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Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
This study has been completed.
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

  Show 53 Study Locations
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
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
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 06, 2009



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