drugset / Trial / NCT00546546

Early Immunosuppressants in Crohn's Disease

NCT00546546

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2005-07
Primary completion
2012-12
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Azathioprine Small molecule 2.5 mg/kg Subcutaneous
Background Methotrexate Small molecule 25 mg

Indications