A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
NCT ID: NCT00420199
Last Updated: 2012-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2007-05-31
2010-05-31
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
DOUBLE
Study Groups
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Abatacept + Methotrexate (Double-blind period)
Abatacept
Vials (250 mg/vial), intravenous (IV), 10 mg/kg, monthly infusion , 12 months of treatment
Placebo + Methotrexate (Double-blind period)
Placebo
Intravenous (IV) bags, IV, 0 mg, monthly infusion, 12 months of treatment
Interventions
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Abatacept
Vials (250 mg/vial), intravenous (IV), 10 mg/kg, monthly infusion , 12 months of treatment
Placebo
Intravenous (IV) bags, IV, 0 mg, monthly infusion, 12 months of treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 1 erosion in hands/wrists or positive anticyclic citrullinated peptides or rheumatoid factor
* Clinically detectable synovitis of at least 1 wrist/ankle at screening and baseline
* Participants must have been treated with methotrexate, on a weekly dose of at least 15 mg or a maximum tolerated dose (such as, 10 mg weekly) for at least 3 months before screening. Dose of methotrexate must be stable for at least 28 days prior to the first study dose (Day 1)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Brussels, , Belgium
Local Institution
Yvoir, , Belgium
Local Institution
Berlin, , Germany
Local Institution
Berlin, , Germany
Local Institution
Amsterdam, , Netherlands
Local Institution
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Stockholm, , Sweden
Local Institution
London, Greater London, United Kingdom
Local Institution
Leeds, North Yorkshire, United Kingdom
Countries
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References
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Conaghan PG, Durez P, Alten RE, Burmester GR, Tak PP, Klareskog L, Catrina AI, DiCarlo J, Gaillez C, Le Bars M, Zhou X, Peterfy C. Impact of intravenous abatacept on synovitis, osteitis and structural damage in patients with rheumatoid arthritis and an inadequate response to methotrexate: the ASSET randomised controlled trial. Ann Rheum Dis. 2013 Aug;72(8):1287-94. doi: 10.1136/annrheumdis-2012-201611. Epub 2012 Aug 21.
Related Links
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Investigator Inquiry form
Other Identifiers
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Eudract: 2006-003768-67
Identifier Type: -
Identifier Source: secondary_id
IM101-119
Identifier Type: -
Identifier Source: org_study_id
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