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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
- Must provide written informed consent
- Must be an MS subject who completed C-1801, 1802, 1803 and a Dosing Suspension Safety Evaluation
- Must be considered by the Investigator free of signs and symptoms suggestive of PML
- 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
- Considered by the Investigator to be immunocompromised
- History of anti-natalizumab antibodies
- History of abnormal lab results indicative of major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent for 48 weeks.
- History of malignancy
- Known history of HIV infection, hematological malignancy, or organ transplantation
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity
- A significant change from the subject's medical history from the previous natalizumab study
- A clinically significant infectious illness (e.g., cellulites, abscess, pneumonia, septicemia) within 30 days of the screening visit
Treatment History
- Discontinued natalizumab in the previous study due to allergic reaction of SAE
- Discontinued study drug in the previous studies due to an AE or due to reasons other than significant disease progression
- Treatment with immunosuppressant medications (e.g., mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate) within 3 months of screening
- Treatment with interferon or glatiramir acetate within 14 days prior to screening
Miscellaneous
- Female subjects of childbearing potential unwilling to practice effective contraception for the duration of the study
- Women who are breastfeeding, pregnant, or planning to become pregnant during the study
- Current enrollment in any other study treatment or disease study
- Unwillingness or inability to comply with this protocol
- Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment into this study