Early Immunosuppressants in Crohn's Disease

Crohn's Disease Clinical Trial

— RAPID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546546
• Other study ID #: GETAID 2004-2
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2007
• Last updated: April 26, 2015
• Start date: July 2005
• Est. completion date: June 2013

Study information

• Verified date: August 2011
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• early immunosuppressants (azathioprine, methotrexate)
azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated

Locations

Country	Name	City	State
France	Chu Amiens	Amiens
France	Chu Besancon	Besancon
France	CHU CAEN	Caen
France	Chu Clermont-Ferrand	Clermont-ferrand
France	Hopital Beaujon	Clichy
France	Hopital Louis Mourrier	Colombes
France	Hopital Bicetre	Le Kremlin Bicetre
France	Chru Lille	Lille
France	Chu Marseille - Hopital Nord	Marseille
France	Ch Le Raincy Montfermeil	Montfermeil
France	Chu Nantes	Nantes
France	CHU NICE	Nice
France	Hopital Bichat	Paris
France	Hopital Cochin	Paris
France	Hopital Georges Pompidou	Paris
France	Hopital Lariboisiere	Paris
France	Hopital Saint Louis	Paris
France	Hopital St Antoine	Paris
France	Institut Mutualiste Montsouris (Imm)	Paris
France	Hopital Haut Leveque	Pessac
France	CHU LYON	Pierre Benite
France	Chu Reims	Reims
France	Chu Rouen	Rouen
France	Chu Strasbourg	Strasbourg
France	Chu Toulouse	Toulouse
France	Chu Tours	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	Société Nationale Française de Gastroentérologie

Country where clinical trial is conducted

France, 

References & Publications (2)

Beaugerie L, Seksik P, Nion-Larmurier I, Gendre JP, Cosnes J. Predictors of Crohn's disease. Gastroenterology. 2006 Mar;130(3):650-6. — View Citation

Cosnes J, Nion-Larmurier I, Beaugerie L, Afchain P, Tiret E, Gendre JP. Impact of the increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery. Gut. 2005 Feb;54(2):237-41. Erratum in: Gut. 2005 May;54(5):734. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of 3-months periods with remission		3 yrs	No
Secondary	3-yr cumulative steroid dose		3 years	No
Secondary	quality of life questionnaire		3 yrs	No