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NCT00124982 · ClinicalTrials.gov registry record · Phase 3
Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy
A Phase 3 study of Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,286
- Enrollment target
- 20
- Study locations
NCT00124982: Completed Phase 3 study of Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb.
NCT00124982 is a Phase 3 study of Rheumatoid Arthritis that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,286 participants, below the 4,684-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00124982, a Phase 3 study of Rheumatoid Arthritis, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,286 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.
Primary Outcome
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an im
Conditions Studied
Interventions
- DRUG Abatacept
- DRUG Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
- DRUG Anti-Tumor Necrosing Factor (TNF) Therapy
Study Locations (20)
California
- Local Institution - Long Beach
- Local Institution - Palm Springs
- Local Institution - Palo Alto
- Local Institution - San Diego
- Local Institution - Santa Monica
Florida
- Local Institution - Aventura
- Local Institution - Clearwater
- Local Institution - Fort Lauderdale
- Local Institution - Jupiter
Arizona
- Local Institution - Paradise Valley
- Local Institution - Peoria
- Local Institution - Tucson
Connecticut
- Local Institution - Danbury
- Local Institution - Hamden
- Local Institution - Trumbull
Alabama
- Local Institution - Birmingham
- Local Institution - Huntsville
Colorado
- Local Institution - Colorado Springs
- Local Institution - Denver
District of Columbia
- Local Institution - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,286 participants |
| Start Date | 2005-04 |
| Est. Completion | 2009-08 |
| Phase | Phase 3 |
What the finished NCT00124982 record still lists
NCT00124982 is an interventional study that assigns participants to a tested intervention. Its 1,286 participants enrollment target places it among the larger protocols in the corpus, below the 4,684-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 3 interventions - of which Abatacept is the first listed.
NCT00124982 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT00124982 about?
NCT00124982 is a clinical study titled "Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy". The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary object...
What is the current status of trial NCT00124982?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,286 participants. The study started on 2005-04. Estimated completion is 2009-08.
What conditions does trial NCT00124982 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT00124982?
The interventions under investigation include: Abatacept (DRUG), Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD) (DRUG), Anti-Tumor Necrosing Factor (TNF) Therapy (DRUG).
Who is sponsoring clinical trial NCT00124982?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00124982 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00124982's enrollment target sits among peer trials
1,286 18th of 197 higher than 180 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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