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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

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
WithdrawnPhase 3Relapsing MSNCT01337427

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: The study was not feasible to conduct in the US and abroad.

What was tested

Treatment tested

What it measured

Main 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.

    1 year

    Retina scans (OCT)

  • 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

    Retina scans (OCT)

Other measures (11)

  • 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

    Retina scans (OCT)

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

    baseline and 3 months

    Brain volume loss

  • 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

  • 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

  • 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

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

    1 year

    Retina scans (OCT)

  • 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

    Retina scans (OCT)

  • 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

  • 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

  • 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

Who could take part

Relapsing MS · 18 to 55

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Aug 2010

      2. Main results due

        Aug 2013

      3. Finished

        Aug 2013

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