Early Immunosuppressants in Crohn's Disease
RAPID
Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease
1 other identifier
interventional
120
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2005
Longer than P75 for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 18, 2007
CompletedFirst Posted
Study publicly available on registry
October 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedApril 28, 2015
August 1, 2011
7.4 years
October 18, 2007
April 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of 3-months periods with remission
3 yrs
Secondary Outcomes (2)
3-yr cumulative steroid dose
3 years
quality of life questionnaire
3 yrs
Study Arms (2)
control = conventional treatment
NO INTERVENTIONconventional treatment: use of immunosuppressants only if steroid dependency or chronic active disease
Immunossuppresive treatment
EXPERIMENTALSwitch to different immunosuppresive treatment in case of relapse.
Interventions
azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated
Eligibility Criteria
You may qualify if:
- \> 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Chu Amiens
Amiens, 80054, France
Chu Besancon
Besançon, 25030, France
CHU CAEN
Caen, 14033, France
Chu Clermont-Ferrand
Clermont-Ferrand, 63003, France
Hopital Beaujon
Clichy, 92110, France
Hopital Louis Mourrier
Colombes, 92700, France
Hopital Bicetre
Le Kremlin-Bicêtre, 94275, France
Chru Lille
Lille, 59037, France
Chu Marseille - Hopital Nord
Marseille, 13915, France
Ch Le Raincy Montfermeil
Montfermeil, 93370, France
Chu Nantes
Nantes, 44093, France
CHU NICE
Nice, 06202, France
Hopital Lariboisiere
Paris, 75010, France
Hopital Saint Louis
Paris, 75010, France
Hopital St Antoine
Paris, 75012, France
Hopital Cochin
Paris, 75014, France
Hopital Georges Pompidou
Paris, 75015, France
Hopital Bichat
Paris, 75018, France
Institut Mutualiste Montsouris (Imm)
Paris, 75674, France
Hopital Haut Leveque
Pessac, 33604, France
CHU LYON
Pierre-Bénite, 69495, France
Chu Reims
Reims, 51092, France
Chu Rouen
Rouen, 76031, France
Chu Strasbourg
Strasbourg, 67091, France
Chu Toulouse
Toulouse, 31403, France
Chu Tours
Tours, 37044, France
Related Publications (3)
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.
PMID: 16530505BACKGROUNDCosnes 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.
PMID: 15647188BACKGROUNDCosnes 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.
PMID: 23644079DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marc LEMANN, PhD
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- PRINCIPAL INVESTIGATOR
Jacques COSNES, PhD
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2007
First Posted
October 19, 2007
Study Start
July 1, 2005
Primary Completion
December 1, 2012
Study Completion
June 1, 2013
Last Updated
April 28, 2015
Record last verified: 2011-08