NCT00873340已完成不适用
Physical Disability Observational Study in Patients Treated With Betaferon in Daily Practice
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 83
- 主要终点
- To collect observational local data about effectivity related to physical disability progression on the daily routine basis in patients treated with Betaferon
研究概览
简要总结
To gather Observation data about physical disability progression, safety and adherence during the use of Betaferon in daily practice. Patients with any type of Multiple Sclerosis (MS) (MRRS) (PSMS), under treatment with Betaferon.Open Multicentric Observational study.24 months.Evaluation of physical disability in patients treated with Betaferon, using Kurtzke's expanded disability scale (EDSS) in biannual periods
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
- •Patients with a first demyelinating event suggestive of MS, as well as patients with remittent recurrent MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS) will be able to join the study.
排除标准
- •Pregnancy
- •Patients with a history of hypersensitivity to natural or recombinant interferon-beta, human albumin or to any of the excipients
- •Patients with a history of severe depressive disorders and/or suicidal ideation
- •Patient with decompensated liver disease
- •Patient with epilepsy not adequately controlled by treatment
研究组 & 干预措施
Group 1
干预措施: Interferon-1beta (Betaseron, BAY86-5046) (Drug)
结局指标
主要结局
To collect observational local data about effectivity related to physical disability progression on the daily routine basis in patients treated with Betaferon
时间窗: Every 6 months for 2 years
次要结局
- To evaluate Betaferon safety on the daily routine basis(Every 6 months)
- To evaluate patient adherence to Betaferon treatment(Every 6 months)
研究者
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