The purpose of this study is to assess if Abatacept given for six months will prevent
rheumatoid arthritis (RA) in patients who are at risk for the development of RA in
comparison to placebo. High risk patients are defined as those having a positive laboratory
test for anti-cyclic citrullinated peptide (anti-CCP2).
Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of EfficacyNumber of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease
Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months
Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months
Number of Participants With Persistent Symptomatic Clinical Synovitis
Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline
Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months
Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time
Frequency of Human Leukocyte Antigen (HLA) Typing
DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline
Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)
Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response
Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths
Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Local Institution, Bruxelles, Belgium
Local Institution, Leuven, Belgium
Local Institution, Paris, France
Local Institution, Strasbourg Cedex, France
Local Institution, Berlin, Germany
Local Institution, Dresden, Germany
Local Institution, Hamburg, Germany
Local Institution, Hannover, Germany
Local Institution, Heidelberg, Germany
Local Institution, Bari, Italy
Local Institution, Ferrara, Italy
Local Institution, Milano, Italy
Local Institution, Ponce, Puerto Rico
Local Institution, A Coruna, Spain
Local Institution, Barcelona, Spain
Local Institution, Madrid, Spain
Local Institution, Oviedo, Spain
Local Institution, Sevilla, Spain
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
Local Institution, Boulder, Colorado, United States
Local Institution, Colorado Springs, Colorado, United States
Local Institution, Guadalajara, Distrito Federal, Mexico
Local Institution, Ft. Lauderdale, Florida, United States
Local Institution, Leon, Guanajuato, Mexico
Local Institution, Chicago, Illinois, United States
Local Institution, Evansville, Indiana, United States
Local Institution, Guadalajara, Jalisco, Mexico
Local Institution, New Orleans, Louisiana, United States
Local Institution, Cumberland, Maryland, United States
Local Institution, Hagerstown, Maryland, United States
Local Institution, Liverpool, Merseyside, United Kingdom
Local Institution, Morelia, Michioacan, Mexico
Local Institution, Duluth, Minnesota, United States
Local Institution, Durham, North Carolina, United States
Local Institution, Wilmington, North Carolina, United States
Local Institution, Leeds, North Yorkshire, United Kingdom
Local Institution, Oklahoma City, Oklahoma, United States
Local Institution, Willow Grove, Pennsylvania, United States
Local Institution, Cairns, Queensland, Australia
Local Institution, Charleston, South Carolina, United States
Local Institution, Austin, Texas, United States
Local Institution, Clayton, Victoria, Australia
Local Institution, Malvern, Victoria, Australia
Local Institution, Arlington, Virginia, United States
Local Institution, Shenton Park, Western Australia, Australia
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. Erratum in: Ann Rheum Dis. 2011 Aug;70(8):1519.