Impact of Anti-Tumor Necrosis Factor (TNF) Antibodies on the T-lymphocyte and Macrophage Cooperation in Crohn Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00561548
Recruitment Status : Terminated
First Posted : November 21, 2007
Last Update Posted : May 30, 2011
Information provided by:
Centre Hospitalier Universitaire de Nice

Brief Summary:
The aim of this research is to study Crohn 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 regulatory T lymphocytes.

Condition or disease Intervention/treatment Phase
Crohn Disease Procedure: rectosigmoïdal biopsies Not Applicable

Detailed Description:

Crohn disease is an inflammatory disease and 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 of TNF-α by T-lymphocytes and macrophages of the lamina propria.

Anti-TNF-α antibodies usually give good therapeutic results, in particular in patients who are resistent or dependant on steroids. Nevertheless, in Crohn disease, the destructive T-lymphocytes - macrophage interactions, their inhibition by anti-TNFα, and the impact of these antibodies on cellular signaling remain largely unknown.

Two groups of 10 patients with active Crohn disease, with or without azathioprine, and requiring the start 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 enable 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Anti-TNF Antibodies on the T-lymphocyte and Macrophage Cooperation in the Crohn Disease
Study Start Date : May 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Patients with active Crohn disease and with azathioprine treatment
Procedure: rectosigmoïdal biopsies
rectosigmoïdal biopsies

Patient with active crohn disease and without azathioprine disease
Procedure: rectosigmoïdal biopsies
rectosigmoïdal biopsies

Primary Outcome Measures :
  1. Relative variation (%) in apoptotic cells calculated according to the formula: (% of induced apoptotic cells) - (% of spontaneous apoptotic cells) [ Time Frame: before treatment and 10 weeks after treatment ]

Secondary Outcome Measures :
  1. Lymphocyte activation markers and macrophage activation markers [ Time Frame: before treatment and 10 weeks after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patient older than 18
  • social security
  • active Crohn disease defined by a CDAI > 250
  • sigmoïdal and/or rectal lesions
  • requiring treatment by infliximab
  • having never received any anti-TNF treatment
  • a negative pregnancy test for women
  • prescription of efficient contraception for women, having started at least a month before beginning the study, and throughout the duration of the study
  • acceptance to participate in this research and having signed the consent form
  • not participating in any other study

Exclusion Criteria:

  • consent withdrawal
  • the halt of infliximab treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00561548

Fédération des Maladies de l'appareil Digestif et de la Nutrition
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Principal Investigator: Xavier Hébuterne, Professor Centre Hospitalier Universitaire


Responsible Party: Département de la Recherche Clinique et de l'Innovation, CHU de Nice Identifier: NCT00561548     History of Changes
Other Study ID Numbers: 06 - PP - 2006
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: February 2009

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunologic Factors
Physiological Effects of Drugs