Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis

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.

Timeline

Start

2007-09

Primary completion

2014-02

Completion

2014-06

Publications

• Carbonnel F, Colombel JF, Filippi J, Katsanos KH, Peyrin-Biroulet L, Allez M, Nachury M, Novacek G, Danese S, Abitbol V, Bossa F, Moreau J, Bommelaer G, Bourreille A, Fumery M, Roblin X, Reinisch W, Bouhnik Y, Brixi H, Seksik P, Malamut G, Farkkila M, Coulibaly B, Dewit O, Louis E, Deplanque D, Michetti P, Sarter H, Laharie D; European Crohn's and Colitis Organisation; Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Methotrexate Is Not Superior to Placebo for Inducing Steroid-Free Remission, but Induces Steroid-Free Clinical Remission in a Larger Proportion of Patients With Ulcerative Colitis. Gastroenterology. 2016 Feb;150(2):380-8.e4. doi: 10.1053/j.gastro.2015.10.050. Epub 2015 Nov 26.

Drugs

Indications