Trial record 1 of 1 for:
JCV Antibody Program (STRATIFY-2)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: February 17, 2010
Last updated: November 1, 2012
Last verified: November 2012
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.
||Time Perspective: Prospective
||JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2
Primary Outcome Measures:
- Correlation of JCV Antibody positivity and development of PML. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
Secondary Outcome Measures:
- Define the sero prevalence of JCV Antibody in this US representative sample of MS patients. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with relapsing MS receiving commercial Tysabri and patients being considered for such treatment.
- Relapsing MS patients interested in or considering beginning treatment with Tysabri.
- Patients participating in any other Tysabri clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070836
|There are multiple sites throughout the United States in this study. Please contact STRATIFY@biogenidec.com.
|Cambridge, Massachusetts, United States, 2142 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 17, 2010
||November 1, 2012
||United States: Food and Drug Administration
Keywords provided by Biogen Idec:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Physiological Effects of Drugs