JCV Antibody Program (STRATIFY-2)
Define the sero prevalence of JCV Antibody in the MS population and potentially stratify patients into lower or higher risk for developing PML based on antibody status.
|Study Design:||Time Perspective: Prospective|
|Official Title:||JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2|
- Correlation of JCV Antibody positivity and development of PML. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
- Define the sero prevalence of JCV Antibody in this US representative sample of MS patients. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Relapsing Multiple Sclerosis
Patients receiving or considering treatment with Tysabri.
Patients not on Tysabri are also allowed to enroll
This study requires a blood collection at enrollment and annually thereafter for up to two years.
|United States, Massachusetts|
|There are multiple sites throughout the United States in this study. Please contact STRATIFY@biogenidec.com.|
|Cambridge, Massachusetts, United States, 2142|