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).
Study Type
OBSERVATIONAL
Enrollment
111
Central Contact
Burlington, Ontario, Canada
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.
Time frame: 2 years
Number of participants with hospital and emergency episodes of care
Time frame: -1 year, 1 year
Number of missed injections
Time frame: 1 month, 1 year, 2 years
Number of participants who discontinued treatment
Time frame: 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.
Time frame: 1 year, 2 years
Change from Baseline in participants' satisfaction with the device
Participant satisfaction will be measured using a 10-item satisfaction questionnaire.
Time frame: 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).
Time frame: 1 month, 1 year, 2 years
Number of participants with injection site reactions (ISRs)
Time frame: 1 month, 1 year, 2 years
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