Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple Sclerosis

Johns Hopkins University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Relapsing Remitting Multiple Sclerosis

Interventions

BIIB017DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 2 years

Secondary Outcomes

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.

Time frame: baseline and 1 year

Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population.

Time frame: baseline and 3 months

Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population.

Time frame: 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.

Time frame: 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.

Time frame: baseline and 1 year

Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.

Time frame: 1 year

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.

Data from ClinicalTrials.gov

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