An Observational Study Within the CorEvitas Registry to Evaluate Safety and Effectiveness of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs (bDMARDs) in Japan Among Patients Treated for Moderately to Severely Active Rheumatoid Arthritis
Conditions: Arthritis, Rheumatoid
Sponsor: Pfizer

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NON-INTERVENTIONAL (NI) STUDY PROTOCOL
Study Information
Title
An Observational Study within the CorEvitas
Registry to Evaluate Safety and Effectiveness of 
Tofacitinib and Biologic Disease Modifying 
Antirheumatic Drugs (bDMARDs) in Japan 
among Patients Treated for Moderately to 
Severely Active Rheumatoid Arthritis
Protocol Number
A3921429
Protocol Version Identifier
2.0
Date
02 May 2023
Active Substance
L04AA29
Medicinal Product
Toficitinib Citrate
Research Question and Objectives
The research question is to determine the safety 
and efficacy endpoints of patients initiating 
tofacitinib, anti-TNF bDMARDs, non-TNF 
bDMARDs or methotrexate (MTX).
The primary objective is to evaluate safety events 
of interest in each DMARD group by estimating 
marginal means of incidence rates of selected 
safety events of interest. 
Author
 
 
 
 
This document contains confidential information belonging to Pfizer. Except as otherwise agreed to in writing, 
by accepting or reviewing this document, 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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1. TABLE OF CONTENTS
1. TABLE OF CONTENTS.......................................................................................................2
2. LIST OF ABBREVIATIONS................................................................................................4
3. RESPONSIBLE PARTIES....................................................................................................6
4. ABSTRACT...........................................................................................................................6
5. AMENDMENTS AND UPDATES.......................................................................................6
6. MILESTONES.......................................................................................................................7
7. RATIONALE AND BACKGROUND..................................................................................8
8. RESEARCH QUESTION AND OBJECTIVES ...................................................................8
8.1. Primary Objective(s) .................................................................................................8
8.2. Secondary Objective(s) .............................................................................................9
9. RESEARCH METHODS ....................................................................................................10
9.1. Study Design ...........................................................................................................10
9.2. Setting......................................................................................................................10
9.2.1. Inclusion Criteria ........................................................................................10
9.2.2. Exclusion Criteria.......................................................................................10
9.3. Variables..................................................................................................................11
9.4. Data Sources............................................................................................................11
9.5. Study Size................................................................................................................11
9.6. Data Management ...................................................................................................12
9.6.1. Record Retention ........................................................................................12
9.7. Data Analysis ..........................................................................................................13
9.8. Quality Control........................................................................................................13
9.9. Limitations of the Research Methods......................................................................13
9.10. Other Aspects ........................................................................................................14
10. PROTECTION OF HUMAN SUBJECTS ........................................................................14
10.1. Patient Information................................................................................................14
10.2. Patient Consent......................................................................................................14
10.3. Patient Withdrawal................................................................................................14
10.4. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ............14
10.5. Ethical Conduct of the Study ................................................................................14

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11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................14
12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........15
13. REFERENCES ..................................................................................................................16
14. LIST OF TABLES.............................................................................................................17
15. LIST OF FIGURES ...........................................................................................................17
ANNEX 1. LIST OF STAND-ALONE DOCUMENTS.........................................................17
ANNEX 2. ENCEPP CHECKLIST FOR STUDY PROTOCOLS .........................................17
ANNEX 3. ADDITIONAL INFORMATION.........................................................................17

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2. LIST OF ABBREVIATIONS
Abbreviation
Definition
bDMARDs
Biologic Disease-Modifying Antirheumatic Drug
BMI
Body Mass Index
CABG
Coronary Artery Bypass Grafting
CCP
Cyclic Citrullinated Peptide
CDAI
Clinical Disease Activity Index
CDM
Clinical Data Management
CHF
Congestive Heart Failure
CVD
Cardiovascular Disease
DAS
Disease Activity Score
DMARD
Disease-Modifying Antirheumatic Drug
EDC
Electronic Data Capture
EQ-5D
Euro-QoL 5-Dimensional
GPP
Good Pharmacoepidemiology Practices
HAQ
Health Assessment Questionnaire
IEC
Independent Ethics Committee
IRB
Institutional Review Board
JAK
Janus Kinase
JCR
Japanese College of Rheumatology
MCID
Minimally Clinically Important Difference
MTX
Methotrexate
NMSC
Non-Melanoma Skin Cancer

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Abbreviation
Definition
Non-TNFi
Non-Tumor Necrosis Factor Inhibitors
PGA
Physician Global Assessment
PRO
Patient Reported Outcome
RA
Rheumatoid Arthritis
RMP
Registry Monitoring Plan
SAP
Statistical Analysis Plan
SOPs
Standard Operating Procedures
TNFi
Tumor Necrosis Factor inhibitors

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3. RESPONSIBLE PARTIES
Name, 
Degree(s)
Job Title
Affiliation
Address
 
 
 
 
 
4. ABSTRACT
Not applicable.
5. AMENDMENTS AND UPDATES
Amendme
nt 
number
Date
Protocol 
section(s) 
changed 
Summary of 
amendment(s)
Reason
1
02-May-
2023
8.2. 
Secondary 
Objectives
Updated language: 
how 
discontinuations 
handled in 
effectiveness 
analysis
The persistence measure has 
become simpler from 
analysis and interpretation 
perspectives. Therefore, there 
is an increase in precision as 
well.
1
02-May-
2023
9.7. Data 
Analysis
A clarification 
added regarding 
CDAI usage
CDAI was not used in this 
project. No re-
calculation.
1
02-May-
2023
3. 
Responsib
le Parties
Address change of 
a responsible party
Address change of a 
responsible party
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6. MILESTONES
Milestone
Planned Date
Start of Data Collection 
07 October 2022
End of Data Collection
10 October 2022
Final Study Report
10 September 2023

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7. RATIONALE AND BACKGROUND
Rheumatoid arthritis (RA) is a chronic, immune-mediated, inflammatory disease affecting 
many joints, including those in the hands and feet. A recent analysis from a Japanese health 
insurance dataset reported that the estimated prevalence of RA ranged from 706,000 to 
1.2 million individuals, representing 0.6% to 1.0% of the Japanese population.1
Treatment patterns for RA may be markedly different in Japan versus those in North America 
and Europe. For example, a study shows that MTX was prescribed for approximately one-
quarter (27%) of RA patients in this Japanese cohort, in contrast with both European and US 
cohorts with >50% of RA patients treated with MTX.2 The Japanese College of 
Rheumatology (JCR) also puts forth guidelines for the treatment of RA in Japanese patients, 
including specific recommendations for TNF biologics and tofacitinib which may differ or 
provide greater guidance, than the product label.3
More research capturing treatment patterns and corresponding effectiveness and safety in 
Japan are warranted. 
To address this research gap, a previous Pfizer sponsored study ( A3921256) using CorEvitas 
RA Japan data was presented in ACR2020. This study will provide an updated analysis of 
safety and effectiveness outcomes in this population, with two additional years of patient 
data.
8. RESEARCH QUESTION AND OBJECTIVES
The objectives of this study are to describe patients initiating tofacitinib, anti-TNF 
bDMARDs, non-TNF bDMARDS or MTX and to evaluate safety and clinical effectiveness 
endpoints.
8.1. Primary Objective(s) 
The primary objective of this study is to evaluate safety events of interest ie, total
Cardiovascular Disease (CVD), serious infections, total Herpes Zoster, and total malignancy 
excluding NMSC (non-melanoma skin cancer) in the Tofacitinib, non-TNF, anti-TNFi, and 
MTX cohorts by estimating marginal means of incidence rates of selected safety events of 
interest. 
The safety events are defined as follows:

Total CVD- is defined as hypertension requiring hospitalization, cardiac 
revascularization procedure (CABG, stent, angioplasty), ventricular arrhythmia, 
cardiac arrest, myocardial infarction, acute coronary syndrome, unstable angina,
Congestive Heart Failure (CHF) requiring hospitalization, stroke, transient ischemic 
attack, other serious cardiovascular event (specify), deep vein thrombosis, peripheral 
arterial thromboembolic event, urgent peripheral arterial revascularization, peripheral 
ischemia or gangrene (necrosis) and pulmonary embolism.

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
Serious infections – is defined as infections meeting serious adverse event criteria or 
requiring treatment with IV antibiotics. Serious infection types collected in the 
registry are pneumonia, sepsis, joint/bursa, cellulitis/skin, sinusitis, diverticulitis, 
bronchitis, gastroenteritis, meningitis/encephalitis, urinary tract infection, upper 
respiratory infection, active tuberculosis, and other (free text) serious infections. 

Total Herpes Zoster – is defined as serious and non-serious herpes zoster events

Total malignancy excluding NMSC. This includes the following malignancy types 
collected in the registry: lymphoma, lung cancer, breast cancer, skin cancer 
(melanoma), and other cancer
8.2. Secondary Objective(s) 

The secondary objective of the study is to evaluate clinical effectiveness at six 
months follow-up visit following medication initiation in each DMARD group by 
estimating marginal means of selected clinical outcomes and patient-reported 
outcomes (PROs).Change in disease activity: mean change from baseline to 6-months 
of CDAI, J-HAQ, patient pain, patient global assessment, patient fatigue, morning 
stiffness, and EQ-5D-5L.

Achievement of minimally clinically important difference (MCID)4 at 6-month 
follow-up, based on the CDAI value at initiation. Specifically:
MCID >1 if CDAI at baseline is ≤10, 
MCID >6 if CDAI at baseline ranges between (10, 22],
MCID >12 if CDAI at baseline >22.

Modified ACR20/50/70 (mACR20/50/70), defined as 20/50/70% improvement in 
tender and swollen joint count, and 20/50/70% improvement in 2 of the following 
four domains at the 6-month follow-up visit: patient pain assessment, patient
global assessment, physician global assessment (PGA), patient self-addressed 
disability, measured by the J-HAQ score. 
Note on outcome measures for the effectiveness analysis at six months: 
For patients who discontinue the index therapy prior to the six- month follow-up visit:

For binary outcome measures, we will impute non-response (ie, non-achievement of 
outcomes) for these initiators

For continuous variables, we will use the last observed value prior to discontinuation 
(ie, LOCF (last observation carried forward)) as the six month value when calculating 
change from baseline for continuous outcome variables.

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For patients who discontinue index therapyat their 6-month visit:

The value of the outcome at the six-month visit will be used.
9. RESEARCH METHODS 
9.1. Study Design
This is a secondary database observational study conducted in a cohort of RA patients treated 
with biologic and nonbiologic DMARDs, including tofacitinib, collected as part of the 
CorEvitas Japan RA Registry.
9.2. Setting
This is a structured database study using the CorEvitas Japan RA Registry. Data from the 
CorEvitas RA Japan Registry as of September 2022, will be used for this study. The study 
will include data from March 2016 to the latest data cut available in 2022 for both 
effectiveness and safety outcomes.
9.2.1. Inclusion Criteria
Data from the CorEvitas RA Japan Registry as of September 2022, will be used for this 
study. The study will include data from March 2016 to to the latest data cut available in 
2022 for both effectiveness and safety outcomes. Registry inclusion criteria:
1. Be diagnosed with RA according to the 1987 ACR or the ACR/EULAR 2010 RA
Classification Criteria.
2. Be at least 18 years of age or older.
3. Was/Must be prescribed or switching to the following eligible medication for the first 
time ever at the enrollment visit:

csDMARD: methotrexate (closed in February 2018);

Anti-TNF bDMARD: adalimumab (originator or biosimilar), certolizumab pegol, 
etanercept (originator or biosimilar), golimumab, infliximab (originator or 
biosimilar), or any other anti-TNF biosimilar approved during the study;

Non-TNF bDMARD: abatacept, tocilizumab, sarilumab (closed in June 2020);

JAK inhibitor: tofacitinib, baricitinib, peficitinib, filgotinib, upadacitinib.
9.2.2. Exclusion Criteria
Data that are prior to March 2016 and after June 2022.

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9.3. Variables
Detailed definitions and an exhaustive list of variables will be included in the statistical 
analysis plan (SAP). Some of the variables included in the study are as below: 

Baseline Information: Age, Gender, Race, Education, Work Status, Smoking 
History, Body Height, Body Weight, BMI, History of Comorbidities, Duration of RA, 
Serum Positive 
(RF+ and/or CCP+), CDAI, Tender Joints, Swollen Joints, PGA, DAS28-ESR, 
Number of Prior Therapies, Prior Steroid Use, Concomitant Therapy, Patient Global 
Assessment, Patient Fatigue, Patient Pain, and the EQ-5D-5L.

Effectiveness Outcomes: CDAI, Achieving CDAI MCID, Achieving mACR 20, 
Achieving mACR 50, Achieving mACR 70, Pain, Fatigue, Patient Global 
Assessment, Morning Stiffness, J-HAQ, EQ-5D-5L, and Remain on Drug.

Safety Event of Interest: Total CVD, Total Serious Infections, Total Herpes Zoster, 
and Total Cancer excluding NMSC.
9.4. Data Sources
The CorEvitas RA Japan Registry is a prospective, multicenter, observational disease-based 
registry. Longitudinal follow-up data is collected from both patients and their treating 
rheumatologist during routine clinical encounters using the CorEvitas RA Japan Registry 
questionnaires. These questionnaires collect data on patient demographics, disease duration, 
medical history (including all prior and current treatments for RA), smoking status, alcohol 
use, cannabis use, disease activity, PRO measures, disease characteristics, comorbidities and 
adverse events, infections, hospitalizations, and other targeted safety outcomes. Relevant 
standards of care laboratory and images results if reported may also be used. This registry 
collects data from both the physicians and the patients at the time of a regular office visit. 
The registry has enrolled over 2,359 patients with RA. Structured clinical data are available 
in this Registry (eg, disease activity scores, comorbidities, imaging results, PRO data, etc.) 
that is not available in claims databases.
9.5. Study Size
There are two populations of interest: one for the primary objective (safety outcomes) and 
one for secondary objective (clinical effectiveness and PRO). Both populations include RA 
Japan patients who initiate tofacitinib, MTX, TNFi bDMARD, or non-TNFi bDMARD and 
have a baseline available, where initiation is defined as the first ever use of the drug. The 
MTX group will exclude those who initiated MTX in combination with other biologics or 
JAKi.
A preliminary data pull identified 225, 275, 475, and 734 patients initiating tofacitinib, MTX, 
TNFi, and nonTNFi, respectively, that meet the eligibility criteria based on the data available 
from the January 2022 data cut. Latest data cut available will be used in this study.

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9.6. Data Management 
According to internal SOPs, CorEvitas conducts and documents a series of quality reviews. 
All deliverables are reviewed and quality checked by members internal to the analytic team, 
and by senior staff external to the writing team. Deliverables including protocols/SAP, 
interim, final reports, abstracts and manuscripts are subject to review. The following checks 
are covered in this review.
1. Confirm the source of the data and/or results has been documented and verified 
against the source. 
2. Check the internal consistency of the medical research data presented in the 
document. 
3. Confirm the conclusions are accurate, objective, balanced, and consistent with other 
published or released results.
4. Confirm the format and content of the document is aligned with applicable external 
requirements.
5. Final annotated version of any publication(s) (if optional tasks are requested).
Investigators are responsible for the integrity of the data (that is, accuracy, completeness, 
legibility, and timeliness) reported to Pfizer. The investigator follows local laws and 
regulations or institutional practices for document retention.
All information about this observational study and individual subject medical information 
resulting from this study are considered confidential, and disclosure to third parties is 
prohibited except for regulatory authorities and as applicable by law. Publications may result 
from this study.
All statistical analyses will be conducted using Stata Release 16 
 
 and/or R Version 4.2.0 
 
9.6.1. Record Retention
To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, 
CorEvitas agrees to keep all study-related records. The records should be retained by 
CorEvitas according to local regulations or as specified in the vendor contract, whichever is 
longer. CorEvitas must ensure that the records continue to be stored securely for so long as 
they are retained.
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9.7. Data Analysis
Detailed methodology for summary and statistical analyses of data collected in this study will 
be documented in a SAP, which will be dated, filed and maintained by the sponsor. The SAP 
may modify the plans outlined in the protocol; any major modifications of primary endpoint 
definitions or their analyses would be reflected in a protocol amendment.
Pfizer obtained the CDAI scores from third-party study reports and Pfizer did not administer 
the questionnaire.
9.8. Quality Control
Data quality is controlled, monitored, and managed according to the CorEvitas Master 
Registry Monitoring Plan (RMP). All study personnel must complete standardized protocol 
training prior to initiating data collection. Each Investigator is also required to designate one 
staff member as the primary Registry Coordinator responsible for addressing data 
clarifications requests from CorEvitas in a timely manner. All data collectors in the field 
have continuous access to a dedicated Registry Manager who answers questions and provides 
guidance on specific definitions and clinical situations. 
Data quality review (ie, monitoring) occurs at the site level as well as in aggregate to check 
for Case Report Form completeness, consistency, and compliance with all data collection 
requirements set forth in the registry protocol. Monitoring is performed in addition to the edit 
checks and event completion rules configured in the 21 CRF Part 11 compliant EDC system. 
Most of the monitoring is conducted using centralized (ie, remote) methods in accordance 
with the Agency for Healthcare and Research Quality’s (AHRQ) data collection and quality 
assurance recommendations.5 These methods include but are not limited to routine remote 
monitoring visits and automated database quality control listings. Onsite audits of source data 
are also performed for a subset of registry sites as defined by the Master RMP. 
Remote monitoring visits are conducted for the duration of the registry beginning when the 
first patient is enrolled. Qualified monitors within CorEvitas' Clinical Data Management 
(CDM) department are responsible for conducting remote monitoring visits. Registry 
Managers are responsible for site retraining and resolving any compliance issues identified 
during these visits. Sites also receive data clarification requests (ie, queries) at regular 
intervals from designated CDM and Pharmacovigilance personnel. Queries are issued and 
tracked through the study's EDC system. Sites are required to respond to data queries within 
5 to 7 business days of receipt.
9.9. Limitations of the Research Methods
The CorEvitas RA Japan Registry used in this research includes a sample of adults with RA
that are not necessarily representative of all adults with RA in Japan. These are patients with 
RA with clinical visits with rheumatologists.
Selection bias may be introduced if certain subgroups of patients (eg, healthier or sicker 
patients) are routinely included or excluded from the registry.

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Confounding by indication can occur when factors that determine physicians’ selection of a 
particular treatment (eg, disease severity) also affect the outcome being studied. It is also 
possible that drug benefit design and formulary status changes could have affected utilization 
patterns, and in turn, the number of patients who switched medications.
Misclassification is of particular concern within the observational setting due to less stringent 
monitoring relative to clinical trials. While CorEvitas has an established system to identify 
and capture endpoint data, all events cannot be fully verified via source documentation.
9.10. Other Aspects
Not applicable.
10. PROTECTION OF HUMAN SUBJECTS
10.1. Patient Information 
This study involves data that exists in anonymized structured format and contains no patient 
personal information. 
10.2. Patient Consent
As this study involves anonymized structured data, which according to applicable legal 
requirements do not contain data subject to privacy laws, obtaining informed consent from 
patients by Pfizer is not required.
10.3. Patient Withdrawal
Not applicable.
10.4. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
IRB/IEC review was not required as the data from the registry are anonymized and 
structured.
10.5. Ethical Conduct of the Study
The study will be conducted in accordance with legal and regulatory requirements, as well as 
with scientific purpose, value and rigor and follow generally accepted research practices 
described in Guidelines for Good Pharmacoepidemiology Practices (GPP).
11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS 
This study involves data that exist as structured data by the time of study start. In these data 
sources, it is not possible to link (ie, identify a potential association between) a particular 
product and medical event for any individual. Thus, the minimum criteria for reporting an 
adverse event (AE) (ie, identifiable patient, identifiable reporter, a suspect product, and 
event) cannot be met.

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12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
In the event of any prohibition or restriction imposed (eg, clinical hold) by an applicable 
competent authority in any area of the world, or if the responsible party for collecting data 
from the participants is aware of any new information which might influence the evaluation 
of the benefits and risks of a Pfizer product, Pfizer should be informed immediately. The 
protocol and study results will be disclosed on ct.gov.

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13. REFERENCES
1.
Yamanaka H, Sugiyama N, Inoue E et al. Estimates of the prevalence of and current 
treatment practices for rheumatoid arthritis in Japan using reimbursement data from 
health insurance societies and the IORRA cohort. Mod Rheumatol 2014 Jan;24(1):33-
40.
2.
Solomon DH, Kremer J, Curtis JR et al. Explaining the cardiovascular risk associated 
with rheumatoid arthritis: traditional risk factors versus markers of rheumatoid arthritis 
severity. Ann Rheum Dis 2010; 69(11): 1920-5.
3.
Yamanaka, H. Rheumatoid Arthritis Management Guidelines 2014 in Japan. Agency for 
Healthcare Research and Quality (AHRQ), "Data Collection and Quality Assurance," in 
Registries for Evaluating Patient Outcomes: A User’s Guide, 4 ed., vol. 1, September 
2020.
4.
Curtis JR, Yang S, Chen L, Pope JE, Keystone EC, Haraoui B, et al. Determining the 
Minimally Important Difference in the Clinical Disease Activity Index for Improvement 
and Worsening in Early Rheumatoid Arthritis Patients. Arthritis care & research. 
2015;67(10):1345–53.
5.
Battisti WP, Wager E, Baltzer L, et al. Good publication practice for communicating 
company sponsored medical research: GPP3. Annals of Internal Medicine 
2015;163(6):461-64.

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14. LIST OF TABLES
Not applicable.
15. LIST OF FIGURES
None.
ANNEX 1. LIST OF STAND-ALONE DOCUMENTS
None.
ANNEX 2. ENCEPP CHECKLIST FOR STUDY PROTOCOLS
Not required.
ANNEX 3. ADDITIONAL INFORMATION
Not applicable. 

Document Approval Record
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