Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
NCT ID: NCT00097760
Last Updated: 2009-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2003-06-30
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
Natalizumab
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
Natalizumab
Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.
Group 2
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
Placebo
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
Interventions
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Natalizumab
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
Natalizumab
Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.
Placebo
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between the ages of 18 and 55, inclusive
* Baseline EDSS score between 0.0 and 5.0, inclusive
* Have been treated with GA for at least the 12 months prior to randomization
Exclusion Criteria
* MS relapse has occurred within the 50 days prior to randomization
* A clinically significant infectious illness
* History of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.
18 Years
55 Years
ALL
No
Sponsors
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Elan Pharmaceuticals
INDUSTRY
Biogen
INDUSTRY
Responsible Party
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Biogen Idec, Inc.
Principal Investigators
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Biogen Idec, MD
Role: STUDY_DIRECTOR
Biogen
Related Links
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The website 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.
Other Identifiers
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C-1803
Identifier Type: -
Identifier Source: org_study_id
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