Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

Exclusion Criteria

• •Diagnosis or history of neuromyelitis optica (NMO), e.g., a long spinal lesion extending over 3 or more vertebral bodies was detected, or the subject has a history of positive tests for anti-aquaporin-4 (anti-AQP4) antibodies.
• •The subject is considered by the Investigator to be immunocompromised, based on medical history, physical examination, laboratory testing, or prior immunosuppressive or immunomodulating treatment.
• •An MS exacerbation (relapse) within 30 days prior to enrollment or, in the opinion of the Investigator, the subject has not stabilized from a relapse prior to enrollment at Week 0.
• •History of malignancy.
• •Known history of, or positive test result for human immunodeficiency virus (HIV) infection.
• •Known history of or positive test result for hepatitis C virus or hepatitis B virus within the year prior to enrollment.
• •History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
• •A clinically significant infectious illness within 30 days prior to enrollment.
• •Abnormal liver function test results at screening: alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \>2 times of the upper limit of normal (ULN) or bilirubin \>1.5 times of the ULN during screening.
• •Previous treatment with natalizumab, any murine protein, or any other therapeutic monoclonal antibody.
• •Any prior treatment with any of the following medications: total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination.
• •Treatment with immunosuppressant medications, e.g., azathioprine, cyclophosphamide, methotrexate, and fingolimod within 6 months prior to enrollment, or mitoxantrone and cyclosporine within 12 months prior to enrollment.
• •Treatment with any of the following medications or procedures within 6 months prior to enrollment: intravenous immunoglobulin (IVIg), plasmapheresis, or cytapheresis.
• •Treatment with immunomodulatory medications (including IFNβ and glatiramer acetate \[GA\]) within 2 weeks of enrollment.
• •Treatment with any of the following medications within 30 days of enrollment: intravenous corticosteroid treatment, systemic corticosteroid treatment, 4-aminopyridine or related products.
• •Participation in any other investigational treatment within the 6 months prior to enrollment or concurrent with this study.
• •Part B
• •Diagnosis or history of NMO, e.g., a long spinal lesion extending over 3 or more vertebral bodies was detected, or the subject has a history of positive tests for anti-AQP4 antibodies.
• •The subject is considered by the Investigator to be immunocompromised, based on medical history, physical examination, laboratory testing, or prior immunosuppressive or immunomodulating treatment.
• •An MS exacerbation (relapse) within 30 days prior to enrollment or, in the opinion of the Investigator, the subject has not stabilized from a relapse prior to enrollment at Week 0.
• •History of malignancy.
• •Known history, or positive test result of HIV infection.
• •Known history of or positive test result for hepatitis C virus or hepatitis B virus within the year prior to Enrollment.
• •History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
• •A clinically significant infectious illness within 30 days prior to Enrollment.
• •Abnormal liver function test results at screening: ALT or AST \>2 times of the ULN or bilirubin \>1.5 times of the ULN during screening.
• •Previous treatment with natalizumab, any murine protein, or any other therapeutic monoclonal antibody.
• •Any prior treatment with any of the following medications: total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination.
• •Treatment with immunosuppressant medications, e.g., azathioprine, cyclophosphamide, methotrexate, and fingolimod within 6 months prior to enrollment, or mitoxantrone and cyclosporine within 12 months prior to enrollment.
• •Treatment with any of the following medications or procedures within 6 months prior to enrollment: IVIg, plasmapheresis, or cytapheresis.
• •Treatment with immunomodulatory medications (including IFNβ and GA) within 2 weeks of enrollment.
• •Treatment with any of the following medications within 30 days of enrollment: intravenous corticosteroid treatment, systemic corticosteroid treatment, 4-aminopyridine or related products.
• •Participation in any other investigational treatment within the 6 months prior to enrollment or concurrent with this study.