Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.
研究概览
简要总结
The study aims at identifying the type of B and CD4 T cell subsets with pathogenic properties in the different clinical forms of multiple sclerosis. This research might open new therapeutic approaches for the treatment of multiple sclerosis particularly progressive MS.
详细描述
Multiple sclerosis (MS) is a chronic autoimmune disease damaging the central nervous system (CNS). MS is categorized into several distinct forms according to clinical symptoms and medical examinations. Relapsing-remitting multiple sclerosis (RRMS) is characterized by attacks of worsening neurologic function, followed by partial or complete recovery periods. Patients can also present a gradual but steady progression of the disease (progressive forms). While several treatment options are currently available, no treatment completely stops the disease progression. Therefore, a deeper understanding regarding the mechanism of the disease development is essential to generate more efficient treatment strategies. CD4 T cells are known to be significantly involved in the formation of the CNS lesions characteristic of MS.The investigators hypothesize that different types of B and CD4 T cells play major roles in different forms of the disease. They will determine the phenotype and functions of the cells from the immune system particularly B and CD4 T cells present in the blood and cerebro-spinal fluid (CSF) of patients diagnosed with multiple sclerosis or presenting a clinically isolated syndrome.
The study will recruit 150 patients followed in Bordeaux University Hospital and diagnosed for clinically isolated syndrome (CIS) or multiple sclerosis (MS). Blood and CSF will be collected during a scheduled visit to study the properties of cells from the immune system in particular CD4 T cells in multiple sclerosis. Clinical and biological disease activity, treatment and outcomes will be studied in correlation with the properties of blood and CSF lymphocytes. No extra visit will be needed and the blood and CSF samples will be collected at the same times as those collected for clinical purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •male or female subjects ;
- •Age ≥ 18 years;
- •subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome;
- •patients for which a blood draw and / or lumbar puncture to collect CSF is performed for diagnostic or therapeutic purpose;
- •affiliated to an health insurance system;
- •and who agree to participate in the study.
排除标准
- •Pregnant or breastfeeding women,
- •patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
研究组 & 干预措施
patients with multiple sclerosis or clinically isolated syndrome
subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome
干预措施: blood sample (Biological)
patients with multiple sclerosis or clinically isolated syndrome
subjects with MS defined by 2010 revised McDonald criteria or presenting a clinical isolated syndrome
干预措施: cerebro-spinal fluid (Biological)
结局指标
主要结局
Functional and phenotypical characterization of the blood and CSF lymphocytes in MS and CIS patients.
时间窗: At inclusion (day 0)
次要结局
- Size of lesions(At inclusion (day 0))
- duration of the disease(At inclusion (day 0))
- Number of lesions(At inclusion (day 0))
- Types of lesions(At inclusion (day 0))
- age at onset and progression(At inclusion (day 0))
- Localisation of lesions(At inclusion (day 0))
- number of relapses(At inclusion (day 0))
- date of relapses(At inclusion (day 0))
- Treatment(At inclusion (day 0))
- Quantification of disease activity scores(At inclusion (day 0))