BAY86-5046 (Betaseron), Non Interventional Studies

Study Overview
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Brief Summary
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This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.

Official Title
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BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon®

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon beta-1b (Betaferon, BAY 86-5046)
* Device: BETACONNECT auto-injector.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome. Patients must be on treatment with Betaferon or the decision to treat patients with Betaferon has been made by the attending physician. Patient and attending physicians must have agreed on the usage of the BETACONNECT auto-injector device Written informed consent must be obtained. Exclusion Criteria: Patients receiving any other disease modifying drug. Contraindications of Betaferon described in the Summary of Product Characteristics.

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 |
| --- | --- |
| Cohort 1<br>Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect auto-injector | Drug: Interferon beta-1b (Betaferon, BAY 86-5046)<br> <br> Device: BETACONNECT auto-injector.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence measure to Betaferon therapy based on the real BETACONNECT injections | Adherence to therapy will be defined as applying ≥80% of prescribed Betaferon dosages, which can be derived from electronic data stored in the BETACONNECT device. | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire |  | up to 24 weeks | 
| Evaluation of health related quality of life,measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire |  | up to 24 weeks | 
| Evaluation of Anxiety measured with the self-administered Hospital Anxiety and Depression Scale (HADS) |  | up to 24 weeks | 
| Evaluation of Depression measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D) |  | up to 24 weeks | 
| Evaluation of Fatigue measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC) |  | up to 24 weeks | 
| Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT) |  | up to 24 weeks | 
| Local skin reactions recorded by Health Care Provider (HCP) evaluation |  | up to 24 weeks | 
| Evaluation of injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device |  | up to 24 weeks | 
| Number of Treatment-emergent Adverse Events (TEAE) |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CIS, RRMS