Clinical trial NCT00546546: Early Immunosuppressants in Crohn's Disease
Official title: Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Crohn's Disease
Keywords: Crohn
immunosuppressants
natural history
steroids
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
Collaborators: name: Société Nationale Française de Gastroentérologie
First posted: 2007-10-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: number of 3-months periods with remission
timeFrame: 3 yrs
Secondary outcomes:
measure: 3-yr cumulative steroid dose
timeFrame: 3 years
measure: quality of life questionnaire
timeFrame: 3 yrs
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Besancon
country: France
facility: Chu Besancon
city: Caen
country: France
facility: CHU CAEN
city: Clermont-ferrand
country: France
facility: Chu Clermont-Ferrand
city: Clichy
country: France
facility: Hopital Beaujon
city: Colombes
country: France
facility: Hopital Louis Mourrier
city: Le Kremlin Bicetre
country: France
facility: Hopital Bicetre
city: Lille
country: France
facility: Chru Lille
city: Marseille
country: France
facility: Chu Marseille - Hopital Nord
city: Montfermeil
country: France
facility: Ch Le Raincy Montfermeil
city: Nantes
country: France
facility: Chu Nantes
city: Nice
country: France
facility: CHU NICE
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital St Antoine
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Georges Pompidou
city: Paris
country: France
facility: Hopital Bichat
city: Paris
country: France
facility: Institut Mutualiste Montsouris (Imm)
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Pierre Benite
country: France
facility: CHU LYON
city: Reims
country: France
facility: Chu Reims
city: Rouen
country: France
facility: Chu Rouen
city: Strasbourg
country: France
facility: Chu Strasbourg
city: Toulouse
country: France
facility: Chu Toulouse
city: Tours
country: France
facility: Chu Tours
Study officials:
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Marc LEMANN, PhD
role: STUDY_DIRECTOR
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Jacques COSNES, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beaugerie L, Seksik P, Nion-Larmurier I, Gendre JP, Cosnes J. Predictors of Crohn's disease. Gastroenterology. 2006 Mar;130(3):650-6. doi: 10.1053/j.gastro.2005.12.019.
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. doi: 10.1136/gut.2004.045294.
citation: Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.