Multiple Sclerosis
Conditions
Keywords
Cognition, Physical Activity, Relapsing Remitting Multiple Sclerosis
Brief summary
Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.
Interventions
Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Relapsing Remitting Multiple Sclerosis (RRMS), and treated with Betaferon, with the decision for treatment made at the discretion of the attending physician, documented with a prescription of Betaferon by the physician * EDSS 0 - 6 * Written informed consent
Exclusion criteria
* Patients who do not meet the local indication criteria for Betaferon treatment. * Contraindications listed in the local SmPCs have to be considered. * Patients with a history of severe head trauma. * Patients with alcohol and/or drug abuse. * Patients with mental retardation. * Patients with learning disability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive performance as measured by SDMT (Symbol Digit Modalities Test) | 24 months |
| Physical activity as measured by the Baecke questionnaire | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Disability as measured by EDSS (Expanded Disability Status Scale) | 24 months |
| Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions) | 24 months |
| Depression as measured by the CES-D (Center for Epidemiologic Studies Depression) | 24 months |
| Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life) | 24 months |
Countries
Albania, Algeria, Argentina, Belgium, Czechia, Egypt, France, Germany, Greece, Hungary, Israel, Kazakhstan, Netherlands, Portugal, Saudi Arabia, Tunisia, Turkey (Türkiye)
Outcome results
None listed