Status:
COMPLETED
An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
Lead Sponsor:
Takeda
Conditions:
Ulcerative Colitis
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 l...
Eligibility Criteria
Inclusion
- 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)
- May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol
Exclusion
- 1\. Development of any new, unstable, or uncontrolled disease
Key Trial Info
Start Date :
May 22 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2017
Estimated Enrollment :
2243 Patients enrolled
Trial Details
Trial ID
NCT00790933
Start Date
May 22 2009
End Date
October 31 2017
Last Update
May 24 2022
Active Locations (41)
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1
Birmingham, Alabama, United States, 35233
2
San Diego, California, United States, 92114
3
San Francisco, California, United States, 94115
4
Lafayette, Colorado, United States, 80026