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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept

Criteria

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