TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World
The purpose of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAEs) in patients with multiple sclerosis (MS) treated with TYSABRI® (natalizumab).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World|
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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 MS patients treated with TYSABRI® in a clinical practice setting in countries other than the United States and Canada.
The Prescribing Physician will collect patient information at routine clinic visits (using standard data collection tools) at approximately 6-month intervals for 5 years from the first TYSABRI® infusion.