Basiliximab Maintenance in Ulcerative Colitis
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
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis|
- Assess the safety of basiliximab in subjects with ulcerative colitis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Study Drug: basiliximab 40 mg, given as a short intravenous infusion Dosing Schedule: once every 4 weeks Concomitant Therapy: Oral corticosteroids (prednisone or equivalent) will be tapered during the first few months of the study participation Duration of Study Participation: The duration of individual study participation will vary.
Other Name: Simulect