TYGRIS: TYSABRI® Global Observational Program in Safety
N/A
N/A
N/A
N/A
N/A
Open (Enrolling)
Both
Multiple Sclerosis
Both
Multiple Sclerosis
Trial Information
TYGRIS: TYSABRI® Global Observational Program in Safety
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
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.
Outcome Time Frame:
5 years
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
101-MS-402
NCT ID:
NCT00477113
Start Date:
January 2007
Completion Date:
September 2014
Related Keywords:
- Multiple Sclerosis
- Tysabri
- natalizumab
- MS
- Multiple Sclerosis
- TYGRIS
- Multiple Sclerosis
- Sclerosis
Name | Location |
|---|---|
| There may be mulitple sites in this clinical trial. Contact United BioSource Corporation | Kansas City, Missouri 64111 |
