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To evaluate treatment tolerability, adherence and quality of life (QoL) over 1 year in MS (Multiple Sclerosis) participants who have been switched - due to persistent tolerability issues, particularly injection problems - from a subcutaneous injectable disease-modifying treatment (DMT) given several times a week (Rebif, Betaferon or Copaxone) to once weekly Avonex 30 μg given intra-muscularly. Avonex will be applied by the injection device Avonex Pen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interferon beta-1a | 30 μg intramuscularly once a week using an injection device (Avonex Pen). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interferon beta-1a | Device | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to month 4 in injection site tolerability as measured on a composite visual analogue scale (VAS) score ranging from 0-100 | Up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score | Up to 12 months | |
| Change from baseline in the VAS score of systemic tolerability | Up to 12 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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Recruitment by participating clinicians in Switzerland and Czech Republic.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brno | Czechia | ||||
| Research Site |
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| The percentage of participants still on Avonex Pen | Up to 12 months |
| Quality of Life as assessed by the change in Short Form (SF) Health Survey, SF-36 scores | The SF-36 is a short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. | Up to 12 months |
| The percentage of missed injections | Up to 12 months |
| Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score | Fatigue is rated using the self-administered FSMC questionnaire that includes ten questions that relate to motor fatigue and ten to cognitive fatigue. Higher scores indicate higher fatigue. | Up to 12 months |
| Hradec Králové |
| Czechia |
| Research Site | Jihlava | Czechia |
| Research Site | Pilsen | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Teplice | Czechia |
| Research Site | Biel/Bienne | Switzerland |
| Research Site | Langenthal | Switzerland |
| Research Site | Lugano | Switzerland |
| Research Site | Sion | Switzerland |
| Research Site | Wil | Switzerland |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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