At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 416 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 of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating vedolizumab and Placebo for Crohn's Disease. Completed, enrolled 416 participants across 41 sites in 2 countries.
Detailed Summary
This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartNov 2010
Primary CompletionFeb 2012
Study CompletionApr 2012
TodayJul 2026
First PostedOct 19, 2010
Enrollment StartNov 1, 2010
Primary CompletionFeb 1, 2012
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.7 years ago
Interventions
vedolizumabdrug
Vedolizumab for intravenous infusion
Placeboother
Placebo intravenous infusion