NCT03192657Unknown2 期
Basiliximab as a Treatment of Interstitial Pneumonia in Clinical Amyopathic Dermatomyositis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
This is a 52-week, randomized, open and routine treatment controlled study. This study will assess the safety and efficacy of basiliximab as an add-on treatment for interstitial pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are planned to be enrolled in a single center.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill Sontheimer-Bohan-Peter diagnosis criteria for dermatomyositis.
- •Agreement of contraception.
- •Serum creatine Kinase ≤ 1.5 fold of upper normal level.
- •Interstitial pneumonia:
- •(meet at least two in four of following)
- •interstitial pneumonia images in high resolution CT;
- •DLCO (diffusing capacity)≤ 60% predict in lung function test;
- •elevated serum KL-6;
- •serum anti-MDA5 (+).
排除标准
- •Previous application of immunosuppressives or any target treatment for dermatomyositis.
- •Clinically significant active infection including ongoing and chronic infections History of human immunodeficiency virus (HIV).
- •Confirmed Positive tests for hepatitis B or positive test for hepatitis C Active tuberculosis.
- •Abnormal renal function at screening (serum creatine>300μmol/L，or eGFR<60mL/min/1.73m2, or end-stage renal disease).
- •Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level.
- •History of any malignancy.
研究组 & 干预措施
Basiliximab group
Experimental
- Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset.
- Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d.
- Steroids: 1mg/kg/d, calculated with prednisone.
干预措施: Basiliximab (Drug)
Basiliximab group
Experimental
- Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset.
- Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d.
- Steroids: 1mg/kg/d, calculated with prednisone.
干预措施: Calcineurin Inhibitors (Drug)
Basiliximab group
Experimental
- Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset.
- Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d.
- Steroids: 1mg/kg/d, calculated with prednisone.
干预措施: Steroids (Drug)
control group
Active Comparator
- Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d.
- Steroids: 1mg/kg/d, calculated with prednisone.
干预措施: Calcineurin Inhibitors (Drug)
control group
Active Comparator
- Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d.
- Steroids: 1mg/kg/d, calculated with prednisone.
干预措施: Steroids (Drug)
结局指标
主要结局
Survival
时间窗: 52 week
次要结局
- Forced vital capacity(52 week)
- Total lung capacity(52 week)
- Diffusing capacity(52 week)
- Lung CT change(52 week)
- Serum ferritin(52 week)
- Serum KL-6(52 week)
研究者
研究点 (1)
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