Crohn's Disease Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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|
||
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Phase 1 | |
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||
| Completed |
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| Terminated |
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N/A | |
| Completed |
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| Terminated |
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Phase 2 | |
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Phase 1 | |
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Phase 3 |