Efficacy and Safety of JAK Inhibitors in Patients With Systemic Sclerosis and Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- relative change in FVC after 12 months of JAK inhibitor
研究概览
简要总结
Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality.
Janus kinases (JAK) inhibitors are recent therapies in the field of systemic autoimmune diseases, already approved in patients with rheumatoid arthritis.
Use of JAK inhibitors in systemic sclerosis is based on their anti-inflammatory and anti-fibrotic properties. Several preclinical murine models of systemic sclerosis demonstrated the efficacy of ruxolitinib and tofacitinib on cutaneous and pulmonary fibrosis. Recently, tofacitinib was evaluated in SSc patients in two clinical studies and showed significant improvement on skin fibrosis.
The objective of this study is to evaluate efficacy and safety of JAK inhibitors in SSc patients with ILD.
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
- 否
入选标准
- •Patients with systemic sclerosis according to 2013 ACR/EULAR criteria
- •Patients with interstitial lung disease affecting at least 10 % of the lungs on HRCT chest, FVC of at least 40 % of the predicted value and DLCO between 30 % and 90 % of the predicted value
- •Use of JAK inhibitors
排除标准
- •Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)
- •Patients with pulmonary arterial hypertension defined on right heart catheterization
结局指标
主要结局
relative change in FVC after 12 months of JAK inhibitor
时间窗: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
relative change in %predicted FVC after 12 months of JAK inhibitor
次要结局
- relative change in DLCO after 12 months of JAK inhibitor(at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation)
- relative change in skin fibrosis after 12 months of JAK inhibitor(at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation)
研究者
Paul DECKER, MD
Principal Investigator
Central Hospital, Nancy, France