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JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: 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.
This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Research Site
Aurora, Colorado, United States
Research Site
Atlanta, Georgia, United States
Research Site
Cullman, Georgia, United States
Research Site
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
Start Date
March 1, 2010
Primary Completion Date
June 1, 2012
Completion Date
June 1, 2012
Last Updated
October 5, 2016
1,096
ACTUAL participants
Tysabri® (natalizumab)
DRUG
Lead Sponsor
Biogen
Collaborators
NCT06276634
NCT07225504
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06809192