A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

Exclusion Criteria

• •Presence of active lupus nephritis
• •Presence of active central nervous system (CNS) disease requiring treatment with high-dose corticosteroids or immunosuppressive agents
• •Presence of active vasculitis requiring treatment
• •History of arterial or venous thromboses within 12 months of screening
• •Moderate to severe anemia, thrombocytopenia, or neutropenia
• •Any manifestation likely to require, in the investigator's judgment, treatment with high-dose corticosteroids or the addition of an immunosuppressive regimen during the course of the trial
• •Pregnancy or lactation
• •Lack of peripheral venous access
• •History of alcohol or substance abuse within 6 months of screening
• •History of severe allergic or anaphylactic reactions to antibodies or fusion proteins
• •Evidence of significant uncontrolled concomitant diseases
• •Significant laboratory or electrocardiogram (ECG) abnormalities
• •Evidence of any clinically significant abnormality on a chest X-ray
• •Severly impaired renal function
• •Impaired hepatic function
• •Poorly controlled diabetes
• •Conditions other than SLE that could require treatment with corticosteroids
• •History of malignancy except completely excised basal cell carcinoma
• •Congenital immune deficiency
• •Positive tests for antibodies to HIV, hepatitis B (HBS antigen, anti-HBC) or C
• •Positive IgM antibody titers in the presence of negative IgG titers to Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
• •Frequent recurrence of herpes lesions
• •Episode of shingles within one year of screening
• •Positive screening test for latent mycobacterium tuberculosis infection
• •History of severe systemic bacterial, fungal, viral, or parasitic infections within the year prior to screening
• •Any current or recent signs or symptoms of infection
• •Received antibiotics orally (PO) during the 30 days prior to screening or IV antibiotics during the 60 days prior to screening
• •Received a live vaccine within the 30 days prior to screening
• •Has been hospitalized within the 30 days prior to screening
• •Received \> 20 mg/day prednisone for \> 3 days during the 30 days prior to screening
• •Received azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, pulse dose corticosteroids, intravenous immunoglobulin (IVIG), or transfusions within 6 months prior to screening
• •Received cyclophosphamide within 2 years prior to screening
• •Received a monoclonal antibody during the 12 months prior to screening
• •Previously received an investigational treatment directed against interferon alpha
• •Received B-cell depleting therapy (e.g., anti-CD20, anti-CD22)
• •Received investigational treatment during the 30 days prior to screening