JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri®: Stratify-2

Investigator: Douglas Goodin, MD
Sponsor: Biogen Idec, Inc.

Location(s): United States


The purpose of STRATIFY-2 is to better understand whether antibodies to JCV may be used to predict whether a patient is at higher or lower risk for developing PML. Tysabri is associated with an increased risk of Progressive Multifocal Leukoencephalopathy (PML) and JC is the virus that is linked to PML. PML is a rare brain infection that usually causes death or severe disability, often rapidly after diagnosis. Currently there are no proven treatments for clinical management of PML. Even in patients who test positive for antibodies to JCV, PML remains an infrequent event because additional steps must occur for PML to develop. Biogen Idec has developed a blood test that measures antibodies to JCV. Antibodies are produced by the body’s immune system when it detects foreign substances. It is thought that approximately half of MS patients have antibodies to JCV. The UCSF MS Center has enrolled just over 300 patients into this study.