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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
  Purpose
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).

Condition
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477113


Locations
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
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00477113     History of Changes
Other Study ID Numbers: 101MS402
First Submitted: May 21, 2007
First Posted: May 22, 2007
Last Update Posted: June 22, 2015
Last Verified: June 2015

Keywords provided by Biogen:
natalizumab
MS
Tysabri
Multiple Sclerosis
TYGRIS

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs