Text Size

JCV Antibody Program (STRATIFY-2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01070836
First received: February 17, 2010
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Multiple Sclerosis
 Drug: Tysabri

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2

Resource links provided by NLM:

Drug Information available for: Natalizumab
U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Correlation of JCV Antibody positivity and development of PML. [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]

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 ]

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 8000
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)
Groups/Cohorts Assigned Interventions
Relapsing Multiple Sclerosis
Patients receiving or considering treatment with Tysabri.
 Drug: Tysabri
Patients not on Tysabri are also allowed to enroll

Detailed Description:

This study requires a blood collection at enrollment and annually thereafter for up to two years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with relapsing MS receiving commercial Tysabri and patients being considered for such treatment.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070836

Locations
United States, Massachusetts
There are multiple sites throughout the United States in this study. Please contact STRATIFY@biogenidec.com.
Cambridge, Massachusetts, United States, 2142
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01070836     History of Changes
Other Study ID Numbers: 101JC402
Study First Received: February 17, 2010
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
JCV
Sample Collection
PML
Antibody

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Pathologic Processes
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013