BETAPREDICT - MS Patients Treated With BETAferon®: PREDICTors of Treatment Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 162
- 主要终点
- Compliance to therapy (%)
研究概览
简要总结
This study aims to evaluate potential predictors of adherence by investigating a representative cohort of MS patients in Germany treated with Betaferon
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 aged ≥ 18 years with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome
- •Patients on treatment with Betaferon or the decision to treat patients with Betaferon has been made by the attending physician
- •Patients using or willing to use the BETACONNECT autoinjector for Betaferon application
- •Written informed consent
排除标准
- •Patients receiving any other disease modifying drug
- •Contraindications of Betaferon described in the Summary of Product Characteristics
- •Patients participating in any other clinical or non-interventional study, evaluating MS therapy
研究组 & 干预措施
Betaferon
干预措施: Interferon beta-1b (Betaferon, BAY86-5046) (Drug)
Betaferon
干预措施: Betaconnect Autoinjector (Device)
结局指标
主要结局
Compliance to therapy (%)
时间窗: 12 months
Compliance (%) = ((expected # of treatment days during observation period - missed # of treatment days during observation period)/(expected # of treatment days during observation period))\*100
Persistence of therapy (Yes or No)
时间窗: 12 months
Persistence is defined as patients continuing ("persisting") their medication (regardless of the frequency of intake)
Overall adherence to therapy (Yes or No)
时间窗: 12 months
Patients will be defined as being adherent to therapy if they fulfill the following criteria: a. They have been at least 80% compliant, i.e. injected ≥80% of the expected Betaferon dosages and b. They have not dropped out of the study prior to the time of evaluation (i.e. they did not stop Betaferon treatment for any reason including switching to another medication prior to the time of evaluation).
次要结局
- Satisfaction with the BETACONNECT autoinjector, recorded by the patient questionnaire(Up to 24 months)
- Adherence to Betaferon treatment is associated with EDSS change (Yes or No)(12 months, 24 months)
- Adherence to Betaferon treatment is associated with: depression, health related quality of life, coping mechanisms, self-management mechanisms, social support, fatigue, and cognition. (Yes or No)(Up to 24 months)
- Adherence to Betaferon treatment is associated with number of relapses (Yes or No)(12 months, 24 months)
- Adherence to Betaferon treatment is associated with utilities of treatment, recorded by the EQ-5D quality of life questionnaire (Yes or No)(Up to 24 months)