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NCT00406653 · ClinicalTrials.gov registry record · Phase 3
A Study of Abatacept in Patients With Active Crohn's Disease
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Terminated
- Registry status
- Phase 3
- Development phase
- 451
- Enrollment target
NCT00406653: Clinical Trial Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT00406653 is a Phase 3 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 451 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00406653, a Phase 3 study, was terminated before completion, sponsored by Bristol-Myers Squibb.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 451 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.
Primary Outcome
CDAI is a composite index consisting of a weighted scoring of 8 disease variables:number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's Diary kept while on study. CDAI scores range from 0 to \~600 points. Clinical response=CDAI reduction ≥100 points or absolute CDAI \<
Interventions
- DRUG placebo
- DRUG abatacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 451 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-11 |
| Phase | Phase 3 |
Why NCT00406653 stopped before completion
NCT00406653 is an interventional study that assigns participants to a tested intervention. The registered 451 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 (42% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00406653 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00406653 about?
NCT00406653 is a clinical study titled "A Study of Abatacept in Patients With Active Crohn's Disease". The purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active Crohn's Disease in patients who have not had an adequate response to other therapies. The safety of this treatment will also be studied.
What is the current status of trial NCT00406653?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 451 participants. The study started on 2006-12. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00406653?
The interventions under investigation include: placebo (DRUG), abatacept (DRUG).
Who is sponsoring clinical trial NCT00406653?
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 NCT00406653's enrollment target sits among peer trials
451 836th of 2000 higher than 1,164 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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