US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage and Patient Reported Outcomes Via the myBETAapp in Medical Care of Patients With Multiple Sclerosis Treated With BETASERON Using BETACONNECT Autoinjector

Study Overview
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Brief Summary
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In this study researchers want to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with BETASERON using the myBETAapp. Multiple sclerosis (MS) is a disease in which the covering called myelin around the nerves of the central nervous system degenerate. MS is a lifelong disease therefore requiring continuous treatment to delay the disease progression and reduce the rate of relapse (the return of signs and symptoms of). BETASERON is an approved medicine used to reduce the relapse in patients with MS. It is injected into the tissue under the skin using BETACONNECT autoinjector, which automatically captures injection data including injection date, time, speed, and depth and uploads the data into paired myBETAapp. This allows patients to organize and track their progress and share the injection information with their physicians. The medication usage behavior to be collected in this study includes the elements to what extent taking medication matches the presciber's recommendation (adherence, compliance), treatment for the prescribed duration (persistence) is continued and injections were missed. Among MS patients treated with Betaferon using the myBETAapp the study will also collect information on the health-related quality of life , treatment satisfaction and satisfaction with treatment support.

Official Title
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US PROmyBETAapp2.0: Ascertaining Medication Usage and Patient-reported Outcomes (PROs) Via the myBETAapp™ in Patients With Multiple Sclerosis Treated With BETASERON® Using BETACONNECT™ Autoinjector

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon-beta-1b (BETASERON, BAY 86-5046)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 years Treated with BETASERON using the BETACONNECT autoinjector Registered with myBETAapp Provided electronic informed consent Exclusion Criteria: - There are no exclusion criteria for participation in this study

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BETASERON<br>Participants with Multiple Sclerosis treated with BETASERON using BETACONNECT autoinjector and myBETAapp will be enrolled | Drug: Interferon-beta-1b (BETASERON, BAY 86-5046)<br>* Using the BETACONNECT autoinjector and myBETAapp as prescribed by the physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to therapy | Compliance is defined as the the proportion of BETASERON administrations with the correct injection interval within some window. Windows will be set for each individual patient based on prescribed injection frequency. | Up to 6 months | 
| Persistence of therapy | Persistence to BETASERON using the BETACONNECT device will be measured as the number of days between the initial BETASERON administration and the earlier of the last BETASERON administration using the BETACONNECT device or before a minimum 60-day gap in therapy. | Up to 6 months | 
| Adherence to therapy | Adherence to BETASERON using the BETACONNECT device is a dichotomous variable (adherent or non-adherent) defined as receiving at least 80% of the expected number of injections during 6 months of treatment (or up to the point of early termination) as captured by the BETACONNECT device. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient-reported health-related quality of life (HRQOL) | Change in patient-reported health-related quality of life (HRQOL) will be collected via an online study-specific patient survey. | Up to 6 months | 
| Patient satisfaction with the myBETAapp | Patient satisfaction with the myBETAapp will be collected via an online study-specific patient survey. | Up to 6 months | 
| Change in health status evaluated by EQ-5D-5L descriptive system | EQ-5D-5L is a standardized measure of general health status. The EQ-5D-5L descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where respondents indicate their health state on each dimension based on 5 response options (no problems, slight problems, moderate problems, severe problems, and extreme problems). | Up to 6 months | 
| Change in EQ-Visual Analog Score (EQ-VAS) | The EQ-Visual Analog Score (EQ-VAS) allows respondents to rate their health on a 20 cm vertical, visual analog scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine' and provides a single quantitative measure of health. | Up to 6 months | 
| Change in prescription and non-prescription medication usage | Prescription and non-prescription medication usage will be collected via an online study-specific patient survey. | Up to 6 months | 
| Number of relapses |  | Up to 6 months | 
| Number of participants with treatment with corticosteroids due to relapses |  | Up to 6 months | 
| Number of emergency room visits due to relapse |  | Up to 6 months | 
| Number of hospitalizations due to relapse |  | Up to 6 months | 
| Patient self-assessment | Self-assessment includes assessment for mood, memory, vision, urinary symptoms. The assessment will be collected via an online study-specific patient survey. | Up to 6 months | 
| Change in dose of BETASERON prescription |  | Up to 6 months | 
| Change in frequency of BETASERON prescription |  | Up to 6 months | 
| Patient satisfaction with the BETACONNECT autoinjector | Patient satisfaction with the BETACONNECT autoinjector will be collected via an online study-specific patient survey. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS