Clinical Trial: Basiliximab in Moderate to Severe Ulcerative Colitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcera

Brief Summary: 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.

Detailed Summary:
Sponsor: Cerimon Pharmaceuticals

Current Primary Outcome: Change in Mayo Score, Safety [ Time Frame: At week 8 ]

Original Primary Outcome: Change in Mayo Score, Safety

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Pharmacokinetics

Information By: Cerimon Pharmaceuticals

Dates:
Date Received: January 31, 2007
Date Started: January 2007
Date Completion:
Last Updated: December 17, 2008
Last Verified: December 2008