Early Immunosuppressants in Crohn's Disease - Full Text View

Early Immunosuppressants in Crohn's Disease (RAPID)

This study is currently recruiting participants.

Verified by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives, October 2008

First Received: October 18, 2007 Last Updated: October 7, 2008 History of Changes

Sponsors and Collaborators:	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives SNFGE
Information provided by:	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:	NCT00546546

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 IV

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Methotrexate Azathioprine sodium salt Azathioprine

U.S. FDA Resources

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

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 ]

Secondary Outcome Measures:

3-yr cumulative steroid dose
quality of life questionnaire [ Time Frame: 3 yrs ]

Estimated Enrollment:	120
Study Start Date:	July 2005
Estimated Study Completion Date:	July 2008

Arms	Assigned Interventions
2: No Intervention conventional treatment: use of immunosuppressants only if steroid dependency or chronic active disease
1: Experimental	Drug: early immunosuppressants (azathioprine, methotrexate) azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated

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

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

Contacts

Contact: Jacques Cosnes, MD

33 1 49 28 31 68

jacques.cosnes@sat.aphp.fr

Locations

France
Hopital St Antoine	Recruiting
PARIS, France, 75012
Contact: Marc Lemann, MD, PhD 33 1 42 49 95 97 marc.lemann@sls.aphp.fr

Sponsors and Collaborators

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

SNFGE

Investigators

Study Director:

Marc Lemann

GETAID

More Information

Publications:

Beaugerie L, Seksik P, Nion-Larmurier I, Gendre JP, Cosnes J. Predictors of Crohn's disease. Gastroenterology. 2006 Mar;130(3):650-6.

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. Erratum in: Gut. 2005 May;54(5):734.

Study ID Numbers:	GETAID
Study First Received:	October 18, 2007
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00546546 History of Changes
Health Authority:	France: Institutional Ethical Committee

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Crohn
immunosuppressants
natural history
steroids

Study placed in the following topic categories:

Antimetabolites
Crohn's Disease
Immunologic Factors
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Folic Acid Antagonists
Intestinal Diseases

Ileal Diseases
Immunosuppressive Agents
Folic Acid
Digestive System Diseases
Azathioprine
Crohn Disease
Methotrexate
Antirheumatic Agents
Gastroenteritis

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Inflammatory Bowel Diseases
Reproductive Control Agents
Ileal Diseases
Azathioprine
Therapeutic Uses
Abortifacient Agents
Methotrexate

Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Ileitis
Enteritis
Enzyme Inhibitors
Folic Acid Antagonists
Intestinal Diseases
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Digestive System Diseases
Crohn Disease
Gastroenteritis
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009