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NCT00533897 · ClinicalTrials.gov registry record · Phase 3
Phase IIIB Subcutaneous Missed Dose Study
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
NCT00533897: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00533897 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 270 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00533897, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.
Primary Outcome
Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using an enzyme-linked immunosorbent assay (ELISA). Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
Interventions
- DRUG Placebo
- DRUG Abatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2007-11 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT00533897 record still lists
NCT00533897 is an interventional study that assigns participants to a tested intervention. The registered 270 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00533897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00533897 about?
NCT00533897 is a clinical study titled "Phase IIIB Subcutaneous Missed Dose Study". The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.
What is the current status of trial NCT00533897?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2007-11. Estimated completion is 2014-02.
What interventions are being tested in trial NCT00533897?
The interventions under investigation include: Placebo (DRUG), Abatacept (DRUG).
Who is sponsoring clinical trial NCT00533897?
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 NCT00533897's enrollment target sits among peer trials
270 1217th of 2000 higher than 781 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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