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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT04772248
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    First eligible prescription for treating rheumatoid arthritis (RA)
  • TNF Inhibitor — DRUG
    First eligible prescription for treating rheumatoid arthritis (RA)

Study Details

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.

Key Dates

Start date
Feb 22, 2021
Status verified
Mar 2022
Primary completion
Dec 30, 2021
Completion
Dec 30, 2021

Study Design

Enrollment
105,711 participants (actual)

Arms

  • Arm: Patients treated with Tofacitinib
    Real-World Evidence (RWE) and RCT-Duplicate
  • Arm: Patients treated with TNF inhibitors
    Real-World Evidence (RWE) and RCT-Duplicate

Primary Outcome Measure

Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke [ Time Frame: Through study time period (2012-2020) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham And Women's HospitalBostonMassachusetts02120-

Find similar trials in Boston, MA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Brigham And Women's Hospital· Boston, MA

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