Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,332
- 试验地点
- 1
- 主要终点
- Annual Relapse Rate (ARR)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Copaxone subcutaneous injection syringe (hereinafter referred to as Copaxone) in patients with multiple sclerosis in the routine clinical setting.
详细描述
The drug being tested in this study is called Glatiramer acetate is being tested to treat people who have Multiple sclerosis. This study will look at the safety and efficacy of Glatiramer acetate in patients with multiple sclerosis in the routine clinical setting.
The study will enroll approximately 1000 patients.
• Glatiramer acetate subcutaneous injection syringe
This multi-center trial will be conducted in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients treated with Copaxone from the first day of market launch of the product
排除标准
- 未提供
研究组 & 干预措施
Glatiramer acetate
For adults, a 20 mg dose of glatiramer acetate will be subcutaneously administered once daily. Participants will receive interventions as part of routine medical care.
干预措施: Glatiramer acetate (Drug)
结局指标
主要结局
Annual Relapse Rate (ARR)
时间窗: Up to 24 months
The annual relapse rate (ARR) after the start of treatment will be calculated throughout study.
Percentage of participants who had one or more adverse events
时间窗: Up to 24 months
次要结局
- Changes in functional evaluation scores (Functional Systems [FS])(Up to 24 months)
- Changes in functional evaluation scores (Expanded Disability Status Scale [EDSS])(Up to 24 months)
- Changes in the number of lesions from brain MRI findings(Up to 24 months)