This study is to find out if Interferon-beta can recover its effectiveness in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta.
This is a multi-center, open Label, non-comparative Phase IV trial. Eligible Patients will receive treatment with Interferon-beta-1a (AVONEX) 30mcg I.M. once weekly for up to 12 months. In the wash-out period prior to commencing treatment with AVONEX, patients will receive treatment with intermittent Methylprednisolone 500 mg PO Daily for three consecutive days at monthly intervals. The patients will be examined clinically and laboratory tests will be performed at screening (month -1) and after 3, 9, and 15 months. Neutralizing antibody(NAb)titres and Binding antibody(BAb)titres as well as MxA protein levels will be evaluated at screening/baseline (month -1/0) and after 3, 6, 9, 12, and 15 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
dosage and frequency as per label
dosage and frequency as per Biogen Idec protocol
Coordinating Research Site
Turku, Finland
Reduction in the proportion of patients being neutralizing antibody (NAb) positive (titre>20)
Time frame: Month -1 and after 3, 6, 9, 12, and 15 months
Change in MxA protein values
Time frame: Month -1 and after 3, 6, 9, 12, and 15 months
Change in binding antibody (Bab) tires
Time frame: Month -1 and after 3, 6, 9, 12, and 15 months
Proportion of patients with NAb positive titre <5
Time frame: Month -1 and after 3, 6, 9, 12, and 15 months
Change in annualised relapse rate
Time frame: at 3, 6, 9, 12, and 15 months
The number of relapse-free patients
Time frame: at 3, 6, 9, 12, and 15 months
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