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| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date † | November 30, 2001 | ||||||||
| Last Updated Date | June 7, 2006 | ||||||||
| Start Date † | November 2001 | ||||||||
| Current 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. | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00027300 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
Reduction in MRI changes and clinical relapses | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| 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 | ||||||||
| Condition † | Multiple Sclerosis, Relapsing-Remitting | ||||||||
| Intervention † | Drug: Natalizumab | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 900 | ||||||||
| Completion Date | |||||||||
| Primary 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 | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00027300 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Biogen Idec | ||||||||
| Collaborators †† | Elan Pharmaceuticals | ||||||||
| Investigators † |
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| Information Provided By | Biogen Idec | ||||||||
| Verification Date | June 2006 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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