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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. |
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| 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  MSActiveSource.com is a resource for news, information and disease management for all individuals touched by multiple sclerosis. This site is sponsored by Biogen. |
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| 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. |
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| 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 † |
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| Information Provided By | Biogen Idec | ||||||||
| Verification Date | June 2006 | ||||||||
| First Received Date † | November 30, 2001 | ||||||||
| Last Updated Date | June 7, 2006 | ||||||||
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