Effect of Monoclonal Anti-cd303 on the Inhibition of Type I Interferon Secretion in the Peripheral Blood of Patients With Autoimmune Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- in vitro determination of the level of type I interferons by immunoenzymatic ELISA method.
研究概览
简要总结
The pathogenic role of type I interferons (IFNs) in the development of different autoimmune diseases has been extensively described in the literature. Since plasmacytoid dendritic cells (pDCs) are the main source of type I IFNs, there is evidence of the involvement of pDCs in autoimmune diseases. The CD303 surface protein (also called BDCA-2) is specifically expressed by the pDCs.
The hypothesis leading to the realization of this study is to observe, in vitro, an inhibition of the secretion of the type I IFNs by pDCs in the peripheral blood in patients with autoimmune disease, thanks to the action of the anti-CD303 antibody Developed by the LFB Group, which could reduce the inflammatory response and improve patients with autoimmune disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study data collection procedures
- •Patient followed in the department of internal medicine of CHU Lille
- •Patient with one of the following autoimmune disease, defined according to international criteria: systemic lupus erythematosus, systemic sclerosis, Gougerot-Sjögren syndrome and idiopathic thrombocytopenic purpura
- •Being socially insured
排除标准
- •Overlapping syndrome with another autoimmune disease
- •Age ≤18 years
- •Pregnant or nursing women
- •People in emergencies
- •Person incapable of consent
- •Persons deprived of liberty
- •Persons without social security cover
研究组 & 干预措施
Patient
干预措施: Monoclonal anti-cd303 antibody (Biological)
结局指标
主要结局
in vitro determination of the level of type I interferons by immunoenzymatic ELISA method.
时间窗: Baseline
次要结局
- in vitro determination of the level of type I interferons by immunoassay ELISA (by type of MIA)(Baseline)
- in vitro determination of the level of type I interferons by ELISA immunoassay method in patients treated or not with immunosuppressive or immunomodulatory treatment.(Baseline)