TYSABRI Global Observational Program in Safety (TYGRIS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Biogen

ClinicalTrials.gov Identifier:

NCT00477113

First received: May 21, 2007

Last updated: June 18, 2015

Last verified: June 2015

History of Changes

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:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Natalizumab

U.S. FDA Resources

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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
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

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

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
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:


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

ClinicalTrials.gov processed this record on September 23, 2016

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