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101 MS-201

A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002‑E) in Subjects with Relapsing Forms of Multiple Sclerosis

Study Duration
The treatment phase of the study will be for 32 weeks (Week 0 through Week 32).

Key Inclusion Criteria

  1. Must give written informed consent and any authorizations required by local law (e.g., PHI).
  2. Must have a diagnosis of a relapsing form of MS, and the subject must fall within the therapeutic indications stated in the locally approved label for TYSABRI.
  3. Aged 18 to 55 years old, inclusive, at the time of informed consent.
  4. Must be natalizumab naïve.
  5. Must have a baseline EDSS score between 0.0 and 6.5, inclusive.
  6. ust be willing to remain free from concomitant immunosuppressive or immunomodulatory treatment (including interferon-â and glatiramer acetate) for the duration of the study.

Key Exclusion Criteria
Medical History

  1. Diagnosis of primary progressive, or secondary progressive MS without the occurrence of
    relapses (as defined by Lublin and Reingold, 1996).
  2. In the opinion of the investigator, an MS relapse has occurred within 50 days prior to enrollment AND/OR the subject has not stabilized from a previous relapse.
  3. The subject is considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing or due to prior immunosuppressive treatment.
  4. The subject has a history of, or available abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), renal, and/or other major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent for 32 weeks. The Investigator must re-review the subject’s medical fitness for participation and consider any diseases that would preclude treatment.
  5. The subject is unable to have a brain MRI scan (e.g., subject with metal clip to repair cerebral aneurysm).
  6. History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
  7. Known history of human immunodeficiency virus infection or hematological malignancy, or organ transplantation (including anti-rejection therapy).
  8. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
  9. A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to the Screening Visit.

Treatment History

  1. Any previous treatment with natalizumab.
  2. Treatment with immunosuppressant medications (e.g., mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate) within 3 months prior to Screening.
  3. Treatment with immunomodulatory medications (including Interferon-β and glatiramer acetate) within 2 weeks prior to Screening
  4. Treatment with any systemic steroid within 30 days prior to investigational drug administration.


  1. History of alcohol or drug abuse within 2 years prior to randomization.
  2. Female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or willing to practice effective contraception (as defined by the Investigator) during the study.
  3. Women who are breastfeeding, pregnant, or planning to become pregnant while on study.
  4. Current enrollment in any other study treatment or disease study.
  5. 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.
  6. Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment into this study.

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