NCT02159651已完成不适用
Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 主要终点
- Overall survival
研究概览
简要总结
This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patient
- •Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis
排除标准
- 未提供
研究组 & 干预措施
1: Dermatomyositis group
patients with interstitial pneumonia associated with dermatomyositis
干预措施: tacrolimus (Drug)
2: Polymyositis group
patients with interstitial pneumonia associated with polymyositis
干预措施: tacrolimus (Drug)
结局指标
主要结局
Overall survival
时间窗: Up to three years
次要结局
- Safety assessed by the incidence of adverse events(Up to three years)
- Arterial blood gas analysis value (PaO2, AaDO2)(Up to three years)
- Serum KL-6 value (serum SP-D value)(Up to three years)
- Respiratory function test value (%FVC, %DLco)(Up to three years)
- Chest CT findings(Up to three years)
- Patient disposition(Up to three years)
研究者
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