NCT00335985已完成3 期
A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and Dermatomyositis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Changes in manual muscle strength (MMT) scores
研究概览
简要总结
This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based on the changes in manual muscle strength (MMT) scores as primary endpoint, and in addition, to assess the safety of GB-0998.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
- •Patients who have the anamnesis of cerebral infarction or ischemic heart disease, or who having symptom of these diseases.
- •Patients who have been diagnosed as IgA deficiency in their past history.
- •Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant.
- •Patients who were administered immunoglobulin dosage within 6 weeks before consent.
研究组 & 干预措施
1
Experimental
干预措施: GB-0998 (Drug)
2
Placebo Comparator
干预措施: Placebo of GB-0998 (Drug)
结局指标
主要结局
Changes in manual muscle strength (MMT) scores
时间窗: 8 weeks
次要结局
- Adverse events and laboratory tests(8 weeks)
- Changes in the serum levels of creatine kinase (CK) and total scores of activities of daily living (ADL)(8 weeks)
研究者
研究点 (1)
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