NCT03408093已完成不适用
Cross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1b
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
- 120
- 主要终点
- Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test
研究概览
简要总结
The primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more than 6 months in treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) or patients with a first outbreak or clinically isolated syndrome (CIS) that carry more than 6 months in treatment with interferon beta-1b
排除标准
- 未提供
研究组 & 干预措施
Interferon beta-1b
Patients with CIS, RRMS or SPMS who had more than 6 months in treatment
干预措施: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
结局指标
主要结局
Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test
时间窗: Four weeks just before baseline visit
次要结局
- Number of patients with MS diagnosis(At baseline)
- Demographic data(At baseline)
- Time since last relapse(At baseline)
- Time on INFb-1b therapy(At baseline)
- Age at first episode and at diagnosis(At baseline)
- Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team(At baseline)
- Number of patients with adverse events during the last month(Four weeks just before baseline visit)
- Clinical setting characteristics like existence of MS unit(At baseline)
- Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MS(At baseline)
研究者
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