Early Immunosuppressants in Crohn's Disease (RAPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00546546
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : April 28, 2015
Société Nationale Française de Gastroentérologie
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: early immunosuppressants (azathioprine, methotrexate) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease
Study Start Date : July 2005
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
No Intervention: control = conventional treatment
conventional treatment: use of immunosuppressants only if steroid dependency or chronic active disease
Experimental: Immunossuppresive treatment
Switch to different immunosuppresive treatment in case of relapse.
Drug: early immunosuppressants (azathioprine, methotrexate)
azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated
Other Name: Azathioprine = brand name = Imurel

Primary Outcome Measures :
  1. number of 3-months periods with remission [ Time Frame: 3 yrs ]

Secondary Outcome Measures :
  1. 3-yr cumulative steroid dose [ Time Frame: 3 years ]
  2. quality of life questionnaire [ Time Frame: 3 yrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00546546

Chu Amiens
Amiens, France, 80054
Chu Besancon
Besancon, France, 25030
Caen, France, 14033
Chu Clermont-Ferrand
Clermont-ferrand, France, 63003
Hopital Beaujon
Clichy, France, 92110
Hopital Louis Mourrier
Colombes, France, 92700
Hopital Bicetre
Le Kremlin Bicetre, France, 94275
Chru Lille
Lille, France, 59037
Chu Marseille - Hopital Nord
Marseille, France, 13915
Ch Le Raincy Montfermeil
Montfermeil, France, 93370
Chu Nantes
Nantes, France, 44093
Nice, France, 06202
Hopital Lariboisiere
Paris, France, 75010
Hopital Saint Louis
Paris, France, 75010
Hopital St Antoine
Paris, France, 75012
Hopital Cochin
Paris, France, 75014
Hopital Georges Pompidou
Paris, France, 75015
Hopital Bichat
Paris, France, 75018
Institut Mutualiste Montsouris (Imm)
Paris, France, 75674
Hopital Haut Leveque
Pessac, France, 33604
Pierre Benite, France, 69495
Chu Reims
Reims, France, 51092
Chu Rouen
Rouen, France, 76031
Chu Strasbourg
Strasbourg, France, 67091
Chu Toulouse
Toulouse, France, 31403
Chu Tours
Tours, France, 37044
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Société Nationale Française de Gastroentérologie
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives Identifier: NCT00546546     History of Changes
Other Study ID Numbers: GETAID 2004-2
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: August 2011

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
natural history

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunosuppressive Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors