The purpose of this clinical research study is to learn if Abatacept in combination with Methotrexate and Infliximab demonstrate a greater reduction in disease activity over placebo.

Condition	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: Abatacept	Phase III

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

Criteria

Inclusion Criteria:

• Diagnosis of Rheumatoid Arthritis
• 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:

• Subjects who have failed more than 3 DMARDs
• Subjects 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

BMS Call Center      1-866-892-1BMS  Ext. 146 
BMS Call Center Outside the US and Canada      1-215-247-4079  Ext. 146 

Alabama
      Local Institution, Huntsville,  Alabama,  United States; Recruiting
Colorado
      Local Institution, Denver,  Colorado,  United States; Recruiting
Florida
      Local Institution, Boca Raton,  Florida,  United States; Recruiting
      Local Institution, Ft. Lauderdale,  Florida,  United States; Recruiting
      Local Institution, Largo,  Florida,  United States; Recruiting
Indiana
      Local Institution, Indianapolis,  Indiana,  United States; Recruiting
Louisiana
      Local Institution, New Orleans,  Louisiana,  United States; Recruiting
Massachusetts
      Local Institution, Worcester,  Massachusetts,  United States; Recruiting
      Local Institution, Springfield,  Massachusetts,  United States; Recruiting
Mississippi
      Local Institution, Flowood,  Mississippi,  United States; Recruiting
New York
      Local Institution, Syracuse,  New York,  United States; Recruiting
North Carolina
      Local Institution, Charlotte,  North Carolina,  United States; Recruiting
Ohio
      Local Institution, Cincinnati,  Ohio,  United States; Recruiting
Oklahoma
      Local Institution, Oklahoma City,  Oklahoma,  United States; Recruiting
      Local Institution, Tulsa,  Oklahoma,  United States; Recruiting
Pennsylvania
      Local Institution, Bethlehem,  Pennsylvania,  United States; Recruiting
      Local Institution, Willow Grove,  Pennsylvania,  United States; Recruiting
Texas
      Local Institution, Austin,  Texas,  United States; Recruiting
      Local Institution, Dallas,  Texas,  United States; Recruiting
Argentina
      Local Institution, Buenos Aires,  Argentina; Recruiting
      Local Institution, Cordoba,  Argentina; Recruiting
      Local Institution, Tucuman,  Argentina; Recruiting
Argentina, Buenos Aires
      Local Institution, Capital Federal,  Buenos Aires,  Argentina; Recruiting
      Local Institution, Quilmes,  Buenos Aires,  Argentina; Recruiting
Australia, Queensland
      Local Institution, Cairns,  Queensland,  Australia; Recruiting
      Local Institution, Cotton Tree,  Queensland,  Australia; Recruiting
Australia, Victoria
      Local Institution, Clayton,  Victoria,  Australia; Recruiting
      Local Institution, Heidelberg,  Victoria,  Australia; Recruiting
      Local Institution, Malvern,  Victoria,  Australia; Recruiting
      Local Institution, Parkville,  Victoria,  Australia; Recruiting
Australia, Western Australia
      Local Institution, Perth,  Western Australia,  Australia; Recruiting
Brazil
      Local Institution, Rio de Janeiro,  Brazil; Recruiting
      Local Institution, Sao Paulo,  Brazil; Recruiting
Brazil, Parana
      Local Institution, Curitiba,  Parana,  Brazil; Recruiting
Brazil, Pernambuco
      Local Institution, Recife,  Pernambuco,  Brazil; Recruiting
Brazil, Rio Grande Do Sul
      Local Institution, Porto Alegre,  Rio Grande Do Sul,  Brazil; Recruiting
Canada
      Local Institution, Kitchener,  ON,  Canada; Recruiting
Canada, Alberta
      Local Institution, Calgary,  Alberta,  Canada; Recruiting
      Local Institution, Edmonton,  Alberta,  Canada; Recruiting
Canada, Manitoba
      Local Institution, Winnipeg,  Manitoba,  Canada; Recruiting
Canada, Newfoundland and Labrador
      Local Institution, St. Johns,  Newfoundland and Labrador,  Canada; Recruiting
Canada, Ontario
      Local Institution, Hamilton,  Ontario,  Canada; Recruiting
      Local Institution, Ottawa,  Ontario,  Canada; Recruiting
Canada, Quebec
      Local Institution, Montreal,  Quebec,  Canada; Recruiting
      Local Institution, Ste Foy,  Quebec,  Canada; Recruiting
Canada, Saskatchewan
      Local Institution, Saskatoon,  Saskatchewan,  Canada; Recruiting
Czech Republic
      Local Institution, PRAGUE 2,  Czech Republic; Recruiting
Denmark
      Local Institution, Copenhagen,  Denmark; Recruiting
      Local Institution, Copenhagen Nv,  Denmark; Recruiting
Korea, Republic of
      Local Institution, Seoul,  Korea, Republic of; Recruiting
Mexico
      Local Institution, San Luis Potosi,  Mexico; Recruiting
Mexico, Baja California
      Local Institution, Tijuana,  Baja California,  Mexico; Recruiting
Mexico, Distrito Federal
      Local Institution, Mexico,  Distrito Federal,  Mexico; Recruiting
Mexico, Guanajuato
      Local Institution, Leon,  Guanajuato,  Mexico; Recruiting
Mexico, Jalisco
      Local Institution, Guadalajara,  Jalisco,  Mexico; Recruiting
Mexico, Nuevo Leon
      Local Institution, Monterrey,  Nuevo Leon,  Mexico; Recruiting
Peru
      Local Institution, Lima,  Peru; Recruiting
Poland
      Local Institution, Poznan,  Poland; Recruiting
      Local Institution, Sopot,  Poland; Recruiting
      Local Institution, Warszawa,  Poland; Recruiting
Puerto Rico
      Local Institution, San Juan,  Puerto Rico; Recruiting
Russian Federation
      Local Institution, Moscow,  Russian Federation; Recruiting
South Africa, Gauteng
      Local Institution, Muckleneuk,  Gauteng,  South Africa; Recruiting
South Africa, Kwa Zulu Natal
      Local Institution, Berea,  Kwa Zulu Natal,  South Africa; Recruiting
South Africa, Western Cape
      Local Institution, Panorama,  Western Cape,  South Africa; Recruiting
Spain
      Local Institution, A Coruna,  Spain; Recruiting
      Local Institution, Barcelona,  Spain; Recruiting
      Local Institution, Cordoba,  Spain; Recruiting
      Local Institution, Madrid,  Spain; Recruiting
Sweden
      Local Institution, FALUN,  Sweden; Recruiting
      Local Institution, Huddinge,  Sweden; Recruiting
      Local Institution, Linkoping,  Sweden; Recruiting
      Local Institution, Lund,  Sweden; Recruiting
      Local Institution, Stockholm,  Sweden; Recruiting
      Local Institution, Uppsala,  Sweden; Recruiting
Switzerland
      Local Institution, Bern,  Switzerland; Recruiting
      Local Institution, St. Gallen,  Switzerland; Recruiting

Study ID Numbers:  IM101-043
Record last reviewed:  December 2004
Record first received:  November 1, 2004
ClinicalTrials.gov Identifier:  NCT00095147
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-12-23