Systemic Sclerosis and Jak Inhibitors : Emphasis on Macrophages
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Concentration of CCL18 in the condition media of MDM from SSc patients
研究概览
简要总结
The Sclero-JAK project aims to assess the impact of a JAK1/2 inhibitor (ruxolitinib) on activation states of monocytes-derived macrophages (MDM) from systemic sclerosis (SSc) patients
详细描述
Systemic sclerosis is a fibrotic and inflammatory chronic autoimmune disorder with no disease modifiying drug available to date. JAK inhibitors may represent a relevant therapeutic candidate for this disease;
The primary objective of this study is to characterize the impact of Ruxolitinib (a JAK ½ inhibitor) on the prof-fibrotic properties of MDM from SSc patients in vitro.
The primary outcome will be the concentration of CCL18 evaluate by ELISA in the condition media of MDM from SSc patients pre treated or not in vitro by ruxolitinib.
The secondary objectives :
- To characterize the impact of ruxolitinib on other pro-inflammatory or pro-fibrotic cytokines
- To characterize the impact of ruxolitinib on membrane expression of macrophagic polarization markers of MDM from SSc patients
- To evaluate the impact of ruxolitinib on the phenotype of MDM from healthy donors exposed in vitro to the serum of SSc patients.
- To determine the variability of the effects of ruxolitinib on MDM of SSc patients depending on key clinical characteristics (diffuse versus limited SSc, patients with or without Interstitial Lung disease ILD)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 18 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with systemic sclerosis according to the ACR/EULAR 2013 classification criteria for systemic sclerosis or Patients with systemic lupus according to the ACR2019 classification criteria for systemic lupus
- •with informed consent for participation to the study
排除标准
- •patients unable to consent
- •patients with anemia inferior to 7g/dL
结局指标
主要结局
Concentration of CCL18 in the condition media of MDM from SSc patients
时间窗: through study completion, an average of 4 year
at the end of the study
次要结局
未报告次要终点
