GA28949: Phase III Randomized Double-Blind Double-Dummy Placebo-Controlled Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared with Adalimumab and Placebo in Patients with Moderate to Severe Ulcera

Brief description of study

The purpose of this study is to determine whether etrolizumab is a safe and effective treatment in subjects with moderate to severe active ulcerative colitis who have previously had an unsuccessful response to treatment with corticosteroids and/or immunosuppressants such as azathioprine, 6-mercaptopurine, or methotrexate and to see whether etrolizumab is more effective than adalimumab (Humira®) in treating ulcerative colitis. Etrolizumab is an experimental drug, which means it has not been approved by health authorities for the treatment of ulcerative colitis. You might be eligible to participate in this study because you have moderate to severe active ulcerative colitis that has not responded adequately to treatment with immunosuppressants and/or corticosteroids. Etrolizumab is designed to work by blocking the binding of certain white blood cells to the lining of the gastrointestinal tract. By blocking binding of the cells, it is thought to reduce inflammation caused by your ulcerative colitis. Adalimumab works by blocking the action of a protein called “tumor necrosis factor-alpha” (TNF-a). Blocking this protein can reduce the inflammation in your body. Adalimumab is approved for use in ulcerative colitis.

Clinical Study Identifier: s14-01667 Identifier: NCT02171429
Principal Investigator: Seymour Katz
Currently Recruiting

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