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NCT00265122 · ClinicalTrials.gov registry record · Phase 2
A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease
A Phase 2 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 2
- Development phase
- 131
- Enrollment target
NCT00265122: Completed Phase 2 study, sponsored by Centocor.
NCT00265122 is a Phase 2 study that has completed, run by Centocor. The registered enrollment target is 131 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00265122, a Phase 2 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 131 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.
Primary Outcome
The table below provides the number of participants in Population 1 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of \>= 25% and \>= 70 points at Week 8. A reduction in CDAI score correlates with improvement in the severity of illness. The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools
Interventions
- DRUG Placebo IV
- DRUG Placebo SC
- DRUG Ustekinumab 90 mg
- DRUG Ustekinumab 4.5 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2004-04 |
| Est. Completion | 2006-10 |
| Phase | Phase 2 |
What the finished NCT00265122 record still lists
NCT00265122 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo IV is the first listed.
NCT00265122 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00265122 about?
NCT00265122 is a clinical study titled "A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease". The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.
What is the current status of trial NCT00265122?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2004-04. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00265122?
The interventions under investigation include: Placebo IV (DRUG), Placebo SC (DRUG), Ustekinumab 90 mg (DRUG), Ustekinumab 4.5 mg/kg (DRUG).
Who is sponsoring clinical trial NCT00265122?
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 NCT00265122's enrollment target sits among peer trials
131 541st of 2000 higher than 1,458 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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