ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- The primary endpoint will be the percentage of circulating aggregates between platelets and immune cells according to disease activity, assessed by flow cytometry.
研究概览
简要总结
Blood platelets, well known for their role in hemostasis, are abnormally activated in patients suffering from systemic lupus erythematosus (SLE), but also from other immunomediated diseases (scleroderma, vasculitis, myositis, Gougerot-Sjögren's and rheumatoid arthritis) in cases of high disease activity. Once activated, platelets express adhesion molecules such as P-selectin on their surface, enabling them to interact physically with immune cells. In a recent work, we identified that activated platelets from lupus patients interact with regulatory T cells and block their regulatory function, thus participating in the deregulated activation of the immune system in SLE. In addition, inhibition of platelet-immune cell interactions by an anti-P-selectin antibody improved LES symptoms in two mouse models.
The aim of this work is to investigate other potential platelet-immune cell interactions in patients with SLE, in comparison with other autoimmune diseases (systemic scleroderma, ANCA vasculitides, inflammatory myositis, Gougerot-Sjögren syndrome and rheumatoid arthritis).
This study could lead to a better understanding of the role of platelets in the pathophysiology of autoimmune diseases, identify new biomarkers of activity, and assess the potential of new therapeutic avenues in these diseases, such as platelet targeting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 70 years of age
- •Patient affiliated to a health insurance scheme (beneficiary or beneficiary's beneficiary)
- •Patient able to understand the aims and risks of research
- •Patient having signed and dated an informed consent form
- •Patient for whom the diagnosis of at least one of the following pathologies has been confirmed:
- •Systemic lupus erythematosus meeting ACR/EULAR 20195 classification criteria.
- •Systemic scleroderma meeting ACR/EULAR 20136 classification criteria.
- •ANCA vasculitis according to EULAR/ACR 2022.7-9 classification criteria.
- •Inflammatory myositis according to EULAR/ACR 201710 classification criteria.
- •Gougerot-Sjögren syndrome according to EULAR/ACR 2016 classification criteria
- •Rheumatoid arthritis according to ACR/EULAR 201012 classification criteria.
排除标准
- •Patient in exclusion period (determined by a previous or current study)
- •Inability to give patient informed consent (patient in emergency or immediate life-threatening situation)
- •Patient under court protection
- •Patient under guardianship or curatorship
结局指标
主要结局
The primary endpoint will be the percentage of circulating aggregates between platelets and immune cells according to disease activity, assessed by flow cytometry.
时间窗: Every visit for 3 years
次要结局
- Phenotypic impact of platelet/immune cell interaction.(Every visit (each 6 months) for 3 years)