An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Persistence with Avonex PEN therapy at Month 12/End of Study as measured by the percentage of patients remaining on therapy at Month 12/End of Study as reported by a physician.
研究概览
简要总结
The primary objective of the study is to determine physician reported persistence with the Avonex PEN at Month 12/End of Study as well as determining factors associated with persistence. The secondary objectives for this study are as follows: To evaluate the tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To evaluate patient quality of life (QoL) while using the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate overall patient satisfaction with the use of the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12; and To evaluate the percentage of patients switching from caregiver to self-injection at Months 3, 6, and 12.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent
- •Must satisfy the locally approved therapeutic indications for the Avonex PEN
- •Decision to treat with Avonex PEN must precede enrollment
- •Must have no more than two (2) injections with the Avonex PEN prior to enrollment
排除标准
- •Inability to comply with study requirements
- •Other unspecified reasons that, in the opinion of the investigator or Biogen Idec, make the patient unsuitable for enrollment
结局指标
主要结局
Persistence with Avonex PEN therapy at Month 12/End of Study as measured by the percentage of patients remaining on therapy at Month 12/End of Study as reported by a physician.
时间窗: 12 months
次要结局
- Tolerability of Avonex PEN as measured by Injection Site Pain(Months 3, 6, and 12)
- Physician reported persistence as measured by number of patients still on therapy(Month 6)
- Patient reported fear of injection using the Fear of Injection Scale(Months 3, 6 and 12)
- Percent of patients switching from caregiver to self-injection(Months 3, 6, and 12)
- Ease of use and patient's assessment of the injection procedure with the Avonex PEN as measured by Patient Assessment of Injection Procedure(Months 3, 6 and 12)
- Clarity of directions for use of the Avonex PEN as measured by the Avonex PEN Instruction Grading Scale(Month 3)
- Ease of use and patient's assessment of the injection procedure with the Avonex PEN as measured by Ease of Use Grading Scale(Months 3, 6, and 12)
- Patient Quality of Life as measured by the EuroQol 5 domain (EQ-5D) Questionnaire(Months 3, 6, and 12)
- Patient reported satisfaction with the Avonex PEN as measured by the Patient Satisfaction Questionnaire(Months 3, 6 and 12)
- Patient reported adherence as measured by number of doses missed(Over the first 6 months and during Months 6 & 12)
- Tolerability of Avonex PEN as measured by Injection Site Reaction(Months 3, 6 and 12)