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

This study has been terminated.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00561548
First received: November 20, 2007
Last updated: May 27, 2011
Last verified: February 2009

November 20, 2007
May 27, 2011
May 2007
May 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00561548 on ClinicalTrials.gov Archive Site
Lymphocyte activation markers and macrophage activation markers [ Time Frame: before treatment and 10 weeks after treatment ] [ Designated as safety issue: No ]
lymphocytes activation markers and macrophages activation markers [ Time Frame: before treatment and 10 weeks after treatment ]
Not Provided
Not Provided
 
Impact of Anti-Tumor Necrosis Factor (TNF) Antibodies on the T-lymphocyte and Macrophage Cooperation in Crohn Disease
Impact of Anti-TNF Antibodies on the T-lymphocyte and Macrophage Cooperation in the Crohn Disease

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Crohn Disease
Procedure: rectosigmoïdal biopsies
rectosigmoïdal biopsies
  • A
    Patients with active Crohn disease and with azathioprine treatment
    Intervention: Procedure: rectosigmoïdal biopsies
  • B
    Patient with active crohn disease and without azathioprine disease
    Intervention: Procedure: rectosigmoïdal biopsies

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
April 2009
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00561548
06 - PP - 2006, 2006-006877-26
No
Département de la Recherche Clinique et de l'Innovation, CHU de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: Xavier Hébuterne, Professor Centre Hospitalier Universitaire
Centre Hospitalier Universitaire de Nice
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP