A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
NCT ID: NCT00409838
Last Updated: 2013-08-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
113 participants
INTERVENTIONAL
2007-04-30
2011-12-31
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 and Methotrexate
Abatacept
Intravenous (IV) solution, - weight tiered (500 mg \<60 kg); (750 mg 60-100 kg); (1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months
Methotrexate
Tablets, Oral, ≥ 15 mg, weekly, 6 months
Placebo and Methotrexate
(standard of care)
Methotrexate
Tablets, Oral, ≥ 15 mg, weekly, 6 months
Placebo
IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months
Abatacept - Open Label
Open-label extension phase
Abatacept
Solution, intravenous, 10 mg/kg, every 28 days
Methotrexate
Tablets, oral, 15 mg weekly to be adjusted according to patient condition
Interventions
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Abatacept
Intravenous (IV) solution, - weight tiered (500 mg \<60 kg); (750 mg 60-100 kg); (1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 6 months
Methotrexate
Tablets, Oral, ≥ 15 mg, weekly, 6 months
Placebo
IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 6 months
Abatacept
Solution, intravenous, 10 mg/kg, every 28 days
Methotrexate
Tablets, oral, 15 mg weekly to be adjusted according to patient condition
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (Day 1)
* Methotrexate weekly dose as low as 10 mg is permitted for patients who cannot tolerate higher doses
Exclusion Criteria
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
Seoul, Sungdong-Gu, South Korea
Local Institution
Anyang, , South Korea
Local Institution
Daegu, , South Korea
Local Institution
Daejeon, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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IM101-124
Identifier Type: -
Identifier Source: org_study_id
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