Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints

March 1, 2022 updated by: Rishi J. Desai, Brigham and Women's Hospital

There are two main aims of this study.

First aim is to compare the risk of cardiovascular events (including myocardial infarction or stroke), between patients treated with tofacitinib and patients treated with TNF inhibitors (TNFi) for rheumatoid arthritis (RA) among, 1) "real world evidence (RWE)" cohorts including routine care patient population from the US and, 2) "Randomized controlled trial (RCT) DUPLICATE" cohorts including routine care patient population who meet inclusion and exclusion criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis ("ORAL Surveillance", NCT02092467) clinical trial.

Second aim is to examine the risk of myocardial infarction, stroke, heart failure hospitalization, coronary revascularization, and all-cause mortality as separate endpoints when comparing tofacitinib with TNFi in patients with RA among, 1) "real world evidence (RWE)" cohort including routine care patient population from the US and, 2) "Randomized controlled trial (RCT) DUPLICATE" cohort including routine care patient population who meet inclusion and exclusion criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis ("ORAL Surveillance", NCT02092467) clinical trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

105711

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

There will be two independent study populations:

  1. Real-World Evidence (RWE) cohorts: This study population will reflect the patients diagnosed with RA who are routinely treated and managed in setting of clinical practice.
  2. RCT-duplicate cohorts: This study population will emulate "the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis" clinical trial ("ORAL Surveillance", NCT02092467). The inclusion and exclusion criteria of this RCT will be applied to this study population.

Description

Criteria:

Please see https://www.bwhprime.org/resources.html for full code and algorithm definitions.

Eligible cohort entry dates:

  • For US MarketScan, 2012-2018
  • For Optum, 2012-2020
  • For Medicare Claims Database (Parts A, B and D), 2012-2017

Cohort entry date:

  • First TNFi or tofacitinib dispensation/administration date

Inclusion and Exclusion Criteria Common to RWE and RCT-duplicate Cohorts:

  1. Inclusion Criteria

    • Patients treated with tofacitinib or TNF inhibitors in IBM MarketScan, Optum, and Medicare fee-for-service
    • A minimum of 365 days of continuous enrollment in health plan prior to (and including) the cohort entry date
    • Two diagnosis codes for RA in any setting in 365 days baseline period (diagnosis codes between 7 and 365 days apart)

  2. Exclusion Criteria

    • Index drug in 365 days prior to cohort entry date (prevalent users)
    • Missing data on age or gender
    • Admission to nursing facility or hospice on or prior to cohort entry date (ever look-back)
    • TNFi users with history of any Janus kinase (JAK) inhibitors (tofacitinib, upadacitinib, or baricitinib) (ever look-back period)
    • TNFi users initiating with more than one TNFi on same date
    • Tofacitinib users with a prescription of baricitinib, upadacitinib (ever look-back period)
    • Tofacitinib users initiating treatment on multiple JAK inhibitors on same day (tofacitinib and baricitinib, tofacitinib and upadacitinib)

Exclusion criteria specific to RWE cohorts:

  • Patients less than 18 years of age (MarketScan and Optum) and 65 years of age (Medicare) at cohort entry

Inclusion criteria specific to RCT-duplicate cohorts:

  • Patients with at least one methotrexate dispensation (six months look-back period)
  • Patients with at least one cardiovascular risk factor (including smoking, hypertension, dyslipidemia, diabetes mellitus, ischemic heart disease, family history of ischemic heart disease) (one-year look-back period)

Exclusion criteria specific to RCT-duplicate cohorts:

  • Patients less than 50 years of age (MarketScan and Optum) and 65 years
  • Patients recently hospitalized with infections (30-day look-back period)
  • Pregnant patients (one year look-back period)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated with Tofacitinib
Real-World Evidence (RWE) and RCT-Duplicate
Drug: Tofacitinib
First eligible prescription for treating rheumatoid arthritis (RA)
Patients treated with TNF inhibitors
Real-World Evidence (RWE) and RCT-Duplicate
Drug: TNF Inhibitor
First eligible prescription for treating rheumatoid arthritis (RA)
Other Names:
  • adalimumab
  • infliximab
  • etanercept
  • certolizumab pegol
  • golimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke
Time Frame: Through study time period (2012-2020)
Myocardial infarction OR Stroke
Through study time period (2012-2020)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to myocardial infarction
Time Frame: Through study time period (2012-2020)
Through study time period (2012-2020)
Time to stroke
Time Frame: Through study time period (2012-2020)
Through study time period (2012-2020)
Time to heart failure hospitalization
Time Frame: Through study time period (2012-2020)
Through study time period (2012-2020)
Time to coronary revascularization
Time Frame: Through study time period (2012-2020)
Through study time period (2012-2020)
Time to all-cause mortality
Time Frame: Through study time period (2012-2020)
Through study time period (2012-2020)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Rishi Desai, MS, PhD, Assistant Professor of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011P002580-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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