JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to demonstrate that the incidence of progressive
multifocal Leukoencephalopathy (PML) in natalizumab-treated participants who do not have
detectable antibodies to John Cunningham virus (JCV) (antibody negative) is lower than in
participants who have detectable antibodies to JCV (antibody positive).
The secondary objectives of this study are to: Estimate the incidence of PML in
natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody
positive, based on a meta-analysis of data obtained from this study and other data sources;
Define the prevalence of anti-JCV antibody in relapsing multiple sclerosis (MS) participants
receiving natalizumab within the TYSABRI Outreach: United Commitment to Health (TOUCH)
Prescribing Program; Determine changes in anti-JCV antibody status over time.