This Phase II study is a randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rhuMAb Beta7 in patients with moderate to severe ulcerative colitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
Repeating subcutaneous injection
Repeating subcutaneous injection
Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point
Time frame: Week 10
Clinical response as defined by at least a 3-point decrease and 30% reduction from baseline in MCS and a >/=1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1
Time frame: Week 6 and Week 10
Clinical remission defined by a MCS </= 2 with no individual subscore exceeding 1 point
Time frame: Week 6
Proportion of patients with endoscopic score and rectal bleeding score of 0
Time frame: Week 6 and Week 10
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San Diego, California, United States
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Gainesville, Florida, United States
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Atlanta, Georgia, United States
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Chevy Chase, Maryland, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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Great Neck, New York, United States
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Cincinnati, Ohio, United States
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Garran, Australian Capital Territory, Australia
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Clayton, Victoria, Australia
...and 41 more locations