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

Relapsing Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01337427
• Other study ID #: NA_00028117
• Status: Withdrawn
• Phase: Phase 3
• First received: April 7, 2011
• Last updated: September 12, 2014
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

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 ß-1a in 20 mM acetic acid/sodium acetate buffer pH 4.8, 150 mM arginine hydrochloride, and 0.005% Polysorbate 20.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Biogen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population.		baseline and 3 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.		1 year	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.		2 years	No