JCV Antibody Program (STRATIFY-1)

This study has been completed.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01070823
First received: February 17, 2010
Last updated: September 12, 2013
Last verified: October 2012

February 17, 2010
September 12, 2013
March 2010
June 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01070823 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
JCV Antibody Program (STRATIFY-1)
JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-1

Study conducted to define the prevalence of Serum JC Antibody in relapsing MS patients receiving Tysabri or being considered for such treatment.

Analytically validate the JCV antibody assay in a plasma matrix.

This study requires blood and urine collection @ 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 MS receiving commercial Tysabri and patients being considered for such treatment.

Multiple Sclerosis
Drug: Tysabri
Patients not on Tysabri are also allowed to enroll.
Relapsing Multiple Sclerosis
Patients receiving or considering treatment with Tysabri.
Intervention: Drug: Tysabri
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Relapsing MS patients interested in or considering beginning treatment with Tysabri.

Exclusion Criteria:

  • Patients participating in any other Tysabri clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01070823
101JC401
No
Biogen Idec
Biogen Idec
Elan Pharmaceuticals
Not Provided
Biogen Idec
October 2012

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