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The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaseron, Betaferon, BAY86-5046) | Drug | Betaferon was injected subcutaneously as prescribed by the treating physician. |
|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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Multiple sclerosis patients under 18 years old treated with at least one dose of Betaferon until 31.12.2007.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Russia |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |