NCT01061996

Basiliximab Maintenance in Ulcerative Colitis

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Cerimon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Basiliximab	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.

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2010-02-04
• Last updated: 2010-02-04

Locations

1 site across 1 country: United Kingdom