Betaferon Use in Children and Adolescents With Multiple Sclerosis

Study Overview
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Brief Summary
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The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents

Official Title
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Retrospective Data Collection on Betaferon Use in Children and Adolescents With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with Betaferon<br>Patients with very early onset of MS, who received at least one injection of interferon beta-1b as prescribed by the treating physician, before the age of 18. | Drug: Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)<br>* Betaferon was injected subcutaneously as prescribed by the treating physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean expanded disability status scale (EDSS) score at the end of trial participation | 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. | Up to 2 years | 
| 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 | 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. | Up to 2 years | 
| 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 | 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. | Up to 2 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis (MS), Betaseron, Betaferon