Early Immunosuppressants in Crohn's Disease

Phase 4

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: early immunosuppressants (azathioprine, methotrexate)

• Registration Number: NCT00546546
• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-18
• Study First Posted: 2007-10-19
• Status Verified: 2011-08
• Primary Completion: 2012-12
• Study Completion: 2013-06
• Last Update Submitted: 2015-04-26
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunossuppresive treatment	early immunosuppressants (azathioprine, methotrexate)	Switch to different immunosuppresive treatment in case of relapse.

Primary Outcome Measures

Name	Time	Method
number of 3-months periods with remission	3 yrs

Secondary Outcome Measures

Name	Time	Method
quality of life questionnaire	3 yrs
3-yr cumulative steroid dose	3 years

Trial Locations

Locations (26)

CHU CAEN; 🇫🇷 Caen, France

Chu Amiens; 🇫🇷 Amiens, France

Chu Clermont-Ferrand; 🇫🇷 Clermont-ferrand, France

Hopital Louis Mourrier; 🇫🇷 Colombes, France

Hopital Bicetre; 🇫🇷 Le Kremlin Bicetre, France

Hopital Cochin; 🇫🇷 Paris, France

Hopital Bichat; 🇫🇷 Paris, France

Chu Tours; 🇫🇷 Tours, France

Chu Rouen; 🇫🇷 Rouen, France

Chu Strasbourg; 🇫🇷 Strasbourg, France

Chu Toulouse; 🇫🇷 Toulouse, France

Chu Reims; 🇫🇷 Reims, France

Ch Le Raincy Montfermeil; 🇫🇷 Montfermeil, France

Chu Nantes; 🇫🇷 Nantes, France

Hopital Lariboisiere; 🇫🇷 Paris, France

Hopital St Antoine; 🇫🇷 Paris, France

Chu Besancon; 🇫🇷 Besancon, France

CHU NICE; 🇫🇷 Nice, France

Hopital Georges Pompidou; 🇫🇷 Paris, France

Hopital Beaujon; 🇫🇷 Clichy, France

Hopital Haut Leveque; 🇫🇷 Pessac, France

Hopital Saint Louis; 🇫🇷 Paris, France

Chu Marseille - Hopital Nord; 🇫🇷 Marseille, France

Chru Lille; 🇫🇷 Lille, France

CHU LYON; 🇫🇷 Pierre Benite, France

Institut Mutualiste Montsouris (Imm); 🇫🇷 Paris, France