COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Compliance with therapy in the prospective arm
研究概览
简要总结
A phase IV, observational, survey-based study to measure compliance with Avonex® PS therapy in patients with Relapsing-Remitting Multiple Sclerosis, and to compare persistence on therapy 22 months after initial prescription of AVONEX® PS between patients enrolled in the current MS AllianceTM program versus patients enrolled in this program prior to October 2007.
详细描述
Study Design
Five hundred patients will be enrolled in the prospective portion of the study, all of whom will receive AVONEX. Patients will join the study by signing the attached Informed Consent Form (Appendix 1) at their doctor's office at the time of prescription. Innomar will provide the drug to approximately 40 new patients per month, so it will take about twelve to fourteen months to enroll all of the study subjects, assuming that all agree to participate. Once the recruitment period is over, it will take another 22 months to complete the study to the 22-months point for the last subject.
In the retrospective arm of the study, 500 chart reviews will be completed for patients who had participated in the MS Alliance program two (2) to three (3) years ago to determine persistence to therapy over a similar 22 month period.
Study Objectives
Primary Objectives:
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)
- •Prescription of AVONEX® PS (prefilled syringes)
- •Enrolment in the MS AllianceTM program
排除标准
- 未提供
结局指标
主要结局
Compliance with therapy in the prospective arm
时间窗: Week 7-10 and Week 80-83
Persistence on therapy between prospective and retrospective arms
时间窗: 22 months
次要结局
- Patients' satisfaction with new MSA program(Week 7-10 and Week 80-83)