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TYSABRI Global Observational Program in Safety (TYGRIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00477113
First Posted: May 22, 2007
Last Update Posted: June 22, 2015
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.
Information provided by (Responsible Party):
Biogen
May 21, 2007
May 22, 2007
June 22, 2015
January 2007
May 2015   (Final data collection date for primary outcome measure)
Number of participants with serious infections, malignancies, and other SAEs [ Time Frame: 5 years ]
Not Provided
Complete list of historical versions of study NCT00477113 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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TYSABRI Global Observational Program in Safety
TYGRIS: TYSABRI® Global Observational Program in Safety
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).
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood, serum
Non-Probability Sample
MS patients treated with TYSABRI in North America
Multiple Sclerosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2207
May 2015
May 2015   (Final data collection date for primary outcome measure)

Key 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.

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00477113
101MS402
No
Not Provided
Not Provided
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
June 2015