None listed
Conditions
Brief summary
Patients taking beta interferon therapy for multiple sclerosis may develop antibodies to the therapy, called neutralising antibodies. These antibodies can block the action of interferon, reducing its bio-availability for use in the body, thereby reducing its effectiveness as a treatment. This study explores one possible way of reducing the levels of neutralising antibodies in the system by suspending interferon treatment, treating the patient with methylprednisolone to reduce the antibody levels, then restarting interferon therapy by giving AVONEX injections once weekly, and testing to see if the bio-availability or 'effectiveness' of the interferon therapy is restored.
Interventions
Subjects will receive methylprednisolone 500mg oral daily for 3 consecutive days every month followed by AVONEX 30mcg IM weekly once the subject reverts to neutralising antibody negative status.
Sponsors
Biogen Idec Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of relapsing-remitting multiple sclerosis; treated with interferon-b; EDSS below 6.0; test positive for NABs (at least 20 via CPE assay or at least 100 via MxA protein assay) on two consecutive tests at least 3 months apart; reduced bioavailability as measured by MxA mRNA/GAPDH.
Exclusion criteria
No exclusion criteria
Outcome results
None listed