Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
Condition: Relapsing-Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Daclizumab
Intervention description: High yield formulation
Intervention MeSH terms: Daclizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Daclizumab; Tysabri-Switch

Summary:

      The primary objective of the study is to evaluate the effects of treatment with daclizumab on
      the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple
      Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due
      to safety concerns. The secondary objectives of this study in this study population are to
      evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse
      activity including the annualized relapse rate (ARR) and the proportion of participants
      experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related
      outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in
      participants previously treated with natalizumab.
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Must have documented diagnosis of RRMS (McDonald 2010 Criteria) at screening [Polman
             2011].

          -  Must have been treated with natalizumab for at least the 12 months prior to screening
             and have not missed 2 or more consecutive scheduled doses.

          -  Must be naïve to daclizumab and other forms of daclizumab such as Zenapax® prior to
             enrollment.

          -  Must have a confirmed Expanded Disability Status Scale (EDSS) score of 0 to 5.5,
             inclusive, at screening.

          -  Female participants of childbearing potential must practice effective contraception
             from Day -1 and be willing and able to continue contraception for duration of the
             study.

        Key Exclusion Criteria

          -  Current participation in another investigational study.

          -  Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
             (as defined by Lublin and Reingold) [Lublin 2014].

          -  Females breastfeeding, pregnant, or planning to become pregnant; or women who have a
             positive pregnancy test result during screening.

          -  History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior
             to screening.

          -  History of severe hypersensitivity (e.g., anaphylaxis or anaphylactoid reactions) to
             the active ingredient or any of the excipients.

          -  History of severe opportunistic infections (including progressive multifocal
             leukoencephalopathy (PML)) or any clinically significant, cardiac, endocrinologic,
             hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other
             than MS), dermatologic, psychiatric, and renal, or other major disease, as determined
             by the Investigator.

          -  Discontinued natalizumab due to suspicion of PML.

          -  Known active malignancies (participants with cutaneous basal cell carcinoma that has
             been completely excised prior to study entry remain eligible).

          -  The participant is using another MS therapy concomitantly.

          -  Known history of human immunodeficiency virus (HIV).

          -  Positive test result for Hepatitis C virus (test for hepatitis C virus antibody [HCV
             Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and/or
             hepatitis B core antibody [HBcAb]).

          -  The participant has been treated with immunosuppressive or immunomodulating treatments
             including mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate
             mofetil.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.