Department of Neurology

Department Home >

  • Base >
  • You are here
Department of Neurology

101 MS-322

An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, or C-1803 and a Dosing Suspension Safety Evaluation

Study Duration
Natalizumab will be administered as a 300 mg IV infusion every 4 weeks for up to 48 weeks.

Inclusion Criteria

  1. Must provide written informed consent
  2. Must be an MS subject who completed C-1801, 1802, 1803 and a Dosing Suspension Safety Evaluation
  3. Must be considered by the Investigator free of signs and symptoms suggestive of PML
  4. Must be willing to discontinue and remain free of concomitant immunosuppressive or immunomodulatory treatment (including interferon and glatiramir acetate) for the duration of the study

Exclusion Criteria
Medical History

  1. Considered by the Investigator to be immunocompromised
  2. History of anti-natalizumab antibodies
  3. History of abnormal lab results indicative of major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent for 48 weeks.
  4. History of malignancy
  5. Known history of HIV infection, hematological malignancy, or organ transplantation
  6. History of severe allergic or anaphylactic reactions or known drug hypersensitivity
  7. A significant change from the subject's medical history from the previous natalizumab study
  8. A clinically significant infectious illness (e.g., cellulites, abscess, pneumonia, septicemia) within 30 days of the screening visit

Treatment History

  1. Discontinued natalizumab in the previous study due to allergic reaction of SAE
  2. Discontinued study drug in the previous studies due to an AE or due to reasons other than significant disease progression
  3. Treatment with immunosuppressant medications (e.g., mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate) within 3 months of screening
  4. Treatment with interferon or glatiramir acetate within 14 days prior to screening

Miscellaneous

  1. Female subjects of childbearing potential unwilling to practice effective contraception for the duration of the study
  2. Women who are breastfeeding, pregnant, or planning to become pregnant during the study
  3. Current enrollment in any other study treatment or disease study
  4. Unwillingness or inability to comply with this protocol
  5. Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment into this study

Top ^