At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 895 enrolled
Drug / intervention
vedolizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating vedolizumab and Placebo for Ulcerative Colitis. Completed, enrolled 895 participants across 105 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesCanada, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartJan 2009
Primary CompletionDec 2011
Study CompletionMar 2012
TodayJul 2026
First PostedNov 3, 2008
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.7 years ago
Interventions
vedolizumabdrug
Vedolizumab for intravenous infusion
Placeboother
Placebo intravenous infusion