TYGRIS - ROW: TYSABRI Global Observational Program in Safety - Rest of World (TYGRIS - ROW)
|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|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 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|