Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

Participant Flow:   Overall Study

	Placebo	Belimumab 1 mg/kg	Belimumab 10 mg/kg
STARTED	275	271	273
COMPLETED	186	199	191
NOT COMPLETED	89	72	82
Withdrawal by Subject	28	17	20
Adverse Event	23	18	23
Lack of Efficacy	20	12	17
Lack of Compliance	2	2	2
Lost to Follow-up	4	6	6
Protocol Violation	6	6	6
Physician Decision	3	3	4
Other	3	8	4

Reporting Groups

	Description
Placebo	Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 1 mg/kg	Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Belimumab 10 mg/kg	Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.

Baseline Measures

	Placebo	Belimumab 1 mg/kg	Belimumab 10 mg/kg	Total
Number of Participants   [units: participants]	275	271	273	819
Age   [units: years] Mean ± Standard Deviation	40.0  ± 11.9	40.0  ± 11.4	40.5  ± 11.1	40.2  ± 11.5
Age, Customized   [units: participants]
≤ 45 years	189	184	178	551
Between 45 and 65 years	77	83	92	252
≥ 65 years	9	4	3	16
Gender   [units: participants]
Female	252	253	259	764
Male	23	18	14	55
Region of Enrollment   [units: participants]
North America	145	155	136	436
Europe	100	90	105	295
Central America	30	26	32	88

1.  Primary:

SLE Responder Index (SRI) Response Rate at Week 52   [ Time Frame: Baseline, 52 Weeks ]

2.  Secondary:

SRI Response Rate at Week 76   [ Time Frame: Baseline, 76 Weeks ]

3.  Secondary:

Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.   [ Time Frame: Baseline, 52 Weeks ]

4.  Secondary:

Mean Change in Physician's Global Assessment (PGA) at Week 24.   [ Time Frame: Baseline, 24 Weeks ]

5.  Secondary:

Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.   [ Time Frame: Baseline, 24 Weeks ]

6.  Secondary:

Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52   [ Time Frame: Baseline, Weeks 40-52 ]

7.  Other Pre-specified:

Adverse Event (AE) Overview   [ Time Frame: Up to 80 Weeks ]