Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis - Full Text View

Sponsors and Collaborators:	Biogen Idec Elan Pharmaceuticals
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00027300

Purpose

The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.

Condition	Intervention	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: Natalizumab	Phase III

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Natalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years.

Secondary Outcome Measures:

Reduction in MRI changes and clinical relapses

Estimated Enrollment:	900
Study Start Date:	November 2001

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Male and female patients between 18 and 50 years of age who have a diagnosis of relapsing remitting multiple sclerosis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027300

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Locations

United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
East Bay Region Associates in Neurology
Berkeley, California, United States, 94705
UC Davis School of Medicine, Department of Neurology
Davis, California, United States, 95817-2307
United States, Connecticut
Yale University School of Medicine, Department of Neurology
New Haven, Connecticut, United States, 06510
United States, Florida
University of Miami School of Medicine, Department of Neurology
Miami, Florida, United States, 33136
United States, Kansas
University of Kansas Medical Center, Department of Neurology
Kansas City, Kansas, United States, 66160
United States, Michigan
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, United States, 48335
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
Gimbel MS Center
Teaneck, New Jersey, United States, 07666
United States, New Mexico
CMRRC
Albuquerque, New Mexico, United States, 87131
United States, Oregon
Oregon Health Sciences University, Department of Neurology
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
Lehigh Valley Hospital, Neurosciences Research
Allentown, Pennsylvania, United States, 18103
United States, Texas
Texas Neurology
Dallas, Texas, United States, 75214
United States, Washington
University of Washington MS Research Center
Seattle, Washington, United States, 98195
Belgium
Algemeen Ziekenhuis St. Jan
Brugge, Belgium, 8000
National MS Centrum
Melsbroek, Belgium, 1820
LUC- University Centre
Diepenbeek, Belgium, 3590
Canada
Family Medical Centre
Ottawa, Canada, K1N 5C7
MS Research Unit, Center for Clinical Research
Halifax, Canada, B3H 1V7
Canada, British Columbia
Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Manitoba
Health Services Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Kingston General Hospital, Neurology
Kingston, Ontario, Canada, K7L 2V7
University of Toronto, MS Clinic, St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Hospital
London, Ontario, Canada, N6A 5A5
Sunnybrook and Women's College and Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
CHVO Hull Hospital
Quebec City, Quebec, Canada, J8Y 1W7
Czech Republic
Faculty Hospital Plzen - Clinic of Neurology
Plzen, Czech Republic, 304 60
Hospital Pardubice - Department of Neurology
Pardubice, Czech Republic, 532 03
General Teaching Hospital - Neurological Department
Prague, Czech Republic, 2 12802
Faculty Hospital Motol - Neurological Clinic
Prague, Czech Republic, 5 105 06
Faculty Hospital Brno Bohunice
Brno, Czech Republic, 60200
Faculty Hospital St. Anne
Brno, Czech Republic, 656 91
Faculty Hospital Olomouc
Olomouc, Czech Republic, 775 20
Faculty Hospital of Hradec Kralove
HRADEC KRALOVE, Czech Republic, 500 05
Faculty Hospital Of Ostrava Poruba
Ostrava, Czech Republic, 70852
France
CHRU - Hopital de Pontchaillou, Service de Neurologie
Rennes, France, 35033
Hopital de la Timone, Service de Neurologie
Marseille, France, 13385
Germany
St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum
Bochurn, Germany, 44791
Klinika Neurologii
Bydgoszcz, Germany, 85-681
Netherlands
Academisch Ziekenhuis VU
Amsterdam, Netherlands, 1081 HV
United Kingdom
Guy's Hospital
London, United Kingdom, SE1 9RT
St. James University Hospital, Department of Neurology
Leeds, United Kingdom, LS9 7TF
The Radcliffe Infirmary, University Department of Clinical Neurology
Oxford, United Kingdom, OX2 0HE
Kings College Hospital, Kings Neuroscience Center
London, United Kingdom, SE5 9RS
North Staffordshire Royal Infirmary - Neurology Department
Stoke on Trent, United Kingdom, ST4 7LN
Oldchurch Hospital
Essex, United Kingdom, NE1 4LP
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
King's College Hospital
London, United Kingdom, SE5 9RS
Ipswich Hospital NHS Trust - Department of Clinical Neurology
Ipswich, United Kingdom, IP4 5PD
United Kingdom, London
Atkin's Morely Hospital
Wimbledon, London, United Kingdom, SW20 0NE
Institute of Neurology
Queen Square, London, United Kingdom, WC1N 3BG
The Royal London Hospital
Whitechapel, London, United Kingdom, E1 1BB

Sponsors and Collaborators

Biogen Idec

Elan Pharmaceuticals

Investigators

Study Director:	Michael Panzara, MD, MPH	Biogen Idec
Principal Investigator:	Chris Polman, MD	VU Medical Centre

More Information

The web site of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

MSActiveSource.com is a resource for news, information and disease management for all individuals touched by multiple sclerosis. This site is sponsored by Biogen. This link exits the ClinicalTrials.gov site

Publications of Results:

Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910.

Study ID Numbers:	C-1801
Study First Received:	November 30, 2001
Last Updated:	June 7, 2006
ClinicalTrials.gov Identifier:	NCT00027300
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009