NCT05375435招募中4 期
Efficacy and Safety of Triple Therapy Based on Prognostic Risk Stratification in Patients With Anti-MDA5 Antibody-positive Dermatomyositis: a Multicenter, Prospective, Randomized Controlled Study
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- RPILD
研究概览
简要总结
We conduct this study to investigate the efficacy of triple therapy (high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor) compared with dual-therapy regimens (high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor) and whether it reduces the risk of poor pulmonary prognosis in patients with moderate to high risk anti-MDA5+ DM.
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
- Double (Participant, Investigator)
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
- •Adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter
- •Anti-MDA5 Antibody-positive
排除标准
- •Complicated with other connective tissue diseases
- •Complicated with cardiovascular and respiratory disease caused by other reasons
- •Interstitial lung disease caused by environment and drugs
- •Patients with key research missing data or without informed consent
研究组 & 干预措施
experimental group
Experimental
干预措施: triple therapy (Drug)
control group
Experimental
干预措施: dual-therapy (Drug)
结局指标
主要结局
RPILD
时间窗: 6 months
Incidence of RP-ILD in patients after 6 months of treatment
Death
时间窗: 6 months
Mortality rate in patients after 6 months of treatment
次要结局
未报告次要终点
研究者
Wenfeng Tan
Chief Physician
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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