Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg

A Single Center, Randomized, Placebo-Controlled, Double Blind, Parallel Group Study to Evaluate the Tolerability of a Single Dose of Abatacept 30 mg/kg Via Intravenous Infusion in Chinese SLE Subjects With Lupus Nephritis

The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE)

Inclusion Criteria:

• Men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis
• Stable renal disease
• No flaring of other organ systems in a minimum of the last 3 months

Exclusion Criteria:

• Unstable lupus nephritis and serum creatinine >3 mg/dL
• Progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis
• Severe unstable, refractory, or progressive SLE
• History of cancer
• Participants at risk for tuberculosis
• Autoimmune disease other than SLE as main diagnosis
• Human immunodeficiency virus or herpes zoster infection
• Hepatitis-B surface antigen-positive or hepatitis C antibody-positive participants