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NCT00048568 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,250
- Enrollment target
NCT00048568: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00048568 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,250 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00048568, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,250 participants
- Enrollment target
Study Summary
Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied. Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.
Primary Outcome
ACR 20 response requires a patient 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, patient global assessment of disease, patient 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 observed for at l
Interventions
- DRUG Placebo
- DRUG Abatacept
- DRUG Methotrexate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,250 participants |
| Start Date | 2002-12 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00048568 record still lists
NCT00048568 is an interventional study that assigns participants to a tested intervention. Its 1,250 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00048568 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00048568 about?
NCT00048568 is a clinical study titled "A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate". Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be stu...
What is the current status of trial NCT00048568?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,250 participants. The study started on 2002-12. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00048568?
The interventions under investigation include: Placebo (DRUG), Abatacept (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT00048568?
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 NCT00048568's enrollment target sits among peer trials
1,250 207th of 2000 higher than 1,791 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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