BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis
NCT ID: NCT00771329
Last Updated: 2013-09-16
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
PHASE1
53 participants
INTERVENTIONAL
2008-10-31
2011-04-30
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
QUADRUPLE
Study Groups
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1
BIIB023
BIIB023
Single IV doses of BIIB023 in dose-escalating cohorts
2
Placebo (sterile normal saline)
Single IV dose of Placebo
Interventions
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BIIB023
Single IV doses of BIIB023 in dose-escalating cohorts
Placebo (sterile normal saline)
Single IV dose of Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks
* Must have at least 4 swollen and tender joints due to rheumatoid arthritis
Exclusion Criteria
* Serious local infection or systemic infection within 3 months
* Suffering from rheumatic or autoimmune disease other than RA
* History of cancer, heart failure, kidney disease, liver disease, HIV infection, tuberculosis or other serious illness
18 Years
65 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Biogen Idec
Locations
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Research Site
Anniston, Alabama, United States
Research Centre
Palm Desert, California, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Centre
Duncansville, Pennsylvania, United States
Research Centre
Moscow, , Russia
Research Centre
Yaroslavl, , Russia
Countries
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References
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Wisniacki N, Amaravadi L, Galluppi GR, Zheng TS, Zhang R, Kong J, Burkly LC. Safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-TWEAK monoclonal antibody in patients with rheumatoid arthritis. Clin Ther. 2013 Aug;35(8):1137-49. doi: 10.1016/j.clinthera.2013.06.008. Epub 2013 Aug 6.
Other Identifiers
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211RA101
Identifier Type: -
Identifier Source: org_study_id