Multiple Sclerosis (MS) is mainly known as a disease of young to middle adulthood but approximately 5% of all MS cases worldwide involve children that are younger than 16 years. The aim of care of children with Multiple Sclerosis is to prevent or at least to delay any neurological and cognitive impairment as well as progression of the disease as far as possible. Therefore, it is very crucial to diagnose the disease at an early stage as immunomodulatory treatments are available that can delay the progression of Multiple SclerosisTreatment with the immunomodulatory agent Betaferon® in children diagnosed with RRMS and being 12 years or older has been approved by the health authorities. The aim of this observational study is to obtain further data on the safety, tolerability, and effectiveness of Betaferon® under daily living conditions. As this is a non-interventional observational study, routine clinical practice is observed. The application of diagnostic measures and medications as well as physician visits follow the normal routine and is decided upon by the treating physician under recognition of the package insert.
Study Type
OBSERVATIONAL
Enrollment
68
Patients under daily life treatment receiving Betaferon according to local product information.
Unnamed facility
Many Locations, Austria
Unnamed facility
Many Locations, Belgium
Unnamed facility
Many Locations, Finland
Unnamed facility
Many Locations, Germany
Unnamed facility
Many Locations, Israel
Unnamed facility
Many Locations, United Kingdom
Safety and tolerability of Betaferon in this patient population
Time frame: Up 24 months
Proportion of patients being relapse free
Time frame: Up to 24 months
Time to first relapse
Time frame: Up to 24 months
Annualized relapse rate
Time frame: Up to 24 months
Disability progression measured by the expanded disability status scale (EDSS)
Time frame: Up to 24 months
Outcome on neurological function
e.g. IQ assessment using Standard Progressive Matrices (SPM) and Wechsler intelligence scale for children-fourth edition (WISCIV®), assessment of visual and motor integration using Beery VMI , and assessment of attention and concentration using d2 test.
Time frame: Up to 24 months
Fatigue assessed by Fatigue Severity Scale (FSS)
Time frame: Up to 24 months
MRI measurements (if available)
e.g. number of new T2 lesions, number of new contrast enhancing lesions
Time frame: Up to 24 months
MRI measurements and potential correlation with neuropsychological impairment
Time frame: Up to 24 months
Laboratory outcomes
Laboratory examinations: hemoglobin, mean corpuscular volume, platelets, leukocytes, ALAT/GPT, ASAT/GOT, Alkaline phosphatase, and Gamma-GT
Time frame: Up to 24 months
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