A controlled, randomised, double-blind, multicenter study, comparing methotrexate vs placebo in steroid-refractory ulcerative colitis - Meteor study

Besancon University Hospital0 sites4 target enrollmentStarted: TBDLast updated: May 13, 2024

Conditions

Trial Snapshot

No summary available.

•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 <= 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. 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
•* 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
•* 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.

Sponsor

Besancon University Hospital