TYSABRI® Global Observational Program in Safety (TYGRIS)
The purpose of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events in patients with multiple sclerosis (MS) treated with TYSABRI® (natalizumab).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||TYGRIS: TYSABRI® Global Observational Program in Safety|
- 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. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
whole blood, serum
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
The TYSABRI® Global Observational Program in Safety (TYGRIS) is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) patients treated with TYSABRI® in a clinical practice setting in the United States or Canada.
|United States, Missouri|
|There may be mulitple sites in this clinical trial. Contact United BioSource Corporation|
|Kansas City, Missouri, United States, 64111|