Multiple Sclerosis, Relapsing Remitting
Conditions
Brief summary
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.
Interventions
DRUGInterferon beta-1b (Betaferon®, BAY 86-5046)
Patients will be treated with Betaferon
DEVICEBETACONNECT
Auto-injector device to support the injection of Betaferon
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to therapy at the final visit. | Up to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Injection site pain and prophylactic analgesic use | At baseline,4 weeks,12 weeks and 24 weeks | Injection site pain and prophylactic analgesic use will be recorded with the patient questionnaire |
| Health related quality of life | At baseline,12 weeks and 24 weeks | Health related quality of life will be measured with the self-administered Functional Assessment of Multiple Sclerosis (FAMS) questionnaire. |
| Anxiety | At baseline,12 weeks and 24 weeks | Anxiety will be measured with the self-administered Hospital anxiety and depression scale (HADS). |
| Depression | At baseline,12 weeks and 24 weeks | Depression will be measured with the self-administered Center for Epidemiologic Studies Depression Scale (CES-D). |
| Satisfaction with and evaluation of the BETACONNECT auto-injector | At baseline,4 weeks,12 weeks and 24 weeks | Satisfaction with and evaluation of the BETACONNECT auto-injector will be recorded with the patient questionnaire |
| Cognition | At baseline,12 weeks and 24 weeks | Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT). |
| Local skin reactions | At baseline,4 weeks,12 weeks and 24 weeks | Local skin reactions will be recorded by HCP evaluation (local inspection). |
| Injection-related specifics | At 4 weeks,12 weeks and 24 weeks | Injection-related specifics such as injection date, time, and speed will be recorded by the BETACONNECT device |
| Fatigue | At baseline,12 weeks and 24 weeks | Fatigue will be measured with the self-administered Fatigue Scale for Motor and Cognitive functions (FSMC). |
Countries
Austria, Belgium, Bosnia and Herzegovina, Croatia, Czechia, France, Greece, Hungary, Italy, Spain, Switzerland
Outcome results
None listed