NCT01071694撤回不适用
QOLBET Quality Of Life in Patients With Early Relapsing-remitting Multiple Sclerosis Treated With BETaferon® in Korea
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Bayer
- 主要终点
- Quality of life evaluated by several validated questionnaire
研究概览
简要总结
This study is to describe the quality of life of Korean patients with early relapsing-remitting multiple sclerosis during the initial 1 year of treatment with Betaferon with several validated questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Relapsing-remitting MS (RRMS) patients within the first two years after diagnosis according to Poser or McDonald criteria, starting Betaferon treatment, including patients switching from other DMDs
- •Patients who signed informed consent form
排除标准
- •Age lower than 18
研究组 & 干预措施
Group 1
干预措施: Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046) (Drug)
结局指标
主要结局
Quality of life evaluated by several validated questionnaire
时间窗: Baseline, 3, 6, 9, 12 months (+/- 1 month)
次要结局
- Information about safety of Betaferon in routine clinical use(Baseline, 3, 6, 9, 12 months (+/- 1 month))
研究者
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