Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)
Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to compare the pharmacokinetic (PK) and
pharmacodynamics (PD) of single subcutaneous (SC) and intramuscular (IM) doses of 300 mg
natalizumab to intravenous (IV) administration of 300 mg natalizumab in multiple sclerosis
(MS) participants. The secondary objectives are to investigate the safety, tolerability and
PK of repeated natalizumab doses administered SC and IM, to investigate the immunogenicity of
repeated natalizumab doses administered SC and IM, to explore proof of concept within the
secondary progressive multiple sclerosis (SPMS) population using change from baseline in
clinical measures including: expanded disability status scale (EDSS), multiple sclerosis
functional composite scale (MSFC), symbol digit modalities test (SDMT), visual analogue scale
(VAS), and visual function test; and brain magnetic resonance imaging (MRI) measures
including: number of new or newly-enlarging T2 hyperintense lesions, number of new T1
hypointense lesions, number of new gadolinium-enhancing (Gd+) lesions, whole brain atrophy,
magnetization transfer ratio (MTR), and diffusion tensor imaging (DTI) and to observe the
effect of natalizumab administered IV and SC on brain MRI measures in participants with
relapsing forms of MS.