Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00783692 · ClinicalTrials.gov registry record · Phase 3
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
A Phase 3 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,116
- Enrollment target
NCT00783692: Completed Phase 3 study, sponsored by Millennium Pharmaceuticals.
NCT00783692 is a Phase 3 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 1,116 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00783692, a Phase 3 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,116 participants
- Enrollment target
Study Summary
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response and remission at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
Primary Outcome
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 d
Interventions
- OTHER Placebo
- DRUG vedolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,116 participants |
| Start Date | 2008-12 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00783692 record still lists
NCT00783692 is an interventional study that assigns participants to a tested intervention. Its 1,116 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00783692 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00783692 about?
NCT00783692 is a clinical study titled "Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease". The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response and remission 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 NCT00783692?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,116 participants. The study started on 2008-12. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00783692?
The interventions under investigation include: Placebo (OTHER), vedolizumab (DRUG).
Who is sponsoring clinical trial NCT00783692?
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 NCT00783692's enrollment target sits among peer trials
1,116 251st of 2000 higher than 1,750 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02140255 · 1,120 participants · Phase 1
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission
- NCT06618534 · 1,120 participants · Phase 2
Azithromycin for Meningococcal Carriage
- NCT07164131 · 1,120 participants · Phase 4
Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
- NCT05691478 · 1,122 participants · Phase 2
A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia