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Sponsors and Collaborators: |
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives SNFGE |
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Information provided by: | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
ClinicalTrials.gov Identifier: | NCT00546546 |
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 |
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Crohn's Disease |
Drug: early immunosuppressants (azathioprine, methotrexate) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | EFFECT OF EARLY PRESCRIPTION OF IMUNOSUPPRESSANTS ON FIRST THREE-YEAR COURSE OF CROHN'S DISEASE |
Estimated Enrollment: | 120 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | July 2008 |
Arms | Assigned Interventions |
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2: No Intervention
conventional treatment: use of immunosuppressants only if steroid dependency or chronic active disease
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1: Experimental |
Drug: early immunosuppressants (azathioprine, methotrexate)
azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jacques Cosnes, MD | 33 1 49 28 31 68 | jacques.cosnes@sat.aphp.fr |
France | |
Hopital St Antoine | Recruiting |
PARIS, France, 75012 | |
Contact: Marc Lemann, MD, PhD 33 1 42 49 95 97 marc.lemann@sls.aphp.fr |
Study Director: | Marc Lemann | GETAID |
Study ID Numbers: | GETAID |
Study First Received: | October 18, 2007 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00546546 |
Health Authority: | France: Institutional Ethical Committee |
Crohn immunosuppressants natural history steroids |
Folic Acid Azathioprine Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Methotrexate Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists |
Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |