JC-Virus (JCV) Antibody Program (STRATIFY-1)

October 4, 2016 updated by: Biogen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.

Study Type

Observational

Enrollment (Actual)

1096

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Research Site
      • Cullman, Georgia, United States, 35058
        • Research Site
    • Illinois
      • Barrington, Illinois, United States, 60010
        • Research Site
    • Massachusetts
      • Brighton, Massachusetts, United States, 2135
        • Research Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • Research Site
    • Texas
      • Round Rock, Texas, United States, 78681
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with relapsing Multiple Sclerosis (MS) receiving commercial Tysabri® (natalizumab) and patients being considered for such treatment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other Names:
  • natalizumab
  • BG0002

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of serum anti-JC virus (JCV) antibody
Time Frame: Day 1
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
Time Frame: Day 1
Confirm the false negative rate for serum anti-JCV antibody [assay].
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in JCV antibody status over time
Time Frame: Every 6 months for 2 Years
Every 6 months for 2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Elan Pharmaceuticals
United BioSource, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 17, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 18, 2010

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101JC401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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