TYSABRI Global Observational Program in Safety (TYGRIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00477113
First received: May 21, 2007
Last updated: April 23, 2015
Last verified: April 2015

May 21, 2007
April 23, 2015
January 2007
May 2015   (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
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.

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00477113
101MS402
No
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
April 2015

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