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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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BIIB017
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring multiple sclerosis, relapsing, MS, injectable, subcutaneous, SC, PEGylated, interferon, PEG, OCT, Optical Coherence Tomography

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Placebo for 48 weeks, BIIB017 for 48 weeks

    BIIB017 every 2 weeks for 96 weeks

    BIIB017 every 4 weeks for 96 weeks

    Arm Description

    Placebo every 2 weeks for 48 weeks followed by 125 mcg BIIB017 SC every 2 or 4 weeks for 48 weeks.

    125 mcg BIIB017 SC every 2 weeks for 96 weeks.

    125 mcg BIIB017 SC every 4 weeks for 96 weeks.

    Outcomes

    Primary Outcome 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.
    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 Measures

    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.

    Full Information

    First Posted
    April 7, 2011
    Last Updated
    September 12, 2014
    Sponsor
    Johns Hopkins University
    Collaborators
    Biogen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01337427
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was not feasible to conduct in the US and abroad.
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    August 2013 (Anticipated)
    Study Completion Date
    August 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    Biogen

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Relapsing Remitting Multiple Sclerosis
    Keywords
    multiple sclerosis, relapsing, MS, injectable, subcutaneous, SC, PEGylated, interferon, PEG, OCT, Optical Coherence Tomography

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo for 48 weeks, BIIB017 for 48 weeks
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo every 2 weeks for 48 weeks followed by 125 mcg BIIB017 SC every 2 or 4 weeks for 48 weeks.
    Arm Title
    BIIB017 every 2 weeks for 96 weeks
    Arm Type
    Experimental
    Arm Description
    125 mcg BIIB017 SC every 2 weeks for 96 weeks.
    Arm Title
    BIIB017 every 4 weeks for 96 weeks
    Arm Type
    Experimental
    Arm Description
    125 mcg BIIB017 SC every 4 weeks for 96 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    BIIB017
    Other Intervention Name(s)
    PEGylated Interferon beta-1a, PEG IFN β-1a
    Intervention Description
    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 β-1a in 20 mM acetic acid/sodium acetate buffer pH 4.8, 150 mM arginine hydrochloride, and 0.005% Polysorbate 20.
    Primary Outcome Measure Information:
    Title
    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.
    Time Frame
    1 year
    Title
    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.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    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.
    Time Frame
    baseline and 1 year
    Title
    Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population.
    Time Frame
    baseline and 3 months
    Title
    Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population.
    Time Frame
    3 months and 1 year
    Title
    Analysis of macular volume decreases from baseline or 3 months to follow up scans at 12 months in this study population.
    Time Frame
    baseline and 1 year
    Title
    Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 12 months in this study population.
    Time Frame
    baseline and 1 year
    Title
    Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.
    Time Frame
    1 year
    Title
    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.
    Time Frame
    baseline and 2 years
    Title
    Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (24 months) in this study population.
    Time Frame
    3 months and 2 years
    Title
    Analysis of macular volume decreases from baseline or 3 months to follow up scans at 24 months in this study population.
    Time Frame
    baseline and 2 years
    Title
    Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 24 months in this study population.
    Time Frame
    baseline and 2 years
    Title
    Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter Calabresi, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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