Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
270 participants
INTERVENTIONAL
2007-11-30
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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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Abatacept
Abatacept
Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly, (Short Term (3 periods - 12 weeks each; Long Term)
Placebo
Placebo
Solution in pre-filled syringes, Subcutaneously, 0 mg, Weekly, Period II 12 weeks (Short Term)
Interventions
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Abatacept
Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly, (Short Term (3 periods - 12 weeks each; Long Term)
Placebo
Solution in pre-filled syringes, Subcutaneously, 0 mg, Weekly, Period II 12 weeks (Short Term)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease Activity Score (DAS)28-C-Reactive Protein (CRP) score ≥ 3.2 and ≤5.1
* On background methotrexate at least 3 months (≥10mg weekly)
* Must be able to self injection or allow a care giver to do it for them
* Discontinue all Biologics and Disease-Modifying Anti-rheumatic Drugs (DMARDs) except for methotrexate
Exclusion Criteria
* Received treatment with rituximab.
* Participants who have received treatment with leflunomide within 1 year of screening
* Participants who have received treatment with immunoadsorption 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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Wallace Rheumatic Study Center
Los Angeles, California, United States
New England Research Associates, Llc
Trumbull, Connecticut, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Diagnostic Rheumatology And Research,Pc
Indianapolis, Indiana, United States
Klein And Associates, M.D., Pa
Cumberland, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
St. Paul Rheumatology, P.A.
Eagan, Minnesota, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Center For Assessment And Research Of Erie
Erie, Pennsylvania, United States
Columbia Arthritis Center
Columbia, South Carolina, United States
Mountain State Clinical Research
Clarksburg, West Virginia, United States
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Córdoba, Córdoba Province, Argentina
Local Institution
Rosario, Santa Fe Province, Argentina
Local Institution
Santa Fe, Santa Fe Province, Argentina
Local Institution
Trois-Rivières, Quebec, Canada
Local Institution
León, Guanajuato, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Metepec, State of Mexico, Mexico
Local Institution
Mérida, Yucatán, Mexico
Local Institution
Bloemfontein, Free State, South Africa
Local Institution
Muckleneuk, Gauteng, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Berea, KwaZulu-Natal, South Africa
Local Institution
Panorama, Western Cape, South Africa
Countries
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References
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Kaine J, Gladstein G, Strusberg I, Robles M, Louw I, Gujrathi S, Pappu R, Delaet I, Pans M, Ludivico C. Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase Iiib ALLOW study). Ann Rheum Dis. 2012 Jan;71(1):38-44. doi: 10.1136/annrheumdis-2011-200344. Epub 2011 Sep 13.
Other Identifiers
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IM101-167
Identifier Type: -
Identifier Source: org_study_id
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