Betaferon Use in Children and Adolescents With Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)

• Registration Number: NCT03577977
• Lead Sponsor: Bayer

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-06-01
• Primary Completion: 2009-04-15
• Study Completion: 2009-04-15
• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-06-25
• Status Verified: 2018-07
• Study First Posted: 2018-07-05
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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Exclusion Criteria

• Diagnosis other then MS or a demyelinating CNS disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with Betaferon	Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)	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.

Primary Outcome Measures

Name	Time	Method
Number of adverse events described during the trial and described as possibly, likely, or undoubtedly associated with the test drug	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 mild, moderate, or severe adverse events	Up to 2 years
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.
Number of serious adverse events described during the trial	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	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
Number of adverse events described during the trial and classified as an flu-like syndrome	Up to 2 years
Number of cases of betaferon discontinuation due to adverse events	Up to 2 years
Number of adverse events described during the trial and classified as a local reaction	Up to 2 years