Ro60 Expression in Macrophages in Patients with Primary Sjogren's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- SSA/Ro60 interactions
研究概览
简要总结
Context: The Ro60 protein associates with YRNAs (or RNYs) to form the RoRNP complex, which regulates RNA surveillance and maturation. It is hypothesized that its impairment by nuclear penetration of the anti-Ro60 autoantibodies, would deregulate the anti-inflammatory response in monocytes/macrophages (Mo/Mp) in patients with Sjögren's disease (SD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with SSp Subjects aged between 18 and 75, without chronic disease; Subject meeting the classification criteria for SSp; Subject with positive anti-SSA serology; French-speaking subject able to give written consent; Subject affiliated to the Sécurité Sociale or an equivalent scheme; Subject willing to have blood samples taken;
- •Control subjects Subjects aged between 18 and 75, without chronic disease and not meeting SSp classification criteria; Subject who understands and speaks French and is able to give written consent; Subject affiliated to the French Social Security system or an equivalent scheme; Subject willing to have blood taken;
排除标准
- •Subject receiving current anti-inflammatory treatment (e.g. corticosteroid therapy, non-steroidal anti-inflammatory drugs) or a regimen of more than 1 month within the last 3 months;
- •Subject undergoing biotherapy or cytoreductive treatment;
- •Subjects with positive serologies for human immunodeficiency virus (HIV), viral hepatitis B virus (HBV) and viral hepatitis C virus (HCV) in the 3 months preceding the inclusion visit;
- •Protected persons as defined in articles of the French Public Health Code.
研究组 & 干预措施
Sjögren's disease
SSp patients followed by the Internal Medicine Department of Nice University Hospital will be offered participation in this study as part of their usual follow-up.
干预措施: Positive serology for anti-SSA (Diagnostic Test)
Control
Control subjects will be recruited from the nursing staff of Nice University Hospital on a voluntary basis.
结局指标
主要结局
SSA/Ro60 interactions
时间窗: 1 year
To evaluate whether the presence of anti-Ro60 autoantibodies causes the loss of Ro60 binding activity to genomic DNA and the TREX protein complex in PBMC. Measure the presence of anti-Ro60 autoantibodies in blood.
次要结局
- The molecular and functional impact : inflammatory cytokine and chemokine profiles(1 year)
- The molecular and functional impact : clinical and biochemical phenotypes of CD14+ monocytes/macrophages(1 year)
- The molecular and functional impact : cell apoptosis/survival and cellular polarization(1 year)