A Study on the Efficacy and Safety of JAK Inhibitors Versus Calcineurin Inhibitors as Initial Therapy for Interstitial Lung Disease Associated With Antisynthetase Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 12-month survival rate
研究概览
简要总结
This study is a prospective investigation comparing the efficacy and safety of Janus kinase inhibitors versus calcineurin inhibitors as initial therapy for interstitial lung disease associated with antisynthetase syndrome. The goal is to determine which treatment is more effective at improving lung function and preventing disease progression, while comparing their safety profiles. The findings will help provide clearer treatment guidance for doctors and patients.
详细描述
This is a single-center, randomized, open-label, prospective study. Eligible adults with interstitial lung disease associated with antisynthetase syndrome (ASS-ILD) who are treatment-naïve will be randomly assigned to receive either a JAK inhibitor (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) or a calcineurin inhibitor (tacrolimus 0.075 mg/kg/day in two divided doses, or cyclosporine 2-5 mg/kg/day in two divided doses), both in combination with a standard glucocorticoid regimen. The primary endpoint is the 12-month survival rate. Secondary endpoints include changes in lung function, high-resolution CT (HRCT) scores, glucocorticoid dosage reduction, and the proportion of patients achieving low disease activity. Safety and laboratory parameters will be closely monitored throughout the 12-month treatment and follow-up period. Statistical analyses will compare the efficacy and safety profiles between the two treatment arms, and subgroup analyses will be performed to explore potential predictors of treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years.
- •Meet the 2017 EULAR/ACR diagnostic criteria for Anti-synthetase Syndrome (ASS).
- •Presence of Interstitial Lung Disease (ILD) confirmed by High-Resolution Computed Tomography (HRCT).
- •Active disease requiring initiation or intensification of immunosuppressive therapy, with no prior use of glucocorticoids, immunosuppressants, or biologics.
- •Signed informed consent form.
排除标准
- •Diagnosis of Rapidly Progressive ILD (RP-ILD), defined as worsening dyspnea within 1 month and PaO2/FiO2 ratio < 250 mmHg.
- •Active uncontrolled severe infection, malignancy, or major organ failure.
- •Pregnancy or lactation.
- •Contraindications to the study drugs.
- •Concurrent use of other immunosuppressants or biologics.
研究组 & 干预措施
Calcineurin inhibitor group
Participants in this arm will receive either tacrolimus (0.075 mg/kg/day in two divided doses) or cyclosporine (2-5 mg/kg/day in two divided doses) in combination with the same standard glucocorticoid regimen as the experimental group. Treatment duration is 12 months.
干预措施: Calcineurin Inhibitors (CNI) (Drug)
JAK inhibitor group
Participants in this arm will receive one of the JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) in combination with a standard glucocorticoid regimen (methylprednisolone 0.5g IV for 3 days, followed by oral prednisone 0.8-1.0 mg/kg/day tapered to 7.5 mg/day over 12 months). Treatment duration is 12 months.
干预措施: JAK Inhibitor (Drug)
结局指标
主要结局
12-month survival rate
时间窗: 12 months
Proportion of participants surviving at 12 months after randomization, with survival defined as the time from randomization to death from any cause.
次要结局
- Change in HRCT score(Change from baseline to 12 months)
- Rate of glucocorticoid tapering(Over 12 months)
- Annual decline rate of lung function (FVC% and DLCO%)(Change from baseline to 12 months)
- Proportion of patients achieving low disease activity (LDA)(At 6 months and 12 months)
研究者
Qinghong Liu
Physician
China-Japan Friendship Hospital