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NCT00095147 · ClinicalTrials.gov registry record · Phase 3
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 431
- Enrollment target
NCT00095147: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00095147 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 431 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00095147, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 431 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.
Primary Outcome
The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or C-reactive protein (CRP), and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (\> 5.1), low disease activity (\< 3.2) and remission (\< 2.6). A clinically significant response is a decrease in DAS28 score of \>1.2 from baseline.
Interventions
- DRUG Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)
- DRUG Infliximab (INF) + MTX, DB
- DRUG Placebo (PLA) + MTX, DB
- DRUG PLA + MTX switched to ABA+ MTX, DB
- DRUG ABA, open-label (OL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 431 participants |
| Start Date | 2005-02 |
| Est. Completion | 2009-07 |
| Phase | Phase 3 |
What the finished NCT00095147 record still lists
NCT00095147 is an interventional study that assigns participants to a tested intervention. The registered 431 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 5 interventions - of which Abatacept (ABA) + Methotrexate (MTX), double-blind (DB) is the first listed.
NCT00095147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00095147 about?
NCT00095147 is a clinical study titled "Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis". The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.
What is the current status of trial NCT00095147?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 431 participants. The study started on 2005-02. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00095147?
The interventions under investigation include: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB) (DRUG), Infliximab (INF) + MTX, DB (DRUG), Placebo (PLA) + MTX, DB (DRUG), PLA + MTX switched to ABA+ MTX, DB (DRUG), ABA, open-label (OL) (DRUG).
Who is sponsoring clinical trial NCT00095147?
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 NCT00095147's enrollment target sits among peer trials
431 877th of 2000 higher than 1,124 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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