NCT03559465已完成不适用
Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2018年10月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Fibroblast transcriptomic : myofibroblast signature
研究概览
简要总结
B Lymphocytes are thought to play an important role in the pathophysiology of systemic sclerosis. In this study, the profibrosing role of B lymphocytes of patients with systemic sclerosis will be evaluated.
详细描述
B Lymphocytes of patients with systemic sclerosis will be assessed in term of interaction with fibroblasts from patients with systemic sclerosis and compared to healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 是
入选标准
- •systemic sclerosis according to ACR-EULAR 2013
- •written consent
- •available insurance
- •Healthy "blood" and healthy "biopsy" controls
- •written consent
- •available insurance
排除标准
- •overlap with other connective tissue diseases
- •immunosuppressants in the past 12 months
- •corticosteroids ≥10mg/d
- •pregnancy or breast feeding
- •Healthy "blood" and healthy "biopsy" controls
- •systemic sclerosis according to ACR-EULAR 2013
- •another connective tissue diseases
- •immunosuppressants in the past 12 months
- •corticosteroids ≥10mg/d
- •pregnancy or breast feeding
- •With dysimmune inflammatory diseases (except thyroiditis)
- •Presenting an infection in progress or within the previous 15 days
结局指标
主要结局
Fibroblast transcriptomic : myofibroblast signature
时间窗: 36 months
expression of alpha Smooth Muscle Actin
次要结局
- Fibroblast transcriptomic(36 months)
- Difference in collagen infiltration by PicroSirius red staining between the skin biopsies of the two groups(36 months)
- Difference in the inflammatory infiltrate by immunohistological markings between the skin biopsies of the two groups(36 months)
研究者
研究点 (1)
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