An observational study in Multiple Sclerosis, sponsored by Biogen. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2015-04-13.
Sponsored by Biogen · Observational
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).
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 4,296 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Multiple Sclerosis (MS) participants treated with TYSABRI outside of North America
Key Inclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Number of participants with serious infections, malignancies, and other serious adverse events (SAEs)
Time frame: 5 Years
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Biogen