Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: BIIB017; naproxen
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: flu-like symptoms

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.
    

Eligibility criteria:

        Key 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.

        Key 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.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.