Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
NCT ID: NCT00095147
Last Updated: 2015-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
431 participants
INTERVENTIONAL
2005-02-28
2009-07-31
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
QUADRUPLE
Study Groups
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Abatacept (ABA) + Methotrexate (MTX) (double-blind [DB])
Days 1-365
Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)
Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.
Infliximab + MTX (DB)
Days 1-365
Infliximab (INF) + MTX, DB
Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.
Placebo + MTX (DB)
Days 1-197
Placebo (PLA) + MTX, DB
Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.
Placebo + MTX switched to abatacept + MTX (DB)
Participants received placebo plus methotrexate for days 1-197, and abatacept plus methotrexate for days 198-365
PLA + MTX switched to ABA+ MTX, DB
Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months
Abatacept (open-label)
Days 365 to 729 All participants receive Active Drug
ABA, open-label (OL)
Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months
Interventions
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Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)
Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months.
Infliximab (INF) + MTX, DB
Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months.
Placebo (PLA) + MTX, DB
Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months.
PLA + MTX switched to ABA+ MTX, DB
Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months
ABA, open-label (OL)
Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 3 months prior treatment with Methotrexate (MTX)
* At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl
* Washout required for other disease modifying anti-rheumatic drugs (DMARDS)
Exclusion Criteria
* participants previously treated with an approved biologic drug
* History of cancer in the last 5 years
* Severe or recurrent bacterial infection
* Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
* Women of Child Bearing Potential
18 Years
75 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
Huntsville, Alabama, United States
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Denver, Colorado, United States
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Boca Raton, Florida, United States
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Fort Lauderdale, Florida, United States
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Largo, Florida, United States
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Indianapolis, Indiana, United States
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New Orleans, Louisiana, United States
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Flowood, Mississippi, United States
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Syracuse, New York, United States
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Charlotte, North Carolina, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Buenos Aires, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Cairns, Queensland, Australia
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Cotton Tree, Queensland, Australia
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Clayton, Victoria, Australia
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Heidelberg, Victoria, Australia
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Malvern, Victoria, Australia
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Parkville, Victoria, Australia
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Perth, Western Australia, Australia
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Curitiba, Paraná, Brazil
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Recife, Pernambuco, Brazil
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Rio de Janeiro, 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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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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Ottawa, Ontario, Canada
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Montreal, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Kitchener, , Canada
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Prague, , Czechia
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Copenhagen, , Denmark
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Tijuana, Estado de Baja California, Mexico
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León, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, 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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Lima, , Peru
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Poznan, , Poland
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Sopot, , Poland
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Warsaw, , Poland
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Rio Piedras, , Puerto Rico
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Moscow, , Russia
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Muckleneuk, 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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Seoul, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Falun, , Sweden
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Linköping, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Bern, , Switzerland
Local Institution
Sankt Gallen, , Switzerland
Countries
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References
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Schiff M, Keiserman M, Codding C, Songcharoen S, Berman A, Nayiager S, Saldate C, Li T, Aranda R, Becker JC, Lin C, Cornet PL, Dougados M. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2008 Aug;67(8):1096-103. doi: 10.1136/ard.2007.080002. Epub 2007 Nov 29.
Other Identifiers
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IM101-043
Identifier Type: -
Identifier Source: org_study_id
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