TYSABRI Global Observational Program in Safety (TYGRIS)

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: May 21, 2007
Last updated: June 18, 2015
Last verified: June 2015
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).

Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: TYGRIS: TYSABRI® Global Observational Program in Safety

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • Number of participants with serious infections, malignancies, and other SAEs [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA
whole blood, serum

Enrollment: 2207
Study Start Date: January 2007
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Detailed Description:
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.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MS patients treated with TYSABRI in North America

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477113

United States, Missouri
There may be mulitple sites in this clinical trial. Contact United BioSource Corporation
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Study Director: Medical Director Biogen
  More Information

Additional Information:
No publications provided

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00477113     History of Changes
Other Study ID Numbers: 101MS402
Study First Received: May 21, 2007
Last Updated: June 18, 2015
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Biogen:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on November 24, 2015