A controlled, randomised, double-blind, multicenter study, comparing methotrexate vs placebo in steroid-refractory ulcerative colitis
- Conditions
- Crohns DiseaseM. Crohn10017969
- Registration Number
- NL-OMON32416
- Lead Sponsor
- Besancon University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 4
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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Success at the 16th and the 24th week of treatment is the main criteria.<br /><br>The success is measured by:<br /><br>- Remission according to a Mayo Disease Activity Index <= 2 with no items >1,<br /><br>and<br /><br>- complete stop of prednisone or prednisolone for 7 days or more.<br /><br>and<br /><br>- no other immunosuppressive or colectomy between inclusion and the 24th week</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Success on the 16th week measured according to 6.1<br /><br>- Success on the 24th week measured according to 6.1<br /><br>- Clinical remission on each visit<br /><br>- Steroid cumulative dose in both groups at 16th and 24th weeks.<br /><br>- CRP measurements on each visit<br /><br>- Side effects in both groups</p><br>