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TYGRIS: TYSABRI® Global Observational Program in Safety


N/A
N/A
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Open (Enrolling)
Both
Multiple Sclerosis

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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 CorporationKansas City, Missouri  64111