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| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date † | February 15, 2002 | ||||||||
| Last Updated Date | June 7, 2006 | ||||||||
| Start Date † | January 2002 | ||||||||
| Current Primary Outcome Measures † |
The primary outcome objective was to determine whether add natalizumab to Avonex reduces the number clinical relapses and the level of disability at 1 year | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00030966 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
If this combination reduces MRI lesions and the overall rate of clinical relapses | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title † | Safety and Efficacy of Natalizumab in Combination With Avonex 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, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis | ||||||||
| Brief Summary | The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (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 * | Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911-23. | ||||||||
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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 † | 1200 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † |
AND
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| Gender | Both | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States, Austria, Belgium, France, Germany, Israel, Italy | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00030966 | ||||||||
| 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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