The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.
This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.
Study Type
OBSERVATIONAL
Enrollment
1,096
Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program
Research Site
Aurora, Colorado, United States
Research Site
Atlanta, Georgia, United States
Research Site
Cullman, Georgia, United States
Research Site
Prevalence of serum anti-JC virus (JCV) antibody
Prevalence of anti-JCV antibodies will be estimated as the number of participants with anti-JCV antibodies detected in serum divided by the total number of participants with a serum sample that was evaluated.
Time frame: Day 1
Number of participants with a false negative test
Confirm the false negative rate for serum anti-JCV antibody \[assay\].
Time frame: Day 1
Changes in JCV antibody status over time
Time frame: Every 6 months for 2 Years
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Barrington, Illinois, United States
Research Site
Brighton, Massachusetts, United States
Research Site
Farmington Hills, Michigan, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Portland, Oregon, United States
Research Site
Round Rock, Texas, United States
Research Site
Salt Lake City, Utah, United States
...and 1 more locations