JCV Antibody Program: STRATIFY-2 for persons using Tysabri for Multiple Sclerosis

Information found below, was provided by Chris N, from Reno, NV.

Subj: U.S. JCV Antibody Program: STRATIFY-2

All,

I just got back from giving blood for the new JCV Antibody Study Program [code name STRATIFY-2] before doing so I was asked to sign the necessary paperwork for voluntary inclusion in the study

What is the JCV Antibody Program: The code name for the 2 year study is STRATIFY-2 being sponsored by Biogen (the maker of Tysabri). Because Tysabri is associated with an increased risk of PML and the JC virus is being linked to PML. Biogen has now developed a blood test that measures antibodies to JCV. Antiobodies are produced by the body's immune system when it detects foreign substances. It is through that approximately 1/2 of MS patients have antibodies to JCV. The purpose of STRATIFY-2 is to better understand whether antibodies to JCV may be used to predict whether a patient is ar higher or lower risk for developing PML. .

The code name for the 2 year study is STRATIFY-2 being sponsored by Biogen (the maker of Tysabri). Because Tysabri is associated with an increased risk of PML and the JC virus is being linked to PML. Biogen has now developed a blood test that measures antibodies to JCV. Antiobodies are produced by the body's immune system when it detects foreign substances. It is through that approximately 1/2 of MS patients have antibodies to JCV. 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.

  This is a research question and it is not known whether detection of antibodies to JCV in an individual can predict their risk of developing PML. For this reason, the test result from this study should be used in Tysabri treatment decision [i.e. should the patient take Tysabri, if yes then is a holiday needed/required? if yes, for how long?]

Blood samples will be collected from at least 8,000 patients in the US who have relapse-remitting Multiple Sclerosis. Participation in STRATIFY-2 is voluntary and is expected to last 2 years. There is NO drug treatment provided in this study.

Patients in study will provide a sample of blood [1 1/2 teaspoons] 3 times, once at the start and then yearly for up to 2 years.

What are the benefits of participating in STRATIFY-2?
There are no direct health benefits for participating in this study. However, the information collected in this study may help Biogen and your doctor better understand JCV and risk factors for developing PML.


Risks: None known at this time.

My Doc's infusion nurse only drew a blood sample today. No urine sample was taken at this time.
Long story short-if you have JC antibodies already built up in your system then you may be at a higher risk for developing PML.

If antibodies already exist in your system : (  -this would have been generated by another virus you had at some point in your medical history.

If No current antibodies were in your system at the time of first STRATIFY-2 blood sample : ). Could develop at a later time which would be detected in future STRATIFY-2 blood samples taken.

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