NCT00542152

Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis

A Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PHASE: IV TYPE OF STUDY: With direct benefit. DESCRIPTIVE: Multicenter, randomized, open label study. INCLUSION CRITERIA: Steroid-refractory ulcerative colitis. OBJECTIVES: To compare the efficacy of cyclosporine with infliximab in steroid- refractory attacks of ulcerative colitis. STUDY TREATMENTS:Cyclosporine 2mg/kg/day intravenous(IV)for 7days then Neoral 4mg/kg/day orally for 3 months. Infliximab 5mg/kg at Weeks 0, 2 and 6. NUMBER OF PATIENTS: 50 patients in each group i.e. a total of 100 patients. INCLUSION PERIOD: 24 months. STUDY DURATION: 27 months. MAIN EVALUATION CRITERIA: Clinical response at D7 according to the Lichtiger Index score AND Clinical Remission at D98 according to the Mayo Disease Activity Index score SECONDARY EVALUATION CRITERIA: Clinical remission at D98 (according to the Mayo Disease Activity Index score) Endoscopic response Colectomy rate Tolerance

Conditions

• Ulcerative Colitis
• Steroid Refractory

Interventions

Type	Name	Description
DRUG	CYCLOSPORINE VS INFLIXIMAB	* Cyclosporine 2mg/kg/day intravenous for 7 days then Neoral 4mg/kg/day orally for 3 months. * Infliximab 5mg/kg at weeks 0, 2 and 6

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-06-01
• Completion: 2010-10-01
• First posted: 2007-10-10
• Last updated: 2011-08-31

Locations

41 sites across 5 countries: Belgium, Finland, France, Italy, Spain