Natalizumab (Tysabri) Re-Initiation of Dosing (STRATA)
Relapsing-Remitting Multiple Sclerosis
About this trial
This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring Multiple Sclerosis, MS
Eligibility Criteria
Key Inclusion Criteria MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and a Dosing Suspension Safety Evaluation (neurological examination or a magnetic resonance imaging scan) or participated in the IMA 04001 (STARS) Study Subjects who are considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-beta and glatiramer acetate) while being treated with natalizumab during the study. In addition, subjects who completed 48 weeks of treatment in Study 101-MS-322 (NCT00306592) in Canada will be allowed to enter this study at the start of the long-term treatment period (Week 52 - 480). Key Exclusion Criteria Considered by the Investigator to be immunocompromised History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies History of any major disease or malignancy Discontinued natalizumab in a previous study due to allergic reaction NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
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Arms of the Study
Arm 1
Experimental
Natalizumab
300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks