At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 34 enrolled
Drug / intervention
Vedolizumab +1 moredrug
Likely dose
Vedolizumab 300 mgfrom 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 Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE)
In Brief
A Phase 4 clinical trial evaluating Vedolizumab and Placebo for Crohn's Disease. Completed, enrolled 34 participants across 18 sites in 7 countries.
Detailed Summary
The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesCanada, France, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2015
Enrollment StartAug 2016
Primary CompletionSep 2018
Study CompletionNov 2018
TodayJul 2026
First PostedDec 15, 2015
Enrollment StartAug 10, 2016
Primary CompletionSep 4, 2018
Study CompletionNov 14, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.5 years ago
Interventions
Vedolizumabdrug
Vedolizumab 300 mg IV infusion
Placebodrug
0.9% sodium chloride IV infusion