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Sponsors and Collaborators: |
Biogen Idec Elan Pharmaceuticals |
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Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00027300 |
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 |
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Multiple Sclerosis, Relapsing-Remitting |
Drug: Natalizumab |
Phase III |
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 |
Estimated Enrollment: | 900 |
Study Start Date: | November 2001 |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Male and female patients between 18 and 50 years of age who have a diagnosis of relapsing remitting multiple sclerosis.
Study Director: | Michael Panzara, MD, MPH | Biogen Idec |
Principal Investigator: | Chris Polman, MD | VU Medical Centre |
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 |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |
Pathologic Processes Immune System Diseases Nervous System Diseases |