Skip to main content
OpenTrials
Completed

NCT Number: NCT03577977

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Betaferon was injected subcutaneously as prescribed by the treating physician.

Primary outcomes

  1. Mean expanded disability status scale (EDSS) score at the end of trial participation

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. Mean frequency of complications recorded after start of betaferon therapy

    Time frame: Up to 2 years

  4. Mean EDSS score on the exacerbations recorded after start of betaferon therapy

    Time frame: 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.

  5. 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

  6. Number of mild, moderate, or severe adverse events

    Time frame: Up to 2 years

  7. Number of serious adverse events described during the trial

    Time frame: Up to 2 years

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

    Time frame: Up to 2 years

  9. Number of adverse events described during the trial and classified as a local reaction

    Time frame: Up to 2 years

  10. Number of cases of betaferon discontinuation due to adverse events

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 5, 2018
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.