Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: BIIB019 (Daclizumab High Yield Process); Interferon beta-1a Placebo; Interferon beta-1a; Daclizumab High Yield Process Placebo
Intervention description: Daclizumab High Yield Process for subcutaneous injection; Placebo to interferon beta-1a intramuscular injection; Interferon beta-1a for intramuscular injection; Placebo to Daclizumab High Yield Process subcutaneous injection
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Daclizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1841.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC
      HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in
      participants with relapsing remitting multiple sclerosis.

      The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in
      slowing functional decline and disability progression and maintaining quality of life in this
      participant population.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and
             a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS

          -  Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0,
             inclusive

          -  Male subjects and female subjects of childbearing potential must be willing to
             practice effective contraception during the study and be willing and able to continue
             contraception for 4 months after their last dose of study treatment

        Key Exclusion Criteria:

          -  Known intolerance, contraindication to, or history of non-compliance with Avonex® 30
             µg

          -  History of treatment with Daclizumab High Yield Process (Dac HYP)

          -  History of malignancy

          -  History of severe allergic or anaphylactic reactions

          -  Known hypersensitivity to study drugs or their excipients

          -  History of abnormal laboratory results indicative of any significant disease

          -  History of human immunodeficiency virus (HIV) or other immunodeficient conditions

          -  History of drug or alcohol abuse (as defined by the Investigator) within the 2 years
             prior to randomization

          -  History of seizure disorder or unexplained blackouts OR history of a seizure within 6
             months prior to Baseline

          -  History of suicidal ideation or an episode of clinically severe depression (as
             determined by the Investigator) within 3 months prior to Day 1

          -  An MS relapse that has occurred within the 50 days prior to randomization AND/OR the
             subject has not stabilized from a previous relapse prior to randomization

          -  Known history of, or positive screening test result for hepatitis C virus or hepatitis
             B virus

          -  Varicella or herpes zoster virus infection or any severe viral infection within 6
             weeks before screening

          -  Exposure to varicella zoster virus within 21 days before screening

        NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.