An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease



Status:Completed
Conditions:Colitis, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:May 22, 2009
End Date:October 31, 2017

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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

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.

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
treat people who have ulcerative colitis or Crohn's disease. This study will determine the
safety profile of long-term vedolizumab treatment.

The study enrolled 2243 patients. Participants who received either placebo or vedolizumab 300
mg IV infusion every 4 or 8 weeks in previous vedolizumab studies received:

• Vedolizumab 300 mg

All participants received vedolizumab intravenous infusion every 4 weeks for approximately up
to 510 weeks.

This multicenter trial is being conducted worldwide. The overall time to participate in this
study was up to October 2017 until vedolizumab was available in the country in which the
participant resided, or until participant withdrawal, whichever came first. Participants made
multiple visits to the clinic up to 16 weeks after receiving their last dose of vedolizumab
and were being followed up for 2-years during which a safety questionnaire was administered
by telephone for follow-up assessments.

Inclusion Criteria:

1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study
C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the
investigator, was well tolerated OR b. Moderate to severe Crohn's disease or
ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)

2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or
ulcerative colitis as defined by the protocol

Exclusion Criteria:

1. Development of any new, unstable, or uncontrolled disease
We found this trial at
32
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