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.
Study Type
OBSERVATIONAL
Enrollment
40
Administered as specified in the treatment arm
Research Site
Brno, Czechia
Research Site
Hradec Králové, Czechia
Research Site
Jihlava, Czechia
Research Site
Pilsen, Czechia
Change from baseline to month 4 in injection site tolerability as measured on a composite visual analogue scale (VAS) score ranging from 0-100
Time frame: Up to 4 months
Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score
Time frame: Up to 12 months
Change from baseline in the VAS score of systemic tolerability
Time frame: Up to 12 months
The percentage of participants still on Avonex Pen
Time frame: 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.
Time frame: Up to 12 months
The percentage of missed injections
Time frame: 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.
Time frame: Up to 12 months
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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
...and 1 more locations