An observational study in Relapsing-Remitting Multiple Sclerosis, Clinical Isolated Syndrome (CIS) and Multiple Sclerosis, sponsored by Biogen. Completed at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-27.
Sponsored by Biogen · Observational
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Recruitment by participating clinicians in Switzerland and Czech Republic.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
30 μg intramuscularly once a week using an injection device (Avonex Pen).
Device: interferon beta-1a
Administered as specified in the treatment arm
Also known as: BG9418, Avonex Pen, Avonex
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
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Biogen