Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

Study participants receive standard therapy (induction and maintenance) for lupus nephritis
in addition to receiving either placebo (no active medicine) or belimumab. Induction therapy
starts before the first dose of study drug (belimumab or placebo). Maintenance therapy begins
after completion of induction therapy and continues for the remainder of the study.
Participants receive study drug throughout the entire study, during both induction and
maintenance periods. The controlled period of the study is 104 weeks. The random assignment
in this study is "1 to 1" which means you have an equal chance of receiving treatment with
belimumab or placebo. Participants who successfully complete the 104-week study may enter
into a 6-month open-label extension. All participants in the open-label extension receive
belimumab.

Key Inclusion Criteria:

- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.

- Biopsy confirmed active lupus nephritis.

- Clinically active lupus renal disease at screening requiring /receiving induction
therapy with Standard of Care medications.

- Autoantibody-positive.

Key Exclusion Criteria:

- Pregnant or nursing.

- On dialysis within the past year.

- Treatment with belimumab within the past year .

- Receipt of induction therapy with cyclophosphamide within 3 months prior to induction
therapy for the study.

- Receipt of any B cell targeted therapy (for example, rituximab), investigational
biological agent within the past year.

- Severe active central nervous system (CNS) lupus.

- Required management of acute or chronic infections within the past 60 days.

- Current drug or alcohol abuse or dependence.

- Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

- History of severe allergic reaction to contrast agents or biological medicines.