EUCTR2006-005299-42-BE
Active, not recruiting
Not Applicable
A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GETAID
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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