JC-Virus (JCV) Antibody Program
- Registration Number
- NCT01070823
- Lead Sponsor
- Biogen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1096
- Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab).
Key
- 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/exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Relapsing Multiple Sclerosis Tysabri® (natalizumab) Participants receiving or considering treatment with Tysabri® (natalizumab).
- Primary Outcome Measures
Name Time Method Number of participants with a false negative test Day 1 Confirm the false negative rate for serum anti-JCV antibody \[assay\].
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.
- Secondary Outcome Measures
Name Time Method Changes in JCV antibody status over time Every 6 months for 2 Years
Trial Locations
- Locations (1)
Research Site
🇺🇸Milwaukee, Wisconsin, United States