A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF

• Conditions: - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.; MedDRA version: 9.1Level: LLTClassification code 10045282Term: UC

• Registration Number: EUCTR2006-005299-42-FR
• Lead Sponsor: GETAID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Age > 18 years.
- Diagnosis of UC according to Lennard-Jones criteria (Appendix 1).
- Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.
- Severe acute flare of UC with a Lichtiger Index score > 10 (Appendix 2).
- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days.
- Adequate contraception for male or female subjects of childbearing potential, which will be continued throughout the study and at least 3 months after study termination.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Pregnant or breast-feeding woman.
-Previous treatment with cyclosporine or infliximab.
-Azathioprine or 6-mercaptopurine treatment initiated more than 4 weeks before inclusion.
-Indication for immediate surgery.
-History of colorectal dysplasia.
-Diagnosis of Crohn's disease.
-Positive stool tests for amoebiasis and/or positive bacteriological culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools.
-Renal failure (creatininemia > upper limit of normal laboratory value).
-Uncontrolled high blood pressure.
- HIV, HBV viral infection (except the presence of positive anti-HBs antibodies) with serology not older than 3 months.
-Uncontrolled bacterial or active viral infection.
-Past medical history of malignant condition in the last 5 years (including leukaemia, lymphoma and myelodysplasia) except for baso-cellular cutaneous cancers.
- Past medical history of myocardial infarction or heart failure.
-Intradermal reaction to Tuberculin (Tubertest® 5 units) > 5mm.
-Active tuberculosis
-Untreated latent tuberculosis (see national recommendations. Appendix 3).
-Abnormal blood count with polynuclear neutrophils < 1,500 G/L or white cells < 3,000, or platelets < 100,000 G/L.
-Unexplained rise higher than 3 times the normal level for transaminases, alkaline phosphatases and/or higher than twice the normal level for bilirubin.
-Non-compliant subjects.
-Participation in another therapeutic study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified