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Early Immunosuppressants in Crohn's Disease (RAPID)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
early immunosuppressants (azathioprine, methotrexate)
Sponsored by
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn, immunosuppressants, natural history, steroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Amiens
  • Chu Besancon
  • CHU CAEN
  • Chu Clermont-Ferrand
  • Hopital Beaujon
  • Hopital Louis Mourrier
  • Hopital Bicetre
  • Chru Lille
  • Chu Marseille - Hopital Nord
  • Ch Le Raincy Montfermeil
  • Chu Nantes
  • CHU NICE
  • Hopital Lariboisiere
  • Hopital Saint Louis
  • Hopital St Antoine
  • Hopital Cochin
  • Hopital Georges Pompidou
  • Hopital Bichat
  • Institut Mutualiste Montsouris (Imm)
  • Hopital Haut Leveque
  • CHU LYON
  • Chu Reims
  • Chu Rouen
  • Chu Strasbourg
  • Chu Toulouse
  • Chu Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control = conventional treatment

Immunossuppresive treatment

Arm Description

conventional treatment: use of immunosuppressants only if steroid dependency or chronic active disease

Switch to different immunosuppresive treatment in case of relapse.

Outcomes

Primary Outcome Measures

number of 3-months periods with remission

Secondary Outcome Measures

3-yr cumulative steroid dose
quality of life questionnaire

Full Information

First Posted
October 18, 2007
Last Updated
April 26, 2015
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborators
Société Nationale Française de Gastroentérologie
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1. Study Identification

Unique Protocol Identification Number
NCT00546546
Brief Title
Early Immunosuppressants in Crohn's Disease
Acronym
RAPID
Official Title
Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Collaborators
Société Nationale Française de Gastroentérologie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn, immunosuppressants, natural history, steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control = conventional treatment
Arm Type
No Intervention
Arm Description
conventional treatment: use of immunosuppressants only if steroid dependency or chronic active disease
Arm Title
Immunossuppresive treatment
Arm Type
Experimental
Arm Description
Switch to different immunosuppresive treatment in case of relapse.
Intervention Type
Drug
Intervention Name(s)
early immunosuppressants (azathioprine, methotrexate)
Other Intervention Name(s)
Azathioprine = brand name = Imurel
Intervention Description
azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated
Primary Outcome Measure Information:
Title
number of 3-months periods with remission
Time Frame
3 yrs
Secondary Outcome Measure Information:
Title
3-yr cumulative steroid dose
Time Frame
3 years
Title
quality of life questionnaire
Time Frame
3 yrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc LEMANN, PhD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jacques COSNES, PhD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Chu Besancon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CHU CAEN
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Chu Clermont-Ferrand
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Louis Mourrier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Hopital Bicetre
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Chru Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Chu Marseille - Hopital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Ch Le Raincy Montfermeil
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Chu Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU NICE
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital St Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hopital Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Institut Mutualiste Montsouris (Imm)
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU LYON
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Chu Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Chu Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Chu Toulouse
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Chu Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16530505
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.
Results Reference
background
PubMed Identifier
15647188
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. Erratum In: Gut. 2005 May;54(5):734.
Results Reference
background
PubMed Identifier
23644079
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.
Results Reference
derived

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Early Immunosuppressants in Crohn's Disease

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