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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04772248
Recruitment Status : Completed
First Posted : February 26, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Rishi J. Desai, Brigham and Women's Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Tofacitinib Drug: TNF Inhibitor

Study Design
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Study Type : Observational
Actual Enrollment : 105711 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints
Actual Study Start Date : February 22, 2021
Actual Primary Completion Date : December 30, 2021
Actual Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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:
  • infliximab
  • adalimumab
  • certolizumab pegol
  • etanercept
  • golimumab


Outcome Measures
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Primary Outcome Measures :
  1. Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke [ Time Frame: Through study time period (2012-2020) ]
    Myocardial infarction OR Stroke


Secondary Outcome Measures :
  1. Time to myocardial infarction [ Time Frame: Through study time period (2012-2020) ]
  2. Time to stroke [ Time Frame: Through study time period (2012-2020) ]
  3. Time to heart failure hospitalization [ Time Frame: Through study time period (2012-2020) ]
  4. Time to coronary revascularization [ Time Frame: Through study time period (2012-2020) ]
  5. Time to all-cause mortality [ Time Frame: Through study time period (2012-2020) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772248


Locations
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United States, Massachusetts
Brigham And Women's Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Rishi Desai, MS, PhD Assistant Professor of Medicine
  Study Documents (Full-Text)

Documents provided by Rishi J. Desai, Brigham and Women's Hospital:
Study Protocol  [PDF] May 19, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rishi J. Desai, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04772248    
Other Study ID Numbers: 2011P002580-202
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Etanercept
Golimumab
Tumor Necrosis Factor Inhibitors
Infliximab
Certolizumab Pegol
Tofacitinib
 Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action