JCV Antibody Program (STRATIFY-1)
Study conducted to define the prevalence of Serum JC Antibody in relapsing MS patients receiving Tysabri or being considered for such treatment.
Analytically validate the JCV antibody assay in a plasma matrix.
|Study Design:||Time Perspective: Prospective|
|Official Title:||JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-1|
- Define the prevalence of serum JC virus (JCV) antibody in patients with relapsing Multiple Sclerosis receiving or considering treatment with Tysabri. Confirm the false negative rate for the serum JCV antibody assay. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Analytically validate the JCV antibody assay in plasma matrix and determine changes in JCV antibody status over time. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
Serum, Urine and Plasma
|Study Start Date:||March 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Relapsing Multiple Sclerosis
Patients receiving or considering treatment with Tysabri.
Patients not on Tysabri are also allowed to enroll.
This study requires blood and urine collection @ enrollment and every 6 months thereafter for up two years.
|United States, Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Georgia|
|Atlanta, Georgia, United States, 30327|
|Cullman, Georgia, United States, 35058|
|United States, Illinois|
|Barrington, Illinois, United States, 60010|
|United States, Massachusetts|
|Brighton, Massachusetts, United States, 2135|
|United States, Michigan|
|Farmington Hills, Michigan, United States, 48334|
|United States, North Carolina|
|Raleigh, North Carolina, United States, 27607|
|United States, Oregon|
|Portland, Oregon, United States, 97225|
|United States, Texas|
|Round Rock, Texas, United States, 78681|
|United States, Utah|
|Salt Lake City, Utah, United States|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53215|