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

This study has been completed.
Sponsor:
Collaborators:
United BioSource Corporation
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01070823
First received: February 17, 2010
Last updated: August 18, 2014
Last verified: August 2014

February 17, 2010
August 18, 2014
March 2010
June 2012   (final data collection date for primary outcome measure)
  • Prevalence of serum anti-JC virus (JCV) antibody [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Analytically validate the JCV antibody assay in plasma matrix and determine changes in JCV antibody status over time. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
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.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01070823
101JC401
No
Biogen Idec
Biogen Idec
  • United BioSource Corporation
  • Elan Pharmaceuticals
Study Director: Medical Director Biogen Idec
Biogen Idec
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP