Clinical trial NCT00963833: Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
Official title: Study Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
MS
Non-interventional
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-08-24
Enrollment: 68
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment naive children and adolescents aged 12 to 16 years at inclusion diagnosed with RRMS.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability of Betaferon in this patient population
timeFrame: Up 24 months
Secondary outcomes:
measure: Proportion of patients being relapse free
timeFrame: Up to 24 months
measure: Time to first relapse
timeFrame: Up to 24 months
measure: Annualized relapse rate
timeFrame: Up to 24 months
measure: Disability progression measured by the expanded disability status scale (EDSS)
timeFrame: Up to 24 months
measure: Outcome on neurological function
timeFrame: Up to 24 months
measure: Fatigue assessed by Fatigue Severity Scale (FSS)
timeFrame: Up to 24 months
measure: MRI measurements (if available)
timeFrame: Up to 24 months
measure: MRI measurements and potential correlation with neuropsychological impairment
timeFrame: Up to 24 months
measure: Laboratory outcomes
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Many Locations
country: Austria
city: Many Locations
country: Belgium
city: Many Locations
country: Finland
city: Many Locations
country: Germany
city: Many Locations
country: Israel
city: Many Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: