Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 629
- 主要终点
- Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation
研究概览
简要总结
This will be prospective, multicentre, observational study. Patients who will initiate treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0) i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient demographics, medical history data, safety parameters, presence of flu-like symptoms and measures to prevent or treat these symptoms will be collected.
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
- •Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald (2005) criteria
- •Age >/= 18 years old
- •Treatment MS patients in whom the attending physician has decided to initiate therapy with interferon beta-1b; Betaferon
- •Minimum 6 months wash-out period from previous IFNβ
- •Written Informed Consent signed
排除标准
- •Patients previously treated with any of the disease modifying drugs (DMDs), with the exception of IFNβ therapy which ended at least 6 months earlier
- •Patients receiving treatment with IFN beta other than Betaferon (Bayer)
结局指标
主要结局
Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation
时间窗: 6 months
MS patient with Flu-Like Symptoms (FLS) demographic profile
时间窗: Up to 1 month
For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height.
Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS
时间窗: 6 months
次要结局
- The impact of FLS on patients daily activities as measured by current professional/educational status(From baseline up to 6 months)
- Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period(6 months)