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NCT00336492 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
A Phase 3 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
NCT00336492: Completed Phase 3 study, sponsored by Centocor.
NCT00336492 is a Phase 3 study that has completed, run by Centocor. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00336492, a Phase 3 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
Primary Outcome
Range is 0 to 12 points, where 0 is the least disease activity, and 12 is the most disease activity. Clinical response at Week 8 is defined as a decrease from baseline in the Mayo score(based on symptoms of ulcerative colitis) by \>=30% and \>= 3 points, with a decrease in the rectal bleeding subscore \>=1 or a rectal bleeding subscore of 0 or 1. Treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, or had protocol-prohibited
Interventions
- BIOLOGICAL infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2006-09 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
What the finished NCT00336492 record still lists
NCT00336492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which infliximab is the first listed.
NCT00336492 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00336492 about?
NCT00336492 is a clinical study titled "A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis". The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
What is the current status of trial NCT00336492?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2006-09. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00336492?
The interventions under investigation include: infliximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00336492?
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 NCT00336492's enrollment target sits among peer trials
60 1804th of 2000 higher than 177 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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