Natalizumab High Titer Immunogenicity and Safety - Full Text View

Purpose

Biogen Idec is studying natalizumab (TYSABRI®) produced by a modified manufacturing process.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: natalizumab	Phase II

MedlinePlus related topics:

Multiple Sclerosis

ChemIDplus related topics:

Natalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Open Label, Single Group Assignment, Bio-equivalence Study

Official Title:	A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple Sclerosis

Further study details as provided by Biogen Idec:

Enrollment:	113
Study Start Date:	October 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Detailed Description:

This study is a multicenter, single-arm, open-label study in subjects with relapsing forms of MS. The population will include subjects who are appropriate for natalizumab treatment in that the inclusion criteria are in accordance with local labeling.

Clinical and laboratory safety assessments will be performed throughout the study for up to 32 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of a relapsing form of MS
Must fall within the therapeutic indications stated in the locally approved label for TYSABRI
Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

protocol-defined inclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516893

Locations


United States, District of Columbia
	Research Site
	Washington, District of Columbia, United States, 20007

United States, Florida
	Research Site
	Maitland, Florida, United States, 32751
	Research Site
	Miami, Florida, United States, 33136

United States, Georgia
	Research Site
	Atlanta, Georgia, United States, 30327

United States, Michigan
	Research Site
	Farmington Hills, Michigan, United States, 48334

United States, New York
	Research Site
	New York, New York, United States, 10003
	Research Site
	Buffalo, New York, United States, 14203

United States, North Carolina
	Research Site
	Charlotte, North Carolina, United States, 28207

United States, Pennsylvania
	Reseach Site
	Philadelphia, Pennsylvania, United States, 19104
	Research Site
	Pittsburgh, Pennsylvania, United States, 15212

United States, Texas
	Research site
	Round Rock, Texas, United States, 78681
	Research Site
	Dallas, Texas, United States, 75214

United States, Wisconsin
	research Site
	Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Biogen Idec

Elan Pharmaceuticals

Investigators


Study Director:	Study Director	Biogen Idec

More Information

Study ID Numbers:	101MS201
First Received:	August 14, 2007
Last Updated:	January 28, 2008
ClinicalTrials.gov Identifier:	NCT00516893
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

natalizumab

TYSABRI

Multiple Sclerosis

Relapsing Forms of Multiple Sclerosis

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 07, 2008

Sponsors and Collaborators:	Biogen Idec Elan Pharmaceuticals
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00516893