Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
Condition: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: BIIB019 (Daclizumab)
Intervention description: Participants will receive open-label treatment with BIIB019 150 mg subcutaneous injection every 4 weeks for up to 5 years.
Intervention MeSH terms: Daclizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1501.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess the safety and tolerability of long-term
      treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants
      with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301
      (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).

      Secondary objectives of this study in this study population are as follows:

      To describe MS-related outcomes, including MS relapse, disability progression, MS lesion
      formation, and participant-reported impact of MS, following long-term treatment with DAC HYP
      To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To
      assess the safety, tolerability, and efficacy of switching to DAC HYP in participants
      previously on long-term treatment with interferon β-1a (Avonex) in Study
      205MS301(NCT01064401).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must be a subject currently participating in Study 205MS301 (NCT01064401), or subject
             currently participating in Study 205MS203 (NCT01051349) or Study 205MS302
             (NCT01462318) who has completed End of Study Visit (Week 96 or later).

          -  Women of childbearing potential must 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:

          -  Any subject who permanently discontinued study treatment in Study 205MS301
             (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) prior to
             the end of the study treatment period, or had an Early Termination visit in Study
             205MS301, Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).

          -  Any significant change in the subject's medical history that would preclude
             administration of BIIB019, including laboratory tests or a current clinically
             significant condition that, in the opinion of the Investigator, would have excluded
             the subject's participation in Study 205MS301 (NCT01064401), Study 205MS203
             (NCT01051349) or Study 205MS302 (NCT01462318).

        The Investigator must re review the subject's medical fitness for participation and
        consider any factors that would preclude treatment in this Study 205MS303.

        NOTE: Other protocol-defined inclusion/exclusion criteria may apply.