Status:
COMPLETED
Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age 18 to 80
- Diagnosis of moderately to severely active Crohn's disease
- Crohn's Disease involvement of the ileum and/or colon
- Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
- May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol
- Exclusion Criteria
- Evidence of abdominal abscess at the initial screening visit
- Extensive colonic resection, subtotal or total colectomy
- History of \>3 small bowel resections or diagnosis of short bowel syndrome
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
- Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
- Active or latent tuberculosis
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT01224171
Start Date
November 1 2010
End Date
April 1 2012
Last Update
July 21 2014
Active Locations (41)
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1
Gastroenterology of the Rockies
Lafayette, Colorado, United States, 80026
2
Gastroenterology Center of Connecticut P.C.
Hamden, Connecticut, United States, 65180
3
University of Florida
Gainesville, Florida, United States, 32610
4
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136