Trials / Completed
CompletedNCT00483847
TYGRIS - ROW: TYSABRI Global Observational Program in Safety - Rest of World
TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,296 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAEs) in participants with multiple sclerosis (MS) treated with TYSABRI (natalizumab).
Detailed description
The TYSABRI Global Observational Program in Safety for Rest of World (TYGRIS - ROW)is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) participants treated with TYSABRI in a clinical practice setting in countries other than the United States and Canada. The Prescribing Physician will collect participant information at routine clinic visits (using standard data collection tools) at approximately 6-month intervals for 5 years from the first TYSABRI infusion.
Conditions
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2014-11-01
- Completion
- 2014-11-01
- First posted
- 2007-06-07
- Last updated
- 2015-04-13
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00483847. Inclusion in this directory is not an endorsement.