Status:
COMPLETED
Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
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 tr...
Eligibility Criteria
Inclusion
- 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:
- 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)
- 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)
Exclusion
Key Trial Info
Start Date :
February 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
105711 Patients enrolled
Trial Details
Trial ID
NCT04772248
Start Date
February 22 2021
End Date
December 30 2021
Last Update
March 2 2022
Active Locations (1)
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1
Brigham And Women's Hospital
Boston, Massachusetts, United States, 02120