Early Immunosuppressants in Crohn's Disease (RAPID)

April 26, 2015 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Besancon, France, 25030
        • CHU Besancon
      • Caen, France, 14033
        • CHU Caen
      • Clermont-ferrand, France, 63003
        • CHU Clermont-Ferrand
      • Clichy, France, 92110
        • Hôpital Beaujon
      • Colombes, France, 92700
        • Hopital Louis Mourrier
      • Le Kremlin Bicetre, France, 94275
        • Hôpital Bicêtre
      • Lille, France, 59037
        • Chru Lille
      • Marseille, France, 13915
        • Chu Marseille - Hopital Nord
      • Montfermeil, France, 93370
        • Ch Le Raincy Montfermeil
      • Nantes, France, 44093
        • CHU Nantes
      • Nice, France, 06202
        • CHU Nice
      • Paris, France, 75010
        • Hopital Saint Louis
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Paris, France, 75014
        • Hopital Cochin
      • Paris, France, 75012
        • Hôpital St Antoine
      • Paris, France, 75015
        • Hopital Georges Pompidou
      • Paris, France, 75674
        • Institut Mutualiste Montsouris (IMM)
      • Paris, France, 75018
        • Hôpital Bichat
      • Pessac, France, 33604
        • Hôpital Haut Lévêque
      • Pierre Benite, France, 69495
        • CHU Lyon
      • Reims, France, 51092
        • CHU Reims
      • Rouen, France, 76031
        • CHU Rouen
      • Strasbourg, France, 67091
        • CHU Strasbourg
      • Toulouse, France, 31403
        • Chu Toulouse
      • Tours, France, 37044
        • CHU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Azathioprine = brand name = Imurel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of 3-months periods with remission
Time Frame: 3 yrs
3 yrs

Secondary Outcome Measures

Outcome Measure
Time Frame
3-yr cumulative steroid dose
Time Frame: 3 years
3 years
quality of life questionnaire
Time Frame: 3 yrs
3 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 18, 2007

First Submitted That Met QC Criteria

October 18, 2007

First Posted (Estimate)

October 19, 2007

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 26, 2015

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID 2004-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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