Early Immunosuppressants in Crohn's Disease (RAPID)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Société Nationale Française de Gastroentérologie
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
NCT00546546
First received: October 18, 2007
Last updated: August 30, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Crohn's Disease
Drug: early immunosuppressants (azathioprine, methotrexate)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Primary Outcome Measures:
  • number of 3-months periods with remission [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 3-yr cumulative steroid dose [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • quality of life questionnaire [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2005
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546546

Locations
France
Chu Amiens
Amiens, France, 80054
Chu Besancon
Besancon, France, 25030
CHU CAEN
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
CHU NICE
Nice, France, 06202
Hopital Saint Louis
Paris, France, 75010
Hopital St Antoine
Paris, France, 75012
Hopital Lariboisiere
Paris, France, 75010
Institut Mutualiste Montsouris (Imm)
Paris, France, 75674
Hopital Cochin
Paris, France, 75014
Hopital Bichat
Paris, France, 75018
Hopital Georges Pompidou
Paris, France, 75015
Hopital Haut Leveque
Pessac, France, 33604
CHU LYON
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
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT00546546     History of Changes
Other Study ID Numbers: GETAID 2004-2
Study First Received: October 18, 2007
Last Updated: August 30, 2011
Health Authority: France: Institutional Ethical Committee

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

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

ClinicalTrials.gov processed this record on October 29, 2014