NCT02142764已完成不适用
Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS).
University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Analysis of pentamers (> 0,1 % of the CD3 + CD8 + T-cells) will be statistically compared between the 3 groups of patients.
研究概览
简要总结
Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the central nervous system. In spite of many works, the data in the literature concerning the antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient.
详细描述
30 patients distributed in 3 groups of 10 patients with specific inclusion criteria will participate in this trial:
- 10 MS patients in early disease onset,
- 10 MS patients under Natalizumab treatment
- and control group of 10 patients with other neurological diseases.
The aim of this clinical trial is to detect the CD8+ myelin specific T-Cells in the blood of Multiple Sclerosis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Group 1: HLA-A2 patients whose Multiple Sclerosis has just been diagnosed
- •18 year old and older patients,
- •HLA-A2 Patients with Multiple Sclerosis or clinically isolated syndrome at high risk of being affected by Multiple Sclerosis (criteria of spatial scattering according to the 2010 or 2005 McDonald's criteria)
- •Patients without treatment or treated with immunomodulating therapy
- •Patients affiliated to health insurance coverage
- •Information and comprehensive agreement signed by the patient and the investigator
- •Group 2: HLA-A2 patients hospitalized in the neurology department who are not affected with a neuroimmunological disorder
- •18 year old and older patients,
- •HLA-A2 patients hospitalized in the neurology department
- •Patient not affected by Multiple Sclerosis or a related inflammatory disorder
- •Affiliated or profitable subject of a national insurance scheme
- •Patients affiliated to health insurance coverage
- •Information and comprehensive agreement signed by the patient and the investigator
- •Group 3: HLA-A2 Multiple Sclerosis patients treated by Natalizumab therapy
- •18 year old and older patients,
- •HLA-A2 patients with relapsing remitting (RR) MS fulfilling McDonald 2005 or 2010 Multiple Sclerosis diagnostic criteria
- •Patients treated by Natalizumab therapy for at least 3 months
- •Patients affiliated to health insurance coverage
- •Information and comprehensive agreement signed by the patient and the investigator
排除标准
- •Group 1 and 3:
- •Patients undergoing immunosuppressive therapy at present or in the past except Natalizumab
- •Pregnant women
- •Patients undergoing immunosuppressive therapy at present or in the past
- •Patients affected by Multiple Sclerosis or a related disorder
- •Pregnant women
结局指标
主要结局
Analysis of pentamers (> 0,1 % of the CD3 + CD8 + T-cells) will be statistically compared between the 3 groups of patients.
时间窗: 6 months after the inclusion
This analysis will enable us to detect CD8+ myelin specific T-cells in the blood of Multiple Sclerosis
次要结局
- The results will be correlated with the patients MRI data(6 months after the inclusion)
- The results will be correlated with the patients clinical(6 months after the inclusion)
- Description of lymphocyte immunophenotyping and dosage of immunoglobulins in patients treated with Natalizumab(6 months after the inclusion)
研究者
研究点 (2)
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