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

Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)0 个研究点目标入组 100 人开始时间: 2007年12月27日最近更新: 2013年9月16日

试验速览

暂无简介。

•?? 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

•?? 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).

发起方

Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.)