An Open-Label, Observational, Multicenter Study to Evaluate the Impact of AVONEX PEN Autoinjector Therapy on Work Capacity of Multiple Sclerosis Patients in Canada
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Change from Baseline in work capacity
研究概览
简要总结
This study is primarily designed to evaluate the impact of AVONEX PEN autoinjector on work capacity of participants with multiple sclerosis (MS) starting on this device. This study will also evaluate as secondary endpoints various patient-reported outcomes over the short-term (1 month), including adherence, treatment satisfaction and convenience, and the long-term (12 and 24 months), including adherence, persistence, quality of life (QOL), treatment satisfaction and convenience. It will also assess health resource utilization by MS participants starting on AVONEX PEN autoinjector, as well as overall safety/tolerability, and will correlate all secondary outcomes with the primary (i.e., work capacity).
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be prescribed AVONEX PEN as per local labeling (Product Monograph) and enrolled in MS Alliance (MSA) program
- •If being switched from another DMT, must be on this DMT for at least 6 months
- •Last DMT the subject is switched from must be injectable
- •Must be able to physically demonstrate use of the AVONEX PEN autoinjector device and be able to self-administer the injections
- •Must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI)
- •Must be able to understand and comply with the protocol
排除标准
- •Female subjects considering becoming pregnant while in the study or who are currently pregnant or breast-feeding
- •Current enrollment in any investigational study involving drug, biologic or non-drug therapy
- •Participation in other clinical studies within the past 6 months
- •Treatment with immunosuppressive regimens (e.g. cyclophosphamide, azathioprine, methotrexate or mitoxantrone) or with intravenous immunoglobulin (IVIg) in the last 6 months
- •The most recent DMT the subject is switched from is non-injectable (i.e., oral)
- •Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrollment
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Change from Baseline in work capacity
时间窗: 2 years
Work capacity will be assessed by a telephone-based survey which consists of 10 questions asking participant's about the effect of MS on their ability to work and perform regular activities.
次要结局
- Number of participants with hospital and emergency episodes of care(-1 year, 1 year)
- Change from Baseline in Global Quality of life score(1 year, 2 years)
- Number of missed injections(1 month, 1 year, 2 years)
- Number of participants who discontinued treatment(1 year, 2 years)
- Change from Baseline in ease of use of the device(1 month, 1 year, 2 years)
- Number of participants with injection site reactions (ISRs)(1 month, 1 year, 2 years)
- Change from Baseline in participants' satisfaction with the device(1 month, 1 year, 2 years)