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

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ClinicalTrials.gov Identifier: NCT01070823
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : October 5, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Tysabri® (natalizumab)

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

Study Design

Study Type : Observational
Actual Enrollment : 1096 participants
Time Perspective: Prospective
Official Title: JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1
Study Start Date : March 2010
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. Number of participants with a false negative test [ Time Frame: Day 1 ]
    Confirm the false negative rate for serum anti-JCV antibody [assay].


Secondary Outcome Measures :
  1. Changes in JCV antibody status over time [ Time Frame: Every 6 months for 2 Years ]

Biospecimen Retention:   Samples Without DNA
Serum, Urine and Plasma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with relapsing Multiple Sclerosis (MS) receiving commercial Tysabri® (natalizumab) and patients being considered for such treatment.
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070823


Locations
United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30327
Research Site
Cullman, Georgia, United States, 35058
United States, Illinois
Research Site
Barrington, Illinois, United States, 60010
United States, Massachusetts
Research Site
Brighton, Massachusetts, United States, 2135
United States, Michigan
Research Site
Farmington Hills, Michigan, United States, 48334
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27607
United States, Oregon
Research Site
Portland, Oregon, United States, 97225
United States, Texas
Research Site
Round Rock, Texas, United States, 78681
United States, Utah
Research Site
Salt Lake City, Utah, United States
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Biogen
United BioSource Corporation
Elan Pharmaceuticals
Investigators
Study Director: Medical Director Biogen
More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01070823     History of Changes
Other Study ID Numbers: 101JC401
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by Biogen:
Sample Collection
JCV
PML

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Natalizumab
Immunologic Factors
Physiological Effects of Drugs