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

Purpose

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.

Condition	Intervention	Phase
Relapsing Remitting Multiple Sclerosis	Drug: BIIB017	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis Nuclear Scans

Drug Information available for: Interferon Interferon Beta-1a

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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. [ Time Frame: baseline and 2 years ] [ Designated as safety issue: No ]
Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (24 months) in this study population. [ Time Frame: 3 months and 2 years ] [ Designated as safety issue: No ]
Analysis of macular volume decreases from baseline or 3 months to follow up scans at 24 months in this study population. [ Time Frame: baseline and 2 years ] [ Designated as safety issue: No ]
Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 24 months in this study population. [ Time Frame: baseline and 2 years ] [ Designated as safety issue: No ]
Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	August 2010
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337427

Contacts

Contact: E'Tona Ford, BS

4105022489

eford7@jhmi.edu

Locations

United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21287
Contact: E'Tona Ford 410-502-2489 eford7@jhmi.edu
Principal Investigator: Peter Calabresi, MD
Sub-Investigator: John Ratchford, MD
Sub-Investigator: Christopher Eckstein, MD
Sub-Investigator: Shiv Saidha, MBBCH
Sub-Investigator: Scott Newsome, DO

Sponsors and Collaborators

Johns Hopkins University

Biogen Idec

Investigators

Principal Investigator:

Peter Calabresi, MD

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Peter Calabresi, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01337427 History of Changes
Other Study ID Numbers:	NA_00028117
Study First Received:	April 7, 2011
Last Updated:	April 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

multiple sclerosis
relapsing
MS
injectable
subcutaneous
SC

PEGylated
interferon
PEG
OCT
Optical Coherence Tomography

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta

Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 23, 2013