TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World
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).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World|
- Number of participants with serious infections, malignancies, and other serious adverse events (SAEs) [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
|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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483847
|There are multiple sites throughout Europe in this clinical trial. Contact Advanced Medical Services (AMS).|
|Mannheim, Germany, D-68167|
|Study Director:||Medical Director||Biogen Idec|