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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772248
• Other study ID #: 2011P002580-202
• Status: Completed
• Start date: February 22, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105711
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tofacitinib
First eligible prescription for treating rheumatoid arthritis (RA)
• TNF Inhibitor
First eligible prescription for treating rheumatoid arthritis (RA)

Locations

Country	Name	City	State
United States	Brigham And Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke	Myocardial infarction OR Stroke	Through study time period (2012-2020)
Secondary	Time to myocardial infarction		Through study time period (2012-2020)
Secondary	Time to stroke		Through study time period (2012-2020)
Secondary	Time to heart failure hospitalization		Through study time period (2012-2020)
Secondary	Time to coronary revascularization		Through study time period (2012-2020)
Secondary	Time to all-cause mortality		Through study time period (2012-2020)