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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: TNF Inhibitor; Drug: Tofacitinib

• Registration Number: NCT04772248
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-22
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-26
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105711

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with TNF inhibitors	TNF Inhibitor	Real-World Evidence (RWE) and RCT-Duplicate
Patients treated with Tofacitinib	Tofacitinib	Real-World Evidence (RWE) and RCT-Duplicate

Primary Outcome Measures

Name	Time	Method
Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke	Through study time period (2012-2020)	Myocardial infarction OR Stroke

Secondary Outcome Measures

Name	Time	Method
Time to stroke	Through study time period (2012-2020)
Time to myocardial infarction	Through study time period (2012-2020)
Time to coronary revascularization	Through study time period (2012-2020)
Time to all-cause mortality	Through study time period (2012-2020)
Time to heart failure hospitalization	Through study time period (2012-2020)

Trial Locations

Locations (1)

Brigham And Women's Hospital; 🇺🇸 Boston, Massachusetts, United States