a DMARD)
4 weeks
Two or more concurrent non-biologic 
DMARDs
4 weeks (8 weeks for 
leflunomide if 
cholestyramine 
washout not done)
High potency opioid analgesics 
(eg, methadone, hydromorphone, 
buprenorphine, fentanyl)
4 weeks
Oral corticosteroids >10 mg/day of 
prednisone or equivalent
4 weeks
Injectable corticosteroids 
4 weeks
Intra-articular 
corticosteroids may 
be given as rescue 
medication (See 
Appendix 3).
Intra-articular hyaluronate sodium
4 weeks
May be given as 
rescue medication
(See Appendix 3).
Any other non-biological investigational 
or experimental therapy or procedure for 
psoriasis, PsA or rheumatoid arthritis
12 weeks unless 
otherwise specified in 
this table
Live or attenuated live vaccine
6 weeks
Recombinant subunit vaccines 
(eg, Shingrix)
4 weeks


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Prohibited Medication
Discontinuation 
and/or washout time 
prior to first dose of 
study drug
Note
Topical treatments that could affect 
psoriasis, eg, corticosteroids (including 
but not limited to hydrocortisone 
17 butyrate, hydrocortisone valerate, and 
hydrocortisone/hydrocortisone acetate 
with concentration higher than 1%), tars, 
keratolytics, anthralin, vitamin D 
analogs, and retinoids
2 weeks
The following topical 
treatments are 
allowed: 
non-medicated 
emollients for use 
over the whole body; 
topical steroids 
including 
hydrocortisone and 
hydrocortisone 
acetate 1% for the 
palms, soles, face and 
intertriginous areas 
only; tar and salicylic 
acid preparations for 
the scalp only and 
shampoos free of 
corticosteroid for the 
scalp only.
UVB (narrowband or broadband) 
phototherapy
2 weeks
Psoralens + UVA phototherapy (PUVA)
4 weeks
Medications that prolong the QT/QTc 
interval
7 days or 5 half-lives 
(whichever is longer)
Please refer to drug 
label.
Other prohibited medication, moderate 
and strong CYP3A inhibitors or inducers, 
strong P-gp inhibitors, P-gp substrate, 
and substrates of OCT2/MATE as listed 
in the table below
7 days or 5 half-lives 
(whichever is longer)


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List of prohibited CYP3A Inhibitors, CYP3A inducers, strong P-gp inhibitors, P-gp
substrates, and substrates of OCT2/MATE*.
Moderate and strong CYP3A 
inhibitors
Moderate and strong 
CYP3A inducers
Strong P-gp
inhibitors
P-gp 
substrates
Substrates of
OCT2/MATE
HIV antivirals:
-delavirdine(Rescriptor)
-indinavir (Crixivan)
-nelfinavir (Viracept)
-ritonavir (Kaletra, Norvir)
-saquinavir (Fortovase)
amiodarone(Cordarone,
Pacerone)
cimetidine (Tagamet)
ciprofloxacin (Cipro)
clarithromycin (Biaxin,
Prevpac)
diethyl-dithiocarbamate
diltiazem (Cardizem, Tiazac)
erythromycin
fluconazole (Diflucan)
fluvoxamine (Luvox)
gestodene (Femodene,
Melodene, Minulette, Mirelle,
Triodene ED)
grapefruit juice and marmalade
itraconazole (Sporanox)
ketoconazole (Nizoral)
mifepristone (Mifeprex,
RU486)
nefazodone (Serzone)
norfloxacin (Shibroxin,
Noroxin)
norfluoxetine
mibefradil
verapamil (Calan SR, Covera
HS, Isoptin SR, Tarka,
Verelan)
HIV antivirals:
-efavirenz (Sustiva)
-nevirapine (Viramune)
barbiturates
carbamazepine (Carbatrol,
Tegretol)
modafinil (Provigil)
phenobarbital
phenytoin (Dilantin,
Phenytek)
pioglitazone (Actos)
rifampin (Rifadin, Rifamate,
Rifater)
rifabutin (Mycobutin) 
St. John’s wort
troglitazone (Rezulin)
Quinidine
Digoxin
dofetilide
* This is not an all-inclusive list.  These prohibited drugs (table above) require at least a 7 day or 5 half-life 
(whichever is longer) washout period prior to the first dose of study medication.  Note: efavirenz, nevirapine, 
barbiturates, carbamazepine, phenobarbital, St. John’s Wort, rifabutin should be discontinued at least 30 days 
prior to first dose of study drug based on half-life of these drugs, and that amiodarone should be discontinued at 
least 290 days prior to the first dose of study drug based on a half-life of 58 days.  Topical (including skin or 
mucous membranes) application of antibacterial (eg, clarithromycin, erythromycin and norfloxacin) and 
antifungal (fluconazole, ketoconazole and itraconazole) medications is permitted.  For a medical condition 
(other than PsA) where it is important for the subject’s safety to continue a prohibited drug, and where there is 
no study-permitted alternative, the subject must not participate in this study. 


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Appendix 3. Rescue Therapy
The only medications that are allowed for rescue are listed here.
Acetaminophen/paracetamol 
Acetaminophen/ paracetamol is allowable as rescue medication if dosed no more than 
2.6 gm/day for no more than 10 consecutive days.  There is no limit to the duration of 
non-consecutive use of rescue medications. 

If a subject is already taking stable background doses of acetaminophen/paracetamol, 
s/he may increase the dose up to 2.6 gm/day for up to 10 consecutive days for rescue 
purposes. 

Acetaminophen/paracetamol is not permitted as a part of combination products such 
as over-the-counter “cold remedies” or in combination with opioids if the total 
acetaminophen/paracetamol dose will exceed 2.6 gm/day.
Opioids 
Non-prohibited opioids may be added or increased to a maximum potency equivalent of 
30 mg of orally-administered morphine.  The following paradigm should be used to 
determine appropriate opioid rescue therapy:
For subjects who are NOT on background opioid therapy: any of the following single opioid 
agents may be given as rescue medication (with or without acetaminophen/paracetamol) for 
no more than 10 consecutive days in the following total daily doses:

Tramadol (with or without acetaminophen/paracetamol), not to exceed 300 mg total 
daily dose.

Hydrocodone (with or without acetaminophen/paracetamol), not to exceed 30 mg 
total daily dose.

Oxycodone (with or without acetaminophen/paracetamol), not to exceed 15 mg total 
daily dose.
For subjects who ARE on stable, background opioid therapy:

They may NOT add a second opioid agent for rescue.

If their background opioid medication is 1 of the 3 listed above, they may, within the 
above maximum total dosage limits, increase the dosage for up to 10 consecutive 
days for rescue purposes.


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
If their background medication is a short-acting (half-life <5 hrs, Appendix 4) opioid 
that is not one of those listed above, they may increase the dosage for up to 
10 consecutive days (up to a total daily dose which must not exceed the potency 
equivalent of 30 mg of orally-administered morphine) for rescue purposes.

Sustained release opioid formulations (eg, OxyContin, MS Contin®) and opioids
with half-lives greater than 5 hours (eg, propoxyphene) may NOT be USED for 
rescue medication.

Sustained release opioid formulations (eg, OxyContin®, MS Contin®) and opioids
with half-lives greater than 5 hours (eg, propoxyphene) may NOT be INCREASED 
for rescue purposes.
Intra-articular injection (at or after the Week 16 visit only)
Intra-articular corticosteroids or hyaluronate sodium may be given at or after the Week 16 
visit.  If performed at the Week 16 visit, intra-articular injections must be given after all 
assessments are completed.  Injected joints will also be considered as having their 
pre-injection status (swollen and/or painful/tender) and should not be counted for the 
remainder of the trial.

Intra-articular corticosteroids may be given at or after the Week 16 visit in no more 
than two joints, in a cumulative dose of no more than 40 mg methylprednisolone or
its equivalent in any 6 month study period.  The total allowed intra-articular 
corticosteroid dose may be divided into separate injections (eg, 20 mg, 20 mg).  
Intra-articular corticosteroids should not be administered within 4 weeks prior to a 
study visit.

Intra-articular hyaluronate sodium injections may be administered for indications in 
accordance with the local label at or after the Week 16 visit in no more than two 
joints in any 6 month study period. 
Note: 

Subjects who require rescue for more than 10 consecutive days should be 
discontinued from the study. There is no limit to the duration of non-consecutive use 
of rescue medications. 

Subjects must not be dosed with rescue medication during the 24 hours prior to a 
study visit except if adjustment is needed because subject is experiencing intolerable 
pain. 

Baseline stable use acetaminophen/paracetamol or opioids should NOT be 
discontinued in advance of study visits. 


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Appendix 4. Maximum Allowed Total Daily Dose of Opioid Analgesics
Drug
Maximum 
Allowed Total 
Daily Dose
Relative potency 
to oral morphine
Half-Life
Tramadol 
(Ultram, Zydol; Zamadol, Ultracet, 
Tramal)
300 mg
~0.1
4.7 – 5.1 hrs
Hydrocodone 
(Vicodin, Lortab)
30 mg
1
3.8 – 4.5 hrs
Oxycodone 
(Roxicodone; Percocet, Tylox)
15 mg
~2
3.2 hrs
Codeine 
(Paveral, Tylenol #2 and #3)
200 mg
0.15
2.5 – 3.5 hrs
Morphine
30 mg
1
1.5 – 4 hrs
Meperidine 
(Demerol, Pethidine)
300 mg
0.1
3.2 – 3.7 hrs
Propoxyphene HCl 
(Darvon, Darvocet, Doloxene), 
Propoxyphene napsylate 
(Darvon-N, Darvocet-N 100)
300 mg 
propoxyphene 
HCl, 400 mg 
propoxyphene 
napsylate
~0.1
6-12 hrs; 30-36 hrs. for
active metabolite 
(norpropoxyphene)
References:
Twycross R, Wilcock A, Thorp S. Palliative Care Formulary.  Abingdon: Radcliffe Medical Press, 1998.
Twycross R, Pain relief in advanced cancer.  Edinburgh: Churchill Livingstone, 1994.
Note: 

Sites should contact project team for acceptable alternative preparations and related
data.

High potency opioid analgesics (eg, methadone, hydromorphone, buprenorphine, and 
fentanyl) are prohibited. 


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Appendix 5. Oral Corticosteroid Equivalents
The following is a summary of corticosteroid equivalents.
Oral corticosteroids – subjects already taking oral corticosteroids must be on a stable dose of 
10 mg/day of prednisone or equivalent for at least 4 weeks prior to first dose of study drug.  
Tapering or discontinuation of the corticosteroid treatment is only allowed after Week 52, 
unless required for toxicity, and should be performed slowly at the discretion of the 
investigator.
Compound
Equivalent Dose (mg)
Prednisone
10
Prednisolone
10
6-methylprednisolone
8
Triamcinolone
8
Betamethasone
1.2
Dexamethasone
1.5
Hydrocortisone
40
Cortisone
50
Deflazacort
12
Cloprednol
5
Prednylidene
12
Note: 

These dose relationships apply to oral administration.

Intravenous or intramuscular corticosteroids are not allowed during this study either 
as a stable concomitant medication or as rescue medication.  Intra-articular 
corticosteroids are allowed but only as rescue therapy (See Appendix 3 Rescue 
Therapy).


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Appendix 6. Discontinuation Criteria
Study drug will be discontinued and the subject withdrawn from the study treatment in the 
event of any of the following: 
Study Treatment: 

Requirement of rescue medication for more than 10 consecutive days; 

Interrupting study drug for more than 14 consecutive days;

Less than 80% compliant with the dosage regimen for any two consecutive visit 
periods.
Adverse Events:

Serious infections defined as any infection (viral, bacterial, or fungal) requiring 
parenteral antimicrobial therapy or hospitalization for treatment, or meeting other 
criteria that require the infection to be classified as a serious adverse event (SAE); 

Serious thromboembolic events, including venous thrombosis (including but not 
limited to deep vein thrombosis [DVT], pulmonary embolism [PE]), arterial 
thrombosis, and cerebrovascular events (thromboembolic stroke, transient ischemic 
attack [TIA], etc.) requiring hospitalization for treatment, or meeting other criteria 
that require the thromboembolic event to be classified as a serious adverse event 
(SAE);

Other serious or severe adverse events, after consultation with the sponsor clinician.
Laboratory Abnormalities (repeat laboratory tests should occur within 1 week):

Two sequential absolute neutrophil counts <1.0 x 109/L (<1000/mm3); 

Two sequential hemoglobin values <8.0 g/dL (80 g/L); 

Two sequential absolute lymphocyte counts <0.5 x 109/L (<500/mm3); 

Two sequential platelet counts <75 x 109/L (<75,000/mm3); 

Two sequential creatine kinase (CK) elevations >10 times the upper limit of normal, 
unless the causality is known not to be medically serious (eg, exercise or trauma 
induced); 

Two sequential AST or ALT elevation 3 times the upper limit of normal with at
least one total bilirubin value 2 times the upper limit of normal†;


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
Two sequential AST or ALT elevation 3 times the upper limit of normal
accompanied by signs or symptoms consistent with hepatic injury†;

Two sequential AST or ALT elevation 5 times the upper limit of normal, regardless 
of total bilirubin or accompanying signs or symptoms†;

Two sequential total bilirubin value 1.5 times the upper limit of normal (subjects 
with a history of Gilbert's syndrome may have a direct bilirubin measured and would 
be eligible for this study provided the direct bilirubin is < upper limit of normal)†; 
†In each case, there is a need for additional investigations, such as review of ethanol, recreational drug 
and dietary supplement consumption; testing for acute hepatitis A, B or C infection and biliary tract 
imaging should be promptly discussed with the sponsor or designee.

Potential Cases of Decreased eGFR: If an individual subject demonstrates 
CONCOMITANT serum creatinine-based eGFR AND serum Cystatin C-based eGFR 
decline of 30% compared to the subject’s baseline eGFR, then the subject should not 
be further dosed and adequate, immediate, supportive measures including immediate 
evaluation by a nephrologist (preferably within 24 hours) with appropriate 
management and treatment as clinically indicated.  Results should be repeated as 
indicated by the nephrologist or weekly at a minimum until the eGFR returns to 
baseline 15%, or the renal parameters are deemed to be stable by the nephrologist 
and/or PI.  If the subject cannot be seen by a nephrologist within 24 hours (as 
described above), then the subject should be sent to a local emergency room for 
evaluation and treatment as clinically indicated.
ECG:

Marked prolongation of the QTcF interval to >500 msec or >60 msec change from 
baseline (Day 1) ECG.  If QTcF exceeds these limits, the ECG should be repeated 
two more times and the average of the three QTcF should be used to determine the 
discontinuation.
Other:

A confirmed positive urine pregnancy test in a woman of childbearing potential.

A male has been exposed (eg, because of treatment or environmental exposure) to the 
investigational product prior to or around the time of conception and/or is exposed 
during his partner’s pregnancy. 
Note: 

Whenever possible, the investigator should consult with a member of the Pfizer study 
team before discontinuation of the subject.


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
Discontinuation/End of Treatment Monitoring for Adverse Events, Laboratory, Vital 
Signs or ECG: The procedures scheduled for Week 52/Early Termination Visit will 
be performed on the last day the subject takes the investigational product or as soon 
as possible thereafter. Any subject meeting discontinuation criteria must enter into 
the Follow up Period with additional follow up visit occurring 1 week after their last 
dose or Early Termination Visit whenever possible, and follow up until any clinically 
relevant abnormalities or adverse events have resolved, returned to a baseline state, or 
are deemed clinically stable.  The only exception to this is when a subject specifically 
withdraws consent for any further contact with him or her.


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Appendix 7. Laboratory Abnormalities Require Re-Testing
The following laboratory abnormalities require prompt re-testing within 1 week until 
resolution or agreement with Pfizer:

Absolute neutrophil count 1.5 x109/L (<1500/mm3);

Hemoglobin <9.0 g/dL;

Platelet count below <100 x109/L (100,000/mm3);

Lymphocytes <0.6 x109/L (600/mm3);

Creatine kinase (CK) >3xULN (this also triggers urine myoglobin).


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Appendix 8. Example of Effective, but Not Highly Effective Methods of Contraception
The following methods of contraception are considered effective, but not highly effective 
methods (failure rate of ≥1% per year):
1. Progestogen-only oral hormonal contraception where inhibition of ovulation is not the 
primary mode of action.
2. Male or female condom with or without spermicide.
3. Cervical cap, diaphragm, or sponge with spermicide.
4. A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (doublebarrier methods).
Note that periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal 
(coitus interruptus), spermicides only, and lactational amenorrhoea method (LAM) are not
acceptable methods of contraception. 
Male condom and female condom should not be used together (due to risk of failure with 
friction).

SAP_001.pdf: 
Protocol B7931030 (PF-06700841) Statistical Analysis Plan
PFIZER CONFIDENTIAL 
Page 1
Protocol B7931030
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 
STUDY OF PF-06700841 TO EVALUATE THE EFFICACY AT 16 WEEKS AND TO 
EVALUATE THE SAFETY AND EFFICACY UP TO 1 YEAR IN SUBJECTS WITH 
ACTIVE PSORIATIC ARTHRITIS
Statistical Analysis Plan 
(SAP)
Version:
3
Date:
2 Feb 2021  


Protocol B7931030 (PF-06700841) Statistical Analysis Plan
PFIZER CONFIDENTIAL 
Page 2
TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................5
LIST OF FIGURES ...................................................................................................................5
APPENDICES ...........................................................................................................................5
1. VERSION HISTORY............................................................................................................6
2. INTRODUCTION .................................................................................................................7
2.1. Study Objectives, Endpoints, and Estimands............................................................7
2.1.1. Primary Estimand .......................................................................................10
2.1.2. Secondary Estimand(s)...............................................................................10
2.1.2.1. ACR50/90 response at Week 16 ...............................................10
2.1.2.2. PASI75/90 response at Week 16...............................................10
2.1.2.3. Change from baseline in HAQ-DI at Week 16 .........................10
2.2. Study Design ...........................................................................................................10
3. ENDPOINTS AND BASELINE VARIABLES: DEFINITIONS AND 
CONVENTIONS ................................................................................................................12
3.1. Primary Endpoint ....................................................................................................12
3.2. Secondary Endpoints...............................................................................................12
3.2.1. Secondary Endpoints – PsA Core Domain Set...........................................12
3.2.2. Secondary Endpoints - Patient Reported Outcomes...................................13
3.2.3. Secondary Endpoints – Composite Outcomes............................................13
3.4. Baseline Variables...................................................................................................14
3.5. Safety Endpoints .....................................................................................................14
3.5.1. Adverse Events...........................................................................................14
3.5.2. Laboratory Data..........................................................................................15
3.5.3. Vital Signs ..................................................................................................15
3.5.4. Electrocardiograms.....................................................................................15
4. ANALYSIS SETS (POPULATIONS FOR ANALYSIS)...................................................15
5. GENERAL METHODOLOGY AND CONVENTIONS....................................................16
5.1. Hypotheses and Decision Rules ..............................................................................16
5.2. General Methods .....................................................................................................16
5.2.1. Analyses for Binary Endpoints...................................................................17
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5.2.1.1. Normal Approximation .............................................................17
5.2.1.2. Cochran-Mantel-Haenszel Method ...........................................18
5.2.1.3. Logistic Regression Analysis....................................................18
5.2.1.4. Longitudinal Analysis for Binary Endpoint..............................18
5.2.2. Analyses for Continuous Endpoints ...........................................................19
5.2.2.1. Longitudinal Model for Repeated Measures.............................19
5.2.2.2. Jump to Reference Imputation Model.......................................19
5.3. Methods to Manage Missing Data ..........................................................................20
5.3.1. Binary Endpoints ........................................................................................20
5.3.2. Continuous endpoints .................................................................................20
5.3.4. Missing Dates .............................................................................................21
6. ANALYSES AND SUMMARIES ......................................................................................22
6.1. Primary Endpoint ....................................................................................................22
6.1.1. The proportion of subjects achieving ACR20 response at Week 16..........22
6.1.1.1. Main Analysis ...........................................................................22
6.1.1.2. Sensitivity/Supplementary Analyses.........................................23
6.2. Secondary Endpoint(s) ............................................................................................23
6.2.1. The proportion of subjects achieving ACR20 response at Week 16 in 
the subgroup of subjects who are TNFα inhibitor naïve..................................23
6.2.1.1. Main Analysis ...........................................................................23
6.2.1.2. Sensitivity/Supplementary Analyses.........................................24
6.2.2. The proportion of subjects achieving an ACR20 response at all 
treatment timepoints (other than Week 16) .....................................................24
6.2.3. The proportion of subjects achieving ACR50 and ACR70 response at 
all treatment timepoints....................................................................................25
6.2.4. Change from baseline in the ACR response criteria components ..............25
6.2.5. The proportion of subjects achieving PASI75/90/100 response.................26
6.2.6. Change from baseline in the enthesitis score..............................................26
6.2.7. Change from baseline in the Dactylitis Severity Score ..............................27
6.2.8. Change from baseline in the Nail Psoriasis Severity Index........................27
6.2.9. Change from baseline in the Patient’s Global Joint and Skin 
Assessment – Visual Analog Scale (PGJS-VAS)............................................27
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6.2.10. Change from baseline in the Functional Assessment of Chronic 
Illness Therapy – Fatigue (FACIT-Fatigue) ....................................................27
6.2.11. Change from baseline in the Short-Form-36 Health Survey (SF-36) 
Version 2, Acute ..............................................................................................27
6.2.12. The proportion of subjects achieving Minimal Disease Activity 
(MDA) and Very Low Disease (VLDA) response ..........................................27
6.2.13. Change from baseline in the Disease Activity Index for Reactive 
Arthritis/PsA (DAREA/DAPSA).....................................................................27
6.2.14. The proportion of subjects achieving the Psoriatic Arthritis 
Response Criteria (PsARC) .............................................................................28
6.2.15. Change from baseline in the Psoriatic Arthritis Disease Activity 
Score (PASDAS) .............................................................................................28
 
 
 
 
 
 
6.4. Subset Analyses.......................................................................................................30
6.5. Baseline and Other Summaries and Analyses.........................................................30
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6.5.1. Baseline Summaries....................................................................................30
6.5.2. Study Conduct and Participant Disposition................................................32
6.5.3. Study Treatment Exposure .........................................................................32
6.5.4. Concomitant Medications and Nondrug Treatments..................................32
6.6. Safety Summaries and Analyses .............................................................................32
6.6.1. Adverse Events...........................................................................................32
6.6.2. Laboratory Data..........................................................................................33
6.6.3. Vital Signs ..................................................................................................33
6.6.4. Electrocardiograms.....................................................................................33
7. INTERIM ANALYSES.......................................................................................................33
7.1. Introduction .............................................................................................................33
7.2. Interim Analyses and Summaries............................................................................34
8. REFERENCES ....................................................................................................................34
9. APPENDICES .....................................................................................................................36
LIST OF TABLES
Table 1.
Summary of Changes..................................................................................6
Table 2.
Treatment Sequence..................................................................................11
Table 3.
Safety QTc Assessment ............................................................................33
LIST OF FIGURES
Figure 1.
Schematic of Study Design.......................................................................11
APPENDICES
Appendix 1.1. Endpoint Derivations .......................................................................................36


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1. VERSION HISTORY
Table 1.
Summary of Changes
Version/
Date
Associated Protocol 
Amendment
Rationale
Specific Changes
v3 / 2 Feb
2021
Protocol
Administrative
Change Letter
(PACL)
26 Oct 2020
Amendment 2
22 Oct 2019
Revisions 
and 
clarifications 
made in 
statistical 
analysis post 
BDR
Section 3.4 – updated that the 
stratification factor (prior TNFi 
exposure) will be based on 
randomization file (not CRF). 
Sections 6.2.4, 6.3.13 and 6.3.14 –
removed summaries of absolute values
Section 6.4 – removed all subgroup 
analyses except ACR20 for Prior TNFi 
exposure (yes, no) – no longer needed.
Section 6.5.1 - added Concomitant 
Methotrexate Dose at Baseline (mg/wk), 
Baseline Rheumatoid Factor Positive,
Baseline Cyclic Citrullinated Peptide 
Antibody Positive, Day 1 usage of 
DMARDS, MTX and NSAIDS to the 
summary of baseline disease 
characteristics; removed Baseline PGJA-
VAS (incorrect endpoint but no longer 
needed).
Section 6.5.2 – removed entire section 
and moved Prior TNFi exposure to 
Baseline Disease Characteristics table
Sections 3.5.4 & 6.6.4 – changed how 
ECG data will be presented in the CSR 
(due to the change in ECG machines 
during the study).
Section 6.6.5 – removed listing of 
physical examination
Other minor changes. 
v2 / 24 Apr 
2020
Protocol 
Administrative 
Change Letter 
(PACL)
17 Apr 2020
Amendment 2
22 Oct 2019
Revisions and 
clarifications
made in 
statistical 
analysis
Section 2.1.1, 2.1.2.3, 6.1.1.1 and 
6.2.1.1. Rescue medication taking is 
removed from the intercurrent event list
due to its highly overlapping with the 
other intercurrent event of premature 
treatment discontinuation.
Section 5.3.1 and 5.3.2. Details 
regarding missing data due to COVID-
19 are added.


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• Section 6.2.4. Definition of HAQ-DI 
responder is corrected to ‘change from 
baseline in HAQ-DI<-0.3’. 
 
• With a small overall proprotion of study 
participants having prior exposure to 
TNFi, this covariate was removed from 
model-based analysis to avoid 
convergence issues. 
• Other minor changes. 
v1/ 10 Dec 
2019
Amendment 2
22 Oct 2019
N/A
N/A
2. INTRODUCTION
This statistical analysis plan (SAP) provides the detailed methodology for summary and 
statistical analyses of the data collected in Study B7931030.  This document may modify the 
plans outlined in the protocol; however, any major modifications of the primary endpoint 
definition or its analysis will also be reflected in a protocol amendment.
2.1. Study Objectives, Endpoints, and Estimands
Primary Objective(s):
Primary Endpoint(s):
•
To evaluate the efficacy of 
PF-06700841 compared to 
placebo in subjects with 
active psoriatic arthritis 
(PsA).
•
The proportion of subjects achieving an American 
College of Rheumatology 20 (ACR20) response at 
Week 16.
Secondary Objective(s):
Secondary Endpoint(s):
•
To evaluate the efficacy of 
PF-06700841 compared to 
placebo in subjects with 
active PsA who are TNFα 
inhibitor naïve.
•
The proportion of subjects achieving an ACR20 
response at Week 16 in the subgroup of subjects 
who are TNFα inhibitor naïve.
•
To evaluate the 
improvement in signs and 
symptoms related PsA 
Core Domain Set in PF-
06700841 treated subjects.
Assessed at all treatment timepoints: 
•
The proportion of subjects achieving an ACR20 
response at all treatment timepoints (other than 
Week 16), and proportion of subjects achieving an 
ACR50 and ACR70 response;
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
Change from baseline in the ACR response criteria 
components (Tender/painful joint count, Swollen 
joint count, Patient’s Assessment of Arthritis Pain, 
Patient’s Global Assessment of Arthritis, 
Physician’s Global Assessment of Arthritis, Health 
Assessment Questionnaire [HAQ] disability index 
[DI], and hsCRP);

The proportion of subjects achieving a Psoriasis 
Area and Severity Index 75/90/100 
(PASI75/90/100) response; 

Change from baseline in the enthesitis score (using 
the Spondyloarthritis Research Consortium of 
Canada [SPARCC] Enthesitis Index and Leeds 
Enthesitis Index);

Change from baseline in the Dactylitis Severity 
Score;

Change from baseline in the Nail Psoriasis Severity 
Index (NAPSI) Score. 

To evaluate the 
improvement in patient 
reported outcome measures 
related PsA Core Domain 
Set in PF-06700841 treated 
subjects.
Assessed at all treatment timepoints: 

Change from baseline in the Patient’s Global Joint 
and Skin Assessment Visual Analog Scale 
(PGJSVAS); 

Change from baseline in the Functional Assessment 
of Chronic Illness Therapy Fatigue 
(FACITFatigue); 
Assessed at all treatment timepoints except Week 2: 

Change from baseline in the ShortForm36 Health 
Survey (SF36) Version 2, Acute. 

To evaluate the 
improvement in additional 
composite outcome 
measures in PF-06700841 
treated subjects.
Assessed at all treatment timepoints except Week 2:

The proportion of subjects achieving Minimal 
Disease Activity (MDA) and Very Low Disease 
Activity (VLDA) response;

Change from baseline in the Disease Activity Index 
for Reactive Arthritis/PsA (DAREA/DAPSA);

The proportion of subjects achieving the Psoriatic 
Arthritis Response Criteria (PsARC); 

Change from baseline in the Psoriatic Arthritis 
Disease Activity Score (PASDAS).

To evaluate the safety and 
tolerability of PF-
06700841.

Incidence of adverse events (AEs), serious adverse 
events (SAEs) and serious infectious events (SIEs), 
withdrawals due to AEs and SAEs, and laboratory 


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abnormalities, changes in vital signs, and 
electrocardiogram (ECG) findings throughout the 
study.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
•
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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2.1.1. Primary Estimand
The primary estimand of this study is defined according to the primary objective and in 
alignment with the primary endpoint.  It includes the following 4 attributes: 

Population: Subjects who have active psoriatic arthritis (PsA) and who are 
randomized;

Variable: binary endpoint of American College of Rheumatology 20 (ACR20) 
response at Week 16. 

Intercurrent event (IE): premature treatment discontinuation.

Population-level summary: Treatment differences in proportion of subjects who 
achieving ACR20 response at Week 16 between each dose group of PF-06700841 
and placebo.
2.1.2. Secondary Estimand(s)
2.1.2.1. ACR50/90 response at Week 16
The estimands for ACR50/90 at Week 16 are defined in the same manner as the primary 
estimand for the ACR20 at Week 16.
2.1.2.2. PASI75/90 response at Week 16
The estimands for PASI75/90/100 at Week 16 are defined in the same manner as the primary 
estimand for the ACR20 at Week 16 with the exception that the population will consist of a 
subgroup of patients who have baseline BSA≥3% and PASI>0.
2.1.2.3. Change from baseline in HAQ-DI at Week 16
The estimand for this endpoint is defined as a hypothetical estimand as follows.  

Population: Subjects who have active psoriatic arthritis (PsA) and who are 
randomized;

Variable: Change from baseline in HAQ-DI at Week 16. 

Intercurrent event (IE):  premature treatment discontinuation. 

Population-level summary: Treatment differences in change from baseline in HAQ-
DI at Week 16 between each dose group of PF-06700841 and placebo.
2.2. Study Design
This is a Phase 2b, randomized, double-blind, placebo-controlled, dose-ranging, parallel 
treatment group, efficacy and safety study designed to characterize the dose response of 
PF-06700841 in subjects with active PsA.  A total of approximately 196 subjects will be 


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randomized in a 4:4:1:1:2:2 ratio to one of the six parallel treatment sequences as shown in 
Table 1. 
Table 2.
Treatment Sequence
Treatment 
Sequence
Treatment
Subject 
Size
A
PF-06700841 60 mg QD
56
B
PF-06700841 30 mg QD
56
C1
PF-06700841 10 mg QD first & advance to 60 mg QD after the Week 16 visit
14
D2
PF-06700841 10 mg QD first & advance to 30 mg QD after the Week 16 visit
14
E1
Placebo QD first & advance to PF-06700841 60 mg QD after the Week 16 visit
28
F2
Placebo QD first & advance to PF-06700841 30 mg QD after the Week 16 visit
28
1.
Starting after the Week 16 visit, subjects randomized to treatment sequences C or E will receive 
PF-06700841 60 mg QD in a blinded fashion for the remainder of the study.
2.
Starting after the Week 16 visit, subjects randomized to treatment sequences D or F will receive 
PF-06700841 30 mg QD in a blinded fashion for the remainder of the study.
The primary efficacy endpoint is the ACR20 response rate at Week 16.  For the treatment 
comparison of each of three active treatment regimens (60 mg QD, 30 mg QD and 10 mg 
QD) versus placebo in the primary endpoint, this results in a 2:2:1:2 allocation ratio (in the 
order of 60 mg QD, 30 mg QD, 10 mg QD and placebo). 
A schematic of the study design is shown below: 
Figure 1.
Schematic of Study Design


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3. ENDPOINTS AND BASELINE VARIABLES: DEFINITIONS AND 
CONVENTIONS
Study endpoints are listed in this section. Details regarding the endpoint derivations are 
included in the Appendix 1.1. The baseline values of variables used to derive these endpoints 
will be measurements at the Baseline (Day 1) Visit. If the measurement at the Baseline Visit 
is not available but the variable is measured in the screening visit, then the measurement at 
the screening visit will be used as the baseline value. 
Visual analog scale (VAS) data will need to be rescaled prior to any calculation and analysis. 
VAS is recorded in terms of length at mark (X in mm) and overall length of line (Y in mm). 
The rescaled VAS for use in analysis will be: Z=X/Y × 100mm or X/Y × 10cm depending on 
endpoints or the use in defining other endpoints (see Appendix 1.1 for details). 
3.1. Primary Endpoint

The proportion of subjects achieving an American College of Rheumatology 20 (ACR20) 
response at Week 16.
3.2. Secondary Endpoints
3.2.1. Secondary Endpoints – PsA Core Domain Set 

The proportion of subjects achieving an ACR20 response at Week 16 in the subgroup of 
subjects who are TNFinhibitor naïve.

The proportion of subjects achieving an ACR20 response at all treatment timepoints 
(other than Week 16)

The proportion of subjects achieving an ACR50 and ACR70 response.

Change from baseline in the ACR response criteria components, including

Tender/painful joint count,

Swollen joint count,

Patient’s Assessment of Arthritis Pain (VAS),

Patient’s Global Assessment of Arthritis (VAS),

Physician’s Global Assessment of Arthritis (VAS),

Health Assessment Questionnaire (HAQ) disability index (DI) [HAQ-DI], and 

hsCRP.

The proportion of subjects achieving a Psoriasis Area and Severity Index 75/90/100 
(PASI75/90/100) response.

Change from baseline in the enthesitis score, using

Spondyloarthritis Research Consortium of Canada [SPARCC] Enthesitis Index, and

Leeds Enthesitis Index.

Change from baseline in the Dactylitis Severity Score.

Change from baseline in the Nail Psoriasis Severity Index (NAPSI) Score.


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3.2.2. Secondary Endpoints - Patient Reported Outcomes
•
Change from baseline in the Patient’s Global Joint and Skin Assessment-Visual Analog 
Scale (PGJS-VAS) at all treatment timepoints; 
•
Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue 
(FACIT-Fatigue) at all treatment timepoints; 
•
Change from baseline in the Short-Form-36 Health Survey (SF-36) Version 2, Acute, at 
all treatment timepoints except Week 2.
3.2.3. Secondary Endpoints – Composite Outcomes
•
The proportion of subjects achieving Minimal Disease Activity (MDA) and Very Low 
Disease Activity (VLDA) response at all treatment timepoints except Week 2;
•
Change from baseline in the Disease Activity Index for Reactive Arthritis/PsA 
(DAREA/DAPSA) at all treatment timepoints except Week 2;
•
The proportion of subjects achieving the Psoriatic Arthritis Response Criteria (PsARC) at 
all treatment timepoints except Week 2; 
•
Change from baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) at all 
treatment timepoints except Week 2.
 
 
 
 
 
  
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3.4. Baseline Variables
The study procedure and clinical assessments are described in the protocol (Section 6.2.1). 
All patient reported outcomes (PROs) should be completed prior to any other study 
procedures. Some clinical assessments will be assessed in both Screening and Baseline visits 
for the determination of the eligibility for enrolment, but the measurements from the Baseline 
(Day 1) visit will be used in the summaries of baseline variables unless the Day 1 data are 
missing. Data from the screening period may be used if Day 1 data are missing.  If multiple 
data points are available, we will use the last observation before Day 1 dosing except the 
ECG. The stratification factor (prior TNFi exposure) will be based on the randomization file. 
3.5. Safety Endpoints
•
Incidence of adverse events (AEs)
•
Serious adverse events (SAEs)
•
Serious infectious events (SIEs) 
•
Withdrawals due to AEs and SAEs 
•
Laboratory abnormalities 
•
Changes from baseline in vital signs
•
Electrocardiogram (ECG) measurements
ECGs will be read and interpreted locally and centrally. Only locally read ECG data will be 
reported in the CSR. According to study protocol, the ECG at screening will be repeated two 
more times if QTcF exceeds 450 ms in the first reading and the average of the three QTcFs 
will be used to determine the subject eligibility. Triplicate ECGs will be obtained on Baseline 
(Day 1). In these cases, the average of the three QTcF values will be used in the summaries.
3.5.1. Adverse Events
In additional to standard safety displays, a 3-tier approach will be used to summarize AEs.
Under this approach, AEs are classified into 1 of 3 tiers. Different analyses will be performed 
for different tiers (see Section 6.6.1).
•
Tier 1 events: These are prespecified events of clinical importance and are maintained in 
a list in the product’s Safety Review Plan.
•
Tier 2 events: These are events that are not tier 1 but are “common.”   A Medical 
Dictionary for Regulatory Activities (MedDRA) preferred term (PT) is defined as a 
Tier 2 event if there are at least 3 subjects in any treatment group reported the event.
•
Tier 3 events: These are events that are neither Tier 1 nor Tier 2 events.
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The 3 tiers are mutually exclusive. Tier 3 events will be included in standard safety displays 
and not separately displayed in specified Tier 3 tables. 
3.5.2. Laboratory Data
The laboratory tests will be performed at time points identified in the Schedule of Activities.  
Unscheduled clinical laboratory measurements may be obtained at any time to assess any 
perceived safety concerns. Data from central laboratories will be used for statistical analyses.
3.5.3. Vital Signs
Vital signs (blood pressure, pulse rate, and temperature) will be measured at times specified 
in the Schedule of Activities.   
3.5.4. Electrocardiograms
Standard 12-lead ECGs should be collected at times specified in the Schedule of Activities.
The baseline ECG values (the last measurement prior to receive study treatment on Day 1) 
will serve as each subject’s baseline values. If Day 1 ECG is missing, then screening ECG 
will serve as baseline value.  Data from local ECG readings will be summarized in statistical 
analyses. 
Baseline and change from baseline in ECG will be summarized descriptively. Categorical 
summaries of the ECG data will also be provided.
4. ANALYSIS SETS (POPULATIONS FOR ANALYSIS)
Below is a description of the Analysis Sets (i.e. Population for Analysis) defined for the 
study. Data for all participants will be assessed to determine if participants meet the criteria 
for inclusion in each analysis population prior to unblinding and releasing the database and 
classifications will be documented per standard operating procedures.
Population
Description
Evaluable Population
All participants who were randomized to the study and received 
at least one dose of the randomized study treatment.  The 
Evaluable Population is the primary efficacy analysis 
population. Participants will be analyzed according to the 
randomized treatment group.
Safety Analysis
Population
All participants who received at least one dose of the 
randomized study treatment.  Participants will be analyzed 
according to study treatment they actually received. A 
randomized but not treated participant will be excluded from 
the safety analyses.  
 
 
  
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Population
Description
PD Analysis Population
All participants who received at least one dose of randomized 
study treatment and in whom at least one value of the PD 
parameter of interest is reported. 
5. GENERAL METHODOLOGY AND CONVENTIONS
5.1. Hypotheses and Decision Rules
The study is designed to evaluate the efficacy of PF-06700841 compared to placebo in 
subjects with active PsA. Each of the three dose groups of PF-06700841 will be formally 
tested in the primary endpoint (ACR20 at Week 16) and a selected list of secondary 
endpoints (PASI75, ACR50, PASI90, PASI100 and HAQ-DI at Week 16) for superiority 
against placebo. 
For each dose group of PF-06700841 within each endpoint, the null hypothesis is that there is 
no difference between PF-06700841 and placebo, and the alternative hypothesis is that there 
is a difference between PF-06700841 and placebo. 
In order to control for type-I error, the Dunnett’s method will be used for the primary 
endpoint of ACR20 at Week 16 to adjust for multiplicity. The overall family-wise type-I 
error rate is set at 1-sided 5% (or equivalently 2-sided 10%). This test will serve as a 
gatekeeper for further formal testing of secondary endpoints. Specifically, if any PF-
06700841 dose regimen is superior to placebo under the Dunnett’s test, selected secondary 
endpoints at Week 16 for that dose regimen will be tested for superiority against placebo 
hierarchically in the order of PASI75 ACR50 PASI90 PASI100 HAQ-DI. Each 
endpoint will be tested at the significance level of 1-sided 5% (or equivalently 2-sided 10%).
5.2. General Methods
In general, the data for all continuous endpoints will be summarized by timepoint and 
treatment sequence group (or combined treatment sequence when appropriate) in tables 
containing descriptive statistics (N, mean, standard deviation, standard error of the mean,
minimum, 1st, 2nd (median) and 3rd quartiles and maximum) for baseline and change or 
percent change from baseline for those endpoints measured at baseline. The displays 
described above will only contain available data with no imputation. The data for all 
categorical endpoints will be summarized by contingency tables that show the 
counts/frequency in the various categories by treatment sequence group at each timepoint.  
For binary endpoint (e.g. ACR20), non-response imputation will be applied for the missing 
data in the summary tables.
For analyses through Week 16, the treatment sequence E and F will be combined into a 
single placebo group and the treatment sequence C and D will be combined into a single PF-
06700841 10mg group. The following treatment comparisons with placebo will be made at 
each visit, where applicable,


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•
PF-06700841 60 mg QD (treatment sequence A) vs. placebo (combined treatment
sequences E and F);
•
PF-06700841 30 mg QD (treatment sequence B) vs. placebo (combined treatment 
sequences E and F);
•
PF-06700841 10 mg QD (combined treatment sequences C and D) vs. placebo 
(combined treatment sequences E and F).
For analyses through the Follow-up Visit (Week 56), endpoints will be summarized by 
treatment sequence using descriptive statistics. 
The primary efficacy analysis will be conducted on data collected during the first 16 weeks 
where comparisons to placebo will entail combining treatment sequences E and F to form 
one placebo group. The primary comparisons will be between each PF-06700841 dose
group and placebo (combined) at Week 16. Formal hypothesis testings for treatment 
comparisons will be performed for ACR20, ACR50, PASI75, PASI90, PASI100 and HAQ-
DI endpoints at Week 16 only in the sequence as described in the Section 5.1.
Treatment comparisons for these endpoints at post-baseline visits other than Week 16 or 
other endpoints at all post-baseline visits will be summarized using descriptive statistics 
only. 
5.2.1. Analyses for Binary Endpoints
Data for all binary endpoints will be summarized by treatment group and visit in tabular 
and/or graphic format  with descriptive statistics, including N (number of subjects evaluable 
for the endpoint in the corresponding treatment group/visit), n (number of responders), 
response rates (%), standard errors of the response rate, and 95% confidence intervals (CIs) 
based on normal approximation (Section 5.2.1.1). Treatment differences between each dose 
group of PF-06700841 and placebo will be summarized by point estimates and two-sided 
90% CIs (Section 5.2.1.1).     
5.2.1.1. Normal Approximation
The normal approximation for the 95% CIs of a binomial proportion will be calculated as
݌̂ േ1.96ට௣ොሺଵି௣ොሻ
௡
,
where ݌̂ is the observed proportion for the binary endpoint and n is the sample size. If there is 
no (i.e. 0) or 100% response, 0.5 will be added to the number of responses and 1 will be 
added to the denominator for the calculation of standard errors and 95% CIs. 
The normal approximation for the difference in binomial proportion will be used to test the 
superiority of each dose group of PF-06700841 against placebo in the binary endpoints, 
including ACR20/50 and PASI 75/90/100 under the testing procedure described in Section 
5.1. Specifically, the test statistics for the difference in binomial random variables between 
each dose group of PF-06700841 and placebo are calculated as 


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ܼ௞ൌ
௣ොೖି௣ොು
ට
೛ෝೖሺభష೛ෝೖሻ
೙ೖ
ା೛ෝುሺభష೛ෝುሻ
೙ು
, ݇ൌ1,2,3,
where ݌௞
ෞ(k=1,2,3) and ݌௉
ෞare observed proportion of responders in three PF-06700841 dose 
groups (60mg QD [k=1], 30mg QD [k=2] and 10mg QD [k=3]) and placebo group, 
respectively, and ݊௞(k=1,2,3) and ݊௉are sample sizes in the respective treatment groups. 
The normal approximation to each of the test statistics will be used for each dose group of 
PF-06700841 in comparison to the placebo group. 
Treatment differences in binary response rates between each dose group of PF-06700841 and 
placebo will be summarized by point estimates and two-sided 90% CIs using normal 
approximation method. Two-sided 90% CIs will be calculated as
ሺ݌̂௞െ݌̂௉ሻേ1.645ඨ݌̂௞ሺ1 െ݌̂௞ሻ
݊௞
൅݌̂௉ሺ1 െ݌̂௉ሻ
݊௉
, ݇ൌ1,2,3
If there is no (i.e. 0) or 100% response in any of the treatment comparison with the placebo 
group, 0.5 will be added to the number of responses and 1 will be added to the denominator 
for each group within the treatment comparison in the calculation of treatment differences, 
standard errors, 90% CIs and 2-sided p-values (Agresti, 2013). 
5.2.1.2. Cochran-Mantel-Haenszel Method
To adjust for the effect of prior TNFi exposure, treatment differences in the binary response 
rates can be summarized using the Cochran-Mantel-Haenszel method (Agresti, 2013). This 
analysis will be conducted as a sensitive analysis to the primary analysis using the normal 
approximation method without adjusting for the effect of prior TNFi exposure. This method 
will also be used to summarize treatment differences in other endpoints when appropriate. 
5.2.1.3. Logistic Regression Analysis
A logistic regression model will be fit for the primary endpoint as a sensitivity analysis, with 
treatment as covariate. When appropriate, this analysis will be conducted for other binary 
endpoints. 
5.2.1.4. Longitudinal Analysis for Binary Endpoint
As a supplementary analysis of longitudinal binary responses (ACR20, ACR50 and ACR70), 
scheduled to be collected multiple times during the first 16 weeks of the study, a generalized 
linear mixed model (GLMM) for repeated binary measures will be used.  This model will 
have fixed effects for time (discrete), treatment, and time by treatment interaction; the 
dependent variable will be logit of the probability of “response”.  A common AR(1)
variance-covariance matrix for all treatment groups will be used to model the variability
among observations within a subject. If AR(1) matrix fails to converge, compound 
symmetry will be attempted. The parameters of the model will be estimated with pseudo-
likelihood type methods using PROC GLIMMIX in SAS (SAS/STAT User’s Guide). 
Simulations investigating generalized linear models (GLM) for correlated binary data fit with 


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PROC GLIMMIX indicate good performance as measured by type I error, CI coverage and 
bias even in the presence of data that is MAR (Liu and Zhan, 2011). From this model, one 
can obtain estimate of the probability of “response” for each treatment group at each 
timepoint (at Week 16 or prior) as well inferential comparisons (odds ratio, CI and p-value)
between treatment groups.
If a response rate is 0 or 100% at a visit for a treatment group that may lead to convergence 
issue, data from that visit for all the treatment groups will be removed from the model fitting. 
5.2.2. Analyses for Continuous Endpoints
In general, the data for all continuous endpoints will be summarized by treatment group and 
visit in tables containing descriptive statistics (N, mean, standard deviation, standard error of 
the mean, minimum, 1st, 2nd (i.e., median) and 3rd quartiles and maximum) for actual and 
change from baseline (or percent change from baseline) values for those endpoints measured 
at baseline. 
5.2.2.1. Longitudinal Model for Repeated Measures 
Data for longitudinally collected continuous endpoints at 2 or more post-baseline visits 
during the first 16 weeks may be analyzed as change or percent change from baseline with a 
marginal model for repeated measures (MMRM) that includes the fixed effect of treatment, 
visit (discrete variable, up to Week 16), treatment by visit interaction, and baseline value. An 
unstructured (UN) variance-covariance matrix will be fit whenever possible. If there is 
convergence issue with UN matrix, the model will be fit with heterogeneous compound 
symmetry (CSH) matrix. This model will generate maximum likelihood estimates under the 
assumption of MAR, but no imputations will be made for missing data. Subjects in treatment 
sequences C and D will be combined into a single group for PF-06700841 10 mg QD; 
subjects in treatment sequences E and F will be combined into a single group for placebo. 
Pairwise comparisons between each PF-06700841 dose group and placebo at each time 
points will be generated from this model with least square means for treatment differences, 
90% CIs and 2-sided p-values.  
5.2.2.2. Jump to Reference Imputation Model
As a supplementary analysis for MMRM, a multiple imputation (MI) approach will be used 
(Carpenter et al., 2013).  The specific MI that will be implemented applies the “jump to 
reference” (JTR) imputation approach to the active dose groups but MAR imputation 
approach to the combined placebo group. The joint distribution of a subject’s data across the 
timepoints up to and including Week 16 will be assumed to be multivariate normal (MVN).  
Each treatment group is assumed to have different sets of means.  For dropouts randomized 
to an active group, applying JTR, the means of the MVN distribution across time for each 
dropout will be equal to those estimated means for that active group prior to dropping out, 
and equal to those estimated means for the placebo group post-dropout. For each imputation,
the parameters of the MVN distributions will be sampled from the posterior distributions 
using Markov Chain Monte Carlo (MCMC) methods.  The distribution of each subject’s 
imputed values, conditional on his or her past values, will hence be MVN and a function of 
the subject’s past values and the sampled parameters.  The effect of past values on the 


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imputed values will depend on the strength of the correlation and the residuals (past values 
minus their expected values).  For active group dropouts, the residuals will be computed 
using their respective active group means at the timepoints prior to dropout.  While measures 
at timepoints prior to Week 16 are used in this MI approach, once one generates multiple 
complete datasets (100 to 1000 depending on feasibility) through imputation, the ANCOVA
model described in 5.2.2.3 will be used to analyze just the data through Week 16 for 
treatment comparisons between each dose group of PF-06700841 and the combined placebo.
Inference will be performed according to the Rubin’s Rule (Rubin, 1987) for combining the 
multiple estimates and standard errors.
5.3. Methods to Manage Missing Data
In general, missing values in any endpoints will not be imputed when these endpoints are 
summarized using descriptive statistics. Missing values for safety endpoints will not be
imputed.
5.3.1. Binary Endpoints
In the primary analysis of the primary endpoint, ACR20 response rate at Week 16, missing 
values due to a subject dropping from the study for any reason (e.g., lack of efficacy or 
adverse event), except for COVID-19, will be handled by non-responder imputation (NRI).
In addition, if a subject discontinues treatment prematurely but not due to COVID-19, data 
collected at study visits after post treatment discontinuation will be censored, and subjects 
will be considered as non-responder for visits post treatment discontinuations.  This approach 
will be used for all “response-type” endpoints (ACR20/50/70, PASI 75/90/100, MDA, 
VLDA and PsARC) at all timepoints under all the analysis methods specified in this 
document, with the exception of the GLMM method (Section 5.2.1.4). For the analysis of 
presence of dactylitis/enthesitis, missing data will not be imputed. Note that if a subject 
discontinues from the study at a visit of interest, say Week 16, but the value of the endpoint is 
not missing at Week 16, the value of the endpoint will be used for Week 16.
For a composite “response-type” endpoint (such as ACR20), if values in any of the 
components at a timepoint is missing, the component variables that are not missing will be 
used to determine the response status.  If one could not determine the response status in the 
presence of missing components at the timepoint, then the composite response-type endpoint 
status is considered “non-response” for that timepoint for all of the inferential analyses
except the supplementary analysis for ACR endpoints up to Week 16 using a GLMM model
(see Section 5.2.1.4), where MAR will be assumed for missing data.
If a subject misses a visit due to COVID-19, he/she will be excluded from the analysis for 
that visit; If a subject discontinues treatment or withdraws from the study due to COVID-19, 
he/she will be excluded from the analyses after the treatment discontinuation visit or study 
withdrawal visit, respectively.  
5.3.2. Continuous endpoints
Continuous endpoints that are collected at multiple post-baseline timepoints during the first 
16 weeks will be analyzed with a MMRM model (Section 5.2.2.1). This model will yield 


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unbiased estimates and valid inferences in the presence of data that is missing at random 
(MAR). If a subject misses a visit, discontinues treatment, or withdraws from the study at or 
prior to Week 16 due to COVID-19, the subject will NOT be excluded from the MMRM 
analysis. The missing data due to COVID-19 are assumed to be missing completely at 
random (MCAR) and the methodology in the MMRM model could apply.  
As a supplementary analysis, a multiple imputation (MI) approach (Section 5.2.2.2) will also 
be used for the analysis of change from baseline in HAQ-DI at Week 16. If a subject misses 
a visit, discontinues treatment, or withdraws from the study at or before Week 16 due to 
COVID-19, the subject will be excluded from the MMRM analysis. 
For descriptive summary of the continuous endpoints, if a subject misses a visit due to 
COVID-19, he/she will be excluded from the analysis for that visit; If a subject discontinues 
treatment or withdraws from the study due to COVID-19, he/she will be excluded from the 
analyses after the treatment discontinuation visit or study withdrawal visit, respectively. 
For PRO instructions (SF-36, 
and FACIT-F), rules suggested by the 
developers of these will be followed in calculating scores when individual question/items 
may be missing. If these rules are not enough for calculating a score, then the endpoint will 
be considered to have a missing value, and the methods to manage missing values as 
specified above will follow in the analyses of these endpoints. 
 
  
 
 
 
 
 
 
5.3.4. Missing Dates
In compliance with Pfizer standards, if the day of the month is missing for any date used in a 
calculation, the 1st of the month will be used to replace the missing date unless the
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calculation results in a negative time duration (eg, date of resolution cannot be prior to date 
of onset; if replacing resolution date with the 1st of the month results in a negative duration, 
the resolution date will be set to the onset date).  Pfizer standards are similarly used if both 
month and day are missing (January 1 unless negative time duration). 
If the start date is missing for an AE, the AE is considered to be treatment emergent unless 
the collection date is prior to the treatment start date.
6. ANALYSES AND SUMMARIES
6.1. Primary Endpoint
6.1.1. The proportion of subjects achieving ACR20 response at Week 16
6.1.1.1. Main Analysis

Estimand strategy: Composite (Section 2.1.1).

Analysis set: Evaluable Population (Section 4). All participants who were randomized to 
the study and received at least one dose of the randomized study treatment.  

Analysis methodology: Proportion of subjects achieving ACR20 response at Week 16 
will be estimated by point estimates. Treatment comparison with placebo and two-sided 
90% CIs will be tested using the normal approximation method, where the variance will 
be estimated by unpooled method (Section 5.2.1.1). 

Intercurrent events (post baseline but prior to Week 16 assessments) and missing data: 

Treatment discontinuation: Per protocol Appendix 6, a participant will be 
withdrawn from treatment if experiences treatment compliance issues, certain AE, 
or abnormality findings in laboratory or ECG values. Any participants meeting 
discontinuation criteria must enter into the Follow-up Period with additional 
follow up visit occurring 1 week after their last dose of Early Termination Visit 
whenever possible.  Data post treatment discontinuation will be censored and 
study participants who discontinue treatment prior to Week 16 will be considered 
as ‘non-responders’. 

Handling of missing data due to COVID-19 is detailed in Section 5.3.1.

The number and proportion of participants achieving ACR20 response at Week 16 will 
be presented for each treatment group. 

Treatment differences, 2-sided 90% CIs, raw p-values and adjusted p-values (Dunnett’s 
method) between each dose group of PF-06700841 and placebo in the ACR20 response 
rate at Week 16 will be presented,  using normal approximation method (Section 5.2.1.1). 

Plot of the proportion of participants achieving ACR20 response at Week 16 by treatment 
group and plot of risk difference at Week 16 with 2-sided 90% CIs by dose group of PF-
06700841 compared to placebo. 


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6.1.1.2. Sensitivity/Supplementary Analyses
Sensitivity Analyses

Cochran-Mantel-Haenszel Analysis: Treatment differences, 2-sided 90% CIs and raw p-
values between each dose group of PF-06700841 and placebo in the ACR20 response 
rate at Week 16 will be presented,  using Cochran-Mantel-Haenszel method (Section 
5.2.1.2).

Logistic regression analysis of ACR20 response rate at Week 16 (Section 5.2.1.3). 
Missing data will be handled in the same way as the primary analysis. The odds ratio for 
the comparison of each dose group of PF-06700841 with the placebo group, the 2-sided 
90% CIs, raw p-values and adjusted p-values (Dunnett’s method) for odds ratio will be 
presented. The risk difference between each dose group of PF-06700841 and placebo 
(calculated using the observed placebo rate and estimated odds ratio from the logistic 
regression model) and 2-sided 90% confidence interval for risk difference will also be 
presented.  
Supplementary Analyses

Analysis of longitudinal ACR20 response rate (up to Week 16) using GLMM model 
(Section 5.2.1.4) will be performed. The odds ratio for the comparison of each dose group 
of PF-06700841 with the placebo group, the 2-sided 90% CIs will be presented by visit. 
6.2. Secondary Endpoint(s)
6.2.1. The proportion of subjects achieving ACR20 response at Week 16 in the 
subgroup of subjects who are TNFα inhibitor naïve.
6.2.1.1. Main Analysis

Estimand strategy: Composite

Analysis set: the subgroup of subjects who are TNFα inhibitor naïve in the Evaluable 
Population (Section 4).  

Analysis methodology: Proportion of subjects achieving ACR20 response at Week 16 
will be estimated by point estimates. Treatment comparison with placebo and two-sided 
90% CIs will be tested using the normal approximation method, where the variance will 
be estimated by unpooled method (Section 5.2.1.1). 

Intercurrent events (post baseline but prior to Week 16 assessments) and missing data: 

Same as in Section 6.1.1.1 

The number and proportion of participants achieving ACR20 response at Week 16 will 
be presented for each treatment group. 


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
Treatment differences, 2-sided 90% CIs and raw p-values between each dose group of 
PF-06700841 and placebo in the ACR20 response rate at Week 16 will be presented,  
using normal approximation method (Section 5.2.1.1). 

Plot of the proportion of participants achieving ACR20 response at Week 16 by treatment 
group and plot of risk difference at Week 16 with 2-sided 90% CIs by dose group of PF-
06700841 compared to placebo. 
6.2.1.2. Sensitivity/Supplementary Analyses
Sensitivity Analyses

Logistic regression analysis of ACR20 response rate at Week 16 (Section 5.2.1.3). 
Missing data will be handled in the same way as the primary analysis. The odds ratio for 
the comparison of each dose group of PF-06700841 with the placebo group, the 2-sided 
90% CIs, raw p-values and adjusted p-values (Dunnett’s method) for odds ratio will be 
presented. The risk difference between each dose group of PF-06700841 and placebo 
(calculated using the observed placebo rate and estimated odds ratio from the logistic 
regression model) and 2-sided 90% confidence interval for risk difference will also be 
presented.  
Supplementary Analysis – GLMM model

Analysis of longitudinal ACR20 response rate (up to Week 16) using GLMM model 
(Section 5.2.1.4) will be performed. 

The ACR20 response rates by visit will be estimated from the fitted GLMM model. 

The odds ratio for the comparison of each dose group of PF-06700841 with the placebo 
group and the corresponding 2-sided 90% CIs will be presented by visit.
6.2.2. The proportion of subjects achieving an ACR20 response at all treatment 
timepoints (other than Week 16)

Analysis set: Evaluable Population (Section 4).

Analysis methodology: Proportion of subjects achieving ACR20 response at all visits will 
be estimated by point estimates. Treatment comparisons with placebo and two-sided 90% 
CIs will be made using the normal approximation method, where the variance will be 
estimated by unpooled method (Section 5.2.1.1). 

The number and proportion of participants achieving ACR20 response will be presented 
for each treatment group by timepoint. 

Treatment differences and 2-sided 90% CIs between each dose group of PF-06700841 
and placebo in the ACR20 response rate at all visits (other than Week 16) will be 
presented,  using normal approximation method (Section 5.2.1.1). 


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
Plot of proportion of participants achieving ACR20 response by treatment group and 
timepoints (including Week 16).

Plot of treatment differences between each dose group of PF-06700841 and placebo with 
2-sided 90% CIs by timepoints (including Week 16).
6.2.3. The proportion of subjects achieving ACR50 and ACR70 response at all 
treatment timepoints

Analysis set: Evaluable Population (Section 4).

Analysis methodology: Proportion of subjects achieving ACR50/ACR70 response at all 
visits will be estimated by point estimates. Treatment comparisons with placebo and two-
sided 90% CIs will be made using the normal approximation method, where the variance 
will be estimated by unpooled method (Section 5.2.1.1). 

The number and proportion of participants achieving ACR50/ACR70 response will be 
presented for each treatment group. 

Treatment differences and 2-sided 90% CIs between each dose group of PF-06700841 
and placebo in the ACR50/ACR70 response rate at all visits will be presented,  using 
normal approximation method (Section 5.2.1.1). 

Plot of the proportion of participants achieving ACR50/ACR70 response by treatment 
group and timepoints.

Plot of the treatment difference between each dose group of PF-06700841 and placebo 
with 2-sided 90% CIs by timepoints.
6.2.4. Change from baseline in the ACR response criteria components

Analysis set: PD Analysis Population for hsCRP; Evaluable Population for all other 
criteria components (Section 4).

ACR response criteria components include tender/painful joint count, swollen joint count, 
patient’s assessment of arthritis pain, patient’s global assessment of arthritis, physician’s 
global assessment of arthritis, HAQ-DI and hsCRP.

Each component endpoint will be summarized descriptively by the treatment group and 
visit.
o
The sample size, mean, standard deviation, median, minimum, and maximum at the 
baseline and postbaseline visits for baseline and change from baseline values will be 
presented by treatment group and visits (Section 5.2.2). 
o
Treatment differences and 2-sided 90% CIs between each dose group of PF-
06700841 and placebo at all postbaseline visits will be presented for each component 
endpoint. 


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
For each component endpoint, an MMRM model (Section 5.2.2.1) will be fit to the 
longitudinal data (up to Week 16). MAR is assumed for missing data in MMRM model 
analysis.
o
The least-squares (LS) means, 90% CIs for the LS means, treatment differences in the 
LS means between each dose group of PF-06700841 and placebo, and the 
corresponding 90% CIs will be presented for change from baseline in each 
component endpoint for all post-baseline visits.  

Analysis of HAQ-DI  
o
Hypothesis testing of HAQ-DI at Week 16 will be based on the MMRM model. 
Treatment comparisons will be performed based on the fitted MMRM model. 
Handling of missing data due to COVID-19 is detailed in Section 5.3.2.As a 
supplementary analysis, the HAQ-DI will also be analyzed using a multiple 
imputation approach for missing data (Section 5.2.2.2).
o
A responder analysis of HAQ-DI will be performed, where a responder in HAQ-DI is 
defined as the change from baseline in HAQ-DI<-0.3. The analysis methodology will 
be the same as Section 6.2.3.
6.2.5. The proportion of subjects achieving PASI75/90/100 response 

Analysis Set: the subgroup of subjects with baseline BSA≥3% and PASI>0 in the 
Evaluable Population (Section 4).  

Analysis methodology: Same as Section 6.2.3.

The number and proportion of participants achieving PASI75/90/100 response will be 
presented for each treatment group.  

Treatment differences and 2-sided 90% CIs between each dose group of PF-06700841 
and placebo in the PASI75/90/100 response rate at all visits will be presented,  using 
normal approximation method (Section 5.2.1.1). 

Plot of the proportion of participants achieving PASI75/90/100 response by treatment 
group and timepoints.

Plot of treatment differences between each dose group of PF-06700841 and placebo with 
2-sided 90% CIs by timepoints.
6.2.6. Change from baseline in the enthesitis score

Enthesitis will be evaluated based on both SPARCC Enthesitis Index and Leeds 
Enthesitis Index. Analysis of enthesitis score will be performed for both indicies.

Analysis Set: the subgroup of subjects with baseline enthesitis score >0 in the Evaluable 
Population (Section 4).


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
Analysis strategy: Same as in Section 6.2.4.
6.2.7. Change from baseline in the Dactylitis Severity Score

Analysis Set: the subgroup of subjects with baseline Dactylitis Severity Score (DSS)>0 in 
the Evaluable Population (Section 4).  

Analysis strategy: Same as in Section 6.2.4.
6.2.8. Change from baseline in the Nail Psoriasis Severity Index 

Analysis Set: the subgroup of subjects with baseline Nail Psoriasis Severity Index 
(NAPSI) >0 in the Evaluable Population (Section 4).  

Analysis strategy: Same as in Section 6.2.4.
6.2.9. Change from baseline in the Patient’s Global Joint and Skin Assessment – Visual 
Analog Scale (PGJS-VAS)

Analysis Set: Evaluable Population (Section 4).  

Analysis strategy: Same as in Section 6.2.4.
6.2.10. Change from baseline in the Functional Assessment of Chronic Illness Therapy 
– Fatigue (FACIT-Fatigue)

Analysis Set: Evaluable Population (Section 4).  

Analysis strategy: Same as in Section 6.2.4.
6.2.11. Change from baseline in the Short-Form-36 Health Survey (SF-36) Version 2, 
Acute

Analysis Set: Evaluable Population (Section 4).  

Analysis strategy: Same as in Section 6.2.4.
6.2.12. The proportion of subjects achieving Minimal Disease Activity (MDA) and Very 
Low Disease (VLDA) response

Analysis Set: Evaluable Population (Section 4).  

Analysis strategy: Same as in Section 6.2.2.
6.2.13. Change from baseline in the Disease Activity Index for Reactive Arthritis/PsA 
(DAREA/DAPSA)

Analysis Set: subjects in the Evaluable Population (Section 4) with baseline 
DAREA/DAPSA

Analysis strategy: Same as in Section 6.2.4.


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6.2.14. The proportion of subjects achieving the Psoriatic Arthritis Response Criteria 
(PsARC)
•
Analysis Set: Evaluable Population (Section 4)
•
Analysis strategy: Same as in Section 6.2.2.
6.2.15. Change from baseline in the Psoriatic Arthritis Disease Activity Score 
(PASDAS)
•
Analysis Set: Evaluable Population (Section 4).  
•
Analysis strategy: Same as in Section 6.2.4.
 
 
 
  
  
  
  
 
  
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C
C
I
C
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6.4. Subset Analyses
Subgroup analysis will be performed for ACR20 for Prior TNFi exposure (yes, no).
6.5. Baseline and Other Summaries and Analyses
6.5.1. Baseline Summaries
Baseline characteristics will include but may not be limited to the ones listed below and 
will be summarized descriptively. For continuous variables, the summary will include N, 
mean, SD and range; for binary and categorical variables, the summary will include 
frequencies and percentages. A missing category will be included for those subjects with 
missing value. In addition to displays by treatment groups, the summaries will also be 
provided for all the treatment groups combined.
Demographic characteristics:
•
Baseline age (2 categorizations:18-44, 45-64, ≥65 years; and continuous in years);
•
Sex (female, male);
•
Race (white, black, Asian, other);
•
Ethnicity (Hispanic/Latino, non-Hispanic/Latino);
•
Baseline body weight (<60, ≥60 to ≤100, >100 kg; and continuous in kg),
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•
Baseline height (cm, continuous);
•
Baseline Body Mass Index (BMI: <18.5, 18.5 to <25, 25 to <30, 30 to <40, and ≥40 
kg/m2; and continuous kg/m2);
•
Screening smoking status (never smoked, ex-smoker, smoker);
•
Alcohol use [yes, no; continuous (units/week) for subjects who consumed any 
alcohol, ie, responded Yes].
Baseline disease characteristics
•
PsA duration (<2, ≥2 years; and continuous in years);
•
Baseline PsA Subtype: (<5 joints, ≥5 joints);
•
Baseline PASDAS: (≤3.2, >3.2 to <5.4, ≥5.4; and continuous);
•
Baseline swollen joint count (66) (continuous);
•
Baseline tender/painful joint count (68) (continuous);
•
Baseline HAQ-DI (continuous);
•
Screening presence of distal interphalangeal joints involvement (yes, no);
•
Screening presence of arthritis mutilans (yes, no);
•
Baseline presence of enthesitis measured by SPARCC enthesitis index or LEI (yes, 
no). Yes, is defined for those subjects with baseline SPARCC enthesitis index >0 or 
LEI >0;
•
Baseline presence of enthesitis measured by SPARCC enthesitis index (yes, no). Yes,
is defined for those subjects with baseline SPARCC enthesitis index >0;
•
Baseline presence of enthesitis measured by LEI (yes, no). Yes, is defined for those 
subjects with baseline LEI >0;
•
Baseline enthesitis index measured by SPARCC enthesitis index (continuous) for 
those subjects with SPARCC enthesitis index >0 at baseline;
•
Baseline enthesitis index measured by LEI (continuous) for those with LEI >0 at 
baseline;
•
Baseline presence of dactylitis (yes, no). Yes, is defined for those subjects with 
baseline DSS >0;
•
Baseline DSS (continuous) for those subjects with DSS >0 at baseline;
•
Baseline total psoriatic BSA ( >=0 to <3, ≥3%);
•
Baseline total psoriatic BSA (continuous) for those with BSA >0% at baseline,
•
Baseline PASI (0, >0 to ≤20, >20);
•
Baseline PASI (continuous) for those subjects with BSA≥3% and PASI>0 at baseline,
•
Baseline SF-36 (physical functioning domain, physical component score [PCS] and 
mental component score [MCS]);
•
Baseline FACIT-F (FACIT-F total score);
•
Baseline SF-36 MCS (<42, >=42)
•
Baseline CRP (≤2.87, >2.87 mg/L; and continuous in mg/L);
C
C
C
C
I
C
C


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
Concomitant Methotrexate Dose at Baseline (mg/wk)

Baseline Rheumatoid Factor Positive

Baseline Cyclic Citrullinated Peptide Antibody Positive

Concomitant DMARDs at Day 1

Concomitant MTX at Day 1

Concomitant NSAIDs at Day 1

Concomitant ORAL STEROIDS at Day 1

Prior TNFi exposure (yes, no);
6.5.2. Study Conduct and Participant Disposition
Participant disposition will be summarized by treatment sequence. 
6.5.3. Study Treatment Exposure
Study treatment exposure will be summarized by treatment sequence and combined when 
appropriate.  
6.5.4. Concomitant Medications and Nondrug Treatments
All concomitant medication(s) and nondrug treatment will be provided in the listings.
6.6. Safety Summaries and Analyses
6.6.1. Adverse Events
In the 3-tier approach, the number and percentage of subjects with AEs over the first 16 
weeks will be provided for each treatment group. 

Tier 1 events will not be analyzed in this study.  

Tier 2 events will be analyzed using asymptotic methods proposed by Miettinen and 
Nurminen (1985).  Risk differences between each dose group of PF-06700841 and
placebo and the corresponding 2-sided 95% CIs will be reported. Results will be 
presented in tabular displays and sorted by System Organ Class (SOC) and preferred 
terms (PT) within SOC, alphabetically, as well as by magnitude in risk difference. 
Graphic displays (e.g. forest plots) may be provided when appropriate. P-values will 
not be reported for Tier-2 events thus no multiplicity adjustment will be applicable. 

For Tier 2 events outputs, include footnotes to provide proper interpretation of p-
values (Tier 1 events) and CIs, describe how comparison is conducted, e.g.: p-values 
and CIs are not adjusted for multiplicity and should be used for screening purpose 
only. The 95% CIs are provided to help gauge the precision of the estimates for risk 
difference. Risk difference is computed as PF-06700841 versus placebo. Footnotes 
should also state which methods were used to derive the p-values and confidence 
intervals.

Tier-3 AEs will not be summarized separately but will be included as part of the 
overall AE summary. Tier-3 events will be reported with the observed proportions 
without comparative statistics. 


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It should be recognized that most studies are not designed to reliably demonstrate a causal 
relationship between the use of a pharmaceutical product and an adverse event or a group of 
adverse events. Except for select events in unique situations, studies do not employ formal 
adjudication procedures for the purpose of event classification. As such, safety analysis is 
generally considered as an exploratory analysis and its purpose is to generate hypotheses for 
further investigation. The 3-tier approach facilitates this exploratory analysis.
6.6.2. Laboratory Data
Laboratory data will be listed and summarized by treatment in accordance with the sponsor 
reporting standards. Results from central labs will be used for statistical analyses. Baseline is 
defined in Section 3.4.
6.6.3. Vital Signs
Absolute values and changes from baseline in systolic and diastolic blood pressure, 
respiratory rate, pulse rate and temperature will be summarized by treatment and time 
post-dose, according to sponsor reporting standards. Baseline is defined in Section 3.4.
6.6.4. Electrocardiograms
Data from central readings will not be included in the CSR - all outputs will be produced 
using local ECG readings.
Baseline and change from baseline in ECG will be summarised descriptively up to Week 
16 using 4 treatment groups (as described in Section 6.2). Baseline and change from 
baseline in ECG will be summarised at Week 52 using only those subjects using the same 
local read ECG machine at both Baseline and Week 52 visits using 6 treatment sequences 
(as described in Section 6.2).
Categorical summaries of the ECG data will be provided up to Week 16. For all visits 
from Week 20 to Week 52, only absolute categories will be reported.
Table 3.
Safety QTc Assessment 
Degree of 
Prolongation
Mild (ms)
Moderate (ms)
Severe (ms)
Absolute value
>450-480
>480-500
>500
Increase from baseline
30-60
>60
In addition, the number of participants with uncorrected QT values >500 ms will be 
summarized.
7. INTERIM ANALYSES
7.1. Introduction
An administrative interim analysis may be performed when approximately 60% of subjects 
have completed Week 16 visit or have the opportunity to complete the Week 16 visit.  If 
performed, this interim analysis would be conducted by an unblinded team independent of 
this study team and the safety and efficacy results from the interim analysis may be reviewed 
by an Internal Review Committee (IRC).  No members of the study team will be part of the 


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IRC.  The interim analysis, if performed, will not be used to drive any decisions for the 
current study; however, it may be used for internal business decisions regarding future study 
planning.
During the interim analysis, some members of the study team may be unblinded and replaced 
with blinded colleagues.  The subjects, investigators, and individuals from the sponsor (or 
designee) who interact with the investigators and monitor safety will continue to be blinded 
to individual study treatments throughout the follow up period of the study.
Before any interim analysis is conducted, the details of the objectives, decision criteria, 
dissemination plan, and method of maintaining the study blind as per Pfizer’s standard 
operating procedures (SOPs) will be documented and approved in an internal review 
committee (IRC) charter.  
7.2. Interim Analyses and Summaries
If performed, interim analyses will use the same analyses and summaries as described in 
Section 5 and 6, with the exception that hypothesis testings will not be formally performed
because the sample size at IA would not provide adequate power. Due to the rapid study 
enrolment, the interim analysis was not conducted. 
8. REFERENCES
1.
Agresti A, Categorical Data Analysis, 2013, 3rd Edition, New York: John Wiley & 
Sons.
2.
Alberti KG, Eckel RH, Grundy SM, et al. Harmonizing the metabolic syndrome: a
joint interim statement of the International Diabetes Federation Task Force on 
Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American 
Heart Association; World Heart Federation; International Atherosclerosis Society; and
International Association for the Study of Obesity. Circulation, 2009, 120: 1640-1645.
3.
Bruce B, Fries JF. The health assessment questionnaire (HAQ). Clinical and
Experimental Rheumatology; 2005, 23 (Supp. 39), S14-S18.
4.
Carpenter JR, Roger JH and Kenward MG.  Analysis of longitudinal trials with 
protocol deviation:  a framework for relevant, accessible assumptions, and inference 
via multiple imputation. Journal of Pharmaceutical Statistics; 2013, 23: 1352-1371.
5.
Gladman DD, Tom BDMM, Mease PJ and Farewell VT. Informing Response Criteria 
for Psoriatic Arthritis (PsA). II: Further Considerations and a Proposal - The PsA
Joint Activity Index. J Rheumatol 2010, 37: 2559–2565.
6.
Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of 
psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines 
of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008, 
58: 851-64.


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7.
Helliwell PS, Fitzgerald O, Fransen J, et al. The development of candidate 
composite disease activity and responder indices for psoriatic arthritis (GRACE 
project). Ann Rheum Dis, 2013, 72: 986–991.
8.
Liu, GR and Zhan X Comparisons of methods for analysis of repeated binary
responses with missing data.  Journal of Biopharmaceutical Statistics, 2011, 21: 371-
392.
9.
Madsen OR. Is DAS28-CRP with three and four variables interchangeable in 
individual patients selected for biological treatment in daily clinical practice? Clin 
Rheumatol, 2011, 30: 1577–1582.
10.
Mease PJ, Woolley JM, Bitman B, Wang BC, Globe DR, Singh A. Minimally
important difference of Health Assessment Questionnaire in psoriatic arthritis: 
relating thresholds of improvement in functional ability to patient-rated importance 
and satisfaction. J Rheumatol 2011, 38: 2461-2465.
11.
Miettinen O and Nurminen M. Comparative analysis of two rates. Statistics in 
Medicine, 1985, 4: 213-226.Mumtaz A, Gallagher P, Kirby B, et al. Development 
of a preliminary composite disease activity index in psoriatic arthritis. Ann Rheum 
Dis, 2011, 70: 272-277.
12.
Ramiro S, van Tubergen A, van der Heijde D, van den Bosch F, Dougados M, 
Landewé R. How to deal with missing items in BASDAI and BASFI. 
Rheumatology, 2014, 53: 374-376.
13.
Rubin DB (1987). Multiple imputation for nonresponse in surveys.  New York: 
Wiley.Schoels M, Aletaha D, Funovits J, Kavanaugh A, Baker D, Smolen JS. 
Application of the DAREA/DAPSA score for assessment of disease activity in
psoriatic arthritis. Ann Rheum Dis, 2010, 69: 1441-1447.


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9. APPENDICES
Appendix 1.1. Endpoint Derivations
ACR assessments
The American College of Rheumatology’s definition for calculating improvement in RA 
(ACR20) is calculated as a ≥20% improvement in tender and swollen joint counts and ≥20%
improvement in 3 of the 5 remaining ACR-core set measures: patient and physician global 
assessments, pain, disability, and an acute-phase reactant.  Similarly, ACR50 and 70 are 
calculated with the respective percent improvement.  This efficacy measurement will be 
made at every study visit.  The specific components of the ACR Assessments that will be 
used in this study are:

Tender/Painful Joint count (68); 

Swollen Joint Count (66);

Patient’s Assessment of Arthritis Pain (VAS in mm); 

Patient’s Global Assessment of Arthritis (VAS in mm); 

Physician’s Global Assessment of Arthritis (VAS in mm); 

C-Reactive Protein (CRP) (in mg/L);

Health Assessment Questionnaire – Disability Index (HAQ-DI).
If the value in any of the components at a timepoint is missing, the component variables that 
are not missing will be used to determine the response status. Explicitly,
1) If either tender or swollen joint count is missing or both are missing, ACR20/50/70 
will be missing,
2) Of the other 5 remaining components,
a.
if >2 components are missing, ACR20/50/70 will be missing,
b. if 1 of the components is missing and if < 3 components satisfy the improvement 
criteria, then ACR20/50/70 will be missing,
c.
if 2 of the components is missing and if < 3 components satisfy the improvement 
criteria, then ACR20/50/70 will be missing.
Lower limit of quantification (LLOQ) for CRP is 0.020 mg/dL (or 0.200 mg/L). Any CRP 
value below the LLOQ will be reported as “<0.020” in database and will be set to 0.019 
mg/dL. The unit for CRP will be mg/dL or mg/L depending on endpoint of interest. The 
normal range for the CRP is ≤2.87 mg/L.
The VAS data will need to be rescaled prior to any calculation (Section 3).
Health Assessment Questionnaire – Disability Index (HAQ-DI)
The HAQ-DI assesses the degree of difficulty a subject has experienced during the past week 
in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, 


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hygiene, reach, grip, and other activities.  Each activity category or domain consists of 2-3 
items.  For each question in the questionnaire, the level of difficulty is scored from 0 to 3 
with 0 representing “no difficulty,” 1 as “some difficulty,” 2 as “much difficulty,” and 3 as 
“unable to do”. 
The domain score for each domain is the maximum (ie, worst) of the scores from the 
items/questions within the domain. If this domain score is ≥ 2, no further adjustment is 
needed. If it is < 2 (ie, 0 or 1) but no aids, devices or help from another person is indicated, 
then also no adjustment is needed. However, if it is < 2 and any aid, device or help from 
another person is indicated, then it is further adjusted upward to 2 as described below.
Any activity that requires assistance from another individual or requires the use of an aid or 
an assistive device adjusts to a minimum score of 2 to represent a more limited functional 
status.
Domain
If domain score is either 0 or 1, adjust to 2 when the following is 
satisfied.
Dressing and 
grooming
“Devices used for dressing (button hook, zipper pull, long-handled shoe 
horn, etc)” or help from others on “Dressing and Grooming” is checked
Arising
“Special or built up chair” or help from others on “Arising” is checked.
Eating
“Built up or special utensils” or help from others on “Eating” is checked.
Walking
“Cane”, “Walker”, “Crutches”, “Wheelchair”, or help form others on
“Walking” is checked
Hygiene
“Raised toilet seat”, “Bathtub bar”, “Long-handled appliances in 
bathroom”, “Bathtub seat” or help from others on “Hygiene” is checked.
Reach
“Long-handled appliances for reach” or help from others on “Reach” is 
checked
Grip
“Jar opener (for jars previously opened)” or help from others on 
“Gripping or opening things” is checked.
Activities
Help from others on “Errands and chores” is checked.
Note: For “Other, (specify)”, whether checked or unchecked or specifying the other “aids or 
devices” in this category, is not to be used in the adjustment of the domain score.
For each domain, the domain score will be determined by non-missing scores from the 
questions. A domain score will only be missing if all scores within the domain are missing. 
The HAQ-DI score is the average of all the 8 domain scores. If > 2 domain scores are not 
complete or missing, HAQ-DI score is considered missing, else the HAQ-DI score is 
computed as the average of the non-missing domain scores (Bruce & Fries, 2005). A higher 
score represents a more limited physical functional status/ability.
DAS 28-3 (CRP)
The Disease Activity Score (DAS) is a derived measurement with differential weighting 
given to each component.  DAS 28-3 (CRP) will be calculated from measurements made at 
all visits (Madsen, 2011).
The components of the DAS 28-3 arthritis assessment are: 


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Tender/Painful Joint Count (28);
Swollen Joint Count (28);
C-Reactive Protein (CRP in mg/L).
 
 
PsA Response Criteria (PsARC)
The PsARC will be collected/derived at all visits in addition to the ACR response 
criteria. The PsARC consists of 4 measurements:
Tender joint count (68) - TJC;
Swollen joint count (66) - SJC;
Physician’s Global Assessment of Arthritis (VAS); 
Patient’s Global Assessment of Arthritis (VAS).
The same tender/painful joint count and swollen joint count used for ACR response criteria 
will be applied to the PsA Response Criteria.  In order to be a ‘PsARC responder’, subjects 
must achieve improvement in 2 of 4 measures, one of which must be joint pain or swelling, 
without worsening in any measure.
Specifically, the PsARC response is defined as improvement in two of the following 4 
criteria, one of which must be joint pain or swelling, without worsening in any measure: (1) 
≥20% improvement in Physician’s Global Assessment of Arthritis (VAS); (2) ≥20% 
improvement in Patient’s Global Assessment of Arthritis (VAS); (3) ≥30% improvement in 
tender joint count (68); and (4) ≥30% improvement in swollen joint count (66) (Gottlieb et al 
2008).
If values in any of the components at a timepoint were missing, the component variables that 
were not missing were used to determine the response status.  If one could not determine the 
response status in the presence of missing components at the timepoint, then the PsARC 
response will be considered as missing. Specifically, the following algorithm will be used for 
the derivation of the PsARC response.
PsARC Response
Algorithm
Responder
Meet improvement criteria for at least 2 components, at least one of 
which is TJC or SJC; AND
No worsening component and no missing component.
Non-responder
Both TJC and SJC available but not meeting improvement criterion; OR
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(Number of components meeting the improvement criteria) + (Number of 
missing components) <= 1; OR
At least one worsening component
Missing
Otherwise
The VAS data will need to be rescaled prior to any calculation (Section 3).
 
  
 
 
  
 
 
 
 
Disease Activity Index for Reactive Arthritis/Psoriatic Arthritis
(DAREA/DAPSA)
DAREA/DAPSA (Schoels et al 2010) is a composite instrument to assess peripheral joint 
involvement that is based upon numerical summation of 5 variables of disease activity: 
tender/painful joint count + swollen joint count (using SJC66/ TJC68 assessments), patient’s 
global assessment of Arthritis (PtGA in cm), patient’s assessment of Arthritis Pain (PAIN in 
cm) and CRP (in mg/dL).  Since DAREA reflects domains found important in PsA, it has
been proposed to serve as a Disease Activity Index for Psoriatic Arthritis (DAPSA). 
DAREA/DAPSA is calculated at every study visit during the treatment period except Week 2 
visit as follows:
DAREA/DAPSA= SJC66 + TJC68 + PtGA + PAIN + CRP.
Any missing component will result in DAREA/DAPSA as missing.
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The VAS data will need to be rescaled prior to any calculation (Section 3).
Minimal Disease Activity (MAD) Score and Very Low Disease Activity (VLDA) Score
A psoriatic arthritis patient is defined as having Minimal Disease Activity response (MDA
response, yes/no) when the patient meets 5 of the 7 following criteria: 1) tender joint count
1; 2) swollen joint count 1; 3) PASI score 1 or BSA 3%; 4) patient Arthritis Pain (VAS)
15 mm; 5) patient’s global arthritis assessment (VAS) 20 mm; 6) HAQ-DI score 0.5; 7)
tender entheseal points (using Leed’s enthesitis Index) 1. A patient is in VLDA when all 
seven criteria are met. 
If < 5 non-missing component criteria are satisfied and at least one of the remaining 
component criteria is missing, then the MDA response will be set as missing.
The VAS data will need to be rescaled prior to any calculation (Section 3).
Psoriatic Arthritis Disease Activity Score (PASDAS)
PASDAS (Helliwell et al 2013) is a composite PsA disease activity score that includes the 
following components: patient’s global joint and skin assessment (VAS in mm), physician’s 
global psoriatic arthritis assessment (VAS in mm), swollen (66 joints) and tender joint 
counts (68 joints), Leeds Enthesitis Index score, tender dactylitic digit score, physical 
component summary score (PCS) of SF-36 and CRP (mg/L) (Helliwell et al. 2013).
PASDAS=(((0.18 x √Physician global VAS) + (0.159 x √Patient global VAS)
- (0.253x √SF36-PCS) + (0.101 x LN(Swollen joint count + 1))
+ (0.048 x LN(Tender joint count + 1)) 
                  + (0.23 x LN(Leeds enthesitis index score + 1))
+ (0.37 x LN(Tender dactylitis count + 1))
+ (0.102 x LN(CRP + 1)) + 2) x 1.5
where LN() is the natural logarithm. For patient’s global joint and skin assessment (VAS), it 
is obtained only from the first question in the CRF for assessing subject’s global joint and 
skin, “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?” The physician’s global psoriatic 
arthritis assessment (VAS) is obtained from the CRF at the prompt: “THE SUBJECT’S 
OVERALL PSORIATIC ARTHRITIS AT THIS TIME IS...”. The tender dactylitis digit 
score is the number of digits out of 20 (fingers and toes) where rating of either 2 (digit is 
tender and swollen (active)) or 3 (digit is very swollen and tender or very tender and swollen 
(highly active)) is registered. Any missing component will result in PASDAS as missing. The 
VAS data will need to be rescaled prior to any calculation (Section 3). A higher PASDAS 
score indicates a higher disease activity.
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The Psoriasis Area and Severity Index (PASI) quantifies the severity of a subject’s psoriasis 
based on both lesion severity and the percentage of body surface area (BSA) affected.
•
Lesion severity: The basic characteristics of psoriatic lesions – erythema, induration 
and scaling – provide a means for assessing the severity of lesions. Assessment of 
these three main signs is performed separately for four areas of the body: head and 
neck, upper limbs, trunk (including axillae and groin), and lower limbs (including 
buttocks).  Average erythema, induration and scaling are rated for each body area 
according to a 5-point scale: 0, no involvement; 1, slight; 2, moderate; 3, marked; 4, 
very marked.
•
Body surface area involvement (%BSA): The extent (%) to which each of the four 
areas of the body is affected by psoriasis is assigned a numerical score according to the
following area scoring criteria: 0, no involvement; 1, >0 to 9%; 2, 10 to 29%; 3, 30 to
49%; 4, 50 to 69%; 5, 70 to 89%; 6, 90 to 100%.
In each area, the sum of the severity rating scores for erythema, induration and scaling is 
multiplied by the score representing the percentage of this area involved by psoriasis, 
multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The 
sum of the numbers obtained for each of the four body areas is the PASI.
PASI = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl) 
Where A = area of involvement score; E = erythema; I =induration; S = scaling; h = head;
u = upper limbs; t = trunk; l = lower limbs.
The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores 
representing increasing severity of psoriasis.
Each PASI clinical signs component score can be computed as:
PASI_E = 0.1Ah (Eh) + 0.2Au (Eu) + 0.3At (Et) + 0.4Al (El) 
PASI_I = 0.1Ah (Ih) + 0.2Au (Iu) + 0.3At (It) + 0.4Al (Il) 
PASI_S = 0.1Ah (Sh) + 0.2Au (Su) + 0.3At (St) + 0.4Sl (Sl)
Any missing component will result in PASI as missing. In addition to the analysis of PASI
scores, BSA (%) will be summarized descriptively.
 
 
 
 
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Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
FACIT-F is a 13 item questionnaire (each item score ranges from 0 to 4). There will be 3 
endpoints derived: ∆FACIT-F total score, ∆FACIT-F experience domain score and ∆FACIT-
F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 
items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items of 
Q1 I feel fatigued, Q2 I feel weak all over, Q3 I feel listless (“washed out”), Q4 I feel tired 
and Q7 I have energy, while FACIT-F impact domain score (range 0-32) is calculated by 
summing the remaining 8 items. Note that all the scores except Q7 & Q8 should be reversed 
(ie, 0 →4, 1→3, 3→1, 4→0) prior to summing for both the total score and the domain scores 
such that higher scores represent better functioning.
All responses are added with equal weight to obtain the total score. In cases where some 
answers are missing, a total score is prorated from the score of the answered items, so long as 
more than 50% of the items (i.e., at least 7 of 13 for FACIT-F total score, at least 3 of 5 for 
FACIT-F experience domain score, and at least 5 of 8 for FACIT-F impact domain score) are 
answered.
Short Form 36 (SF-36, version 2, acute)
The SF-36 v.2 (Acute version) is a 36-item generic health status measure. It measures
8 general health concepts or domains: physical functioning, role physical, bodily pain, 
general health, vitality, social functioning, role emotional and mental health. These domains
can also be summarized as physical and mental component scores.
These 8 domains are as follows:
a.  Physical Functioning (PF).  This score is based on the responses to the 10 items that 
compose Question 3 and reflects the degree to which various physical activities have 
been limited in the previous week by the subject’s health.
b.   Role-Physical (RP).
This score is based on the responses to the four items that 
compose Question 4 and reflects the relative amount of time that the subject has had 
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problems with work or other regular daily activities as a result of their physical 
health during the previous week.
c.  Bodily Pain (BP).
This score is based on the responses to Questions 7 and 8 and 
reflects bodily pain and its effects on normal work during the previous week.
d.   General Health (GH).
This score is based on responses to Question 1 and the four 
items in Question 11 and reflects the subject’s perception of their general health 
during the previous week.
e.  Vitality (VT).
This score is based on responses to Question 9 items a, e and g, and 
reflects the subject’s physical energy level relative to time during the previous week.
f.
Social Functioning (SF). This score is based on responses to Questions 6 and
reflects how physical health or emotional problems have interfered with social 
activities during the previous week.
g.   Role-Emotional (RE).
This score is based on responses to the three items in 
Question 5 and reflects the amount of time during the previous week that
emotional problems have interfered with work or regular daily activities.
h.   Mental Health (MH).  This score is based on responses to Question 9 items b, c, d, f, 
and h and reflects various mental/emotional states relative to time during the previous 
week.
The summary component scores are:

Physical Component Summary (PCS).

Mental Component Summary (MCS).
In addition, there is another subscale in the SF-36: Health Transition (TR). This score is 
based on the response to Question 2 and is a rating of current general health compared to one 
week previous.
The summary component scores, PCS and MCS, are based on a normalized sum of the 8 
scale scores PF, RP, BP, GH, VT, SF, RE, and MH. All domains and summary components 
are scored such that a higher score indicates a higher functioning or health level.
Data Derivation Details to Obtain Scale Scores for SF-36


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VARIABLE
DERIVATION
SF-36 PF scale score
raw score = sum (items 3A, 3B, 3C, 3D, 3E, 3F, 3G, 3H, 3I, 3J)
PF = (raw score – 10) * 5
PF_Z = (PF – 82.62455) / 24.43176
PF scale score = (PF_Z*10) + 50
When calculating the raw score, if 5 or more of the items are non-missing then
replace any missing values as follows:
Calculate the mean of the answered questions, using the number of answered
questions as the denominator. Substitute the mean for any missing scores.
Otherwise, if less than 5 of the items are non-missing then PF
scale score is missing.
The response scale for each activity ranges from 1 to 3 where
1=limited a lot, 2=limited a little, and 3=not limited at all.
A higher PF scale score indicates better physical functioning.
SF-36 RP scale score
raw score = sum (items 4A, 4B, 4C, and 4D) RP = [(raw score -4)/16] * 100
RP_Z = (RP – 82.65109) / 26.19282
RP scale score = (RP_Z * 10) + 50
When calculating the raw score, if 2 or more of the items are non-missing then
replace any missing values as follows:
Calculate the mean of the answered questions, using the number of answered
questions as the denominator.  Substitute the mean for any missing scores.
Otherwise, if less than 2 of the items are non-missing then RP scale score is
missing.
The response scale for each item ranges from 1 to 5 where
1=All of the time, 2=Most of the time, 3=Some of the time,
4=A little of the time, and 5=None of the time. A higher RP scale score 
indicates better role-physical functioning.


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SF-36 BP scale score
raw score = sum (reversed item 7 and reversed item 8) 
BP = (raw score -2) * 10 
BP_Z = (BP – 73.86999) / 24.00884
BP scale score = (BP_Z * 10) + 50
Reverse direction of Item 7 as follows
if =1, set to 6
if =2, set to 5.4 
if =3, set to 4.2 
if =4, set to 3.1 
if =5, set to 2.2 
if =6, set to 1
Reverse direction of item 8 as follows:
if =1 and original item 7 value =1, set to 6
if =1 and original item 7 value >=2, set to 5 
if =2, set to 4
if =3, set to 3 
if =4, set to 2 
if =5, set to 1
If item 7 is answered and item 8 is missing, set 8 = reversed 7 as defined above.
If item 8 is answered and item 7 is missing, set item 7 as reverse item 8 as 
follows
if =1, set to 6
if =2, set to 4.75
if=3, set to 3.5 
if=4, set to 2.25 
if=5, set to 1
If 1 or more questions were answered, calculate BP scale score as defined 
above. If neither question was answered then BP scale score is missing.
The scale for Question 7, amount of bodily pain, ranges from 1 to 6, where
1=None, 2=Very mild, 3=mild, 4=Moderate, 5=Severe, and 6=Very severe.
The scale for Question 8, the degree to which pain interfered with normal 
work, ranges from 1 to 5, where
1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit, and 5=Extremely.
A higher BP scale score indicates lack of bodily pain.


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SF-36 GH scale score
raw score = sum (reversed item 1, item 11A, reversed 11B, 11C and reversed
11D)
GH = (raw score -5) * 5
GH_Z = (GH – 70.78372) / 21.28902
GH scale score = (GH_Z * 10) + 50
Reverse direction of Item 1 as follows:
if =1, set to 5
if =2, set to 4.4 
if =3, set to 3.4 
if =4, set to 2
if =5, set to 1
Reverse direction of item 11B and 11D by subtracting score from 6.
When calculating the raw score, if 3 or more of the items are non-missing then
replace any missing values as follows:
Calculate the mean of the answered questions, using the number of answered
questions as the denominator.
Substitute the mean for any missing scores.
Otherwise, if less than 3 of the items are non-missing then GH scale score is
missing.
Responses for Question 1, an assessment of self-perceived health status, range
from 1 to 5, where
1=Excellent, 2=Very good, 3=Good, 4=Fair, and 5=Poor.
Responses for the items in Question 11 range from 1 to 5, where
1=Definitely true, 2=Mostly true, 3=Don’t know, 4=Mostly false, and
5=Definitely false and reflect the subject’s perception of their relative health
and expectations of their future health status.
A higher GH scale score indicates better general health perceptions.


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SF-36 VT scale score
raw score = sum (reversed item 9a, reversed 9e, 9g and 9i) 
VT = [(raw score -4)/16] * 100
VT_Z = (VT – 58.41968) / 20.87823
VT scale score = (VT_Z * 10) + 50
Reverse direction of Items 9a and 9e by subtracting score from 6.
When calculating the raw score, if 2 or more of the items are non-missing then
replace any missing values as follows:
Calculate the mean of the answered questions, using the number of 
answered questions as the denominator.
Substitute the mean for any missing scores.
Otherwise, if less than 2 of the items are non-missing then VT scale score is
missing.
The scale for these items ranges from 1 to 5, where
1=All of the time, 2=Most of the time, 3=Some of the time, 4=A little of the
time, and 5=None of the time.
A higher VT scale score indicates more vitality.
SF-36 SF scale score
raw score = sum (reversed 6 and 10) SF = [(raw score -2) / 8] * 100
SF_Z = (SF – 85.11568) / 23.24464
SF scale score = (SF_Z * 10) + 50
Reverse direction of score for item 6 by subtracting score from 6. 
When calculating the raw score, if 1 of the items is missing then substitute the
missing score with the score on the non- missing item. If both items are
missing then SF scale score is missing.
Responses to Question 6, an assessment of the extent to which health/emotional
problems interfered with social activities, range from 1 to 5, where
1=Not at all, 2=Slightly, 3=Moderately, 4=Quite a bit, and 5=Extremely.
Responses to Question 10 reflect the amount of time that health/emotional
problems interfered with social activities and range from 1 to 5, where
1=All of the time, 2=Most of the time, 3=Some of the time, 4=A little of the
time, and 5=None of the time.
A higher SF scale score indicates better social functioning.


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SF-36 RE scale score
raw score = sum (items 5A, 5B, and 5C)
RE = [(raw score -3) / 12] * 100
RE_Z = (RE – 87.50009) / 22.01216
RE scale score = (RE_Z * 10) + 50
When calculating the raw score, if 2 or more of the items are non-missing then
replace any missing values as follows:
Calculate the mean of the answered questions, using the number of 
answered questions as the denominator.
Substitute the mean for any missing scores.
Otherwise, if less than 2 of the items are non-missing then RE scale score is
missing.
Responses to the items in Question 5 range from 1 to 5, where
1=All of the time, 2=Most of the time, 3=Some of the time, 4=A little of the
time, and 5=None of the time.
A higher RE scale score indicates better role-emotional functioning.
SF-36 MH scale score
raw score = sum (items 9B, 9C, reversed 9D, 9F and reversed 9H) 
MH = (raw score - 5) * 5
MH_Z = (MH – 75.76034) / 18.04746
MH scale score = (MH_Z * 10) + 50
Reverse direction of scores for 9D and 9H, by subtracting score from 6.
If 3 or more of the items are non-missing, then replace any missing values as
follows:
Calculate the mean of the answered questions, using the number of
answered questions as the denominator.
Substitute the mean for any missing scores.
Otherwise, if less than 3 of the items are non-missing then MH scale score
is missing.
The scale for these items ranges from 1 to 5, where
1=All of the time, 2=Most of the time, 3=Some of the time, 4=A little of the
time, and 5=None of the time.
A higher MH scale score indicates better mental health.


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SF-36 TR scale score
raw score = item 2
TR scale score = raw score
The scale for this item ranges from 1 to 5, where
1=Much better now than one week ago,
2=Somewhat better now than one week ago,
3=About the same as one week ago,
4=Somewhat worse now than one week ago, and
5=Much worse now than one week ago.
A higher TR scale score indicates worse general health currently relative to one
week previous.
SF-36 PCS score
PCS score includes the 8 scales for GH, PF, RP, RE, SF, MH, BP, and VT.
PF1= (PF-82.62455)/24.43176;
RP1=(RP-82.65109)/26.19282; 
BP1=(BP-73.86999)/24.00884;
GH1 = (GH-70.78372)/21.28902;
VT1= (VT-58.41968)/20.87823;
SF1=(SF-85.11568)/23.24464;
RE1= (RE-87.50009)/22.01216; 
MH1=(MH-75.76034)/18.04746;
Raw Score = ((GH1*.24954)+(PF1* .42402)+(RP1*.35119)
+ (RE1*-.19206)+(SF1*-.00753)+(MH1*-.22069)+(BP1*.31754)
+ (VT1*.02877))
PCS Summary Scale Score = (raw score *10) + 50
Raw Score is missing if one of the component scale scores is missing.
SF-36 MCS score
MCS score includes the 8 scales for GH, PF, RP, RE, SF, MH, BP, and VT.
PF1= (PF-82.62455)/24.43176;
RP1=(RP-82.65109)/26.19282; 
BP1=(BP-73.86999)/24.00884;
GH1 = (GH-70.78372)/21.28902;
VT1= (VT-58.41968)/20.87823;
SF1=(SF-85.11568)/23.24464;
RE1= (RE-87.50009)/22.01216; 
MH1=(MH-75.76034)/18.04746;
Raw Score =((GH1*-.01571)+(PF1*-.22999)+(RP1*-.12329)
+ (RE1*.43407)+(SF1*.26876)+(MH1*.48581)+(BP1*- 0.09731)
+ (VT1*.23534))
MCS Summary Scale Score = (raw score*10)+50
Raw score is missing if one of the component scale scores in missing.


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CCI
CCI


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List of Abbreviations
Abbreviation
Term
ACR
American College of Rheumatology
AE
Adverse Event
ANCOVA
Analysis of Covariance
AR
Autoregressive
BASDAI
Bath Ankylosing Spondylitis Disease Assessment Index
BLQ
Below the limit of quantification
CI
Confidence Interval
CMH
Cochran-Mantel-Haenszel
CRF
Case Report Form
CRP
C-Reactive Protein
DAREA/DAPSA
Disease Activity Index for Reactive Arthritis/Psoriatic Arthritis
DAS
Disease Activity Score
DLQI
Dermatology Life Quality Index
DMARDs
Disease-modifying Antirheumatic Drugs
ECG
Electrocardiogram
FACS
Fluorescence-Activated Cell Sorting
FAS
Full Analysis Set
GLM
Generalized Linear Model
GLMM
Generalized Linear Mixed Model
GLIMMIX
Generalized linear mixed-effects model with repeated measures
HAQ-DI
Health Assessment Questionnaire – Disability Index
IE
Intercurrent Event
IRC
Internal Review Committee
ITT
Intent-to-Treat
JTR
Jump to Reference
LLOQ
Lower Limit of Quantitation
LOCF
Last Observation Carried Forward
MAR
Missing at Random
MedDRA
Medical Dictionary for Regulatory Activities
MCMC
Markov Chain Monte Carlo
MCS
Mental Component Summary
MDA
Minimal Disease Activity
MI
Multiple Imputation
MMRM
Marginal Model for Repeated Measures
MVN
Multivariate Normal
NAPSI
Nail Psoriasis Severity Index
NRI
Non-Responder Imputation
PASDAS
Psoriatic Arthritis Disease Activity Score
PASI
Psoriasis Area and Severity Index
PCS
Physical Component Summary
CC
I


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Abbreviation
Term
PD
Pharmacodynamic(s)
PGJS
Patient’s Global Joint and Skin Assessment
PK
Pharmacokinetic(s)
PsA
Psoriatic Arthritis
PsARC
Psoriatic Arthritis Response Criteria
PT
Preferred Terms
QTc
Corrected QT
QTcF
Corrected QT (Fridericia method)
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SF-36
Short-Form-36
SIE
Serious Infectious Events
SJC
Swollen Joint Count
SOC
System Organ Class
SOP
standard operating procedure
SPARCC
Spondyloarthritis Research Consortium of Canada
TJC
Tender Joint Count
UN
Unstructured
VAS
Visual Analog Scale
VLDA
Very Low Disease Activity
CCI
CCI
CCI