NCT02121444已完成不适用
BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®
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
- 151
- 主要终点
- Adherence measure to Betaferon therapy based on the real BETACONNECT injections
研究概览
简要总结
This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.
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 the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome.
- •Patients must be on treatment with Betaferon or the decision to treat patients with Betaferon has been made by the attending physician.
- •Patient and attending physicians must have agreed on the usage of the BETACONNECT auto-injector device
- •Written informed consent must be obtained.
排除标准
- •Patients receiving any other disease modifying drug.
- •Contraindications of Betaferon described in the Summary of Product Characteristics.
研究组 & 干预措施
Cohort 1
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector
干预措施: BETACONNECT auto-injector. (Device)
Cohort 1
Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector
干预措施: Interferon beta-1b (Betaferon, BAY 86-5046) (Drug)
结局指标
主要结局
Adherence measure to Betaferon therapy based on the real BETACONNECT injections
时间窗: up to 24 weeks
Adherence to therapy will be defined as applying ≥80% of prescribed Betaferon dosages, which can be derived from electronic data stored in the BETACONNECT device.
次要结局
- Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire(up to 24 weeks)
- Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire(up to 24 weeks)
- Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS)(up to 24 weeks)
- Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D)(up to 24 weeks)
- Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC)(up to 24 weeks)
- Local skin reactions recorded by Health Care Provider (HCP) evaluation(up to 24 weeks)
- Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT)(up to 24 weeks)
- Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device(up to 24 weeks)
- Number of Treatment-emergent Adverse Events (TEAE)(up to 24 weeks)
研究者
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