At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,243 enrolled
Drug / intervention
Vedolizumabdrug
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, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating Vedolizumab for Ulcerative Colitis and Crohn's Disease. Completed, enrolled 2,243 participants across 41 sites in 10 countries.
Detailed Summary
The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis, Crohn's Disease
CountriesAustralia, Belgium, Canada, Czechia, Germany, Hungary, Israel, Malaysia, South Korea, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartMay 2009
Primary CompletionOct 2017
TodayJul 2026
First PostedNov 14, 2008
Enrollment StartMay 22, 2009
Primary CompletionOct 31, 2017
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 17.6 years ago
Interventions
Vedolizumabdrug
Vedolizumab intravenous infusion