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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 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.

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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.

Conditions Studied

Rheumatoid Arthritis

Interventions

  • DRUG Tofacitinib
  • DRUG TNF Inhibitor

Study Locations (1)

Massachusetts

  • Brigham And Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 105,711 participants
Start Date 2021-02-22
Est. Completion 2021-12-30

Sponsor

Brigham and Women's Hospital

937 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04772248

The ClinicalTrials.gov registry entry for NCT04772248 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 105,711 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 4,154-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (2445% higher). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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