NCT01224171

Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required. Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	vedolizumab	Vedolizumab for intravenous infusion
OTHER	Placebo	Placebo intravenous infusion

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-02-01
• Completion: 2012-04-01
• First posted: 2010-10-19
• Last updated: 2014-07-21
• Results posted: 2014-07-21

Locations

41 sites across 2 countries: United States, Canada