Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients
NCT ID: NCT00124449
Last Updated: 2015-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2005-02-28
2008-04-30
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
DOUBLE
Study Groups
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1
Abatacept
solution, intravenous injection, monthly, 169 days
weight based:
\<60 kg = 500 mg
60 to 100 kg = 750 mg
\>100 kg = 1 g
2
placebo
solution, intravenous injection, 0 mg, monthly, 169 days
Interventions
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Abatacept
solution, intravenous injection, monthly, 169 days
weight based:
\<60 kg = 500 mg
60 to 100 kg = 750 mg
\>100 kg = 1 g
placebo
solution, intravenous injection, 0 mg, monthly, 169 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical synovitis of two or more joints
* At least one but not more than three of the criteria for diagnosis of RA (1987).
* No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics.
* Duration of disease must be 18 months or less.
* Positive for antibodies against cyclic citrullinated peptides.
Exclusion Criteria
* Active vasculitis of a major organ system.
* Severe or recurrent bacterial infection.
* History of cancer in the last five years except certain skin cancers.
* Herpes zoster that resolved less than 2 months prior to enrollment
18 Years
75 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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Local Institution
Huntsville, Alabama, United States
Local Institution
Mobile, Alabama, United States
Local Institution
Huntington Beach, California, United States
Local Institution
Los Angeles, California, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Fort Lauderdale, Florida, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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New Orleans, Louisiana, United States
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Cumberland, Maryland, United States
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Hagerstown, Maryland, United States
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Duluth, Minnesota, United States
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Durham, North Carolina, United States
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Wilmington, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Willow Grove, Pennsylvania, United States
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Charleston, South Carolina, United States
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Austin, Texas, United States
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Arlington, Virginia, United States
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Cairns, Queensland, Australia
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Clayton, Victoria, Australia
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Malvern, Victoria, Australia
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Shenton Park, Western Australia, Australia
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Brussels, , Belgium
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Leuven, , Belgium
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Paris, , France
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Strasbourg, , France
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Berlin, , Germany
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Dresden, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Bari, , Italy
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Ferrara, , Italy
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Milan, , Italy
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León, Guanajuato, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Mexico City, Mexico
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Morelia, Michioacan, Mexico
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Ponce, , Puerto Rico
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A Coruña, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Oviedo, , Spain
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Seville, , Spain
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Liverpool, Merseyside, United Kingdom
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Leeds, North Yorkshire, United Kingdom
Countries
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References
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Emery P, Durez P, Dougados M, Legerton CW, Becker JC, Vratsanos G, Genant HK, Peterfy C, Mitra P, Overfield S, Qi K, Westhovens R. Impact of T-cell costimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial). Ann Rheum Dis. 2010 Mar;69(3):510-6. doi: 10.1136/ard.2009.119016. Epub 2009 Nov 23.
Other Identifiers
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IM101-046
Identifier Type: -
Identifier Source: org_study_id
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