Extrait

To demonstrate the efficacy of RAD001 in CD patients by testing the hypothesis that RAD001 6 mg/day QD is superior to AZA in maintaining patients in steroid-free remission throughout the following co-primary objectives: 1. To compare the proportion of patients in RAD001 and AZA arms who, after achieving remission within 3 months, maintained steroid- free remission for a minimum of 9 months (from end month 3 to end month 12). 2. To compare the proportion of patients in RAD001 and placebo arms who, after achieving remission within 3 months, maintained steroid-free remission for a minimum of 9 months (from end month 3 to end month 12). 3. To assess safety of RAD001 in CD patients.

Critère d'inclusion

• Crohn’s Disease

Liens

• euctr