A CONTROLLED, RANDOMISED,DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR

Besancon University Hospitaö0 个研究点开始时间: 2008年11月10日最近更新: 2012年3月19日

试验速览

暂无简介。

•- Between 18 and 75 years of age.
•- UC diagnosed according to the Lennard-Jones criteria (Appendix 1) with endoscopic colorectal lesions, whatever their extension may be.
•- Active or inactive disease, but the patient be treated with prednisone at a dose between 10 and 40mg, and clinically improved with this treatment
•- Steroid-dependence defined by at least 1 unsuccessfull attempt to stop stystemic steroid therapy during the last 12 weeks (cf. ECCO Sonsensus for Crohn). Steroid therapy might have been completely stopped if it has been restarted within the last 30 days.
•- Under an adequate contraception for male or female subjects of childbearing potential: barrier methods of contraception (condom, female condom, diaphragm, spermicidal gel) and oral contraception started at least 15 days before inclusion. This contraception will be continued throughout the study duration 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

•-Patients refractory to oral steroids (no improvement after 2 weeks of 10 - 40mg of prednisone)
•- Indication to a colectomy.
•-Pregnant or breast-feeding female subjects.
•-No efficacious contraception.
•-NSAIDS or cotrimoxazole intake upon inclusion, or probenecide intake within 1 month prior to inclusion.
•- Anti-TNF treatment within 2 months prior to inclusion.
•- Azathioprine, mercaptopurine, cyclosporin or thalidomide within 1 month prior to inclusion.
•- Chronic (broncho) pneumopathy.
•- Renal failure (creatininaemia >upper limit of normal laboratory values limit).
•- Liver disease apart from primary sclerosing cholangitis.
•- Unexplained rise higher than twice the normal level for transaminases, alkaline phosphatases and/or bilirubin.
•- Folate level - Infection by HIV, HBV (except in case of positive antibodies anti-HBs), HCV with serologies not older than 3 months.
•- Past history of malignant condition (including leukaemia, lymphoma and myelodysplasia) except for base-cellular cutaneous cancers.
•- Obesity (BMI >30)

发起方

Besancon University Hospitaö