Crohns Disease M. Crohn
Conditions
Interventions
Methotrexate and placebo. Regimen will be 1 intramuscular injection
every week, always on the same weekday.
A 5mg tablet of folic acid (will be prescribed every week, 24 hours to 48 hours
after the
m
Sponsors
Besancon University Hospital
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA Patients, male or female, will be eligible if they meet the following criteria: * 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 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. 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: mechanic 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.
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA * Indication to a colectomy. * Alcoholism (more than 21 glasses per week for male subjects and 14 glasses per week for female subjects). 1 glass corresponds to 3 cl of strong alcohol, 10 cl glass of wine or a half pint of beer. * 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-TNFa 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 30). * Diabetes mellitus. * Known hypersensitivity to methotrexate. * Non-compliant subject. * Participation in another therapeutic study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - Success on the 16th week measured according to 6.1 - Success on the 24th week measured according to 6.1 - Clinical remission on each visit - Steroid cumulative dose in both groups at 16th and 24th weeks. - CRP measurements on each visit - Side effects in both groups | — |
Primary
| Measure | Time frame |
|---|---|
| Success at the 16th and the 24th week of treatment is the main criteria. The success is measured by: - Remission according to a Mayo Disease Activity Index 1, and - complete stop of prednisone or prednisolone for 7 days or more. and - no other immunosuppressive or colectomy between inclusion and the 24th week | — |
Countries
Netherlands
Outcome results
None listed