Betaferon Use in Children and Adolescents With Multiple Sclerosis

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

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Russian Federation
  • Multiple Locations, Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multiple sclerosis patients under 18 years old treated with at least one dose of Betaferon until 31.12.2007.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated with Betaferon; 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); Betaferon was injected subcutaneously as prescribed by the treating physician.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2008
• Primary Completion (Actual): April 15, 2009
• Study Completion (Actual): April 15, 2009

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Multiple sclerosis (MS), Betaseron, Betaferon
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon-beta; Interferon beta-1b
• Other Study ID Numbers: 2008/01743

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No