JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab
(STRATIFY-2 Trial)

Recruiting in Palo Alto (17 mi)

+375 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Biogen

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

Inclusion Criteria

Relapsing MS patients receiving commercial natalizumab

Patients receiving natalizumab and their prescribers must be enrolled in the TOUCH Prescribing Program.

Patients with suspected or confirmed PML who are at or referred to a participating STRATIFY-2 site may enroll into STRATIFY-2 for purposes of PML sample collection.

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