JPRN-jRCT2080220256已完成3 期
Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 26
研究概览
简要总结
We randomly assigned 26 subjects (16 PM and 10 DM) to receive either GB-0998 or placebo. Intragroup comparison in the GB-0998 group showed statistically significant improvements due to GB-0998 administration in the primary endpoint (manual muscle test score) and secondary endpoints (serum creatine kinase level and activities of daily living score).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Patients who have been defined as definite based on the criteria of Bohan and Peter for polymyositis and dermatomyositis.
- •Patients who are defined as steroid-resistant ones based on the changes of scores on manual muscle testing (MMT) and serum levels of creatine kinase (CK) during observation period before administration of drug.
排除标准
- •Patients with malignant tumors.
- •Patients with acute interstitial pneumonia, including acute exacerbation of chronic.
- •Patients with severe muscular atrophy for a long period.
- •Patients with severe infectious disease.
- •Patients who have the anamnesis of shock or hypersensitivity to this drug.
- •Patients with severe hepatic disorder or severe renal disorder.
研究者
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