TYSABRI® Global Observational Program in Safety (TYGRIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00477113
First received: May 21, 2007
Last updated: June 12, 2014
Last verified: June 2014

May 21, 2007
June 12, 2014
January 2007
September 2014   (final data collection date for primary outcome measure)
Number of participants with serious infections, malignancies, and other serious adverse events (SAEs) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00477113 on ClinicalTrials.gov Archive Site
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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 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 TYSABRI® 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2207
September 2014
September 2014   (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.

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00477113
101MS402
No
Biogen Idec
Biogen Idec
Not Provided
Study Director: Medical Director Biogen Idec
Biogen Idec
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP