Femme et Homme
- | Pays :
- Austria
- Israel
- Netherlands
- Les 3 autres...
- | Organes : -
- | Spécialités : -
Extrait
- 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.
Critère d'inclusion
- Ulcerative colitis