Betaferon Use in Children and Adolescents With Multiple Sclerosis

Bayer70 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)DRUG

Betaferon was injected subcutaneously as prescribed by the treating physician.

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Multiple Locations, Russia

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 2 years

Mean frequency of complications recorded after start of betaferon therapy

Time frame: 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.

Time frame: Up to 2 years

Number of adverse events described during the trial and described as possibly, likely, or undoubtedly associated with the test drug

Time frame: Up to 2 years

Number of mild, moderate, or severe adverse events

Time frame: Up to 2 years

Number of serious adverse events described during the trial

Time frame: Up to 2 years

Number of adverse events described during the trial and classified as an flu-like syndrome

Time frame: Up to 2 years

Data from ClinicalTrials.gov

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