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临床试验/NCT04206644
NCT04206644进行中(未招募)不适用

Systemic Sclerosis and Jak Inhibitors : Emphasis on Macrophages

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年1月21日最近更新:
适应症

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 :

  1. To characterize the impact of ruxolitinib on other pro-inflammatory or pro-fibrotic cytokines
  2. To characterize the impact of ruxolitinib on membrane expression of macrophagic polarization markers of MDM from SSc patients
  3. To evaluate the impact of ruxolitinib on the phenotype of MDM from healthy donors exposed in vitro to the serum of SSc patients.
  4. 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

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

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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