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TYSABRI Global Observational Program in Safety (TYGRIS)

This study has been completed.
Information provided by (Responsible Party):
Biogen 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 ]

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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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 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

Responsible Party: Biogen Identifier: NCT00477113     History of Changes
Other Study ID Numbers: 101MS402
Study First Received: May 21, 2007
Last Updated: June 18, 2015

Keywords provided by Biogen:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017