Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
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.