Study Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 68
- Primary Endpoint
- Safety and tolerability of Betaferon in this patient population
Study Overview
Brief Summary
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Treatment naive children and adolescents of 12 to 16 years of age at inclusion with a diagnosis of RRMS according to revised McDonald or Poser criteria and decision taken by the investigator to treat with Betaferon. The local Betaferon product information must be considered.
Exclusion Criteria
- •Contraindications stated in the local Betaferon product information; warnings and precautions must be considered.
Arms & Interventions
Group 1
Intervention: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
Outcomes
Primary Outcomes
Safety and tolerability of Betaferon in this patient population
Time Frame: Up 24 months
Secondary Outcomes
- MRI measurements and potential correlation with neuropsychological impairment(Up to 24 months)
- Time to first relapse(Up to 24 months)
- Disability progression measured by the expanded disability status scale (EDSS)(Up to 24 months)
- Proportion of patients being relapse free(Up to 24 months)
- Annualized relapse rate(Up to 24 months)
- Outcome on neurological function(Up to 24 months)
- Fatigue assessed by Fatigue Severity Scale (FSS)(Up to 24 months)
- MRI measurements (if available)(Up to 24 months)
- Laboratory outcomes(Up to 24 months)