Tofacitinib Use in Rituximab-Experienced RA Patients
Conditions: Arthritis, Rheumatoid
Sponsor: Pfizer

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 1 of 18
NON-INTERVENTIONAL (NI) STUDY PROTOCOL
Study Information
Title
Tofacitinib Use in Rituximab-Experienced 
RA Patients
Protocol number
A3921420
Protocol version identifier
3.0
Date
13 January 2023
Active substance
Tofacitinib citrate
Medicinal product
Xeljanz 
Research question and objectives
To characterize the use of tofacitinib 
after use of rituximab in patients with RA in 
a real-world setting.
Primary: Describe the characteristics of 
tofacitinib initiators with a history of 
rituximab exposure, at time 
of tofacitinib initiation.
Secondary: Describe 6-month 
outcomes for tofacitinib initiators with a 
history of rituximab exposure.
Author
Pfizer, Inc
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.
PPD
PPD

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 2 of 18
1. TABLE OF CONTENTS
1. TABLE OF CONTENTS.......................................................................................................2
2. LIST OF ABBREVIATIONS................................................................................................4
3. RESPONSIBLE PARTIES....................................................................................................5
4. ABSTRACT...........................................................................................................................6
5. AMENDMENTS AND UPDATES.......................................................................................7
6. MILESTONES.......................................................................................................................8
7. RATIONALE AND BACKGROUND..................................................................................8
8. RESEARCH QUESTION AND OBJECTIVES ...................................................................8
8.1. Primary Objective(s) .................................................................................................8
8.1.1. Hypotheses....................................................................................................8
8.2. Secondary Objective(s) .............................................................................................8
8.2.1. Hypotheses....................................................................................................8
8.3. Exploratory Objective(s)...........................................................................................8
9. RESEARCH METHODS ......................................................................................................9
9.1. Study Design .............................................................................................................9
9.2. Setting........................................................................................................................9
9.2.1. Inclusion Criteria ..........................................................................................9
9.2.2. Exclusion Criteria.......................................................................................10
9.3. Variables..................................................................................................................10
9.4. Data Sources............................................................................................................10
9.4.1. Exposure .....................................................................................................11
9.4.2. Study Outcomes..........................................................................................11
9.5. Study Size................................................................................................................12
9.6. Data Management ...................................................................................................13
9.6.1. Case Report Form (CRFs)/Data Collection Tool (DCTs) Data 
Record..............................................................................................................13
9.6.2. Record Retention ........................................................................................13
9.7. Data Analysis ..........................................................................................................13
9.8. Quality Control........................................................................................................13
9.9. Limitations of the Research Methods......................................................................14

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 3 of 18
9.10. Other Aspects ........................................................................................................15
9.10.1. Strengths ...................................................................................................15
9.11. CorEvitas Publication Policy ................................................................................15
10. PROTECTION OF HUMAN SUBJECTS ........................................................................15
10.1. Patient Information................................................................................................15
10.2. Patient Consent......................................................................................................15
10.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ............15
10.4. Ethical Conduct of the Study ................................................................................16
11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................16
12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........16
13. REFERENCES ..................................................................................................................17
14. LIST OF TABLES.............................................................................................................18
15. LIST OF FIGURES ...........................................................................................................18
16. ANNEX 1. LIST OF STAND ALONE DOCUMENTS ...................................................18
17. ANNEX 2. ADDITIONAL INFORMATION...................................................................18

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 4 of 18
2. LIST OF ABBREVIATIONS
Abbreviation
Term
AE
adverse event
AHRQ
Agency for Healthcare and Research Quality
CDAI
Clinical Disease Activity Index
CDM
Clinical Data Management
CRF
case report form
CSA
Clinical study agreement
DCT
Data collection tool
EDC
Electronic Data Capture
HAQ
Health Assessment Questionnaire
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISPOR
International Society for Pharmacoeconomics and 
Outcomes Research
RA
rheumatoid arthritis
RMP
Registry Monitoring Plan
SAP
Statistical Analysis Plan
TB
tuberculosis
TNF
tumor necrosis factor
TNFi
tumor necrosis factor inhibitor
US
United States

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 5 of 18
3. RESPONSIBLE PARTIES
Principal Investigator(s) of the Protocol
Name, degree(s)
Job Title
Affiliation
Address
, MD
 
 
, 
MD
.
 
 
 
 
 
 
 
 
,
 
, PhD
 
 
 PhD
 
 ScD
 
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 6 of 18
4. ABSTRACT
Not Applicable.

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 7 of 18
5. AMENDMENTS AND UPDATES
Amendment 
number
Date
Protocol 
section(s) 
changed
Summary of amendment(s)
Reason
1.0
Section 9.6.2.
Not applicable, however:
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.
Administrative change: Section 
9.6.2. should be deleted for 
studies with no human review of 
unstructured data as per CT24 
WI-GL02-RF02
1.0
August 4th
Nov 4th
Section 3.
Job title update and change of 1 Pfizer 
Principal Investigator
Change of 1 Pfizer Principal 
Investigator
Administrative change: Job 
position changed, and 1 Pfizer 
Principal Investigator change
1.0
Nov 11th
Section 6
Start of data collection
2.0
13 January 
2023
Section 9.1
Language added in the Study Design 
section. 
To clarify that the data analyzed
by Pfizer already exists in the 
CoreVitas registry. 
2.0
13 January 
2023
Section 3
Added 1 Pfizer Principal Investigator 
to the list
Administrative change: 1 Pfizer 
Principal Investigator added.

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 8 of 18
6. MILESTONES
Milestone
Planned date
Start of data collection 
11 Nov 2022 
End of data collection
31 December 2022
Final study report
30 November 2023
7. RATIONALE AND BACKGROUND
Rheumatoid arthritis (RA) is a chronic, immune-mediated, inflammatory disease affecting 
many joints, including those in the hands and feet. RA has a wide global presence and is 
estimated to affect 0.5 to 1% of the general population.1
Some authorities in emerging markets prioritize use of rituximab in treatment of RA because 
of its relatively lower cost and availability in hospitals. Newer molecules (eg, tofacitinib)
usually do not have clinical trial data in rituximab-experienced RA patients. There is a 
need to understand the use and effectiveness of tofacitinib in the real-world, to
provide information for healthcare providers in these emerging market settings.
8. RESEARCH QUESTION AND OBJECTIVES
The objective of this study is to characterize the use of tofacitinib after use of rituximab in
patients with RA in a real-world setting.
8.1. Primary Objective(s) 
Describe the characteristics of tofacitinib initiators with a history of rituximab exposure, at 
time of tofacitinib initiation.
8.1.1. Hypotheses
This is a descriptive study without an a priori hypothesis.
8.2. Secondary Objective(s)
Describe 6-month outcomes for tofacitinib initiators with a history of rituximab exposure.
8.2.1. Hypotheses
This study is descriptive with no formal hypothesis, but it is anticipated that outcomes will 
improve over the 6-month time period.
8.3. Exploratory Objective(s) 
None.

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 9 of 18
9. RESEARCH METHODS 
9.1. Study Design 
This will be a retrospective analysis of a prospective observational cohort using the
CorEvitas RA Registry. This study will evaluate existing data that was previously captured 
within the registry at the time of study start for analysis, which is specified in the protocol 
below. This study will describe demographic and clinical characteristics of adult patients 
with RA initiating tofacitinib with a history of rituximab use. This study will also describe 
changes in clinical and patient reported outcomes over time. The index date will be defined 
as the date of tofacitinib initiation at or after enrollment in the registry; initiation is defined as 
first ever use of tofacitinib.
9.2. Setting
The CorEvitas RA Registry is an ongoing longitudinal clinical registry that was established 
in 2001. Longitudinal follow-up data is collected from both patients and their treating 
rheumatologist during routine clinical encounters using the CorEvitas RA 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, patient reported outcome measures, disease
characteristics, comorbidities and adverse events, infections, hospitalizations, and other 
targeted safety outcomes. Blood collection, endoscopy and other diagnostic tests are not 
required for participation; however, relevant standard of care laboratory and imaging results 
are reported when available.
9.2.1. Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the 
study:
Objective 1 Inclusion Criteria: 

Enrolled in the CorEvitas RA Registry and initiated tofacitinib on or after November 
2012.

Initiate tofacitinib (defined as first ever use of tofacitinib) at Registry enrollment visit 
or at a Registry follow-up visit after November 2012.

Have prior use of rituximab.

Have Clinical Disease Activity Index (CDAI) measured at baseline.
Objective 2 Inclusion Criteria:

Enrolled in the CorEvitas RA Registry and initiated tofacitinib on or after November 
2012.

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 10 of 18

Initiate tofacitinib (defined as first ever use of tofacitinib) at Registry enrollment visit 
or at a Registry follow-up, after November 2012.

Have prior use of rituximab.

Have CDAI measured at baseline and appropriate follow-up visit.

Have any of the following:
a.
A 6-month follow-up visit with persistent use of tofacitinib.
b. A 6-month follow-up visit with a tofacitinib discontinuation occurring prior to the 
6-month visit, with no new biologic systemic drug used prior to the 6-month study 
visit.
c.
A study visit at or prior to the 6-month window with a tofacitinib discontinuation 
occurring at the study visit.
d. (Sensitivity analysis only) Any tofacitinib discontinuation prior to the 6-month 
study window.
9.2.2. Exclusion Criteria
There are no exclusion criteria for this study (ie, for either Objective 1 or Objective 2).
9.3. Variables
Please refer to Statistical Analysis Plan (SAP).
9.4. Data Sources 
The CorEvitas RA Registry is an observational registry and therefore collects patient and 
physician data at patient clinical visits with the rheumatologist. Unlike clinical studies, visits 
are not timed at exact uniform time periods. Thus, time period definitions for the current 
study need to accommodate this unique feature of observational registries.
“Index visit” is defined as the visit when tofacitinib was initiated, ie, first ever use of 
tofacitinib. Only initiations at or after enrollment into the Registry are included.
A “6-month” follow-up is defined as a clinical visit to the rheumatologist 3 to 9 months from 
the enrollment visit in accordance with the Registry protocol. 

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 11 of 18
Initiations between visits
If tofacitinib is initiated between visits, then baseline variables from the visit prior to the 
initiation of tofacitinib will be used, as long as the prior visit occurred within four months of 
the tofacitinib start date. Initiations that occur between visits and where the prior visit is
greater than 4 months from the initiation will be excluded.
Multiple visits in the same time window
Given the observational nature of the data, it is possible for patients to have more than one 
visit that falls within a given follow-up period’s allowed time window. For example, a patient 
might have a visit with outcomes collected at 5 months and then 9 months, both of which 
would qualify as a “6-month” visit. In that case, the latest visit will be chosen as the 
“6-month” follow-up since we would like to consider the longest follow-up possible. The
exception to this rule is if values for the primary outcome are unavailable for the latest visit, 
in which case the first visit will be used instead.
Discontinuations prior to follow-up
For patients who discontinued tofacitinib prior to follow-up and who do not switch to another 
drug, the clinical or patient-reported outcome value at the follow-up visit will be used. If a 
patient discontinues and switches to another biologic/tsDMARD, the value at the switch visit, 
if available, will be used; otherwise, the value will be set to missing.
9.4.1. Exposure 
The exposure of interest in this study is first ever tofacitinib use after any prior rituximab use. 
All patients in the study will be classified as exposed. 
9.4.2. Study Outcomes
Objective 1: Characterize Patients at tofacitinib initiation
Primary Outcome: 

Objective 1 is to characterize patients at tofacitinib initiation. All variables as outlined 
in the SAP will be summarized for this aim.
Objective: Describe change in 6-month outcomes.
Primary Outcome:

Change in CDAI.

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 12 of 18
Secondary Outcomes:

Achievement of Minimum Clinically Important Difference (MCID):2 (change in 
CDAI from baseline to follow-up =∆CDAI).
CDAI at Index
MCID to Define Improvement in 
Disease Activity at FU Visit
If ∆CDAI>MCID
Low: CDAI≤10
1
Moderate: 10>CDAI≤22
6
High>22
12

Change in HAQ.

Change in patient pain.

Change in patient fatigue.

Number (%) of tofacitinib discontinuations prior to or at 6-month visit.
9.5. Study Size
As of the 31 March 2021 data cut, there were 390 tofacitinib initiators with history of 
rituximab use. Of these:

~376 have baseline CDAI information.

Line of therapy (and baseline CDAI) is available for ~373, of whom n=8 (2%) are 
3rd line and n=365 (98%) are 4th line.

Note: since population is restricted to those with prior rituximab use, 3rd line use 
reflects patients with prior rituximab use only 4th line reflects patients with one or 
more prior biologic in addition to rituximab.

~107 have CDAI information at baseline and 6 months follow-up.

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 13 of 18
9.6. Data Management 
All statistical analyses will be conducted using Stata Release 16 (StataCorp LLC, College 
Station TX) and/or R Version 4.0.3 (The R Foundation for Statistical Computing, Vienna 
Austria).
9.6.1. Case Report Form (CRFs)/Data Collection Tool (DCTs) Data Record
Not Applicable, however:

All study data exist as structured data by the time of study start.

The conversion of unstructured data to structured data during the implementation of 
the protocol is performed solely by a computer using automated/algorithmic methods, 
such as natural language processing.
9.6.2. Record Retention
Not Applicable, however:
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.
9.7. Data Analysis
Detailed methodology for summary and statistical analyses of data collected in this study will 
be documented in the 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.
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. 
The majority of monitoring is conducted using centralized (ie, remote) methods in 

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 14 of 18
accordance with the Agency for Healthcare and Research Quality’s (AHRQ) data collection 
and quality assurance recommendations.3 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 Registry used in this research includes a sample of adults with RA that are 
not necessarily representative of all adults with RA in the US, or of those in emerging 
markets outside the United States (US). In particular, these are patients with RA with clinical 
visits with rheumatologists.
Most importantly for this study, in the US rituximab is typically prescribed as a later line
therapy, after failure of one or more tumor necrosis factor inhibitor (TNFi). It is also given as
a first-line bDMARD to patients with contraindications to tumor necrosis factor (TNF)
inhibitors (eg, interstitial lung disease).4 This may differ from prescribing patterns in 
countries other than the US, which could influence the generalizability of the results to RA 
patients outside of the US. 
In addition, history of medication use prior to enrollment is derived from what is reported by 
patients and their current rheumatologist within the registry. Since the registry is not based
on an inception cohort, patients may not be able to recall their entire medication history, 
leading to possible mischaracterization regarding prior use of rituximab. The registry
captures physician-reported prescribing, but there are no measures of patient adherence. 
Confounding by indication can occur when factors that determine physicians’ selection of a 
particular treatment (eg, disease severity, comorbidities) also affect the outcome being 
studied. There are certain conditions (tuberculosis [TB], lymphoma) that would prompt the 
prescribing of rituximab. This population could have different outcomes than a population 
without these comorbidity histories. 

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 15 of 18
Patients who maintain treatment at 6 months may have different outcomes compared to the 
outcomes those who discontinue or switch would have had, had they not 
discontinued/switched. This study takes steps to mitigate this potential bias by including 
values at follow-up for those who discontinue treatment and values at switch for those who 
switch, as described above. 
9.10. Other Aspects
9.10.1. Strengths 
CorEvitas was founded in 2000 without any ownership links to the pharmaceutical industry.
CorEvitas has a clear track record of published scientific research using the CorEvitas data to 
provide answers to clinically relevant questions in a real-world setting.
The CorEvitas RA Registry is a longitudinal prospective registry collecting data from both 
patients and providers on RA treatment and a wide range of both physician- and patient-
reported disease outcomes. This provides a unique resource on the real-world use of biologic 
drugs in the US. The registry contains clinical data (eg, disease activity scores, comorbidities, 
patient-reported outcomes data, etc.) that are not available in claims databases. 
9.11. CorEvitas Publication Policy
All analyses for the public domain are subject to the CorEvitas publication policy (please see
the full policy for details; the policy is available upon request). Briefly, the policy describes 
our adherence to industry best practices for the development, conduct and reporting of 
research. For comparative studies (any study that assesses effectiveness, persistency, safety 
and other outcomes in >1 treatment group), analyses need to mitigate sources 
of systematic bias. In addition, safety studies cannot be performed where the analyses may 
undermine ongoing or recently completed regulatory commitments. Lastly, courtesy review 
is provided for comparative studies that impact subscribers including safety studies for 
subscribers with current or recently conducted regulatory commitments.
10. PROTECTION OF HUMAN SUBJECTS
10.1. Patient Information 
This study involves data that exist in anonymized structured format and contain 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. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
This study does not contain any identifying patient information (eg, name) and is exempt 
from IRB review.

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 16 of 18
10.4. 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 Good Practices for Outcomes Research issued by the International Society for
Pharmacoeconomics and Outcomes Research (ISPOR) and contained in the CT24-WI-GL02-
RF04.
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, individual patient data are not retrieved or validated, and 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.
12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS
For all publications relating to the Study, Pfizer 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.
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 party responsible for collecting data
from the participant 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.

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 17 of 18
13. REFERENCES
1.
A. J. Silman and J. E. Pearson, "Epidemiology and genetics of rheumatoid arthritis," 
Arthritis Res, vol. 4 Suppl 3, no. Suppl 3, pp. S265-72, 2002.
2.
J. R. Curtis, S. Yang, L. Chen, J. E. Pope, E. C. Keystone, B. Haraoui, G. Boire, J. C. 
Thorne, D. Tin, C. A. Hitchon, C. O. 3. Bingham and V. P. Bykerk, "Determining the 
Minimally Important Difference in the Clinical Disease Activity Index for Improvement 
and Worsening in Early Rheumatoid Arthritis Patients," Arthritis Care Res (Hoboken), 
vol. 67, no. 10, pp. 1345-53, 2015.
3.
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.
L. Garcia-Montoya, C. Villota-Eraso and M. Yusof, "Lessons for rituximab therapy in 
patients with rheumatoid arthritis," The Lancet Rheumatology, 2020.

Tofacitinib
A3921420 NON-INTERVENTIONAL STUDY PROTOCOL
Amendment 2, Version 3.0, 13 January 2023
PFIZER CONFIDENTIAL
Page 18 of 18
14. LIST OF TABLES 
Table shells are included in the SAP.
15. LIST OF FIGURES
Figures are included in the SAP.
16. ANNEX 1. LIST OF STAND ALONE DOCUMENTS
Not Applicable.
17. ANNEX 2. ADDITIONAL INFORMATION
Not applicable.

Document Approval Record
Document Name:
	
       
 ! 	 " 
Document Title:
	
       
 ! 	 " 
Signed By:
Date(GMT)
Signing Capacity
&"& 	'('(

 ))
PPD