TYGRIS - ROW: TYSABRI Global Observational Program in Safety - Rest of World (TYGRIS - ROW)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00483847|
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : April 13, 2015
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||4296 participants|
|Official Title:||TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
- Number of participants with serious infections, malignancies, and other serious adverse events (SAEs) [ Time Frame: 5 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|