The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, active lupus flares in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints. All subjects will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: Abatacept, Prednisone or Prednisone equivalent	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects must be diagnosed with SLE and be experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit.
• Stable dose of prednisone (<30mg) for at least one month.

Exclusion Criteria:

• Subjects experiencing an active lupus flare in the kidney or central nervous systems.
• Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study.
• Subjects with active viral or bacterial infections.
• Subjects with any other autoimmune disease as a main diagnosis.
• Prior treatment with rituximab.

Please refer to this study by ClinicalTrials.gov identifier  NCT00119678

BMS Call Center      1-866-892-1BMS  Ext. 175 
BMS Call Center Outside the US and Canda      1-215-347-4079  Ext. 175 

Alabama
      Local Institution, Huntsville,  Alabama,  United States; Not yet recruiting
Arizona
      Local Institution, Tucson,  Arizona,  United States; Not yet recruiting
California
      Local Institution, La Jolla,  California,  United States; Not yet recruiting
      Local Institution, Long Beach,  California,  United States; Not yet recruiting
      Local Institution, Los Angeles,  California,  United States; Not yet recruiting
      Local Institution, Palo Alto,  California,  United States; Not yet recruiting
      Local Institution, San Francisco,  California,  United States; Not yet recruiting
Colorado
      Local Institution, Colorado Springs,  Colorado,  United States; Not yet recruiting
      Local Institution, Denver,  Colorado,  United States; Not yet recruiting
Florida
      Local Institution, Ft. Lauderdale,  Florida,  United States; Not yet recruiting
Illinois
      Local Institution, Chicago,  Illinois,  United States; Not yet recruiting
Indiana
      Local Institution, Evansville,  Indiana,  United States; Not yet recruiting
Kentucky
      Local Institution, Louisville,  Kentucky,  United States; Not yet recruiting
Maryland
      Local Institution, Baltimore,  Maryland,  United States; Not yet recruiting
Minnesota
      Local Institution, Minneapolis,  Minnesota,  United States; Not yet recruiting
Nevada
      Local Institution, Las Vegas,  Nevada,  United States; Not yet recruiting
New York
      Local Institution, Brooklyn,  New York,  United States; Not yet recruiting
      Local Institution, Lake Success,  New York,  United States; Not yet recruiting
      Local Institution, New York,  New York,  United States; Not yet recruiting
      Local Institution, Syracuse,  New York,  United States; Not yet recruiting
North Carolina
      Local Institution, Chapel Hill,  North Carolina,  United States; Not yet recruiting
      Local Institution, Durham,  North Carolina,  United States; Not yet recruiting
Ohio
      Local Institution, Mayfield Village,  Ohio,  United States; Not yet recruiting
Oklahoma
      Local Institution, Oklahoma City,  Oklahoma,  United States; Not yet recruiting
Pennsylvania
      Local Institution, Pittsburgh,  Pennsylvania,  United States; Not yet recruiting
South Carolina
      Local Institution, Charleston,  South Carolina,  United States; Not yet recruiting
Texas
      Local Institution, Dallas,  Texas,  United States; Not yet recruiting
      Local Institution, Sugarland,  Texas,  United States; Not yet recruiting
Wisconsin
      Local Institution, Glendale,  Wisconsin,  United States; Not yet recruiting
Australia, Queensland
      Local Institution, Cairns,  Queensland,  Australia; Not yet recruiting
      Local Institution, Cotton Tree,  Queensland,  Australia; Not yet recruiting
Australia, Victoria
      Local Institution, Clayton,  Victoria,  Australia; Not yet recruiting
      Local Institution, Heidelberg,  Victoria,  Australia; Not yet recruiting
      Local Institution, Malvern,  Victoria,  Australia; Recruiting
Austria
      Local Institution, Graz,  Austria; Not yet recruiting
      Local Institution, Wien,  Austria; Not yet recruiting
Belgium
      Local Institution, BRUXELLES,  Belgium; Not yet recruiting
      Local Institution, Leuven,  Belgium; Not yet recruiting
Brazil
      Local Institution, Sao Paulo,  Brazil; Recruiting
Brazil, Goias
      Local Institution, Goiania,  Goias,  Brazil; Not yet recruiting
Brazil, Rio De Janeiro
      Local Institution, Rio de Janeiro - RJ,  Rio De Janeiro,  Brazil; Not yet recruiting
Brazil, Rio Grande Do Sul
      Local Institution, Porto Alegre,  Rio Grande Do Sul,  Brazil; Not yet recruiting
Brazil, Sao Paulo
      Local Institution, Campinas,  Sao Paulo,  Brazil; Not yet recruiting
Canada, British Columbia
      Local Institution, Vancouver,  British Columbia,  Canada; Not yet recruiting
Canada, Ontario
      Local Institution, Toronto,  Ontario,  Canada; Not yet recruiting
Canada, Quebec
      Local Institution, Montral,  Quebec,  Canada; Not yet recruiting
France
      Local Institution, Bordeaux Cedex,  France; Not yet recruiting
      Local Institution, Lille Cedex,  France; Not yet recruiting
      Local Institution, Montpellier Cedex 5,  France; Not yet recruiting
      Local Institution, Paris Cedex 13,  France; Not yet recruiting
      Local Institution, Paris Cedex 14,  France; Not yet recruiting
      Local Institution, Strasbourg Cedex,  France; Not yet recruiting
Germany
      Local Institution, Berlin,  Germany; Not yet recruiting
      Local Institution, Dresden,  Germany; Not yet recruiting
      Local Institution, Duesseldorf,  Germany; Not yet recruiting
      Local Institution, Erlangen,  Germany; Not yet recruiting
      Local Institution, Freiburg,  Germany; Not yet recruiting
      Local Institution, Hannover,  Germany; Not yet recruiting
      Local Institution, Muenster,  Germany; Not yet recruiting
Italy
      Local Institution, Ferrara,  Italy; Not yet recruiting
      Local Institution, Milano,  Italy; Not yet recruiting
      Local Institution, Pisa,  Italy; Not yet recruiting
      Local Institution, Roma,  Italy; Not yet recruiting
Korea, Republic of
      Local Institution, Seoul,  Korea, Republic of; Recruiting
Korea, Republic of, Sungdong-Gu
      Local Institution, Seoul,  Sungdong-Gu,  Korea, Republic of; Not yet recruiting
Mexico
      Local Institution, Aguascalientes,  Mexico; Not yet recruiting
      Local Institution, Distrito Federal,  Mexico; Not yet recruiting
Mexico, Distrito Federal
      Local Institution, Mexico City,  Distrito Federal,  Mexico; Not yet recruiting
Mexico, Michioacan
      Aguascalientes, Morelia,  Michioacan,  Mexico; Not yet recruiting
Puerto Rico
      Local Institution, Ponce,  Puerto Rico; Not yet recruiting
      Local Institution, San Juan,  Puerto Rico; Not yet recruiting
South Africa, Gauteng
      Local Institution, Soweto,  Gauteng,  South Africa; Recruiting
South Africa, Kwa Zulu Natal
      Local Institution, Berea,  Kwa Zulu Natal,  South Africa; Recruiting
South Africa, West Cape
      Local Institution, Panorama,  West Cape,  South Africa; Recruiting
Sweden
      Local Institution, Lund,  Sweden; Recruiting
      Local Institution, Stockholm,  Sweden; Recruiting
Taiwan
      Local Institution, Kaohsiung,  Taiwan; Recruiting
      Local Institution, Taichung,  Taiwan; Recruiting
      Local Institution, Taipei,  Taiwan; Recruiting
United Kingdom, Greater London
      Local Institution, London,  Greater London,  United Kingdom; Not yet recruiting
United Kingdom, West Midlands
      Local Institution, Birmingham,  West Midlands,  United Kingdom; Not yet recruiting

Study ID Numbers:  IM101-042
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 14, 2005
ClinicalTrials.gov Identifier:  NCT00119678
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26