Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00498589
• Date of registration: 09/07/2007
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Besancon
• Public title: Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis METEOR
• Scientific title: A Controlled, Randomized, Double-blind, Multicenter Study, Comparing Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis
• Date of first enrolment: September 2007
• Target sample size: 110
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00498589
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Austria, Belgium, France, Israel, Italy, Netherlands

Contacts

• Name: Franck Carbonnel
• Affiliation: CHU Besançon

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: methotrexate

Drug: placebo

Primary Outcome(s)

Remission without steroids, immunosuppressives and without colectomy [Time Frame: week 16]

Secondary ID(s)

GETAID 2006-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors