Evaluation of Antigen-specific Th1 and T17 Cells, ILC and MAIT in Patients With Antisynthetase Syndrome and Interstitial Lung Disease
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
- 否
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
Paul DECKER, MD
Principal Investigator
Central Hospital, Nancy, France
