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

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis

Intervention: BIIB017 (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Peter Calabresi, MD, Principal Investigator, Affiliation: Johns Hopkins University

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.

Clinical Details

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

Primary outcome:

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.

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.

Secondary outcome:

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.

Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population.

Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population.

Analysis of macular volume decreases from baseline or 3 months to follow up scans at 12 months in this study population.

Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 12 months in this study population.

Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.

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.

Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (24 months) in this study population.

Analysis of macular volume decreases from baseline or 3 months to follow up scans at 24 months in this study population.

Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 24 months in this study population.

Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: August 2010
Last updated: September 12, 2014

Page last updated: August 20, 2015

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