Canadian Avonex PEN Productivity Study

Study Overview
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Brief Summary
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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).

Official Title
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An Open-Label, Observational, Multicenter Study to Evaluate the Impact of AVONEX PEN Autoinjector Therapy on Work Capacity of Multiple Sclerosis Patients in Canada

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 Key Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in work capacity | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with hospital and emergency episodes of care |  | -1 year, 1 year | 
| Number of missed injections |  | 1 month, 1 year, 2 years | 
| Number of participants who discontinued treatment |  | 1 year, 2 years | 
| Change from Baseline in Global Quality of life score | Quality of life will be assessed by a Multiple Sclerosis Quality of Life (MSQOL) questionnaire. This 54-item questionnaire addresses overall health and daily activities. | 1 year, 2 years | 
| Change from Baseline in participants' satisfaction with the device | Participant satisfaction will be measured using a 10-item satisfaction questionnaire. | 1 month, 1 year, 2 years | 
| Change from Baseline in ease of use of the device | Ease of use will be assessed on a scale from 0 (extremely difficult) to 10 (extremely easy). | 1 month, 1 year, 2 years | 
| Number of participants with injection site reactions (ISRs) |  | 1 month, 1 year, 2 years |