Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
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.
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.