A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN CORTICOSTEROID-DEPENDENT ULCERATIVE COLITIS - METEOR
- Conditions
- Steroid-dependent ulcerative colitis
- Registration Number
- EUCTR2006-003607-40-BE
- Lead Sponsor
- Besancon University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 110
- 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.
- A Mayo Disease Activity Index 4, with no item >1 for the clinical part of the score and from 0 to 2 for the endoscopic part at the time of inclusion.
- Steroid-dependence defined by at least 1 unsuccessful attempt to stop systemic steroid therapy during the last 12 weeks. (cf. ECCO Consensus for Crohn). Steroid therapy might have been completely stopped if it has been restarted within the last 30 days.
- To be receiving a treatment of prednisone at a dose between 10 and 40mg, stable for at least 2 weeks at the time of inclusion.
- 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
- Indication to a colectomy.
- Alcoholism (more than 21 glasses/week for male subjects and 14 glasses/week for female subjects)
- 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.
- Modification of mesalazine or olsalazine dosage 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 < normal 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 baso-cellular cutaneous cancers.
- Obesity (BMI>30).
- Diabetes mellitus
- Known hypersensitivity to methotrexate
- Non-compliant subject
- Participation in another therapeutic study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method