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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).
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| 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 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Enrollment will consist of approximately 500 participants who have been prescribed AVONEX PEN in accord with its labeling (Product Monograph). This will include participants who are naïve to disease modifying therapies (DMTs) as well as those who are being switched from another injectable DMT.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Contact | Burlington | Ontario | Canada |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |