JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab

Completed

Conditions studied: Relapsing Multiple Sclerosis

In brief

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.

Key facts

Study ID
NCT01070836
Run by
Biogen
People needed
35895
Starts
2010-03-01
Expected to finish
2015-11-01
Last updated by the study team
2016-09-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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