Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: BIIB019 (Daclizumab); trivalent seasonal influenza vaccine
Intervention description: Administered as specified in the treatment arm.; All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site
Intervention MeSH terms: Daclizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 410.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: MS; Multiple Sclerosis

Summary:

      Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield
      Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple
      sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP
      and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS)
      relapse, slowing disability progression, and reducing new MS lesion formation in this study
      population.
    

Eligibility criteria:

        Main Study Eligibility:

        Key Inclusion Criteria:

          -  Ability to understand the purpose and risks of the study and provide signed and dated
             informed consent and authorization to use protected health information (PHI) in
             accordance with national and local subject privacy regulations.

          -  Subjects who have completed 52 weeks in Study 205MS202 (NCT00870740) and were
             compliant with the 205MS202 protocol in the opinion of the Investigator.

          -  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:

          -  Subjects with any significant change in their medical status from the previous study
             that would prelude administration of Daclizumab High Yield Process (DAC HYP) as
             determined by the Investigator including laboratory tests or a current clinically
             significant condition that, in the opinion of the Investigator, would have excluded
             the subject's participation in the 205MS201 (NCT00390221) or 205MS202 (NCT00870740)
             studies. The Investigator must re-review the subject's medical fitness for
             participation and must consider any diseases that would preclude treatment.

          -  Any subject who has permanently discontinued study treatment in Study 205MS202
             (NCT00870740) due to an adverse event.

          -  Current enrollment in any investigational drug study other than Study 205MS202
             (NCT00870740).

          -  Ongoing treatment with any approved or experimental disease-modifying treatment for
             multiple sclerosis.

          -  For subjects currently taking valproic acid, carbamazepine, lamotrigine, or phenytoin:

               -  Subjects treated with any of these agents for fewer than 6 months prior to study
                  entry are excluded from study participation unless they discontinue the agent(s)
                  prior to study entry.

               -  Subjects treated with 2 or more of these agents for more than 6 months prior to
                  study entry are excluded from study participation unless they reduce to ≤1 agent
                  prior to study entry.

               -  Subjects who have had dose escalations of one of these agents within the 6 months
                  prior to study entry are excluded from study participation unless they revert to
                  a previous dose that had been used for at least 6 months prior to study entry or
                  unless they discontinue the agent prior to study entry

          -  Subjects who are currently receiving treatment with isoniazid, propylthiouracil, or
             nimesulide at the time of study entry and are not able to discontinue the agent or
             change to an alternative medication allowed by the protocol.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.