JC-Virus (JCV) Antibody Program (STRATIFY-1)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1|
- Prevalence of serum anti-JC virus (JCV) antibody [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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.
- Number of participants with a false negative test [ Time Frame: Day 1 ] [ Designated as safety issue: No ]Confirm the false negative rate for serum anti-JCV antibody [assay].
- Changes in JCV antibody status over time [ Time Frame: Every 6 months for 2 Years ] [ Designated as safety issue: No ]
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
Participants receiving or considering treatment with Tysabri® (natalizumab).
Drug: Tysabri® (natalizumab)
Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program
This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070823
|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|
|Study Director:||Medical Director||Biogen Idec|