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NCT04798287 · ClinicalTrials.gov registry record
Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints
A clinical trial, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- 105,711
- Enrollment target
NCT04798287 is a clinical trial that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 105,711 participants.
The verdict
NCT04798287 has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- 105,711 participants
- Enrollment target
Study Summary
There are two main aims of this study. First aim is to compare the risk of composite cancer outcomes, 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 common solid cancers (lung, colorectal, breast, prostate), hematological cancers, and non-melanoma skin cancer as separated 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.
Interventions
- DRUG Tofacitinib
- DRUG TNF Inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105,711 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2022-05-16 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04798287
The ClinicalTrials.gov registry entry for NCT04798287 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. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tofacitinib is the first listed.
NCT04798287 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04798287 about?
NCT04798287 is a clinical study titled "Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints". There are two main aims of this study. First aim is to compare the risk of composite cancer outcomes, 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 ...
What is the current status of trial NCT04798287?
This trial is currently completed. The enrollment target is 105,711 participants. The study started on 2021-03-10. Estimated completion is 2022-05-16.
What interventions are being tested in trial NCT04798287?
The interventions under investigation include: Tofacitinib (DRUG), TNF Inhibitor (DRUG).
Who is sponsoring clinical trial NCT04798287?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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