This study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment
This is a multi-centre, prospective, open label, non-comparative phase IV trial. Eligible patients will receive treatment with IFN-beta-1a AVONEX® 30 mcg i.m. once weekly for 12 months.The patients will be examined clinically and NAb titres will be performed at screening and after 12 months. Adverse event source verification will be performed during the documentation period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
dosage and frequency as per Biogen Idec protocol
Research Site
Gothenburg, Sweden
Coordinating Research Site
Huddinge, Sweden
Research Site
Jönköping, Sweden
Research Site
Karlstad, Sweden
Research Site
Stockholm, Sweden
neutralizing antibody levels will be followed
Time frame: 12 months
Proportion of patients with NAb positive titre > 20.
Time frame: 12 months
Relative change from baseline (screening) of NAb titre
Time frame: 12 months
Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients
Time frame: 12 months and as needed for relapses
The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS.
Time frame: 12 months
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