Early Immunosuppressants in Crohn's Disease (RAPID)

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status and phase: Completed; Phase 4

Conditions: Crohn's Disease

Treatments: Drug: early immunosuppressants (azathioprine, methotrexate)

Study type: Interventional

Funder types: Other

Identifiers

NCT00546546

GETAID 2004-2

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

control = conventional treatment

No Intervention group

Description:

conventional treatment: use of immunosuppressants only if steroid dependency or chronic active disease

Immunossuppresive treatment

Experimental group

Description:

Switch to different immunosuppresive treatment in case of relapse.

Treatment:

Drug: early immunosuppressants (azathioprine, methotrexate)