Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT00027300 |
Recruitment Status :
Completed
First Posted : December 3, 2001
Last Update Posted : January 9, 2017
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Sponsor:
Biogen
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen
Tracking Information | |||||||
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First Submitted Date ICMJE | November 30, 2001 | ||||||
First Posted Date ICMJE | December 3, 2001 | ||||||
Last Update Posted Date | January 9, 2017 | ||||||
Study Start Date ICMJE | November 2001 | ||||||
Actual Primary Completion Date | November 2004 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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. [ Time Frame: 1 year and 2 years ] | ||||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Reduction in MRI changes and clinical relapses [ Time Frame: 1 year ] | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis | ||||||
Official Title ICMJE | 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 | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Multiple Sclerosis, Relapsing-Remitting | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
900 | ||||||
Original Enrollment ICMJE | Not Provided | ||||||
Actual Study Completion Date ICMJE | January 2005 | ||||||
Actual Primary Completion Date | November 2004 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Belgium, Canada, Czech Republic, France, Germany, Netherlands, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00027300 | ||||||
Other Study ID Numbers ICMJE | C-1801 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Biogen Idec Medical Director, Biogen Idec | ||||||
Original Responsible Party | Not Provided | ||||||
Current Study Sponsor ICMJE | Biogen | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Elan Pharmaceuticals | ||||||
Investigators ICMJE |
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PRS Account | Biogen | ||||||
Verification Date | January 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |