Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)

NCT ID: NCT01939002

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-11-30

Brief Summary

The primary objective of this study is to determine the proportion of participants with relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS) after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017).

Secondary objectives are: to determine the severity and frequency (measured by flu-like symptom score [FLS-S]) of FLS in these participants; to determine the duration (measured in number of hours) of FLS in these participants; to determine the effect of BIIB017 on other participant-reported outcomes, including treatment satisfaction (measured with the Treatment Satisfaction Questionnaire for Medication [TSQM]) and disability status (measured with the Patient Determined Disease Steps [PDDS]) over a 56-week period; to determine whether interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to assess the use of additional medications (in addition to current medications used to treat FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout the study period; to characterize the immunogenicity profiles of participants switching from prior IFN-β therapy to BIIB017.

Conditions

Relapsing Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIIB017 plus current FLS therapy

Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.

Group Type: EXPERIMENTAL

BIIB017

Intervention Type: DRUG

BIIB017 plus naproxen

Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.

Group Type: EXPERIMENTAL

BIIB017

Intervention Type: DRUG

naproxen

Intervention Type: DRUG

Interventions

BIIB017

Intervention Type: DRUG

naproxen

Intervention Type: DRUG

Other Intervention Names

Plegridy; peginterferon beta-1a; PEGylated interferon beta-1a; PEG IFN β-1a; naproxen sodium; Aleve; NSAID; long-acting nonsteroidal anti-inflammatory drug

Eligibility Criteria

Inclusion Criteria

• Must have a confirmed diagnosis of relapsing forms of multiple sclerosis (MS), as defined by McDonald criteria #1-4 [Polman 2005]
• Must have neurological findings consistent with an Expanded Disability Status Scale (EDSS) score of 0.0 - 5.0
• Must be treated with IFN-β and must be receiving a stable dose of IFN-β for at least 4 months immediately prior to screening
• All male patients and female patients of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.

Exclusion Criteria

• Primary progressive, secondary progressive, or progressive relapsing MS [Lublin and Reingold 1996]. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapse but are distinguished from patients with relapsing MS by the lack of clinically stable periods or clinical improvement
• History of severe allergic or anaphylactic reactions or known hypersensitivity to medication which might suggest potential for a reaction to IFN β-1a or polyethylene glycol
• History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured)
• History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline
• Known allergy to any component of the BIIB017 formulation
• An MS relapse that has occurred within the 50 days prior to Baseline (Day 1) and/or lack of stabilization from a previous relapse prior to Baseline.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Research Site

Gilbert, Arizona, United States

Research Site

Phoenix, Arizona, United States

Research Site

Phoenix, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

Boulder, Colorado, United States

Research Site

Fort Collins, Colorado, United States

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Dover, Delaware, United States

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Newark, Delaware, United States

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Jacksonville, Florida, United States

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Melbourne, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

Research Site

Louisville, Kentucky, United States

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Boston, Massachusetts, United States

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Lexington, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Great Falls, Montana, United States

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Lincoln, Nebraska, United States

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Latham, New York, United States

Research Site

Plainview, New York, United States

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Asheville, North Carolina, United States

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Akron, Ohio, United States

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Dayton, Ohio, United States

Research Site

Uniontown, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Greenville, South Carolina, United States

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Franklin, Tennessee, United States

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Knoxville, Tennessee, United States

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Salt Lake City, Utah, United States

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Newport News, Virginia, United States

Research Site

Roanoke, Virginia, United States

Research Site

Spokane, Washington, United States

Countries

United States

Other Identifiers

105MS303

Identifier Type: -

Identifier Source: org_study_id