Relapsing-Remitting Multiple Sclerosis Clinical Trial
Official title:
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, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation
The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.
Study 101-MS-322 (NCT00306592) was conducted to evaluate the safety of natalizumab
monotherapy following re-exposure to natalizumab in former clinical trial participants in
Studies C-1801 (NCT00027300), C-1802 (NCT00030966), and C-1803 (NCT00097760) and included
subjects in North America. In parallel with the conduct of that study, this study
(101-MS-321 [NCT00297232]) was initiated for participants in Europe and the rest of the
world. In addition, after 48 weeks, participants from 101-MS-322 (NCT00306592) could enter
study 101-MS-321 (NCT 00297232), which was considered the Long-Term Treatment Period of
101-MS-322 (NCT00306592).
The primary purpose and primary outcome for both studies are identical; therefore, the
combined long-term data from both studies are presented. (Combined Week 48 data from both
studies are presented in the 101-MS-322 [NCT00306592] record.)
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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