Relapsing-Remitting Multiple Sclerosis Clinical Trial
Official title:
A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability
This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a washout period in patients with Multiple Sclerosis who have previously developed neutralizing antibodies to Interferon-Beta
This is an explorative multi-centre, open label, non-comparative trial investigating whether
it is possible to recover IFN-beta efficacy in breakthrough relapsing-remitting multiple
sclerosis patients with high titres of neutralizing IFN-beta antibodies.
Prior to enrollment, treated MS subjects must have been on interferon-beta-1a or
interferon-beta-1b for a minimum of 12 months and have reduced bioavailability as defined by
the relative expression of MxA mRNA/GAPDH.
Subjects will complete a washout period with concurrent methylprednisolone 500mg PO daily
for 3 days every month until they become Neutralizing Antibody negative. Subjects will then
be challenged with AVONEX 30mcg IM weekly. Bioavailability will be measured every three
months to determine return of biological activity. Clinical and MRI parameters, safety and
tolerability will be compared to baseline to determine efficacy.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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