Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis
- Registration Number
- NCT01491100
- Lead Sponsor
- Bayer
- Brief Summary
Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1085
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
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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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Interferon beta-1b (Betaseron, BAY86-5046) -
- Primary Outcome Measures
Name Time Method Cognitive performance as measured by SDMT (Symbol Digit Modalities Test) 24 months Physical activity as measured by the Baecke questionnaire 24 months
- Secondary Outcome Measures
Name Time Method 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