- Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology
[ACR] Revised Criteria) greater than 6 months before study day 1.
- History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160
- Treatment with more than 20 mg of prednisone per day.
- Evidence of unstable clinically significant disease (e.g., cardiovascular,
cerebrovascular, respiratory, or renal disease, or any other unstable serious
disorder) other than SLE.
- History of cancer (other than resected cutaneous basal and squamous cell carcinoma or
in situ cervical cancer) with less than 5 years' documentation of a disease-free