Multiple Sclerosis
Conditions
Brief summary
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).
Interventions
None listed
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in work capacity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year, 2 years | 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. |
| Number of participants with hospital and emergency episodes of care | -1 year, 1 year | — |
| Change from Baseline in ease of use of the device | 1 month, 1 year, 2 years | Ease of use will be assessed on a scale from 0 (extremely difficult) to 10 (extremely easy). |
| 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 | Participant satisfaction will be measured using a 10-item satisfaction questionnaire. |
Countries
Canada
Outcome results
None listed