TYSABRI® Global Observational Program in Safety - Full Text View

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

MedlinePlus related topics:

Multiple Sclerosis

ChemIDplus related topics:

Natalizumab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	TYGRIS: TYSABRI® Global Observational Program in Safety

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

Biospecimen Description:

whole blood, serum

Estimated Enrollment:	3000
Study Start Date:	January 2007
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 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

Contacts


Contact: Biogen Idec		neurologyclinicaltrials@biogenidec.com

Locations


United States, Missouri
	There may be mulitple sites in this clinical trial. Contact United BioSource Corporation	Recruiting
	Kansas City, Missouri, United States, 64111
	Contact 866-831-2358 LSKC.BiogenIdec.Tysabri@unitedbiosource.com

Sponsors and Collaborators

Biogen Idec

Elan Pharmaceuticals

Investigators


Study Director:	Biogen Idec	Biogen Idec

More Information

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

Responsible Party:	Biogen Idec, Inc. ( Biogen Idec MD )
Study ID Numbers:	101-MS-402
First Received:	May 21, 2007
Last Updated:	August 29, 2008
ClinicalTrials.gov Identifier:	NCT00477113
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Biogen Idec:

Tysabri

natalizumab

Multiple Sclerosis

TYGRIS

MS

Study placed in the following topic categories:

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases

Sclerosis

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes

Immune System Diseases

Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Biogen Idec Elan Pharmaceuticals
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00477113