Multiple Sclerosis
Conditions
Keywords
Sample Collection, JCV, PML
Brief summary
The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.
Detailed description
This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.
Interventions
DRUGTysabri® (natalizumab)
Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program
Sponsors
United BioSource, LLC
Elan Pharmaceuticals
Biogen
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab). Key
Exclusion criteria
* Patients participating in any other Tysabri® (natalizumab) clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study. NOTE: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of serum anti-JC virus (JCV) antibody | Day 1 | Prevalence of anti-JCV antibodies will be estimated as the number of participants with anti-JCV antibodies detected in serum divided by the total number of participants with a serum sample that was evaluated. |
| Number of participants with a false negative test | Day 1 | Confirm the false negative rate for serum anti-JCV antibody \[assay\]. |
Secondary
| Measure | Time frame |
|---|---|
| Changes in JCV antibody status over time | Every 6 months for 2 Years |
Countries
United States
Outcome results
None listed