BG00002 Study in Japanese Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) (Tysabri Japan)

Part A

Inclusion Criteria:

• Must give written informed consent and any authorisations required by local law.
• Must have a diagnosis of a relapsing-remitting MS, as defined by the revised McDonald criteria 1 through 4 (Polman et al, 2005). All other possible neurologic diagnoses must have been reasonably excluded by means of laboratory and/or imaging studies, in the opinion of the Investigator.
• Japanese men and women aged 18 to 65, inclusive, at the time of informed consent.
• All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be able to continue contraception for 12 weeks after their last dose of study treatment.
• Must have an EDSS score between 0.0 and 6.0, inclusive.
• Must have experienced at least 1 medically documented clinical exacerbation within 12 months of Enrolment.
• Must be willing to remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFNβ and chronic systemic corticosteroids) for the duration of the study.
• Prior to Enrolment all subjects must have a baseline MRI, conducted within 35 calendar days prior to Enrolment.

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-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 Enrolment or, in the opinion of the Investigator, the subject has not stabilised from a relapse prior to Enrolment 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 Enrolment.
• History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
• A clinically significant infectious illness within 30 days prior to Enrolment.
• Abnormal Screening liver function test results: 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 BG0002, 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 FTY720 within 6 months prior to Enrolment, or mitoxantrone and cyclosporine within 12 months prior to Enrolment.
• Treatment with any of the following medications or procedures within 6 months prior to Enrolment: intravenous immunoglobulin (IVIg), plasmapheresis, or cytapheresis.
• Treatment with immunomodulatory medications (including IFNβ and GA) within 2 weeks of Enrolment.
• Treatment with any of the following medications within 30 days of Enrolment: intravenous corticosteroid treatment, systemic corticosteroid treatment, 4-aminopyradine or related products.
• Participation in any other investigational treatment within the 6 months prior to Enrolment or concurrent with this study.

Part B

Inclusion Criteria:

• Must give written informed consent and any authorisations required by local law.
• Must have a diagnosis of a relapsing-remitting MS, as defined by the revised McDonald criteria 1 through 4 (Polman et al, 2005). All other possible neurologic diagnoses must have been reasonably excluded by means of laboratory and/or imaging studies, in the opinion of the Investigator.
• Japanese men and women aged 18 to 65, inclusive, at the time of informed consent.
• All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be able to continue contraception for 12 weeks after their last dose of study treatment.
• Must have an EDSS score between 0.0 and 5.5, inclusive.
• Must have experienced at least 1 medically documented clinical exacerbation within 12 months of Enrolment.
• Must be willing to remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFNβ and chronic systemic corticosteroids) for the duration of the study.
• Prior to Enrolment all subjects must have: a screening MRI, or documentation of an MRI within the subject's medical record within 1 year of the screening visit, which reveals 3 or more T2 hyperintense lesions consistent with MS, and a baseline MRI, conducted within 7 calendar days prior to Enrolment, which reveals at least 1 MRI lesion consistent with MS.

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-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 Enrolment or, in the opinion of the Investigator, the subject has not stabilised from a relapse prior to Enrolment 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 Enrolment.
• History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
• A clinically significant infectious illness within 30 days prior to Enrolment.
• Abnormal Screening liver function test results: ALT or AST >2 times of the ULN or bilirubin >1.5 times of the ULN during Screening.
• Previous treatment with BG0002, 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 FTY720 within 6 months prior to Enrolment, or mitoxantrone and cyclosporine within 12 months prior to Enrolment.
• Treatment with any of the following medications or procedures within 6 months prior to Enrolment: IVIg, plasmapheresis, or cytapheresis.
• Treatment with immunomodulatory medications (including IFNβ and GA) within 2 weeks of Enrolment.
• Treatment with any of the following medications within 30 days of Enrolment: intravenous corticosteroid treatment, systemic corticosteroid treatment, 4-aminopyradine or related products.
• Participation in any other investigational treatment within the 6 months prior to Enrolment or concurrent with this study.