A Multi-Centre, Open label Study to Investigate the Recovery of Interferon-b Efficacy in Relapsing-Remitting Multiple Sclerosis Patients with Neutralising IFN-b Antibodies and Reduced Bioavailability.
Phase 4
Recruiting
- Conditions
- Relapsing-remitting Multiple SclerosisNeurological - Multiple sclerosis
- Registration Number
- ACTRN12605000657628
- Lead Sponsor
- Biogen Idec Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Return of bioavailability of AVONEX® (Interferon b-1a) as measured by induction of MxA mRNA.[]
- Secondary Outcome Measures
Name Time Method Effects and safety of a washout period with monthly methylprednisolone followed by challenge with AVONEX® on: Proportion of patients becoming neutralising antibody negative.[];Proportion of patients relapse free.[At 6, 12, 18 and 24 months.];Total relapses[At 27 months.];Proportion of patients with increase in Expanded Disability Status Scale (EDSS).[];Brain atrophy (BPF) measured on MRI[];Cumulative number of new or enlarging T2 lesions; T2 lesions volume; T1 lesions volume.[];Number and volume of enhancing lesions.[];Quality of life assessment as measured on visual analogue scale (VAS).[]