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NCT00771667 · ClinicalTrials.gov registry record · Phase 2
A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy
A Phase 2 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 2
- Development phase
- 526
- Enrollment target
NCT00771667: Completed Phase 2 study, sponsored by Centocor.
NCT00771667 is a Phase 2 study that has completed, run by Centocor. The registered enrollment target is 526 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (295% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00771667, a Phase 2 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 526 participants
- Enrollment target
Study Summary
A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.
Primary Outcome
As measured by the Crohn's Disease Activity Index (CDAI). CDAI scores range from 0 points (minimal disease activity) to over 600 points (severe disease activity). Clinical response was defined as a reduction from baseline of ≥ 100 points. Participants with a baseline CDAI of ≥ 220 to ≤ 248 were considered to be in clinical response if a CDAI score of \< 150 was attained.
Interventions
- DRUG Placebo (IP)
- DRUG Ustekinumab 1mg/kg (IP)
- DRUG Ustekinumab 3 mg/kg (IP)
- DRUG Ustekinumab 6 mg/kg (IP)
- DRUG Placebo IV - Responder - Placebo SC (MP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 526 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT00771667 record still lists
NCT00771667 is an interventional study that assigns participants to a tested intervention. The registered 526 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (295% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo (IP) is the first listed.
NCT00771667 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00771667 about?
NCT00771667 is a clinical study titled "A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy". A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.
What is the current status of trial NCT00771667?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 526 participants. The study started on 2008-12. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00771667?
The interventions under investigation include: Placebo (IP) (DRUG), Ustekinumab 1mg/kg (IP) (DRUG), Ustekinumab 3 mg/kg (IP) (DRUG), Ustekinumab 6 mg/kg (IP) (DRUG), Placebo IV - Responder - Placebo SC (MP) (DRUG).
Who is sponsoring clinical trial NCT00771667?
This trial is sponsored by Centocor, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00771667's enrollment target sits among peer trials
526 65th of 2000 higher than 1,936 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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