Trials / Completed
CompletedNCT01070823
JC-Virus (JCV) Antibody Program
JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,096 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tysabri® (natalizumab) | Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2010-02-18
- Last updated
- 2016-10-05
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01070823. Inclusion in this directory is not an endorsement.