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| ID | Type | Description | Link |
|---|---|---|---|
| BF1213PL | Other Identifier | company internal |
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This will be prospective, multicentre, observational study. Patients who will initiate treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0) i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient demographics, medical history data, safety parameters, presence of flu-like symptoms and measures to prevent or treat these symptoms will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaseron, BAY86-5046) | Biological | Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean severity score of Flu-Like Symptoms (FLS) recorded within the first 6 months following treatment initiation | 6 months | |
| MS patient with Flu-Like Symptoms (FLS) demographic profile | For demographic assessment the following parameters will be recorded at visit 0: birthdate (at least year), sex, weight, height. | Up to 1 month |
| Frequency of usage of particular pharmacological and non-pharmacological practices applied by investigators to prevent or manage FLS | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of FLS on patients daily activities as measured by current professional/educational status | From baseline up to 6 months | |
| Betaferon tolerability measured as occurrence of Adverse Events (AE) and FLS over 6 months period | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult MS patients starting Betaferon therapy
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Poland |
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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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| 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 |