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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00783718 |
This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active ulcerative colitis comprises two phases:
Condition | Intervention | Phase |
---|---|---|
Ulcerative Colitis |
Drug: vedolizumab Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment |
Official Title: | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis |
Estimated Enrollment: | 826 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
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Drug: vedolizumab
Vedolizumab (MLN0002) is given at weeks 0, 2, 6 and then at 4-week intervals, or 8-week intervals for up to one year.
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2: Placebo Comparator
Placebo add-on Comparator
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Other: Placebo
The placebo infusion (IV) will be composed of normal saline. This is given at weeks 0, 2, 6 and then at 4-weekly intervals for up to one year.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
1. Age 18 to 80
2 Diagnosis of moderately to severely active ulcerative colitis
3. 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
4. May be receiving a therapeutic dose of conventional therapies for IBD as defined by the protocol
Exclusion Criteria:
Contact: For a listing of recruitment sites in your area contact: Millennium Medical and Drug Information Center | 1-866-835-2233 | medical@mlnm.com |
United States, Georgia | |
Atlanta Center for Gastroenterology, P.C. | Recruiting |
Decatur, Georgia, United States, 30033 | |
Contact 404-296-1986 | |
United States, North Carolina | |
Northwest Piedmont Clinical Research, Inc. | Not yet recruiting |
Elkin, North Carolina, United States, 28621 | |
Contact 336-835-1225 |
Responsible Party: | Millennium Pharmaceuticals, Inc. ( Asit Parikh, M.D., Associate Medical Director ) |
Study ID Numbers: | C13006 |
Study First Received: | October 31, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00783718 |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases |
Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Pathologic Processes |