Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
119 participants
INTERVENTIONAL
2007-12-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
abatacept
solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open
Methotrexate (MTX)
Participants who were currently receiving methotrexate at a stable dose ≥ 10 mg for at least 4 weeks
SC Abatacept Monotherapy Cohort
In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
abatacept
solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open
Interventions
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abatacept
solution, subcutaneous injection, 125 mg/kg, weekly, 106 days in short term; long term is open
Methotrexate (MTX)
Participants who were currently receiving methotrexate at a stable dose ≥ 10 mg for at least 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects Global Disease Assessment of greater than equal to 20 mm on a visual analog scale
* Discontinue all Biologics and Disease-modifying antirheumatic drugs (DMARDS) except for methotrexate
Exclusion Criteria
* Subjects who have received treatment with immunoadsorbtion columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine
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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Rheumatology Associates Of North Alabama
Huntsville, Alabama, United States
Coastal Clinical Research Inc
Mobile, Alabama, United States
Stanford University School Of Medicine
Palo Alto, California, United States
Boulder Medical Center
Boulder, Colorado, United States
The Arthritis Center
Palm Harbor, Florida, United States
Medical Towers South
Louisville, Kentucky, United States
Westroads Medical Group
Omaha, Nebraska, United States
Regional Rheumatology Associates
Binghamton, New York, United States
Physicians East, Pa
Greenville, North Carolina, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Low Country Rheumatology, Pa
Charleston, South Carolina, United States
Columbia Arthritis Center
Columbia, South Carolina, United States
Rheumatic Disease Center
Glendale, Wisconsin, United States
Local Institution
Maroochydore, Queensland, Australia
Local Institution
Hobart, Tasmania, Australia
Local Institution
Malvern, Victoria, Australia
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
D.f., Mexico City, Mexico
Local Institution
Berea, KwaZulu-Natal, South Africa
Local Institution
Panorama, Western Cape, South Africa
Countries
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References
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Nash P, Nayiager S, Genovese MC, Kivitz AJ, Oelke K, Ludivico C, Palmer W, Rodriguez C, Delaet I, Elegbe A, Corbo M. Immunogenicity, safety, and efficacy of abatacept administered subcutaneously with or without background methotrexate in patients with rheumatoid arthritis: results from a phase III, international, multicenter, parallel-arm, open-label study. Arthritis Care Res (Hoboken). 2013 May;65(5):718-28. doi: 10.1002/acr.21876.
Other Identifiers
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IM101-173
Identifier Type: -
Identifier Source: org_study_id
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