Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 146
- 主要终点
- Number of BETASERON injections as captured by the BETACONNECT device
研究概览
简要总结
The primary objective of this study is to assess adherence and persistence to BETASERON therapy in patients who are using the BETACONNECT auto-injector device (BETACONNECT device).
The secondary objective of this study is to assess patient-reported satisfaction with the BETACONNECT device.
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
- •Male and females greater than or equal to 18 years of age
- •Diagnosis of RRMS according to revised McDonald Criteria (2010) or (CIS)
- •Prescribed BETASERON (note: decision to treat with BETASERON must be made independent of participation in this study)
- •Confirmation of insurance coverage for BETASERON treatment
- •Access to a personal computer to complete online patient satisfaction survey at Week 6
排除标准
- •Currently enrolled in a clinical trial or other observational study for Multiple Sclerosis treatment
- •Documented substance abuse within the previous 6 months prior to study enrollment
- •Any major laboratory value abnormality that the investigator believes would preclude the patient from participating in the study
- •Any medical disorder, condition or history that in the opinion of the investigator would impair the patient's ability to participate in or complete the study
- •Pregnant or nursing
研究组 & 干预措施
Interferon beta-1b
Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device.
干预措施: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
Interferon beta-1b
Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device.
干预措施: BETACONNECT device (Device)
结局指标
主要结局
Number of BETASERON injections as captured by the BETACONNECT device
时间窗: At 6 months
Time (days) between BETASERON injections as captured by BETACONNECT device
时间窗: At 6 months
次要结局
- Patient reported satisfaction by a questionnaire(At 6 weeks)