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

Optical Coherence Tomography (OCT) in a 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

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 Overview

• Status: Withdrawn
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: BIIB017

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo for 48 weeks, BIIB017 for 48 weeks; Placebo every 2 weeks for 48 weeks followed by 125 mcg BIIB017 SC every 2 or 4 weeks for 48 weeks.	Drug: BIIB017; 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.; Other Names: PEGylated Interferon beta-1a; PEG IFN β-1a
Experimental: BIIB017 every 2 weeks for 96 weeks; 125 mcg BIIB017 SC every 2 weeks for 96 weeks.	Drug: BIIB017; 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.; Other Names: PEGylated Interferon beta-1a; PEG IFN β-1a
Experimental: BIIB017 every 4 weeks for 96 weeks; 125 mcg BIIB017 SC every 4 weeks for 96 weeks.	Drug: BIIB017; 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.; Other Names: PEGylated Interferon beta-1a; PEG IFN β-1a

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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 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 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
Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.	2 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Biogen
• Investigators: Principal Investigator: Peter Calabresi, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: April 7, 2011
• First Submitted That Met QC Criteria: April 15, 2011
• First Posted (Estimate): April 18, 2011

Study Record Updates

• Last Update Posted (Estimate): September 15, 2014
• Last Update Submitted That Met QC Criteria: September 12, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: OCT; interferon; MS; subcutaneous; multiple sclerosis; Optical Coherence Tomography; relapsing; injectable; SC; PEGylated; PEG
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferons; Interferon beta-1a; Interferon-beta
• Other Study ID Numbers: NA_00028117