Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, relapsing, MS, injectable, subcutaneous, SC, PEGylated, interferon, PEG, OCT, Optical Coherence Tomography
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.
Interventions
DRUGBIIB017
BIIB017 is supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 mcg dose) of 20 kDa mPEG-O-2-methylpropionaldehyde-modified human IFN β-1a in 20 mM acetic acid/sodium acetate buffer pH 4.8, 150 mM arginine hydrochloride, and 0.005% Polysorbate 20.
Sponsors
Biogen
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 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. | 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 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 |
| 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 baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population. | baseline and 3 months |
Outcome results
None listed