The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
181
3 doses of 40mg, IV at baseline, week 2, and week 4
Change in Mayo Score, Safety
Time frame: At week 8
Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use
Time frame: at week 4 and 8
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Anaheim, California, United States
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Roseville, California, United States
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Golden, Colorado, United States
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Littleton, Colorado, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Urbana, Illinois, United States
...and 58 more locations