Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis
Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
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
Phase:
Phase 4
Details
Lead Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives