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Impact of Anti-TNF Antibodies on the T-lymphocyte and Macrophage Cooperation in the Crohn Disease

18 Years
Not Enrolling
Crohn Disease

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Trial Information

Impact of Anti-TNF Antibodies on the T-lymphocyte and Macrophage Cooperation in the Crohn Disease

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Relative variation (%) in apoptotic cells calculated according to the formula: (% of induced apoptotic cells) - (% of spontaneous apoptotic cells)

Outcome Time Frame:

before treatment and 10 weeks after treatment

Safety Issue:


Principal Investigator

Xavier Hébuterne, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

06 - PP - 2006



Start Date:

May 2007

Completion Date:

April 2009

Related Keywords:

  • Crohn Disease
  • Crohn Disease