Description
Inclusion Criteria:
- * Diagnosis of SLE per current ACR classification criteria
- * Date of SLE diagnosis within 2 years of screening
- * ANA positive (with a titer ≥ 80)
- * anti-ds DNA antibody positive
- * Mild to moderate disease activity define by a SLEDAI-2K ≥4
- * Stable corticosteroid dose in the 4 weeks prior to screening ≤ 30mg/day.
- * If on methotrexate, dose must be stable for 4 weeks
- * Concomitant treatment with hydroxychloroquine unless documented inability to tolerate
- * Able and willing to give written informed consent and comply with the requirements of the study protocol
- * Negative serum pregnancy test (for women of child bearing potential)
- * Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 16 weeks after completion of treatment
Exclusion Criteria:
- * Previous exposure to disease modifying drugs such as azathioprine, mycophenolate mofetil, cyclophosphamide, or cyclosporine.
- * Previous exposure to biologic therapies including rituximab, belimumab or other agents that have been investigated for SLE.
- * Active renal or nervous system disease or disease activity fulfilling BILAG A criteria
- * Use of high dose steroids (\>0.5 mg/kg/ day) within the 4 weeks prior to screening
- * Expectation (by the investigator) that the subject will require treatment with a disease modifying drug within the first 52 weeks of the study
- * Hemoglobin: \< 8.0 gm/dL
- * Platelets: \< 50,000/mm
- * ANC \< 1.0 x 103/mm
- * AST or ALT \>2.5 x Upper Limit of Normal unless related to primary disease.
- * Creatinine clearance ≤ 25ml/min per 1.73 m2
- * Positive Hepatitis B or C serology (Hep B Surface antigen, Hep B core Ab or Hepatitis C antibody)
- * History of positive HIV (HIV conducted during screening if applicable)
- * Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
- * Receipt of a live vaccine within 30 days prior to baseline or concurrently with belimumab
- * Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies
- * Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
- * Hospitalization for treatment of infection within 60 days of Day 0.
- * Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti parasitic agents) within 60 days of Day 0
- * History of serious recurrent or chronic infection
- * Lack of peripheral venous access
- * History of drug, alcohol, or chemical abuse within 365 days prior to Day 0
- * Pregnancy (a negative serum pregnancy test must be obtained for all women of childbearing potential at screening; a urine pregnancy test must be negative \< 7 days prior to first dose and monthly)
- * Lactation
- * History of psychiatric disorder that would interfere with normal participation in this protocol
- * Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- * History of malignant neoplasm within the last 5 years with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- * Evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk
- * History of a primary immunodeficiency
- * Have a significant IgG deficiency (IgG level \< 400 mg/dL)
- * Have an IgA deficiency (IgA level \< 10 mg/dL)
- * Have any other clinically significant abnormal laboratory value in the opinion of the investigator
- * Comorbidities requiring corticosteroid therapy, including those which have required two or more courses of systemic courses of systemic corticosteroids within the previous 12 months
- * Inability to comply with study and follow-up procedures
Ages Eligible for Study:
18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No