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Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

This study has been completed.
Study NCT00027300.   Last updated on June 7, 2006.   Information provided by Biogen Idec

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Descriptive Information Fields
Brief Title  Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
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
Brief Summary

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.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Primary Outcome Measure  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 Measure  Reduction in MRI changes and clinical relapses
Condition  Multiple Sclerosis, Relapsing-Remitting
Intervention  Drug: Natalizumab
MEDLINE PMIDs 16510744
Links 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
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  900
Start Date  November 2001
Completion Date
Eligibility Criteria 

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

Gender Both
Ages 18 Years to 50 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Netherlands,   United Kingdom
Administrative Information Fields
NCT ID  NCT00027300
Organization ID C-1801
Secondary IDs ††
Study Sponsor  Biogen Idec
Collaborators †† Elan Pharmaceuticals
Investigators 
Study Director:     Michael Panzara, MD, MPH     Biogen Idec    
Principal Investigator:     Chris Polman, MD     VU Medical Centre    
Information Provided By Biogen Idec
Verification Date June 2006
First Received Date  November 30, 2001
Last Updated Date June 7, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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