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NCT02092467 · ClinicalTrials.gov registry record · Phase 4
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
A Phase 4 study of Arthritis, Rheumatoid, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 4,372
- Enrollment target
- 20
- Study locations
NCT02092467: Completed Phase 4 study of Arthritis, Rheumatoid, sponsored by Pfizer.
NCT02092467 is a Phase 4 study of Arthritis, Rheumatoid that has completed, run by Pfizer. The registered enrollment target is 4,372 participants, above the 479-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (813% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02092467, a Phase 4 study of Arthritis, Rheumatoid, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4,372 participants
- Enrollment target
- 20
- Study locations
Study Summary
This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.
Primary Outcome
Incidence rate (number of participants with event per 100 participant year \[PY\]) was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Malignancy events, excluding NMSC were adjudicated by a steering committee. The risk period (RP) was the last contact date. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date,
Conditions Studied
Interventions
- DRUG tofacitinib
- BIOLOGICAL adalimumab
- BIOLOGICAL etanercept
Study Locations (20)
California
- Medvin Clinical Research - Covina
- Med Investigations, Inc. - Fair Oaks
- Talbert Medical Group - Huntington Beach
- University of California, San Diego (UCSD)- Perlman Ambulatory Clinic - La Jolla
- Valerius Medical Group And Research Center Of Greater Long Beach, Inc. - Long Beach
- ProHealth Partners - Long Beach
- Keck Medicine of USC - Los Angeles
- California Medical Research Associates Inc - Northridge
- Desert Medical Advances - Palm Desert
- Medvin Clinical Research - Placentia
- Sierra Rheumatology, Inc. - Roseville
- San Diego Arthritis Medical Clinic - San Diego
- Dr. Orrin M. Troum, Md And Medical Associates - Santa Monica
Alabama
- University of Alabama at Birmingham (UAB), Arthritis Clinical Intervention Program - Birmingham
- Rheumatology Associates of North Alabama, PC - Huntsville
- Clinical and Translational Research Center of Alabama, PC - Tuscaloosa
Arizona
- Southern Arizona VA Health Care System (SAVAHCS) - Tucson
- University of Arizona Clinical and Translational Science Research Center - Tucson
Arkansas
- CHI St. Vincent Medical Group Hot Springs - Hot Springs
- Arthritis And Rheumatism Associates LLC - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,372 participants |
| Start Date | 2014-03-14 |
| Est. Completion | 2020-07-22 |
| Phase | Phase 4 |
What the finished NCT02092467 record still lists
NCT02092467 is an interventional study that assigns participants to a tested intervention. Its 4,372 participants enrollment target places it among the larger protocols in the corpus, above the 479-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (813% higher).
The record links to 1 condition, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 3 interventions - of which tofacitinib is the first listed.
NCT02092467 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT02092467 about?
NCT02092467 is a clinical study titled "Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis". This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin...
What is the current status of trial NCT02092467?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4,372 participants. The study started on 2014-03-14. Estimated completion is 2020-07-22.
What conditions does trial NCT02092467 study?
This clinical trial studies the following conditions: Arthritis, Rheumatoid.
What interventions are being tested in trial NCT02092467?
The interventions under investigation include: tofacitinib (DRUG), adalimumab (BIOLOGICAL), etanercept (BIOLOGICAL).
Who is sponsoring clinical trial NCT02092467?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02092467 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02092467's enrollment target sits among peer trials
4,372 1st of 27 higher than 27 of 27 other Arthritis, Rheumatoid trials
participants (enrollment target), bucketed by value
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