Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple Sclerosis
- Registration Number
- NCT01337427
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
This research sub-study is being completed as a part of the Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis (Protocol #: NA_00028117). This substudy is being done to understand the efficacy of BIIB017 by measuring the nerve fiber thickness in the eye.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- A participant in the ADVANCE study aged 18 to 55 years old, inclusive, at the time of informed consent
Exclusion Criteria
- As per the ADVANCE main study
- History of intraocular surgery, retinal disease, glaucoma, or diabetes
- Refractive errors of more than ±6.0 diopters
- Inability to tolerate OCT procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BIIB017 every 2 weeks for 96 weeks BIIB017 125 mcg BIIB017 SC every 2 weeks for 96 weeks. Placebo for 48 weeks, BIIB017 for 48 weeks BIIB017 Placebo every 2 weeks for 48 weeks followed by 125 mcg BIIB017 SC every 2 or 4 weeks for 48 weeks. BIIB017 every 4 weeks for 96 weeks BIIB017 125 mcg BIIB017 SC every 4 weeks for 96 weeks.
- Primary Outcome Measures
Name Time Method To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 24 in the BIIB-17 vs. placebo arms. 2 years To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 12 in the BIIB-17 vs. placebo arms. 1 year
- Secondary Outcome Measures
Name Time Method Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population. 3 months and 1 year Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 12 in the BIIB-17 vs. placebo arms. baseline and 1 year Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population. baseline and 3 months Analysis of macular volume decreases from baseline or 3 months to follow up scans at 12 months in this study population. baseline and 1 year Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 12 months in this study population. baseline and 1 year Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis. 2 years Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 24 in the BIIB-17 vs. placebo arms. baseline and 2 years Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (24 months) in this study population. 3 months and 2 years Analysis of macular volume decreases from baseline or 3 months to follow up scans at 24 months in this study population. baseline and 2 years Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 24 months in this study population. baseline and 2 years