Treatment Patterns and 6 and 12-Month Effectiveness of Tofacitinib in the Corrona Rheumatoid Arthritis Registry
Conditions: Arthritis, Rheumatoid
Sponsor: Pfizer

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NON-INTERVENTIONAL (NI) STUDY PROTOCOL
Study Information
Title
Treatment Patterns and 6 and 12-Month 
Effectiveness of Tofacitinib in the Corrona 
Rheumatoid Arthritis Registry
Protocol number
A3921379
Protocol version identifier
2.0
Date
18 April 2022
Active substance
L04AA29
Medicinal product
Xeljanz (tofacitinib)
Research question and objectives
To describe treatment patterns and 
effectiveness of tofacitinib initiators in the 
Corrona rheumatoid arthritis (RA) Registry. 
•
To describe the demographics, 
clinical characteristics, and treatment 
patterns of tofacitinib initiators at 
time of initiation including
stratification by index year to 
identify changes across time To 
estimate 6-month and 
12 effectiveness in tofacitinib
initiators.
Author
 PhD
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.......................................................................................7
6. MILESTONES.......................................................................................................................8
7. RATIONALE AND BACKGROUND..................................................................................8
8. RESEARCH QUESTION AND OBJECTIVES ...................................................................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............................................................................................................12
9.5. Study Size................................................................................................................13
9.6. Data Management ...................................................................................................13
9.6.1. Record Retention ........................................................................................13
9.7. Data Analysis ..........................................................................................................14
9.8. Quality Control........................................................................................................14
9.9. Limitations of the Research Methods......................................................................14
9.10. Other Aspects ........................................................................................................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 ................................................................................15
11. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................15
12. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........16

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13. REFERENCES ..................................................................................................................17
14. LIST OF TABLES.............................................................................................................18
15. LIST OF FIGURES ...........................................................................................................18
ANNEX 1. LIST OF STAND-ALONE DOCUMENTS.........................................................18
ANNEX 2. ADDITIONAL INFORMATION.........................................................................18

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2. LIST OF ABBREVIATIONS
Abbreviation
Definition
AE
adverse event
BMI
body mass index
CABG
coronary artery bypass grafting
CDAI
Clinical Disease Activity Index
CHF
congestive heart failure
csDMARD
conventional synthetic disease modifying 
antirheumatic drug
CV
cardiovascular
DAS
Disease Activity Score
DAS28
Disease Activity Score in 28 joints
DMARD
disease-modifying antirheumatic drug
DVT
deep vein thrombosis
EQ-5D-5L
European quality of life-5 dimensions
ESR
Erythrocyte Sedimentation Rate
FDA
Food and Drug Administration
HAQ
Health Assessment Questionnaire
IEC
Independent Ethics Committee
ID
identifier
IL
interleukin
IRB
Institutional Review Board
JAK
Janus Kinase

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Abbreviation
Definition
LDA
low disease activity
LLC
limited liability company
mACR
modified American College of Rheumatology (score)
mHAQ
modified Health Assessment Questionnaire
MI
myocardial infarction
MTX
methotrexate
NIS
non-interventional study
NSAID
nonsteroidal anti-inflammatory drug
PCI
percutaneous coronary intervention
RA
rheumatoid arthritis
SAP
Statistical Analysis Plan 
TIA
transient ischemic attack
TNF
Tumor Necrosis Factor
TNFi
tumor necrosis factor inhibitor
US
United States
VAS
visual analog scale

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3. RESPONSIBLE PARTIES
Principal Investigator(s) of the Protocol
Name, degree(s)
Job Title
Affiliation
Address
, PhD
 
PhD
 
 
MD, MPH
 Sc.D.
 
 MSc
 
4. ABSTRACT
Not Applicable.
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5. AMENDMENTS AND UPDATES
Amendment 
number
Date
Protocol 
section(s) 
changed 
Summary of amendment(s)
Reason
1 administrative
18 April
2022
6 Milestones
Milestones were updated.
The planned milestones were 
adjusted to align with information 
in sponsor’s internal systems. 

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6. MILESTONES
Milestone
Planned date
Start of data collection 
31 January 2021
End of data collection 
30 November 2021
Final study report
30 October 2022
7. RATIONALE AND BACKGROUND
Rheumatoid arthritis (RA) is a chronic and systemic inflammatory disease with an estimated
prevalence of 0.5-1.0% and a mean annual incidence of 0.02-0.05% within Western
populations.1 RA is characterized by inflammation, joint destruction, and progressive 
disability. Joint destruction is frequently irreversible resulting in significant cumulative 
morbidity. Patients experience a broad range of co-morbidities. These patients are also 
treated with multiple classes of agents, including nonsteroidal anti-inflammatory drugs 
(NSAIDs), glucocorticoids, and disease modifying antirheumatic drugs (DMARDs)
including biologicals, each of which carry significant risks as well as benefits.
Tofacitinib is the first oral Janus Kinase (JAK) inhibitor to show clinical efficacy in the 
management of RA. Many of the cytokines that are dysregulated in RA signal through 
JAKs.2,3,4 Tofacitinib reduces the production of proinflammatory mediators5 by inhibiting the 
signaling of multiple cytokines important in the pathogenesis of RA. Unlike biological 
therapies, such as tumor necrosis factor (TNF) inhibitors and anti-IL-6 receptor monoclonal 
antibodies that markedly inhibit 1 cytokine pathway over an extended period of time, JAK 
inhibition by tofacitinib results in a pattern of partial and reversible inhibition of the 
intracellular effects from several inflammatory cytokines.
Previous work in the Corrona registry described the early experience of tofacitinib initiators. 
As tofacitinib has been on the market since 2012, it is possible that there has been a shift in 
use of tofacitinib as an earlier line of therapy. Therefore, there is a need to update the 
analyses of treatment patterns and effectiveness. This query will inform the design of future 
comparative effectiveness analyses.
8. RESEARCH QUESTION AND OBJECTIVES
The objective of this study is to describe treatment patterns and effectiveness of tofacitinib
initiators in the Corrona RA Registry. Accordingly, we will:

Describe the demographics clinical characteristics, and treatment patterns of 
tofacitinib initiators at the time of initiation including stratification by index year to 
identify changes across time.

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
Estimate 6-month and 12-month effectiveness in tofacitinib initiators.
9. RESEARCH METHODS 
9.1. Study Design
To meet the study objectives, an observational retrospective cohort study will be conducted 
using patients enrolled in the Corrona RA Registry initiating tofacitinib on or after November 
2012. NOTE: Initiation is defined as first ever use of tofacitinib. Initiators will also be 
required to have initiated tofacitinib at a Corrona visit (enrollment or follow-up), have 
Clinical Disease Activity Index (CDAI) measured at baseline and have a 6-month follow-up 
visit and CDAI measured at the 6-month follow-up visit. 
For further details, please refer to the detailed Statistical Analysis Plan (SAP) included as a 
stand-alone document. 
9.2. Setting
The Corrona RA Registry is a prospective, multicenter, observational disease-based registry 
launched in 2001. This registry contains clinical data (eg, disease activity scores, laboratory 
results, comorbidities, imaging results, patient-reported outcomes data, etc.) that is not 
available in claims databases. The current Corrona dataset includes 189 private and academic 
active clinical sites with over 817 providers throughout 42 states in the US. This registry 
collects data from both the providers and the patients at the time of a regular office visit.
Corrona has enrolled over 54,000 patients with RA. The collection of data from Corrona 
represents over 195,750 patient years of data.
To be included in the Corrona RA Registry, patients must be at least 18 years of age and 
have a diagnosis of RA by a rheumatologist.
9.2.1. Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the 
study:
1. Enrolled in the Corrona RA Registry and initiated tofacitinib on or after 
November 2012.  
2. Initiate tofacitinib (defined as first ever use of tofacitinib) at the Corrona enrollment 
visit or at a Corrona follow-up visit from November 2012 onward. 
3. Have CDAI measured at baseline.
4. Have at least a 6-month follow-up visit and CDAI measured at the 6-month follow-up 
visit.

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9.2.2. Exclusion Criteria
There are no exclusion criteria for this study.
9.3. Variables
Objective 1 (Demographics, clinical characteristics, treatment patterns):
Demographic/socioeconomic characteristics.

Age, sex, race, education, work status, insurance.
Lifestyle.

Weight, body mass index (BMI), smoking status.
History of comorbidities.

History of cardiovascular (CV) disease (include the following: myocardial infarction 
[MI], stroke, acute coronary syndrome, coronary artery disease, congestive heart 
failure [CHF], revascularization procedure including percutaneous coronary 
intervention [PCI], coronary artery bypass grafting [CABG] or coronary artery stents, 
ventricular arrhythmia, cardiac arrest, unstable angina, peripheral ischemia, peripheral 
arterial disease, hypertension, other CV, deep vein thrombosis [DVT] and transient 
ischemic attack [TIA]).

History of malignancy (breast cancer, lung cancer, lymphoma, skin cancer, other 
cancer).

History of hypertension, diabetes, osteoporosis, fibromyalgia, and depression.
Clinical Characteristics and Assessments.

Duration of disease.

Age of onset.

CDAI (continuous, categorical).

Tender joint count (28).

Swollen Joint count (28).

Physician global assessment (0-100).

Disease Activity Score (DAS)28/Erythrocyte Sedimentation Rate (ESR).

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
Patient global assessment (0-100).

Patient reported pain (0-100).

Patient reported fatigue (0-100).

Heath Assessment Questionnaire (HAQ) (0-3).

Modified Heath Assessment Questionnaire (mHAQ).

Morning stiffness (yes/no).

Morning stiffness duration (hours).
Treatment Characteristics and Medication history.

Concomitant therapies (Monotherapy, Combination with: methotrexate (MTX) alone, 
other conventional synthetic disease modifying antirheumatic drug (DMARD), 
conventional synthetic disease modifying antirheumatic drug (csDMARD), 
MTX + other csDMARD).

Number of prior biologics/JAK inhibitors (TNFi: Enbrel, Humira, Remicade, Cimzia, 
Simponi; non-TNFi: Orencia, Actemra, Rituxan, Kineret, Kevzara; JAKis: Olumiant, 
Rinvoq).

Number of prior csDMARDs (MTX, Arava, Azulfidine, Plaquenil, Cyclosporine, 
Imuran, Minocin, Cuprimine, Ridaura).

Steroid use:

History of prednisone use (yes/no);

Current prednisone use (yes/no);

Prednisone dose (in users).  
Reason for initiation of tofacitinib: 

Number of patients with at least 1 initiation reason reported;

Total number of reasons;

% Safety, % Effectiveness, % Cost/Insurance, % Other reasons.

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Reason for Discontinuation of tofacitinib (Among those who discontinue at or before 
6-months): 

Total number (%) of discontinuations;

Number of patients with at least 1 reason reported;

Total number of reasons;

% Safety, % Effectiveness, % Cost/Insurance, % Other reasons.
Objective 2 (6-month effectiveness and 12-month effectiveness).
Primary outcomes:

Achievement of low disease activity (LDA) (CDAI ≤10).
Secondary outcomes:

Achievement of remission (CDAI ≤2.8);

∆CDAI;

∆HAQ;

∆patient pain;

∆patient fatigue;

Achievement of modified American College of Rheumatology (mACR)20/50/70;

Achievement of LDA or remission defined by DAS28(ESR) (<= 3.2);

Achievement of “mild pain”, defined as ≤20mm on 100 visual analog scale 
(VAS).
Additionally, all variables will be stratified in 2 year increments (eg, 2012-2014, 2015-2017, 
2018-2020).
9.4. Data Sources
Patients are enrolled in the Corrona RA Registry during regularly-scheduled office visits. 
Upon enrollment, providers complete a set of Enrollment Questionnaires, including a 28 joint 
count on RA patients. Patients also complete an Enrollment Questionnaire, which captures 
several data elements, including the Health Assessment Questionnaire (HAQ) and the 
European Quality of Life-5 Dimensions (EQ-5D-5L). Both patient and provider reported 

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disease activity measures obtained at each visit are captured in Corrona; this includes tender 
and swollen joint counts (28 joint counts), patient and physician global disease assessment, 
patient pain assessment and HAQ scores. Providers and patients complete follow-up 
Questionnaires approximately every 6 months. During the course of a regularly-scheduled 
office visit, the provider performs assessments as mandated on the Corrona Provider
Questionnaires with recording of pertinent data. Results from specific laboratory tests are 
included, but not mandated. Likewise, during regularly-scheduled office visits, patients are 
asked to complete Questionnaires designed to capture information ranging from their general 
demographics and experience with prescription drug use to an overall global assessment of 
their disease. Early follow-up visits occur and questionnaires are completed whenever a 
registry patient is being prescribed or receiving a first dose of a new (different) eligible 
medication at a routine office visit. Eligible medications are biologics, biosimilars, and JAK
inhibitors FDA-approved for the treatment of RA. The next regularly scheduled visit is 
calculated from the previous visit. Data are collected on patients for as long as they consent 
to remain in the study.
9.5. Study Size
This is a descriptive study thus sample size calculations are not applicable.  
9.6. Data Management 
All statistical analyses will be performed using STATA Version 15.1 (StataCorp, LLC, 
College Station, TX). All analyses will be carried out under the direction of Dr. Ying Shan of 
Corrona.
9.6.1. Record Retention
To enable evaluations and/or inspections/audits from regulatory authorities or Pfizer, 
Corrona agrees to keep all study-related records, including safety reporting forms, source 
documents, 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 Corrona according to local regulations or as specified in the vendor contract, 
whichever is longer. Corrona  must ensure that the records continue to be stored securely for 
so long as they are retained.
If Corrona becomes unable for any reason to continue to retain study records for the required 
period, Pfizer should be prospectively notified. The study records must be transferred to a 
designee acceptable to Pfizer.
Study records must be kept for a minimum of 15 years after completion or discontinuation of 
the study, unless Corrona and Pfizer have expressly agreed to a different period of retention 
via a separate written agreement. Records must be retained for longer than 15 years if 
required by applicable local regulations. 
Corrona must obtain Pfizer's written permission before disposing of any records, even if 
retention requirements have been met.

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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 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
Corrona or its designee monitors the conduct of the registry at each investigative site. 
Monitoring is primarily conducted remotely. Onsite monitoring visits are conducted once 
every 3 years, as needed, or as requested. A review of registry records including, but not 
limited to, the informed consent forms, Questionnaires, original source documents such as 
supporting medical records and office notes, subject study files, and any other registry 
documentation is conducted in accordance with applicable regulatory guidelines and the 
protocol. 
Quality control checks are built into the on-screen data entry systems in an attempt to reduce 
queries and provide immediate feedback to the investigator regarding inadvertent omissions 
and out of range or noncompliant values. Changes made at any time are recorded in an audit 
trail that includes the date, time, and electronic ID of the person making the change.
Corrona will address and resolve discrepancies by requesting clarifications and/or missing 
data from the investigator as needed. Each investigator is expected to designate a point of 
contact to address such inquiries and to promptly address and resolve issues. Representatives 
or designees from Corrona reserve the right to perform random or systematic audits of 
Corrona Questionnaires at an investigator’s site in order to assess the accuracy of the 
reported data compared to the information contained in the original medical records.
9.9. Limitations of the Research Methods
The Corrona RA Registry includes a sample of adults with RA that are not necessarily 
representative of all adults with RA in the US. In particular, these are RA patients with 
clinical visits with rheumatologists. Patients are recruited by rheumatologists who are 
required to indicate diagnosis upon enrollment of the patient into the Corrona RA Registry. 
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 registry reporting is not 
based on a fixed visit schedule, exact timing of visits to fit 6, 12, 24, or 36 months of post 
index data is not available for all patients so windows of time are used to determine eligible 
visits. The “cause” of visits is not captured, although the assumption can likely be made that 
the rheumatologist visit is “RA related.” The registry captures provider reported prescribing; 
there are no measures of patient adherence.

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As this is a real-world study, missing data could be expected for demographic characteristics 
(eg, age, etc.); however, the number of patients with missing data is expected to be very 
small. 
 
9.10. Other Aspects
Not applicable.
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)
There must be prospective approval of the study protocol, protocol amendments, and other 
relevant documents (eg, informed consent forms if applicable) from the relevant IRBs/IECs.
All correspondence with the IRB/IEC must be retained. Copies of IRB/IEC approvals must
be forwarded to Pfizer.
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).
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. 
CCI

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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.  

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13. REFERENCES
1.
Alamanos Y, Drosos AA. Epidemiology of adult rheumatoid arthritis. Autoimmun Rev
2005;4(3):130-6.
2.
Walker JG, and Smith MD. The Jak-STAT pathway in rheumatoid arthritis. J
Rheumatol, 2005;32(9):1650-3.
3.
McInnes IB, Schett G. Cytokines in the pathogenesis of rheumatoid arthritis. Nat Rev
Immunol 2007; 7(6):429-42.
4.
McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med 2011;
365(23):2205-19.
5.
Meyer DM, Jesson MI, Li XO, et al. Anti-inflammatory activity and neutrophil
reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced
arthritis. J Inflamm 2010; 7:41.

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14. LIST OF TABLES 
Table shells are included in the SAP.
15. LIST OF FIGURES
Figures are included in the SAP.
ANNEX 1. LIST OF STAND-ALONE DOCUMENTS
Number
Date
Title
1
09 September
2020
Treatment Patterns and 6 and 12-Month Effectiveness of Tofacitinib 
in the Corrona Rheumatoid Arthritis Registry
ANNEX 2. ADDITIONAL INFORMATION
Not Applicable.

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