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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 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 1,250 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00048568
The ClinicalTrials.gov registry entry for NCT00048568 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00048568 reports 0 study locations.
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.
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