Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis (MS), Betaseron, Betaferon
Brief summary
The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents
Interventions
DRUGInterferon beta-1b (Betaseron, Betaferon, BAY86-5046)
Betaferon was injected subcutaneously as prescribed by the treating physician.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* patients with symptoms consistent with the diagnosis of a demyelinating CNS disease * patients who received at least one injection of Betaferon before age 18 (before their 18th birthday) * recorded use of at least one dose of Betaferon before January 1, 2008
Exclusion criteria
* Diagnosis other then MS or a demyelinating CNS disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean expanded disability status scale (EDSS) score at the end of trial participation | Up to 2 years | The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale. |
| Proportion of patients having the mean EDSS score of less than or equal to 3.0 and more than or equal to 3.5 at the end of the trial | Up to 2 years | The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale. |
| Mean frequency of complications recorded after start of betaferon therapy | Up to 2 years | — |
| Mean EDSS score on the exacerbations recorded after start of betaferon therapy | Up to 2 years | The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale. |
| Number of adverse events described during the trial and described as possibly, likely, or undoubtedly associated with the test drug | Up to 2 years | — |
| Number of mild, moderate, or severe adverse events | Up to 2 years | — |
| Number of serious adverse events described during the trial | Up to 2 years | — |
| Number of adverse events described during the trial and classified as an flu-like syndrome | Up to 2 years | — |
| Number of adverse events described during the trial and classified as a local reaction | Up to 2 years | — |
| Number of cases of betaferon discontinuation due to adverse events | Up to 2 years | — |
Countries
Russia
Outcome results
None listed