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



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:11/8/2014
Start Date:August 2010
End Date:August 2013
Contact:E'Tona Ford, BS
Email:eford7@jhmi.edu
Phone:4105022489

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
Johns Hopkins University
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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mi
from
Baltimore, MD
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