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NCT04772248 · ClinicalTrials.gov registry record
Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints
A clinical trial of Rheumatoid Arthritis, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- 105,711
- Enrollment target
- 1
- Study location
NCT04772248: Completed study of Rheumatoid Arthritis, sponsored by Brigham and Women's Hospital.
NCT04772248 is a study of Rheumatoid Arthritis that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 105,711 participants, above the 4,154-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (2445% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04772248, a study of Rheumatoid Arthritis, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- 105,711 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Myocardial infarction OR Stroke
Conditions Studied
Interventions
- DRUG Tofacitinib
- DRUG TNF Inhibitor
Study Locations (1)
Massachusetts
- Brigham And Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105,711 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2021-12-30 |
What the finished NCT04772248 record still lists
NCT04772248 is an observational study that tracks outcomes without assigning an intervention. Its 105,711 participants enrollment target places it among the larger protocols in the corpus, above the 4,154-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (2445% higher).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Tofacitinib is the first listed.
NCT04772248 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04772248 about?
NCT04772248 is a clinical study titled "Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints". 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)"...
What is the current status of trial NCT04772248?
This trial is currently completed. The enrollment target is 105,711 participants. The study started on 2021-02-22. Estimated completion is 2021-12-30.
What conditions does trial NCT04772248 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT04772248?
The interventions under investigation include: Tofacitinib (DRUG), TNF Inhibitor (DRUG).
Who is sponsoring clinical trial NCT04772248?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04772248 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04772248's enrollment target sits among peer trials
105,711 3rd of 197 higher than 195 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
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