跳至主要内容
临床试验/NCT05691725
NCT05691725已完成不适用

Evaluation of Peripheral Neutrophils in Patients With Antisynthetase Syndrome

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年2月1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
40
试验地点
1
主要终点
Global severity

研究概览

简要总结

Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. A pathogenic role of neutrophils was described during inflammatory myopathies, with increased netosis correlated with disease activity and muscle damage. Higher number of alveolar neutrophils was observed in patients with rapidly progressive forms of interstitial lung disease.

Peripheral neutrophils could represent a simple biomarker of severity and activity in patients with antisynthetase syndrome.

The main objective is to compare circulating neutrophils between severe and non severe patients with antisynthetase syndrome. Secondary objectives are: 1) to evaluate correlation between circulating neutrophils and organ-specific severity, 2) to compare circulating neutrophils at time of diagnosis and circulating neutrophils after 6 months of treatment in patients with antisynthetase syndrome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with antisyntheatse syndrome according to Solomon criteria

排除标准

  • 未提供

结局指标

主要结局

Global severity

时间窗: at diagnosis (Day 0)

composite criteria of global severity: severe interstitial lung disease (ILD) and/or severe muscular disease

Number of circulating neutrophils

时间窗: at diagnosis (Day 0)

circulating neutrophils values (number of cells/mm3)

次要结局

  • ILD severity(at diagnosis (Day 0))
  • Muscular severity(at diagnosis (Day 0))
  • Circulating neutrophils change over time(at 6 months of follow-up)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul DECKER, MD

Principal Investigator

Central Hospital, Nancy, France

研究点 (1)

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