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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01070823
First Posted: February 18, 2010
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
United BioSource Corporation
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen
February 17, 2010
February 18, 2010
October 5, 2016
March 2010
June 2012   (Final data collection date for primary outcome measure)
  • 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.
  • Number of participants with a false negative test [ Time Frame: Day 1 ]
    Confirm the false negative rate for serum anti-JCV antibody [assay].
Define the prevalence of serum JC virus (JCV) antibody in patients with relapsing Multiple Sclerosis receiving or considering treatment with Tysabri. Confirm the false negative rate for the serum JCV antibody assay. [ Time Frame: 2 years ]
Complete list of historical versions of study NCT01070823 on ClinicalTrials.gov Archive Site
Changes in JCV antibody status over time [ Time Frame: Every 6 months for 2 Years ]
Analytically validate the JCV antibody assay in plasma matrix and determine changes in JCV antibody status over time. [ Time Frame: 2 Years ]
Not Provided
Not Provided
 
JC-Virus (JCV) Antibody Program
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.
This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Serum, Urine and Plasma
Probability Sample
Patients with relapsing Multiple Sclerosis (MS) receiving commercial Tysabri® (natalizumab) and patients being considered for such treatment.
Multiple Sclerosis
Drug: Tysabri® (natalizumab)
Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program
Other Names:
  • natalizumab
  • BG0002
Relapsing Multiple Sclerosis
Participants receiving or considering treatment with Tysabri® (natalizumab).
Intervention: Drug: Tysabri® (natalizumab)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1096
June 2012
June 2012   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01070823
101JC401
No
Not Provided
Not Provided
Biogen
Biogen
  • United BioSource Corporation
  • Elan Pharmaceuticals
Study Director: Medical Director Biogen
Biogen
October 2016