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Category: Gastroenterology/Hepatology,
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HIC#14493
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| Title: |
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis |
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Contact:Sandra Oliphant
Phone:(434)982-0871
E-mail:slo2n@virginia.edu
The UVA Digestive Health Center of Excellence is seeking men and women ages 18 to 80 with moderately or severely active Ulcerative Colitis to participate in a clinical trial using the experimental medication vedolizumab. Vedolizumab is an antibody that binds to a4b7; a4b7 encourages the migration of leukocytes (white blood cells) into the GI tissue causing an increase in bowel inflammation. The purpose of this study is to compare the effects, good and/or bad, of vedolizumab with that of a placebo in inducing a clinical response and mucosal healing in participants with moderate or severe Ulcerative Colitis.
Participants that enroll in the study will take vedolizumab 300 mg intravenously or a placebo intravenous infusion for the first 2 treatments at week 0 and week 2; you have a 60% (or greater) chance of receiving vedolizumab.
At Week 6, all participants will be re-randomized based on what their response to the treatment. Participants will be re-randomized to receive 1 of the 3 following treatment regimens:
placebo intravenous infusion once every 4 weeks
vedolizumab 300 mg intravenous infusions once every 4 weeks
vedolizumab 300 mg intravenous infusions once every 8 weeks
with a placebo intravenous infusion once every 8 weeks;
(this will be an alternating schedule).
Eligible participants will have all study-related care and the study medication provided free of charge; please note you will receive compensation for time or travel for each visit. The study treatment with vedolizumab or placebo will be 50 weeks in duration; while the study duration will be 104 weeks.
Contact: Sandra Oliphant, RN (434) 982 - 0871
HIC 14493
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 Primary Investigator: Behm Brian,
Department: Internal Medicine
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Accepts adult enrollment :YES
Accepts minor enrollment :NO |