JCV Antibody Program (STRATIFY-1)
This study has been completed.
Sponsor:
Biogen Idec
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01070823
First received: February 17, 2010
Last updated: November 1, 2012
Last verified: November 2012
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Purpose
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.
| 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-1 |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Natalizumab
U.S. FDA Resources
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
Biospecimen Retention: Samples Without DNA
Serum, Urine and Plasma
| Enrollment: | 1000 |
| Study Start Date: | March 2010 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (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 blood and urine collection @ enrollment and every 6 months thereafter for up 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: NCT01070823
Locations
| United States, Colorado | |
| Research Site | |
| Aurora, Colorado, United States, 80045 | |
| United States, Georgia | |
| Research Site | |
| Atlanta, Georgia, United States, 30327 | |
| Research Site | |
| Cullman, Georgia, United States, 35058 | |
| United States, Illinois | |
| Research Site | |
| Barrington, Illinois, United States, 60010 | |
| United States, Massachusetts | |
| Research Site | |
| Brighton, Massachusetts, United States, 2135 | |
| United States, Michigan | |
| Research Site | |
| Farmington Hills, Michigan, United States, 48334 | |
| United States, North Carolina | |
| Research Site | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Oregon | |
| Research Site | |
| Portland, Oregon, United States, 97225 | |
| United States, Texas | |
| Research Site | |
| Round Rock, Texas, United States, 78681 | |
| United States, Utah | |
| Research Site | |
| Salt Lake City, Utah, United States | |
| United States, Wisconsin | |
| Research Site | |
| Milwaukee, Wisconsin, United States, 53215 | |
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT01070823 History of Changes |
| Other Study ID Numbers: | 101JC401 |
| Study First Received: | February 17, 2010 |
| Last Updated: | November 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biogen Idec:
|
Sample Collection JCV PML |
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 June 17, 2013