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NCT00783718 · ClinicalTrials.gov registry record · Phase 3
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
A Phase 3 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 895
- Enrollment target
NCT00783718: Completed Phase 3 study, sponsored by Millennium Pharmaceuticals.
NCT00783718 is a Phase 3 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 895 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00783718, a Phase 3 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 895 participants
- Enrollment target
Study Summary
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
Primary Outcome
Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic
Interventions
- OTHER Placebo
- DRUG vedolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 895 participants |
| Start Date | 2009-01 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT00783718 record still lists
NCT00783718 is an interventional study that assigns participants to a tested intervention. The registered 895 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00783718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00783718 about?
NCT00783718 is a clinical study titled "Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis". The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
What is the current status of trial NCT00783718?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 895 participants. The study started on 2009-01. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00783718?
The interventions under investigation include: Placebo (OTHER), vedolizumab (DRUG).
Who is sponsoring clinical trial NCT00783718?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00783718's enrollment target sits among peer trials
895 361st of 2000 higher than 1,638 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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