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-CCP2.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: Abatacept	Phase II

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of Undifferentiated Arthritis
• 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 DMARDs / biologics.
• Duration of disease must be 18 months or less.
• Positive for antibodies against cyclic citrullinated peptides.

Exclusion Criteria:

• Women of Child Bearing Potential who are unwilling or unable to use an acceptable method to avoid pregnacy.
• Men unwilling to use an adequate method of contraception.
• Active vaculitis or 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00124449

BMS Call Center      1-866-892-1BMS  Ext. 176 
BMS Call Center Outside the US and Canada      1-215-347-4079  Ext. 176 

Alabama
      Local Institution, Huntsville,  Alabama,  United States; Recruiting
      Local Institution, Mobile,  Alabama,  United States; Recruiting
California
      Local Institution, Huntington Beach,  California,  United States; Recruiting
      Local Institution, Los Angeles,  California,  United States; Recruiting
Colorado
      Local Institution, Boulder,  Colorado,  United States; Recruiting
      Local Institution, Colorado Springs,  Colorado,  United States; Recruiting
Florida
      Local Institution, Ft. Lauderdale,  Florida,  United States; Recruiting
Illinois
      Local Institution, Chicago,  Illinois,  United States; Not yet recruiting
Indiana
      Local Institution, Evansville,  Indiana,  United States; Recruiting
Louisiana
      Local Institution, New Orleans,  Louisiana,  United States; Not yet recruiting
Maryland
      Local Institution, Cumberland,  Maryland,  United States; Recruiting
      Local Institution, Hagerstown,  Maryland,  United States; Recruiting
Minnesota
      Local Institution, Duluth,  Minnesota,  United States; Not yet recruiting
North Carolina
      Local Institution, Durham,  North Carolina,  United States; Recruiting
      Local Institution, Wilmington,  North Carolina,  United States; Recruiting
Pennsylvania
      Local Institution, Willow Grove,  Pennsylvania,  United States; Recruiting
South Carolina
      Local Institution, Charleston,  South Carolina,  United States; Recruiting
Texas
      Local Institution, Austin,  Texas,  United States; No longer recruiting
Virginia
      Local Institution, Arlington,  Virginia,  United States; Recruiting
Australia, Queensland
      Local Institution, Cairns,  Queensland,  Australia; Not yet recruiting
Australia, Victoria
      Local Institution, Clayton,  Victoria,  Australia; Not yet recruiting
      Local Institution, Malvern,  Victoria,  Australia; Not yet recruiting
Belgium
      Local Institution, BRUXELLES,  Belgium; Recruiting
      Local Institution, Leuven,  Belgium; Recruiting
France
      Local Institution, Paris,  France; Recruiting
      Local Institution, Strasbourg Cedex,  France; Recruiting
Germany
      Local Institution, Berlin,  Germany; Not yet recruiting
      Local Institution, Dresden,  Germany; Not yet recruiting
      Local Institution, Hamburg,  Germany; Recruiting
      Local Institution, Hannover,  Germany; Not yet recruiting
      Local Institution, Heidelberg,  Germany; Not yet recruiting
Italy
      Local Institution, Bari,  Italy; Not yet recruiting
      Local Institution, Ferrara,  Italy; Not yet recruiting
      Local Institution, Milano,  Italy; Recruiting
Mexico, Distrito Federal
      Local Institution, Guadalajara,  Distrito Federal,  Mexico; Recruiting
Mexico, Guanajuato
      Local Institution, Leon,  Guanajuato,  Mexico; Recruiting
Mexico, Jalisco
      Local Institution, Guadalajara,  Jalisco,  Mexico; Not yet recruiting
Mexico, Michioacan
      Local Institution, Morelia,  Michioacan,  Mexico; Recruiting
Puerto Rico
      Local Institution, Ponce,  Puerto Rico; Recruiting
Spain
      Local Institution, A Coruna,  Spain; Recruiting
      Local Institution, Barcelona,  Spain; No longer recruiting
      Local Institution, Madrid,  Spain; Recruiting
      Local Institution, Oviedo,  Spain; Not yet recruiting
      Local Institution, Sevilla,  Spain; Recruiting
United Kingdom, Merseyside
      Local Institution, Liverpool,  Merseyside,  United Kingdom; Recruiting
United Kingdom, North Yorkshire
      Local Institution, Leeds,  North Yorkshire,  United Kingdom; Recruiting

Study ID Numbers:  IM101-046
Last Updated:  August 1, 2005
Record first received:  July 27, 2005
ClinicalTrials.gov Identifier:  NCT00124449
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02