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Early Immunosuppressants in Crohn's Disease

NCT00546546 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-04-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

early immunosuppressants (azathioprine, methotrexate)

azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated

Sponsors & Collaborators

  • Société Nationale Française de Gastroentérologie

    collaborator OTHER

  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    lead OTHER

Principal Investigators

  • Marc LEMANN, PhD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

  • Jacques COSNES, PhD · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2012-12-31
Completion
2013-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00546546 on ClinicalTrials.gov