Steroid-dependent ulcerative colitis
Conditions
Interventions
Trade Name: methotrexate bellon
Product Name: methotrexate bellon 25mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methotrexate bellon 25mg/ml
CAS Number: 59 05 2
Current Spons
Sponsors
Besancon University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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. (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
Exclusion criteria
Exclusion criteria: - 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. - 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ? 2 with no items >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 ;Secondary Objective: Success on the 16th week Success on the 16th and 24th weeks Clinical remission on each visit ;Primary end point(s): 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 ? 2 with no items >1* (see appendix 3), 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
Austria, Finland, Netherlands
Outcome results
None listed