Retrospective Data Collection on Betaferon Use in Children and Adolescents With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 70
- Primary Endpoint
- Number of adverse events described during the trial and described as possibly, likely, or undoubtedly associated with the test drug
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Interferon beta-1b (Betaseron, Betaferon, BAY86-5046) (Drug)
Outcomes
Primary Outcomes
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
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.
Number of mild, moderate, or severe adverse events
Time Frame: Up to 2 years
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.
Number of serious adverse events described during the trial
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
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.
Mean frequency of complications recorded after start of betaferon therapy
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
Number of cases of betaferon discontinuation due to adverse events
Time Frame: Up to 2 years
Number of adverse events described during the trial and classified as a local reaction
Time Frame: Up to 2 years
Secondary Outcomes
No secondary outcomes reported