NCT00546546

Early Immunosuppressants in Crohn's Disease

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	early immunosuppressants (azathioprine, methotrexate)	azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated

Timeline

• Start date: 2005-07-01
• Primary completion: 2012-12-01
• Completion: 2013-06-01
• First posted: 2007-10-19
• Last updated: 2015-04-28

Locations

26 sites across 1 country: France