Conditions: Crohn's Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 416
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Participants received placebo intravenous infusion at Weeks 0, 2 and 6. arm 2: Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.

Interventions: intervention 1: vedolizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Vedolizumab for intravenous infusion intervention 2: Placebo intravenous infusion

Protocol document: