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NCT00408629 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 518
- Enrollment target
NCT00408629: Completed Phase 3 study, sponsored by Abbott.
NCT00408629 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 518 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00408629, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 518 participants
- Enrollment target
Study Summary
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).
Primary Outcome
Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), Endoscopy Subscore, and Physician's Global Assessment Subscore (PGA), each of which ranges from 0 (normal) to 3 (severe disease).
Interventions
- BIOLOGICAL placebo
- BIOLOGICAL adalimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2006-11 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
What the finished NCT00408629 record still lists
NCT00408629 is an interventional study that assigns participants to a tested intervention. The registered 518 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 (33% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00408629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00408629 about?
NCT00408629 is a clinical study titled "Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis". This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).
What is the current status of trial NCT00408629?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 518 participants. The study started on 2006-11. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00408629?
The interventions under investigation include: placebo (BIOLOGICAL), adalimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00408629?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00408629's enrollment target sits among peer trials
518 723rd of 2000 higher than 1,277 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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