Early Immunosuppressants in Crohn's Disease

Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease

Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.

Inclusion Criteria:

• > 18 yr old
• diagnosis of Crohn's disease
• intestinal lesions demonstrated during the last 6 months
• disease duration < 6 months
• patients at high risk of disabling disease (having 2 criteria out of the 3 following: age < 40, perinanal disease, steroid for the first flare)

Exclusion Criteria:

• prior prescription of immunosuppressants
• severe course requiring early immunosuppressants (steroid resistance, xtensive disease, disabling perianal disease)
• intestinal resection
• active infectious disease including HIV
• hepatic failure
• renal failure
• pregnancy
• high probability of poor compliance