BETAEVAL Global - The New BETACONNECT Auto-injector : Adherence and EVALuation of Multiple Sclerosis Patients Treated With Betaferon

Study Overview
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Brief Summary
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Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as well as the challenge to achieve high adherence to treatment, evaluating the benefits of any new measure to improve adherence is important. The data storage capabilities of the BETACONNECT device, including the automated recording of injections, will facilitate the collection of reliable data on patient's injection behavior and adherence, which should be unaffected by recall bias or reporting bias. To better understand the utilities of the new BETACONNECT device and characterize its contribution to adherence, we plan to prospectively follow-up MS patients using this device for 24 weeks. The study will take place in a real-life setting in Neurology centers across Europe.

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

Conditions
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Multiple Sclerosis, Relapsing Remitting

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


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 a patient 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.
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>Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome and be on treatment with Betaferon using the BETACONNECT auto-injector device. | Drug: Interferon beta-1b (Betaferon®, BAY 86-5046)<br>* Patients will be treated with Betaferon<br>Device: BETACONNECT<br>* Auto-injector device to support the injection of Betaferon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to therapy at the final visit. |  | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with and evaluation of the BETACONNECT auto-injector | Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire | At baseline,4 weeks,12 weeks and 24 weeks | 
| Injection site pain and prophylactic analgesic use | Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire | At baseline,4 weeks,12 weeks and 24 weeks | 
| Health related quality of life | Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire. | At baseline,12 weeks and 24 weeks | 
| Anxiety | Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS). | At baseline,12 weeks and 24 weeks | 
| Depression | Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D). | At baseline,12 weeks and 24 weeks | 
| Fatigue | Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC). | At baseline,12 weeks and 24 weeks | 
| Cognition | Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT). | At baseline,12 weeks and 24 weeks | 
| Local skin reactions | Local skin reactions will be recorded by HCP evaluation (local inspection). | At baseline,4 weeks,12 weeks and 24 weeks | 
| Injection-related specifics | Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device | At 4 weeks,12 weeks and 24 weeks |