Clinical Trial: Basiliximab Maintenance in Ulcerative Colitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis

Brief Summary:

Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies.

Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population

Detailed Summary:
Sponsor: Cerimon Pharmaceuticals

Current Primary Outcome: Assess the safety of basiliximab in subjects with ulcerative colitis [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Cerimon Pharmaceuticals

Dates:
Date Received: February 2, 2010
Date Started: July 2007
Date Completion:
Last Updated: February 2, 2010
Last Verified: February 2010