Multiple Sclerosis
Conditions
Keywords
RRMS, CIS
Brief summary
This study aims to investigate adherence to therapy among patients treated with Betaferon who are using the BETACONNECT autoinjector.
Interventions
DEVICEBETACONNECT auto-injector.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence measure to Betaferon therapy based on the real BETACONNECT injections | up to 24 weeks | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Satisfaction with and evaluation of the BETACONNECT auto-injector recorded by patient questionnaire | 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 |
| Evaluation of Cognition will be measured by the HCP with the Symbol Digit Modalities Test (SDMT) | up to 24 weeks |
Countries
Germany
Outcome results
None listed