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Sponsored by: |
Centre Hospitalier Universitaire de Nice |
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Information provided by: | Centre Hospitalier Universitaire de Nice |
ClinicalTrials.gov Identifier: | NCT00561548 |
The aim of this research is to study in Cronh disease patients, before and after anti-TNF, the cooperation between lamina propria T-lymphocytes and macrophages, through the expression of co-signalisation molecules and their ligands, the production of cytokines participating in this cooperation, and the potential role of the regulatory T lymphocytes.
Condition | Intervention |
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Crohn Disease |
Procedure: rectosigmoïdal biopsies |
Study Type: | Interventional |
Study Design: | Basic Science, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Impact of Anti-TNF Antibodies on the T-Lymphocyte and Macrophage Cooperation in the Crohn Disease |
Estimated Enrollment: | 20 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A
Patients with an active Crohn disease and with azathioprine treatment
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Procedure: rectosigmoïdal biopsies
rectosigmoïdal biopsies
|
B
Patient with an active crohn disease and without azathioprine disease
|
Procedure: rectosigmoïdal biopsies
rectosigmoïdal biopsies
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Crohn disease is an inflammatory disease; its frequency has been increasing over the last 25 years. The physiopathology involves a failure in the negative regulatory mechanisms of the inflammatory responses in the intestines, along with an excessive production TNF-α by T-lymphocytes and macrophages of the lamina propria.
Anti-TNF-α antibodies usually give good therapeutical results, in particular in patients who are resistent or dependant on steroids. Nevertheless, in Crohn disease, the destructive T-lymphocytes - macrophages interactions, their inhibition by anti-TNFα, and the impact of these antibodies on cellular signaling remain largely unknown.
Two groups de 10 patients with an active Crohn disease, with or without azathioprine, and requiring the beginning of anti-TNF treatment are included in this study. Rectosigmoïdal biopsies and blood tests will be done before starting the treatment, and after 10 weeks of treatment. Surface antigens, cytokines and cellular molecules and the number of apoptotic cells will be analyzed by FACS, and the quantification of RNA will be analyzed by RT-PCR.
This will therefore unable us to study, before and after anti-TNF-α, in patients treated or not with azathioprine, on intestinal and blood lymphocytes, the production of cytokines involved in the lymphocyte-macrophage interaction, and the potential role of regulatory T cells.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cynthia GIRAN, CRA | 04 92 03 45 89 | giran.c@chu-nice.fr |
France | |
Fédération des maladies de l'appareil digestif et de la Nutrition | Recruiting |
NICE, France, 06000 | |
Contact: Xavier Hébuterne, Professor hebuterne.x@chu-nice.fr | |
Principal Investigator: Xavier Hébuterne, Professor |
Principal Investigator: | Xavier Hébuterne, Professor | Centre Hospitalier Universitaire |
Responsible Party: | CHU de Nice ( Département de la Recherche Clinique et de l'Innovation ) |
Study ID Numbers: | 06 - PP - 2006, 2006-006877-26 |
Study First Received: | November 20, 2007 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00561548 |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority; France: Institutional Ethical Committee |
Antibodies Necrosis Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases Immunoglobulins |