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临床试验/NCT05984394
NCT05984394招募中不适用

Evaluation of Antigen-specific Th1 and T17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease

Central Hospital, Nancy, France6 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
6
主要终点
FVC relative change

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. Intesrtitial lung disease (ILD) is a leading cause of mortality in antisynthetase syndrome. Recently, antigen-specific IFN-γ+ CD4+ T cells have been identified in bronchoalveolar fluid (BAL) of patients with antisynthetase syndrome and ILD. Elevated levels of IL1β, IL12, IL18, TNFα, IL17A, IL22 have also been detected in peripheral blood of AS patients, especially those with progressive ILD. Implication of innate lymphoid cells (ILC) and mucosal-associated invariant T cells (MAIT) have not yet been studied in patients with AS. Targeted therapies against Th1 and Th17 cells may represent a promising treatment in patients AS patients with ILD.

Investigators suppose that antigen-specific Th1 and Th17 cells, ILC and MAIT at ILD diagnosis are associated with ILD severity at diagnosis and could predict treatment response at 6 months.

The main objective is to study the correlation between BAL antigen-specific Th1 and Th17 cells at ILD diagnosis and clinical evolution after 6 months of treatment according to initial ILD severity.

研究设计

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

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

  • Patient with new diagnosis of AS with ILD

排除标准

  • Patient with ILD differential diagnosis
  • Corticosteroid treatment, immunosuppresive or immunomodulatory drugs in the past 3 months before diagnosis

结局指标

主要结局

FVC relative change

时间窗: within 6 months after diagnosis

Relative change of FVC percentage

BAL antigen-specific Th1 and Th17 cells

时间窗: baseline (J0)

BAL antigen-specific Th1 and Th17 cells percentages among BAL total CD4+ T cells

次要结局

  • Global activity(baseline (J0))
  • FVC(baseline (J0))
  • BAL antigen-specific Th1 and Th17 cells(baseline (J0))
  • FVC absolute change(within 6 months after diagnosis)

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 (6)

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