Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: natalizumab
Intervention MeSH terms: Natalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to further evaluate the long-term safety and
      tolerability profiles of BG00002 (natalizumab) in Japanese participants with
      relapsing-remitting multiple sclerosis (RRMS). The secondary objective of this study is to
      further evaluate the long-term efficacy profile of BG00002 in Japanese participants with
      RRMS.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability to understand the purpose and risks of the study and provide signed and dated
             informed consent and any authorizations required by local law.

          -  Subjects who participated in and completed all protocol-related evaluations through
             Week 24 of Study 101MS203 (NCT01440101).

          -  Subjects participating in study 101MS204 (NCT01416155) participated either in the open
             label pharmacokinetics-pharmacodynamics study or placebo-controlled study of
             natalizumab 300 mg q4wks (parts A and B of study 101MS203, respectively).

          -  Subjects of childbearing potential must practice effective contraception during the
             study and be willing and able to continue contraception for 12 weeks after their last
             dose of study treatment.

          -  Must be willing to remain free from concomitant immunosuppressive or immunomodulatory
             treatment (including interferon beta [IFNβ] and long-term systemic corticosteroids)
             for the duration of the study.

        Key Exclusion Criteria Medical History

          -  Any significant change in medical history since Study 101MS203 (NCT01440101),
             including laboratory tests, or current clinically important condition that in the
             opinion of the Investigator would have excluded the subject's participation in the
             previous study. The Investigator must re-review the subject's medical fitness for
             participation and consider diseases that would preclude treatment.

          -  Subjects from Study 101MS203 (NCT01440101) who discontinued study treatment due to an
             adverse event.

          -  Subjects who are determined to be persistently positive for anti-BG0002 antibodies
             based on prior testing.

        Treatment History

          -  Treatment with any of the following medications between last dose of study treatment
             in Study 101MS203 (NCT01440101) and the start of this study: intravenous
             immunoglobulin (IVIg), plasmapheresis, cytapheresis, immunosuppressant medications
             (e.g., mitoxantrone, azathioprine, cyclophosphamide, methotrexate, cyclosporine,
             FTY720), immunomodulatory medications (including IFNβ and glatiramer acetate [GA])
             total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination, any
             murine protein, any other therapeutic monoclonal antibody, or any 4-aminopyridine or
             related products.

        Miscellaneous

          -  For female subjects, unless postmenopausal for at least 1 year or surgically sterile
             (does not include tubal ligation), unwillingness to practice effective contraception,
             as defined by the Investigator, during the study. Women considering becoming pregnant
             while on study are to be excluded.

          -  Female subjects who are currently pregnant or breast feeding, including subjects whose
             pregnancy test is positive at Week 0.

          -  Unwillingness or inability to comply with the requirements of this protocol, including
             the presence of any condition (physical, mental, or social) that is likely to affect
             the subject's ability to comply with the study protocol.

          -  Subjects with any other condition, clinical finding, or reason that in the opinion of
             the Investigator and/or the Sponsor makes the subject unsuitable for enrollment into
             the study.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.