JC-Virus (JCV) Antibody Program
Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Tysabri® (natalizumab) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Biogen Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Biogen
Summary
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.
Clinical Details
Official title: JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1
Study design: Time Perspective: Prospective
Primary outcome: Prevalence of serum anti-JC virus (JCV) antibodyNumber of participants with a false negative test
Secondary outcome: Changes in JCV antibody status over time
Detailed description:
This study requires serum, plasma and urine collection at enrollment and every 6 months
thereafter for up two years.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Key Inclusion Criteria:
- Relapsing multiple sclerosis (MS) patients interested in or considering beginning
treatment with Tysabri® (natalizumab).
Key Exclusion Criteria:
- Patients participating in any other Tysabri® (natalizumab) clinical trial or study
sponsored by Biogen Idec or Elan may not participate in this study.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Research Site, Aurora, Colorado 80045, United States
Research Site, Atlanta, Georgia 30327, United States
Research Site, Cullman, Georgia 35058, United States
Research Site, Barrington, Illinois 60010, United States
Research Site, Brighton, Massachusetts 2135, United States
Research Site, Farmington Hills, Michigan 48334, United States
Research Site, Raleigh, North Carolina 27607, United States
Research Site, Portland, Oregon 97225, United States
Research Site, Round Rock, Texas 78681, United States
Research Site, Salt Lake City, Utah, United States
Research Site, Milwaukee, Wisconsin 53215, United States
Additional Information
Starting date: March 2010
Last updated: August 18, 2014
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