A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY

• Conditions: Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6.; MedDRA version: 9.1Level: LLTClassification code 10045365Term: Ulcerative colitis

• Registration Number: EUCTR2006-005299-42-FI
• Lead Sponsor: Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-27
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• 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.
?? 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).

Study & Design

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