Phase III Study in China - Tolerance

Condition(s) targeted: Immunosuppression for Disease, NOS

Intervention: Placebo (Drug); Abatacept (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

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)

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Primary outcome: Number and type of adverse events experienced including serious or unexpected peri-infusional adverse events

Secondary outcome:

Summary of adverse events

Pharmacokinetic analysis (Cmin and Cmax)

Immunogenicity determination (anti-abatacept antibodies)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women, at least 18 years of age diagnosed with SLE and with lupus nephritis

currently stable for the last 3 months without change in their treatment for lupus nephritis

- Stable renal disease

- No flaring of other organ systems in at least the last 3 months

Exclusion Criteria:

- Unstable Lupus Nephritis and serum creatinine >3 mg/dL

- Progressive renal failure, end stage renal disease, renal transplant, requiring

continuous dialysis

- Severe unstable, refractory or progressive SLE

- History of cancer

- Subjects at risk for tuberculosis

- Autoimmune disease other than SLE as main diagnosis

- HIV or Herpes zoster

- Hepatitis-B surface antigen-positive or Hepatitis C antibody-positive subjects

For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com

Local Institution, Shanghai 200001, China; Recruiting
Site 001

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: August 2008
Ending date: November 2008
Last updated: October 20, 2008