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NCT00048581 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 738
- Enrollment target
NCT00048581: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00048581 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 738 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00048581, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 738 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with abatacept will also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months after the start of the study.
Primary Outcome
ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 obser
Interventions
- DRUG Placebo
- DRUG Abatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 738 participants |
| Start Date | 2002-12 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00048581 record still lists
NCT00048581 is an interventional study that assigns participants to a tested intervention. The registered 738 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00048581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00048581 about?
NCT00048581 is a clinical study titled "Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.". The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at...
What is the current status of trial NCT00048581?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 738 participants. The study started on 2002-12. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00048581?
The interventions under investigation include: Placebo (DRUG), Abatacept (DRUG).
Who is sponsoring clinical trial NCT00048581?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00048581's enrollment target sits among peer trials
738 479th of 2000 higher than 1,522 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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