TYSABRI Global Observational Program in Safety
Completed
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT00477113
- Lead Sponsor
- Biogen
- Brief Summary
The Primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAE) in participants with multiple sclerosis (MS) treated with Tysabri (natalizumab).
- Detailed Description
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) participants treated with natalizumab in a clinical practice setting in the United States or Canada.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2207
Inclusion Criteria
- MS patients in the US and Canada receiving TYSABRI under standard clinical care for less than or equal to 3 infusions are eligible to participate in TYGRIS.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with serious infections, malignancies, and other SAEs 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
There may be mulitple sites in this clinical trial. Contact United BioSource Corporation
🇺🇸Kansas City, Missouri, United States