An observational study in Multiple Sclerosis, sponsored by Bayer. Completed at 1 site in Russian Federation. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2018-07-11.
Sponsored by Bayer · Observational
The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 70 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Multiple sclerosis patients under 18 years old treated with at least one dose of Betaferon until 31.12.2007.
Exclusion Criteria:
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.
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
Number of adverse events described during the trial and classified as a local reaction
Time frame: Up to 2 years
Number of cases of betaferon discontinuation due to adverse events
Time frame: Up to 2 years
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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