Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

• PHASE: II

• TYPE OF STUDY : With direct benefit

• DESCRIPTIVE: Multicenter, randomized, double-blind study

• INCLUSION CRITERIA: Steroid-dependent ulcerative colitis

• OBJECTIVES: To show superiority of methotrexate vs placebo in inducing steroid-free remission in steroid-dependent ulcerative colitis

• STUDY TREATMENTS: Methotrexate 1 intramuscular injection (25 mg) per week Placebo 1 intramuscular injection per week

• NUMBERS OF PATIENTS: 55 patients in each group, i.e. a total of 110 patients

• INCLUSION PERIOD: 24 months

• STUDY DURATION: 36 months

• EVALUATION CRITERIA: Remission without steroids, immunosuppressives and without colectomy at 16 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• 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

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 probenecid 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 (creatinaemia > 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.

• Past history of malignant condition (including leukaemia, lymphoma and myelodysplasia) except for baso-cellular cutaneous cancers.