Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Study Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple Sclerosis|
- Safety and tolerability of Betaferon in this patient population [ Time Frame: At 6, 12, 18, and 24 months ] [ Designated as safety issue: Yes ]
- Annualised relapse rate [ Time Frame: At 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- Disability progression [ Time Frame: At 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- Outcome on neuropsychological function [ Time Frame: At baseline and 24 months ] [ Designated as safety issue: No ]
- MRI measurements (if available) [ Time Frame: At 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- MRI measurements and potential correlation with neuropsychological impairment [ Time Frame: At 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Patients under daily life treatment receiving Betaferon according to local product information.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963833
|Many Locations, Austria|
|Many Locations, Belgium|
|Many Locations, Finland|
|Many Locations, Germany|
|Many Locations, Israel|
|Many Locations, Italy|
|Many Locations, United Kingdom|
|Study Director:||Bayer Study Director||Bayer|