Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Immunological profile
研究概览
简要总结
Crohn disease is an inflammatory chronic disease of the bowel the complex physiopathology of which brings in immunological, genetic and environmental factors. At present, the appeal to biotherapics anti-TNFa (infliximab and adalimumab) or anti-IL-12/23 (ustekinumab) in MC represents a major therapeutic progress at the origin of a significant improvement of the symptoms, the healing of the intestinal hurts and the quality of life.
Considering the new immunological targets of these biotherapics, the investigators put the hypothesis that an immunological profile (impulsive person and\or tissular) specific of the patients with one MC is associated with the answer to biotherapics. So, before beginning the treatment the patients expressing strongly the pro-inflammatory cytokine TNFa, would more may be answering machines in anti-TNFa and those with whom the immunological profile is very marked towards the way Th1/Th17 would more may answer favorably the ustekinumab. The identification of immunological profiles capable of predicting before treatment the answer under biotherapics could establish in MC but also in other inflammatory diseases a major step forward to guide the coverage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Patient of more than 18 years old
- •Patient presenting a MC before diagnosed according to the usual criteria
- •Patient in relapse (score CDAI > 150) for at least 1 month
- •requiring Patient a treatment by anti-TNF or ustekinumab according to the indications of the AMM
- •Patient compatible with the realization of endoscopic digestive biopsies
- •Patient having signed a consent of participation
排除标准
- •· patient with Crohn disease with a CDAI score < 150 ·
- •contraindication to anti-TNF and\or ustekinumab ·
- •contraindication to the realization of an iléocoloscopie
- •·- Patient taking anti-inflammatory drugs or antibiotics ·
- •Patient presenting complications of the type intestinal sub-occlusion, fistulas or abdominal abscesses ·
- •Patient having a exclusive perianal disease or having
- •pregnant Women ·
- •Patients having been the object of a vast intestinal resection ·
- •Patient with an ileostomy or a colostomy ·
- •No consent of the patient ·
- •patient under legal protection ·
- •Subject participating in another research which need a period of exclusion
研究组 & 干预措施
anti TNF
Crohn patient with antiTNF treatment
干预措施: Anti-TNF Drug (Drug)
Ustekinumab
Crohn disease with ustekinumab treatment
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Immunological profile
时间窗: Week 14
Identify by cytometry of mass a predictive, blood and/or mucous immunological profile, of the answer at week 14 to a biotherapics by anti-TNFa or anti IL-12 / 23 at suffering patients of Crohn disease in relapse
次要结局
- Mass cytometry dosage of immunological markers week 0-week 14(Week 14)
- Clinical Remission at week 14(Week 14)
- Dosage of inflammatory markers(week 14)