Early Immunosuppressants in Crohn's Disease

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Collaborator: Société Nationale Française de Gastroentérologie
• Treatments: Azathioprine; Immunosuppressive Agents; Methotrexate

Criteria

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