Remission and Joint Damage Progression in Early Rheumatoid Arthritis
NCT ID: NCT00122382
Last Updated: 2010-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1052 participants
INTERVENTIONAL
2005-07-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ABA + MTX
abatacept 10 mg/kg intravenous (IV) + methotrexate
Abatacept
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
methotrexate
Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
Placebo (PLA) + MTX
placebo IV + methotrexate
Abatacept
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
placebo
placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months
methotrexate
Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
Interventions
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Abatacept
abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months
placebo
placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months
methotrexate
Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24
Eligibility Criteria
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Inclusion Criteria
* C-Reactive Protein (CRP) \>= 4.5 mg/L (after amendment)
* Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive
* Tender joints \>=12 and swollen joints \>=10
Exclusion Criteria
* Diagnosed with other rheumatic disease
* History of cancer within 5 years
* Active tuberculosis
* Treatment with another investigation drug within 28 days
* Active bacterial or viral infection
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
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
Talbert Medical Group
Huntington Beach, California, United States
Arthritis Assoc And Osteo Ctr Of Col Sprgs
Colorado Springs, Colorado, United States
New England Research Associates, Llc
Trumbull, Connecticut, United States
Diagnostic Rheumatology And Research
Indianapolis, Indiana, United States
Osteoporosis And Clinical Trials Center
Cumberland, Maryland, United States
Malamet & Klein, Md, Pa
Hagerstown, Maryland, United States
Arthritis Center Of Nebraska
Lincoln, Nebraska, United States
Regional Rheumatology Associates
Binghamton, New York, United States
Carolina Bone & Joint
Charlotte, North Carolina, United States
Physicians East, Pa
Greenville, North Carolina, United States
Carolina Pharmaceutical Research
Statesville, North Carolina, United States
Lion Research
Norman, Oklahoma, United States
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States
Lynn Health Sciences Institute
Oklahoma City, Oklahoma, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Low Country Research Center
Charleston, South Carolina, United States
Walter F Chase Md Pa
Austin, Texas, United States
Arthritis Clinic Of Northern Virginia, P.C.
Arlington, Virginia, United States
Local Institution
Malvern, Victoria, Australia
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Shenton Park, Western Australia, Australia
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Antwerp, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Hasselt, , Belgium
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Leuven, , Belgium
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Rio de Janeiro - Rj, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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St. John's, Newfoundland and Labrador, Canada
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Kitchener, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Prague, , Czechia
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Dijon, , France
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Montpellier, , France
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Nice, , France
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Strasbourg, , France
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Berlin, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Leipzig, , Germany
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Jesi(Ancona), , Italy
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Milan, , Italy
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Chihuahua City, Chihuahua, Mexico
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León, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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D.f., Mexico City, Mexico
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Morelia, Michioacan, Mexico
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Cuernavaca, Morelos, Mexico
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Monterrey, Nuevo León, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Metepec, State of Mexico, Mexico
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Amsterdam, , Netherlands
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Leiden, , Netherlands
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Nijmegen, , Netherlands
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Poznan, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Ponce, , Puerto Rico
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Moscow, , Russia
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Moscow, , Russia
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Bloemfontein, Free State, South Africa
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Muckleneuk, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Berea, KwaZulu-Natal, South Africa
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Panorama, Western Cape, South Africa
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Anyang, , South Korea
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Daegu, , South Korea
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Daejeon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Santander, , Spain
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Seville, , Spain
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Manchester, Greater Manchester, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Leeds, North Yorkshire, United Kingdom
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Newcastle, Northumberland, United Kingdom
Countries
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References
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Durez P, Westhovens R, Baeke F, Elbez Y, Robert S, Ahmad HA. Identification of poor prognostic joint locations in an early rheumatoid arthritis cohort at risk of rapidly progressing disease: a post-hoc analysis of the Phase III AGREE study. BMC Rheumatol. 2022 Apr 14;6(1):24. doi: 10.1186/s41927-022-00252-4.
Jansen DTSL, Emery P, Smolen JS, Westhovens R, Le Bars M, Connolly SE, Ye J, Toes REM, Huizinga TWJ. Conversion to seronegative status after abatacept treatment in patients with early and poor prognostic rheumatoid arthritis is associated with better radiographic outcomes and sustained remission: post hoc analysis of the AGREE study. RMD Open. 2018 Mar 30;4(1):e000564. doi: 10.1136/rmdopen-2017-000564. eCollection 2018.
Smolen JS, Wollenhaupt J, Gomez-Reino JJ, Grassi W, Gaillez C, Poncet C, Le Bars M, Westhovens R. Attainment and characteristics of clinical remission according to the new ACR-EULAR criteria in abatacept-treated patients with early rheumatoid arthritis: new analyses from the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE). Arthritis Res Ther. 2015 Jun 11;17(1):157. doi: 10.1186/s13075-015-0671-9.
Bathon J, Robles M, Ximenes AC, Nayiager S, Wollenhaupt J, Durez P, Gomez-Reino J, Grassi W, Haraoui B, Shergy W, Park SH, Genant H, Peterfy C, Becker JC, Covucci A, Moniz Reed D, Helfrick R, Westhovens R. Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-year outcomes. Ann Rheum Dis. 2011 Nov;70(11):1949-56. doi: 10.1136/ard.2010.145268. Epub 2011 Aug 6.
Other Identifiers
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IM101-023
Identifier Type: -
Identifier Source: org_study_id