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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) antibody

Number 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

Page last updated: August 23, 2015

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