Betaferon Use in Children and Adolescents With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577977
• Other study ID #: 2008/01743
• Status: Completed
• Start date: June 1, 2008
• Est. completion date: April 15, 2009

Study information

• Verified date: July 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 15, 2009
• Est. primary completion date: April 15, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)
Betaferon was injected subcutaneously as prescribed by the treating physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Mean frequency of complications recorded after start of betaferon therapy		Up to 2 years
Primary	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
Primary	Number of adverse events described during the trial and described as possibly, likely, or undoubtedly associated with the test drug		Up to 2 years
Primary	Number of mild, moderate, or severe adverse events		Up to 2 years
Primary	Number of serious adverse events described during the trial		Up to 2 years
Primary	Number of adverse events described during the trial and classified as an flu-like syndrome		Up to 2 years
Primary	Number of adverse events described during the trial and classified as a local reaction		Up to 2 years
Primary	Number of cases of betaferon discontinuation due to adverse events		Up to 2 years

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