Relapsing-Remitting Multiple Sclerosis Clinical Trial
Official title:
A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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