临床试验/NCT01414816

NCT01414816已完成不适用

Betaferon® Regulatory Post-Marketing Surveillance

Bayer0 个研究点目标入组 355 人开始时间: 2008年4月最近更新: 2014年8月21日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Bayer
入组人数: 355
主要终点: Safety variables will be summarized using descriptive statistics based on adverse events.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To identify problems/questions about following items in the clinical practice using Betaferon

Unknown adverse event (especially serious adverse event)
Identification of adverse event occurred in the real practice
Factors that may affect the safety of drug
Factors that may affect the effectiveness of the drug

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: 12 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with diagnosis of MS or CIS and decision taken by the physician to prescribe Betaferon
•Patients who have not participated in Betaferon regulatory Post Marketing Surveillance before.

排除标准

•Exclusion criteria must be read in conjunction with local product information

研究组 & 干预措施

Group 1

干预措施: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)

结局指标

主要结局

Safety variables will be summarized using descriptive statistics based on adverse events.

时间窗: Up to 6 months

次要结局

The efficacy data regarding prevention of relapse due to MS will be estimated based on the number of relapse.(During 6 month)
Progression or aggravation to Multiple sclerosis (MS) will be identified based on the change of Expanded Disability Status Scale (EDSS) and the Magnetic Resonance Imaging (MRI) outcome.(0, 6 month)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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3 期

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