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 or C-1802 and a Dosing Suspension Safety Evaluation

Biogen Idec0 个研究点目标入组 900 人开始时间: 2005年11月30日最近更新: 2020年1月13日

适应症

试验速览

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•Must be an MS subject who completed Study C-1801 or C-1802 and completed a Dosing Suspension Safety Evaluation (neurological examination and an MRI scan); must be considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used); must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFNb and GA) for the duration of the study.

•Considered by the Investigator to be immunocompromised or have a history of organ transplant; history of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies; history of severe allergic or anaphylactic reactions or known drug hypersensitivity; discontinued natalizumab in a previous study due to allergic reaction or any other SAE considered to be related to natalizumab treatment; discontinued study drug in Study C-1801 or C-1802 because of an AE or due to reasons other than significant disease progression (as defined in the C-1801 and C-1802 protocols).

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