JC-Virus (JCV) Antibody Program
STRATIFY-1
JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1
1 other identifier
observational
1,096
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedOctober 5, 2016
October 1, 2016
2.3 years
February 17, 2010
October 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Day 1
Number of participants with a false negative test
Confirm the false negative rate for serum anti-JCV antibody \[assay\].
Day 1
Secondary Outcomes (1)
Changes in JCV antibody status over time
Every 6 months for 2 Years
Study Arms (1)
Relapsing Multiple Sclerosis
Participants receiving or considering treatment with Tysabri® (natalizumab).
Interventions
Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program
Eligibility Criteria
Patients with relapsing Multiple Sclerosis (MS) receiving commercial Tysabri® (natalizumab) and patients being considered for such treatment.
You may qualify if:
- Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab).
You may not qualify if:
- Patients participating in any other Tysabri® (natalizumab) clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
- United BioSource, LLCcollaborator
- Elan Pharmaceuticalscollaborator
Study Sites (11)
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
Biospecimen
Serum, Urine and Plasma
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2010
First Posted
February 18, 2010
Study Start
March 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
October 5, 2016
Record last verified: 2016-10