Clinical trial NCT01337427: Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: multiple sclerosis
relapsing
MS
injectable
subcutaneous
SC
PEGylated
interferon
PEG
OCT
Optical Coherence Tomography
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2011-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: baseline and 1 year
measure: Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population.
timeFrame: baseline and 3 months
measure: Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population.
timeFrame: 3 months and 1 year
measure: Analysis of macular volume decreases from baseline or 3 months to follow up scans at 12 months in this study population.
timeFrame: baseline and 1 year
measure: Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 12 months in this study population.
timeFrame: baseline and 1 year
measure: Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.
timeFrame: 1 year
measure: 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.
timeFrame: baseline and 2 years
measure: Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (24 months) in this study population.
timeFrame: 3 months and 2 years
measure: Analysis of macular volume decreases from baseline or 3 months to follow up scans at 24 months in this study population.
timeFrame: baseline and 2 years
measure: Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 24 months in this study population.
timeFrame: baseline and 2 years
measure: Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Peter Calabresi, MD
role: PRINCIPAL_INVESTIGATOR
References: