跳至主要内容
临床试验/NCT00561548
NCT00561548终止不适用

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

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
20
试验地点
2
主要终点
Relative variation (%) in apoptotic cells calculated according to the formula: (% of induced apoptotic cells) - (% of spontaneous apoptotic cells)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • consent withdrawal
  • the halt of infliximab treatment

结局指标

主要结局

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

时间窗: before treatment and 10 weeks after treatment

次要结局

  • Lymphocyte activation markers and macrophage activation markers(before treatment and 10 weeks after treatment)

研究者

申办方类型
Other

研究点 (2)

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