TYSABRI® Global Observational Program in Safety - Full Text View

TYSABRI® Global Observational Program in Safety (TYGRIS)

This study is ongoing, but not recruiting participants.

First Received on May 21, 2007. Last Updated on July 7, 2011 History of Changes

Sponsor:	Biogen Idec
Collaborator:	Elan Pharmaceuticals
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00477113

Purpose

The purpose of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events in patients 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:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Natalizumab

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

To determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAEs) in patients with Multiple Sclerosis (MS) treated with Tysabri. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples With DNA

whole blood, serum

Enrollment:	3000
Study Start Date:	January 2007
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2014 (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) patients treated with TYSABRI® in a clinical practice setting in the United States or Canada.

Eligibility

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

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.

Contacts and Locations

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 Idec

Elan Pharmaceuticals

More Information

Additional Information:

TYGRIS US Home Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Biogen Idec MD, Biogen Idec, Inc.
ClinicalTrials.gov Identifier:	NCT00477113 History of Changes
Other Study ID Numbers:	101-MS-402
Study First Received:	May 21, 2007
Last Updated:	July 7, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Biogen Idec:

Tysabri
natalizumab
MS
Multiple Sclerosis
TYGRIS

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012