Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis (CYSIF)
|ClinicalTrials.gov Identifier: NCT00542152|
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : August 31, 2011
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
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Steroid Refractory||Drug: CYCLOSPORINE VS INFLIXIMAB||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||October 2010|
Active Comparator: CICLO
Cyclosporine will be administered by continuous intravenous infusion at the initial dose regimen of 2mg/kg per day.
After 24 hours of treatment, cyclosporine trough level will be measured and the dose adapted in order to obtain a cyclosporinaemia level between 150 and 250 ng/ml. Cyclosporinaemia will be reassessed every 48 hours for the duration of the continuous intravenous treatment.
Drug: CYCLOSPORINE VS INFLIXIMAB
Active Comparator: INFLIXIMAB
INFLIXIMAB (REMICADE) Infliximab in the form of a freeze-dried compound is conditioned in 100mg vials. Treatment will first be reconstituted in 250ml isotonic saline solution, and slowly infused at the dose of 5mg/kg in 2 hours.
In patients with clinical response at D7 (Lichtiger Index score < 10 for 2 consecutive days), two additional infliximab infusions will be administered at the dose of 5mg/kg at D14 and D42.
Drug: CYCLOSPORINE VS INFLIXIMAB
- % of patients with treatment failure defined as: absence of clinical response at D7 or absence of remission without steroids at D98 or relapse or severe adverse event leading to treatment interruption or colectomy or fatality between D0 and D98 [ Time Frame: Day 7 ]
- % of patients in clinical response % patients in remission Lichtiger Index score MDAI score Time to discharge Endoscopic response colectomy rate Steroid dosage. Number of adverse events CMV infection [ Time Frame: D98 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542152
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|Principal Investigator:||David LAHARIE, MD||Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives|