* The primary aim of this study is to evaluate the impact of titration, analgesics, and 12 month telephone follow-up period from the B.E.T.A nurse program upon adherence to treatment with Betaseron in patients with a first clinical demyelinating event suggestive of Multiple Sclerosis (MS) and patients with onset of RRMS within the past 12 months * Secondary outcomes include analysis of the following parameters: progression of clinical severity by the expanded disability status scale (EDSS score), health related quality of life (HrQoL), and safety. * Exploratory outcomes include changes over time in cytokine and neurotrophic factor production by immune cells and visual function as assessed by visual examination, OCT measurements and a neuro-ophthalmologic Health-Related Quality of Life questionnaire (NEI-VFQ-25) with 10-item supplement.
Study Type
OBSERVATIONAL
Enrollment
104
Male and females, 18 to 50 years of age, after a first clinical demyelinating event suggestive of multiple sclerosis or with onset of RRMS within the past 12 months
Unnamed facility
Many Locations, Alabama, United States
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Many Locations, Arizona, United States
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Many Locations, Delaware, United States
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Many Locations, District of Columbia, United States
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Many Locations, Florida, United States
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Many Locations, Georgia, United States
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Many Locations, Illinois, United States
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Many Locations, Iowa, United States
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Many Locations, Louisiana, United States
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Many Locations, Maine, United States
...and 9 more locations
Evaluate the impact of titration, analgesics and 12-month BETA nurse follow-up on adherence to Betaseron treatment
Time frame: 12 months
Extended Disability Status Scale (EDSS)
Time frame: 12 months
Functional Assessment in Multiple Sclerosis (FAMS)
Time frame: 12 months
Cytokine and neurotrophic factor production
Time frame: 12 months
Visual function assessed by OCT and NEI-VFQ-25 (25-Item National Eye Institute Visual Functioning Questionnaire)
Time frame: 18 months
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