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A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy

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ClinicalTrials.gov Identifier: NCT01610492
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : June 1, 2015
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glomerulonephritis, Membranous
Intervention Drug: belimumab
Enrollment 14
Recruitment Details Eligible participants were recruited from July 2012 until March 2014, into this 2 part study of a initial treatment phase, a long term treatment phase, and then followed up for a further 6 months. Results have previously been presented for the initial treatment phase, up to the Week 28 and are now presented for the completed study.
Pre-assignment Details Screening occurred within 35 days and no less than 14 days before the first scheduled study treatment dose. Total 21 participants were screened; 14 were randomized and entered the initial treatment phase while 11 participants entered the long-term treatment phase. Common reasons for screen failures were insufficient, or improvements in proteinuria.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Period Title: Overall Study
Started 14
Completed 8
Not Completed 6
Reason Not Completed
Adverse Event             1
Lack of Efficacy             3
Other: Reached stopping criteria             1
Other:Treatment stopped due to remission             1
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
46.1  (13.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
3
  21.4%
Male
11
  78.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
Asian - Central/South Asian Heritage 4
White- White/Caucasian/European Heritage 9
Unknown 1
1.Primary Outcome
Title Change From Baseline in Proteinuria Levels at Week 28
Hide Description Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 hour (h) urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the mean of the pre and post dosing Day 0 values. The ratio is defined as the Week 28 value divided by the Baseline value. Ratio to Baseline: Estimated value = 0.76, 2-sided 95% confidence interval (CI)=0.57 to 1.01. The geometric mean method was used to calculate the CI. The analysis was performed on Intent-to-treat (ITT) Population which comprised of all eligible participants who received at least one dose of investigational drug. Only those participants available at the indicated time point (Week 28) were analyzed.
Time Frame Baseline and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
0.7552
(45.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.57 to 1.01
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titers at Week 28
Hide Description PLA2R autoantibody titers in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio to Baseline by dividing the Week 28 values with the Baseline values. Ratio to Baseline: Estimated value = 0.27, 2-sided 95% CI=0.12 to 0.58. The geometric mean method was used to calculate the CI.
Time Frame Baseline and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time point (Week 28) were analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
0.2666
(171.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Belimumab 10 mg/kg IV
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
0.12 to 0.58
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Proteinuria Levels at the Indicated Time Points
Hide Description Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milligrams per millimole (mg/mmol)
Baseline, n=14 Number Analyzed 14 participants
724.3157
(40.2%)
Week 12, n=13 Number Analyzed 13 participants
670.8655
(46.9%)
Week 28, n=11 Number Analyzed 11 participants
498.1255
(40.9%)
Week 52, n=9 Number Analyzed 9 participants
356.4209
(174.8%)
Week 76, n=8 Number Analyzed 8 participants
274.9714
(70.4%)
Week 104, n=10 Number Analyzed 10 participants
129.9761
(186.0%)
Week 128, n=9 Number Analyzed 9 participants
75.2359
(136.4%)
4.Secondary Outcome
Title Change From Baseline in Proteinuria Levels at the Indicated Time Points
Hide Description Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Week 12, 28, 52, 76, 104 and Week 128/6 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
Week 12; n= 13 Number Analyzed 13 participants
0.9437
(39.3%)
Week 28; n= 11 Number Analyzed 11 participants
0.7552
(45.0%)
Week 52; n= 9 Number Analyzed 9 participants
0.5297
(206.7%)
Week 76; n= 8 Number Analyzed 8 participants
0.4177
(54.3%)
Week 104; n= 10 Number Analyzed 10 participants
0.1874
(189.3%)
Week 128; n= 9 Number Analyzed 9 participants
0.1118
(139.1%)
5.Secondary Outcome
Title Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points
Hide Description Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti-PLA2R enzyme linked immunosorbent assay (ELISA) assay from Euroimmun. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: relative units per milliliter (RU/mL)
Baseline, n=14 Number Analyzed 14 participants
168.3
(138.9%)
Week 12, n=13 Number Analyzed 13 participants
91.0
(200.4%)
Week 28, n=11 Number Analyzed 11 participants
46.4
(319.6%)
Week 52, n=9 Number Analyzed 9 participants
12.9
(358.4%)
Week 76, n=8 Number Analyzed 8 participants
7.5
(140.4%)
Week 104, n=10 Number Analyzed 10 participants
3.7
(72.7%)
Week 128, n=8 Number Analyzed 8 participants
4.4
(112.0%)
6.Secondary Outcome
Title Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points
Hide Description Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from Euroimmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
Week 12; n= 13 Number Analyzed 13 participants
0.5362
(58.1%)
Week 28; n= 11 Number Analyzed 11 participants
0.2666
(171.0%)
Week 52; n= 9 Number Analyzed 9 participants
0.0737
(130.3%)
Week 76; n= 8 Number Analyzed 8 participants
0.0436
(102.8%)
Week 104; n= 10 Number Analyzed 10 participants
0.0212
(169.1%)
Week 128; n= 8 Number Analyzed 8 participants
0.0284
(243.7%)
7.Secondary Outcome
Title Number of Participants With Complete or Partial Remission
Hide Description Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3grams [g]/24 h) with no worsening in renal function (estimated glomerular filtration rate [eGFR] reduction from Baseline <15 percent). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
Week 12; Partial remission; n= 13 Number Analyzed 13 participants
0
Week 12; Complete remission; n= 13 Number Analyzed 13 participants
0
Week 28; Partial remission; n= 11 Number Analyzed 11 participants
1
Week 28; Complete remission; n= 11 Number Analyzed 11 participants
0
Week 52; Partial remission; n= 9 Number Analyzed 9 participants
2
Week 52; Complete remission; n= 9 Number Analyzed 9 participants
1
Week 76; Partial remission; n= 8 Number Analyzed 8 participants
3
Week 76; Complete remission; n= 8 Number Analyzed 8 participants
0
Week 104; Partial remission; n= 10 Number Analyzed 10 participants
6
Week 104; Complete remission; n= 10 Number Analyzed 10 participants
1
Week 128; Partial remission; n= 9 Number Analyzed 9 participants
6
Week 128; Complete remission; n= 9 Number Analyzed 9 participants
1
8.Secondary Outcome
Title Time to Complete or Partial Remission
Hide Description Time to complete or partial remission was estimated using the Kaplan-Meier method. Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15 percent ). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15 percent). Only 1 participant reached complete remission. Hence, statistical analysis for complete remission was not performed.
Time Frame Baseline and up to Week 128/6 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Median (95% Confidence Interval)
Unit of Measure: Weeks
68.20
(28.00 to 93.60)
9.Secondary Outcome
Title Duration of Complete or Partial Remission
Hide Description Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15percent). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50% from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles). NA indicates that data was not available as only 1 participant reached complete remission. Hence, standard deviation for complete remission was not calculated.
Time Frame Baseline and up to Week 128/6 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Days
Complete remission; n= 1 Number Analyzed 1 participants
365.0 [1]   (NA)
Partial remission; n= 9 Number Analyzed 9 participants
378.6  (186.15)
[1]
NA indicates that data was not available as only 1 participant reached complete remission. Hence, standard deviation for complete remission was not calculated.
10.Secondary Outcome
Title Number of Participants With PLA2R Autoantibody Remission
Hide Description Incidence of anti-PLA2R autoantibody remission were evaluated by full response and partial response. Full response is defined as antibody undetectable, partial response is defined as reduction in titers by 50 percent. For anti PLA2R autoantibody data, log transformation was applied before the formal analyses. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104 and 128/6 week post last-dose. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
Week 12; full response; n= 13 Number Analyzed 13 participants
1
Week 12; partial response; n= 13 Number Analyzed 13 participants
3
Week 28; full response; n= 11 Number Analyzed 11 participants
3
Week 28; partial response; n= 11 Number Analyzed 11 participants
6
Week 52; full response; n= 9 Number Analyzed 9 participants
4
Week 52; partial response; n= 9 Number Analyzed 9 participants
5
Week 76; full response; n= 8 Number Analyzed 8 participants
4
Week 76; partial response; n= 8 Number Analyzed 8 participants
4
Week 104; full response; n= 10 Number Analyzed 10 participants
10
Week 104; partial response; n= 10 Number Analyzed 10 participants
0
Week 128; Full response; n= 8 Number Analyzed 8 participants
8
Week 128; partial response; n= 8 Number Analyzed 8 participants
0
11.Secondary Outcome
Title Time to Anti-PLA2R Autoantibody Remission
Hide Description Time to anti-PLA2R autoantibody remission was estimated using Kaplan-Meier method for full response and partial response full response with antibody undetectable and partial response with reduction in titers by 50 percent.
Time Frame Baseline and up to Week 128/6 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Median (95% Confidence Interval)
Unit of Measure: Weeks
Partial response
16.20
(8.00 to 24.00)
Complete response
82.00
(16.00 to 92.00)
12.Secondary Outcome
Title Number of Participants With Anti-PLA2R Autoantibody Relapse
Hide Description Incidence of anti-PLA2R autoantibody relapse defined as antibody detectable after previously undetectable. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104/4 week post last dose, Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Time Frame Baseline and up to Week 128/6 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
Week 12; n= 13 Number Analyzed 13 participants
0
Week 28; n= 11 Number Analyzed 11 participants
0
Week 52; n= 9 Number Analyzed 9 participants
0
Week 76; n= 8 Number Analyzed 8 participants
0
Week 104; n= 10 Number Analyzed 10 participants
0
Week 128; n= 8 Number Analyzed 8 participants
0
13.Secondary Outcome
Title eGFR Levels at the Indicated Time Points
Hide Description eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by National Kidney Foundation-Chronic Kidney Disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: milliliter/minute (mL/min/1.73meter^2)
Baseline; n= 14 Number Analyzed 14 participants
69.8170
(32.9%)
Week 12; n= 13 Number Analyzed 13 participants
66.2639
(35.4%)
Week 28; n= 11 Number Analyzed 11 participants
65.0866
(36.1%)
Week 52; n= 7 Number Analyzed 7 participants
65.1308
(45.0%)
Week 76; n= 8 Number Analyzed 8 participants
61.6732
(47.1%)
Week 104; n= 10 Number Analyzed 10 participants
69.7692
(39.1%)
Week 128; n= 9 Number Analyzed 9 participants
64.7984
(39.2%)
14.Secondary Outcome
Title Change From Baseline in eGFR Levels at the Indicated Time Points
Hide Description eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and up to Week 128/6 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
Week 2, n=14 Number Analyzed 14 participants
0.9954
(10.8%)
Week 4, n= 13 Number Analyzed 13 participants
0.9190
(16.4%)
Week 8, n= 13 Number Analyzed 13 participants
0.9035
(16.2%)
Week 12, n= 13 Number Analyzed 13 participants
0.9339
(17.1%)
Week 16, n= 12 Number Analyzed 12 participants
0.9521
(12.5%)
Week 20, n= 8 Number Analyzed 8 participants
0.9819
(11.8%)
Week 24, n= 11 Number Analyzed 11 participants
0.9274
(17.1%)
Week 28, n= 11 Number Analyzed 11 participants
0.9694
(21.1%)
Week 32, n= 9 Number Analyzed 9 participants
1.0099
(19.5%)
Week 36, n= 11 Number Analyzed 11 participants
0.9692
(17.4%)
Week 40, n= 11 Number Analyzed 11 participants
0.9425
(20.8%)
Week 44, n= 10 Number Analyzed 10 participants
0.9531
(22.6%)
Week 48, n= 8 Number Analyzed 8 participants
0.9929
(23.8%)
Week 52, n= 7 Number Analyzed 7 participants
0.9290
(27.7%)
Week 56, n= 9 Number Analyzed 9 participants
1.0181
(21.9%)
Week 60, n= 9 Number Analyzed 9 participants
0.9805
(26.8%)
Week 64, n=9 Number Analyzed 9 participants
1.0217
(23.5%)
Week 68, n=8 Number Analyzed 8 participants
1.0233
(24.6%)
Week 72, n=8 Number Analyzed 8 participants
1.0168
(28.3%)
Week 76, n=8 Number Analyzed 8 participants
1.0055
(33.3%)
Week 80, n=8 Number Analyzed 8 participants
1.0431
(21.6%)
Week 84, n=8 Number Analyzed 8 participants
0.9959
(25.3%)
Week 88, n=8 Number Analyzed 8 participants
1.0529
(16.3%)
Week 92, n=8 Number Analyzed 8 participants
1.0052
(26.3%)
Week 96, n=8 Number Analyzed 8 participants
1.1204
(22.1%)
Week 100, n=8 Number Analyzed 8 participants
1.1122
(24.7%)
Week 104, n=10 Number Analyzed 10 participants
1.0480
(23.3%)
Week 116; n= 8 Number Analyzed 8 participants
1.0373
(19.8%)
Week 128, n=9 Number Analyzed 9 participants
0.9971
(35.2%)
15.Secondary Outcome
Title Serum Creatinine Levels at the Indicated Time Points
Hide Description Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micromoles/liter (µmol/L)
Baseline; n= 14 Number Analyzed 14 participants
97.1658
(22.8%)
Week 12; n= 13 Number Analyzed 13 participants
100.6421
(26.8%)
Week 28; n= 11 Number Analyzed 11 participants
99.9535
(24.8%)
Week 52; n= 7 Number Analyzed 7 participants
96.6583
(30.2%)
Week 76; n= 8 Number Analyzed 8 participants
103.0265
(32.8%)
Week 104; n= 10 Number Analyzed 10 participants
92.4547
(29.6%)
Week 128; n= 9 Number Analyzed 9 participants
97.7260
(29.7%)
16.Secondary Outcome
Title Change From Baseline in Serum Creatinine Levels at the Indicated Time Points
Hide Description Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
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ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
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Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
Week 12; n= 13 Number Analyzed 13 participants
1.0530
(14.8%)
Week 28; n= 11 Number Analyzed 11 participants
1.0202
(18.6%)
Week 52; n= 7 Number Analyzed 7 participants
1.0581
(23.7%)
Week 76; n= 8 Number Analyzed 8 participants
0.9818
(28.7%)
Week 104; n= 10 Number Analyzed 10 participants
0.9467
(20.1%)
Week 128; n= 9 Number Analyzed 9 participants
0.9874
(30.4%)
17.Secondary Outcome
Title Serum Albumin Levels at Indicated Time Points
Hide Description Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.
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ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
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Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: grams per liter (g/L)
Baseline; n= 14 Number Analyzed 14 participants
23.3306
(22.7%)
Week 12; n= 13 Number Analyzed 13 participants
24.4204
(27.5%)
Week 28; n= 11 Number Analyzed 11 participants
27.8397
(23.4%)
Week 52; n= 7 Number Analyzed 7 participants
31.9927
(18.3%)
Week 76; n= 8 Number Analyzed 8 participants
33.9484
(10.9%)
Week 104; n= 10 Number Analyzed 10 participants
39.1015
(7.5%)
Week 128; n= 9 Number Analyzed 9 participants
39.2009
(8.8%)
18.Secondary Outcome
Title Change From Baseline in Levels of Serum Albumin at the Indicated Time Points
Hide Description Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
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ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
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Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
Week 12; n= 13 Number Analyzed 13 participants
1.0324
(15.0%)
Week 28; n= 11 Number Analyzed 11 participants
1.1211
(16.9%)
Week 52; n= 7 Number Analyzed 7 participants
1.2828
(28.1%)
Week 76; n= 8 Number Analyzed 8 participants
1.3695
(23.8%)
Week 104; n= 10 Number Analyzed 10 participants
1.5879
(19.6%)
Week 128; n= 9 Number Analyzed 9 participants
1.5799
(24.7%)
19.Secondary Outcome
Title Serum Cholesterol Levels at Indicated Time Points
Hide Description Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
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ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
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Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: millimoles per liter (mmol/L)
Baseline; n= 14 Number Analyzed 14 participants
7.6423
(36.0%)
Week 12; n= 13 Number Analyzed 13 participants
7.2336
(31.5%)
Week 28; n= 11 Number Analyzed 11 participants
6.2740
(23.1%)
Week 52; n= 7 Number Analyzed 7 participants
5.8724
(18.6%)
Week 76; n= 8 Number Analyzed 8 participants
5.0211
(18.4%)
Week 104; n= 10 Number Analyzed 10 participants
4.8001
(24.5%)
Week 128; n= 9 Number Analyzed 9 participants
4.2407
(12.7%)
20.Secondary Outcome
Title Change From Baseline in Serum Cholesterol at the Indicated Time Points
Hide Description Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
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ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mmol/L
Week 12; n= 13 Number Analyzed 13 participants
0.9238
(16.8%)
Week 28; n= 11 Number Analyzed 11 participants
0.8896
(14.3%)
Week 52; n= 7 Number Analyzed 7 participants
0.8571
(16.7%)
Week 76; n= 8 Number Analyzed 8 participants
0.7111
(15.0%)
Week 104; n= 10 Number Analyzed 10 participants
0.6851
(17.3%)
Week 128; n= 9 Number Analyzed 9 participants
0.6140
(15.7%)
21.Secondary Outcome
Title Serum Immunoglobulin G (IgG) Levels at Indicated Time Points
Hide Description Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up
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ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: g/L
Baseline; n= 14 Number Analyzed 14 participants
4.026  (1.6810)
Week 12; n= 13 Number Analyzed 13 participants
3.871  (1.5266)
Week 28; n= 11 Number Analyzed 11 participants
4.405  (1.7833)
Week 52; n= 8 Number Analyzed 8 participants
5.823  (2.2572)
Week 76; n= 8 Number Analyzed 8 participants
6.050  (2.1103)
Week 104; n= 10 Number Analyzed 10 participants
7.611  (2.8301)
Week 128; n= 9 Number Analyzed 9 participants
8.609  (2.2597)
22.Secondary Outcome
Title Change From Baseline in Serum IgG at the Indicated Time Points
Hide Description Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow up
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ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Ratio
Week 12; n= 13 Number Analyzed 13 participants
0.055  (0.6625)
Week 28; n= 11 Number Analyzed 11 participants
0.469  (1.4287)
Week 52; n= 8 Number Analyzed 8 participants
1.525  (2.4411)
Week 76; n= 8 Number Analyzed 8 participants
1.619  (1.6681)
Week 104; n= 10 Number Analyzed 10 participants
3.613  (2.5488)
Week 128; n= 9 Number Analyzed 9 participants
4.334  (2.0289)
23.Secondary Outcome
Title Number of Participants With Edema and Edema Extending Beyond Calf
Hide Description Reduction of proteinuria lessens the risk of thromboembolic and cardiovascular effects and reduces the edema in participants. Investigators physically reviewed participants for clinical manifestations of idiopathic membranous glomerulonephropathy (IMGN) (e.g. edema extending beyond calf) during study and analysis was performed at Week 12, 28, 52, 76 Week 104. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Time Frame Baseline and Weeks 12, 28, 52, 76, and 104
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ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
Week 0; oedema; n= 14 13
Week 0; oedema extending beyond calf; n= 14 5
Week 12; oedema; n= 12 9
Week 12; Oedema extending beyond calf; n= 12 1
Week 28;Oedema; n= 11 7
Week 28; Oedema extending beyond calf; n= 11 1
Week 52; oedema; n= 9 4
Week 52;Oedema extending beyond calf; n= 9 1
Week 76;Oedema; n=8 4
Week 76;Oedema extending beyond calf; n= 8 0
4 Week post final dose (PFD); Oedema; n=10 6
4 Week PFD; Oedema extending beyond calf; n= 10 1
Week 104 withdrawn (WD); Oedema; n= 1 0
Week 104 WD;Oedema extending beyond calf; n= 1 0
24.Secondary Outcome
Title Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points
Hide Description The first occurrence of Cmax was determined directly from the serum concentration-time data. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis and all calculations of non-compartmental parameters are being based on actual sampling times.
Time Frame Baseline and up to 4 week post last dose
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PK Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed.
Arm/Group Title Belimumab 10 mg/kg IV
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Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
Day 0, 5 minutes; n= 13 Number Analyzed 13 participants
267996.0  (70598.02)
Week 28, 5 minutes; n= 11 Number Analyzed 11 participants
312462.2  (95171.16)
25.Secondary Outcome
Title Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points
Hide Description Trough concentration (Cmin) samples collected on the specified days are being used to assess attainment whether there was sufficient belimumab despite it being lost in the urine from the proteinuria and to check if it improved as proteinuria resolved. Analysis was performed on pre-infusion samples at weeks 2,4,8,12,28,40,52,76 and the 4 week post last-dose.
Time Frame Baseline and up to 4 week post last dose
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PK Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng/mL
Pre-infusion; Week 2; n= 14 Number Analyzed 14 participants
29940.8  (20918.28)
Pre-infusion; Week 4; n= 12 Number Analyzed 12 participants
41220.9  (35720.14)
Pre-infusion; Week 8; n= 13 Number Analyzed 13 participants
30350.9  (25505.70)
Pre-infusion; Week 12; n= 11 Number Analyzed 11 participants
30913.7  (30681.42)
Pre-infusion; Week 28; n= 11 Number Analyzed 11 participants
34904.7  (26388.60)
Pre-infusion; Week 40; n= 10 Number Analyzed 10 participants
40800.6  (28847.86)
Pre-infusion; Week 52; n= 9 Number Analyzed 9 participants
38375.9  (14136.23)
Pre-infusion; Week 76; n= 8 Number Analyzed 8 participants
65655.8  (32873.33)
4 Weeks post last-dose; n= 9 Number Analyzed 9 participants
60497.3  (28074.37)
26.Secondary Outcome
Title Summary of Area Under the Serum Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-2])
Hide Description The AUC(0-2) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for PK analysis were collected at the following time points: pre-dose (on dosing days): Days 0, 1, 4, 7, 14 and Week 4, 8, 12, 28, 40, 52, 76 and 4 week post last dose. Post-dose (5 minutes after dosing complete): Days 0 and 28. The results will be posted at later date following post hoc analysis.
Time Frame Baseline and up to 4 week post last dose
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Hide Analysis Population Description
PK Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Summary of Total Amount of Urine Excreted Ae(0-24)
Hide Description PK parameters from the urine concentration data: urine Ae(0-24) were assessed. 24 h urine collections for PK analysis were collected after the Day 0 and Weeks 12, 28, 52, 76 doses and at the 4 week post last dose visit. A population approach was undertaken to characterize the population PK parameters and associated variability of belimumab in nephrotic participants. The population approach could have provided derived clearance of belimumab for each participant after the first dose. The population PK analysis was conducted using nonlinear mixed-effect modeling (NONMEM) or appropriate nonlinear mixed-effect analysis software. Several samples were taken pre-dose at Day 0 and some at week 12 incorrectly which affects interpretation.
Time Frame Baseline and Up to 4 week post last dose
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PK Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ng/hour
Day 0; n= 14 Number Analyzed 14 participants
105826.23  (178943.857)
Week 12; n= 12 Number Analyzed 12 participants
95188.14  (130217.976)
Week 28; n= 11 Number Analyzed 11 participants
92997.94  (110142.599)
Week 52; n= 9 Number Analyzed 9 participants
219367.96  (391752.377)
Week 76; n= 8 Number Analyzed 8 participants
145645.34  (267292.225)
4 Week post last dose; n= 6 Number Analyzed 6 participants
7909.34  (16771.559)
28.Secondary Outcome
Title Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score
Hide Description Health-related quality of life was assessed through participant self-completion of the short form health survey (SF-36 version [v2]), a general health related quality of life metrics. Norm-based Scores (NBS) for physical functioning, role emotional, role physical were assessed. The remaining SF-36 component scores require re-scaling and therefore will be added at a later date. SF-36 was administered prior to any procedures at Weeks 12, 28, 52, 76 and 104/4 week post last dose. Item score were recorded and higher score represented better health status. Baseline is defined as Day 0 pre dose value and change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).
Time Frame Baseline and up to Week 104/4 week post last dose
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ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Physical functioning, Week 12; n= 12 Number Analyzed 12 participants
-4.034  (5.1907)
Physical functioning, Week 28; n= 11 Number Analyzed 11 participants
-0.765  (3.6780)
Physical functioning, Week 52; n= 9 Number Analyzed 9 participants
0.468  (7.3489)
Physical functioning, Week 76; n= 7 Number Analyzed 7 participants
0.601  (7.9409)
Physical functioning 4 Week post final dose;n=11 Number Analyzed 11 participants
0.765  (11.7275)
Role emotional, Week 12; n= 12 Number Analyzed 12 participants
-0.000  (10.4831)
Role emotional, Week 28; n= 11 Number Analyzed 11 participants
1.413  (15.1824)
Role emotional, Week 52; n= 9 Number Analyzed 9 participants
3.023  (11.4621)
Role emotional, Week 76; n= 7 Number Analyzed 7 participants
3.332  (7.2475)
Role emotional, 4 Week post final dose; n= 11 Number Analyzed 11 participants
6.007  (10.0413)
Role physical, Week 12; n= 12 Number Analyzed 12 participants
0.816  (11.0681)
Role physical, Week 28; n= 11 Number Analyzed 11 participants
3.340  (8.4324)
Role physical, Week 52; n= 9 Number Analyzed 9 participants
3.537  (9.1726)
Role physical, Week 76; n= 7 Number Analyzed 7 participants
7.697  (12.2803)
Role physical 4 Week post final dose; n= 11 Number Analyzed 11 participants
5.789  (11.4489)
29.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on Safety Population which comprised of all participants who were randomized into the study. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, is a congenital anomaly/birth defect, may require medical or surgical intervention, is associated with liver injury and impaired liver function.
Time Frame Baseline and up to Week 128/6 month follow up
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ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
AE 14
SAE 3
30.Secondary Outcome
Title Number of Participants With Abnormal Clinical Chemistry and Hematology Values
Hide Description Blood samples were collected from participants for evaluation of clinical chemistry and hematology parameters. The clinical chemistry parameters included albumin, alkaline phosphatase (alk.phosph.), alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin, calcium, cholesterol, chloride, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, potassium, lactate dehydrogenase (LD), magnesium, sodium, phosphorus, total protein, blood urea nitrogen (BUN) and uric acid. The hematology parameters included basophils, eosinophil, hemoglobin, hematocrit, lymphocytes, monocytes, total neutrophils, platelets, red blood cells (RBC) count and white blood cells (WBC) count. Participants were counted in the category that their value changes to (low or high) for the specific time points. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Time Frame Baseline and up to Week 116/16 week follow-up visit
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ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
Albumin; Week 12; to high; n= 13 Number Analyzed 13 participants
0
Albumin; Week 12; to low; n= 13 Number Analyzed 13 participants
0
Albumin; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Albumin; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Albumin; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Albumin; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Albumin; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Albumin; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Albumin; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Albumin; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Albumin; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
Albumin; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
Alk.phosph.; Week 12; to high; n= 13 Number Analyzed 13 participants
0
Alk.phosph.; Week 12; to low; n= 13 Number Analyzed 13 participants
0
Alk.phosph.; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Alk.phosph.; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Alk.phosph.; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Alk.phosph.; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Alk.phosph.; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Alk.phosph.; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Alk.phosph.; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Alk.phosph.; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Alk.phosph.; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
Alk.phosph.; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
ALT; Week 12; to high; n= 13 Number Analyzed 13 participants
0
ALT; Week 12; to low; n= 13 Number Analyzed 13 participants
0
ALT; Week 28; to high; n= 11 Number Analyzed 11 participants
0
ALT; Week 28; to low; n= 11 Number Analyzed 11 participants
0
ALT; Week 52; to high; n= 7 Number Analyzed 7 participants
0
ALT; Week 52; to low; n= 7 Number Analyzed 7 participants
0
ALT; Week 76; to high; n= 8 Number Analyzed 8 participants
0
ALT; Week 76; to low; n= 8 Number Analyzed 8 participants
0
ALT; Week 104; to high; n= 10 Number Analyzed 10 participants
0
ALT; Week 104; to low; n= 10 Number Analyzed 10 participants
0
ALT; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
ALT; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
AST; Week 12; to high; n= 13 Number Analyzed 13 participants
0
AST; Week 12; to low; n= 13 Number Analyzed 13 participants
0
AST; Week 28; to high; n= 11 Number Analyzed 11 participants
1
AST; Week 28; to low; n= 11 Number Analyzed 11 participants
0
AST; Week 52; to high; n= 7 Number Analyzed 7 participants
0
AST; Week 52; to low; n= 7 Number Analyzed 7 participants
0
AST; Week 76; to high; n= 8 Number Analyzed 8 participants
0
AST; Week 76; to low; n= 8 Number Analyzed 8 participants
0
AST; Week 104; to high; n= 10 Number Analyzed 10 participants
0
AST; Week 104; to low; n= 10 Number Analyzed 10 participants
0
AST; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
AST; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
Direct bilirubin; Week 12; to high; n= 13 Number Analyzed 13 participants
0
Direct bilirubin; Week 12; to low; n= 13 Number Analyzed 13 participants
0
Direct bilirubin; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Direct bilirubin; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Direct bilirubin; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Direct bilirubin; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Direct bilirubin; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Direct bilirubin; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Direct bilirubin; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Direct bilirubin; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Direct bilirubin; 16 Week follow up; to high; n=8 Number Analyzed 8 participants
0
Direct bilirubin; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
Total bilirubin; Week 12; to high; n= 12 Number Analyzed 12 participants
0
Total bilirubin; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Total bilirubin; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Total bilirubin; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Total bilirubin; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Total bilirubin; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Total bilirubin; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Total bilirubin; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Total bilirubin; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Total bilirubin; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Total bilirubin; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
Total bilirubin; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
Calcium; Week 12; to high; n= 12 Number Analyzed 12 participants
0
Calcium; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Calcium; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Calcium; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Calcium; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Calcium; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Calcium; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Calcium; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Calcium; Week 104; to high; n= 10 Number Analyzed 10 participants
1
Calcium; Week 104; to low; n= 10 Number Analyzed 10 participants
1
Calcium; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
Calcium; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
Cholesterol; Week 12; to high; n= 13 Number Analyzed 13 participants
0
Cholesterol; Week 12; to low; n= 13 Number Analyzed 13 participants
0
Cholesterol; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Cholesterol; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Cholesterol; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Cholesterol; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Cholesterol; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Cholesterol; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Cholesterol; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Cholesterol; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Cholesterol; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
Cholesterol; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
Chloride; Week 12; to high; n= 13 Number Analyzed 13 participants
1
Chloride; Week 12; to low; n= 13 Number Analyzed 13 participants
0
Chloride; Week 28; to high; n= 11 Number Analyzed 11 participants
2
Chloride; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Chloride; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Chloride; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Chloride; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Chloride; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Chloride; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Chloride; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Chloride; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
Chloride; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
Carbon dioxide; Week 12; to high; n= 13 Number Analyzed 13 participants
0
Carbon dioxide; Week 12; to low; n= 13 Number Analyzed 13 participants
1
Carbon dioxide; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Carbon dioxide; Week 28; to low; n= 11 Number Analyzed 11 participants
3
Carbon dioxide; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Carbon dioxide; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Carbon dioxide; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Carbon dioxide; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Carbon dioxide; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Carbon dioxide; Week 104; to low; n= 10 Number Analyzed 10 participants
1
Carbon dioxide; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
Carbon dioxide; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
Creatinine; Week 12; to high; n= 13 Number Analyzed 13 participants
2
Creatinine; Week 12; to low; n= 13 Number Analyzed 13 participants
0
Creatinine; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Creatinine; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Creatinine; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Creatinine; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Creatinine; Week 76; to high; n= 8 Number Analyzed 8 participants
2
Creatinine; Week 76; to low; n= 8 Number Analyzed 8 participants
1
Creatinine; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Creatinine; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Creatinine; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
Creatinine; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
GGT; Week 12; to high; n= 13 Number Analyzed 13 participants
0
GGT; Week 12; to low; n= 13 Number Analyzed 13 participants
0
GGT; Week 28; to high; n= 11 Number Analyzed 11 participants
0
GGT; Week 28; to low; n= 11 Number Analyzed 11 participants
0
GGT; Week 52; to high; n= 7 Number Analyzed 7 participants
0
GGT; Week 52; to low; n= 7 Number Analyzed 7 participants
0
GGT; Week 76; to high; n= 8 Number Analyzed 8 participants
0
GGT; Week 76; to low; n= 8 Number Analyzed 8 participants
0
GGT; Week 104; to high; n= 10 Number Analyzed 10 participants
0
GGT; Week 104; to low; n= 10 Number Analyzed 10 participants
0
GGT; 16 Week follow up; to high; n=8 Number Analyzed 8 participants
0
GGT; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
Glucose; Week 12; to high; n= 13 Number Analyzed 13 participants
3
Glucose; Week 12; to low; n= 13 Number Analyzed 13 participants
0
Glucose; Week 28; to high; n= 11 Number Analyzed 11 participants
4
Glucose; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Glucose; Week 52; to high; n= 7 Number Analyzed 7 participants
2
Glucose; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Glucose; Week 76; to high; n= 8 Number Analyzed 8 participants
3
Glucose; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Glucose; Week 104; to high; n= 10 Number Analyzed 10 participants
1
Glucose; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Glucose; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
1
Glucose; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
1
Potassium; Week 12; to high; n= 13 Number Analyzed 13 participants
0
Potassium; Week 12; to low; n= 13 Number Analyzed 13 participants
0
Potassium; Week 28; to high; n= 11 Number Analyzed 11 participants
1
Potassium; Week 28; to low; n= 11 Number Analyzed 11 participants
1
Potassium; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Potassium; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Potassium; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Potassium; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Potassium; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Potassium; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Potassium; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
Potassium; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
LD; Week 12; to high; n= 13 Number Analyzed 13 participants
3
LD; Week 12; to low; n= 13 Number Analyzed 13 participants
0
LD; Week 28; to high; n= 11 Number Analyzed 11 participants
2
LD; Week 28; to low; n= 11 Number Analyzed 11 participants
0
LD; Week 52; to high; n= 7 Number Analyzed 7 participants
1
LD; Week 52; to low; n= 7 Number Analyzed 7 participants
0
LD; Week 76; to high; n= 8 Number Analyzed 8 participants
1
LD; Week 76; to low; n= 8 Number Analyzed 8 participants
0
LD;Week 104; to high; n= 10 Number Analyzed 10 participants
0
LD;Week 104; to low; n= 10 Number Analyzed 10 participants
0
LD; 16 week follow-up; to high; n= 8 Number Analyzed 8 participants
0
LD; 16 week follow up; to low; n= 8 Number Analyzed 8 participants
0
Magnesium; Week 12; to high; n= 13 Number Analyzed 13 participants
1
Magnesium; Week 12; to low; n= 13 Number Analyzed 13 participants
0
Magnesium; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Magnesium; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Magnesium; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Magnesium; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Magnesium; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Magnesium; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Magnesium; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Magnesium; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Magnesium; 16 week follow up; to high; n= 8 Number Analyzed 8 participants
0
Magnesium; 16 week follow up; to low; n= 8 Number Analyzed 8 participants
0
Sodium; Week 12; to high; n= 12 Number Analyzed 12 participants
0
Sodium; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Sodium; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Sodium; Week 28; to low; n= 11 Number Analyzed 11 participants
1
Sodium; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Sodium; Week 52; to low; n= 7 Number Analyzed 7 participants
1
Sodium; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Sodium; Week 76; to low; n= 8 Number Analyzed 8 participants
1
Sodium; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Sodium; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Sodium; 16 week follow p; to high; n= 8 Number Analyzed 8 participants
0
Sodium; 16 week follow up; to low; n= 8 Number Analyzed 8 participants
1
Phosphorus; Week 12; to high; n= 13 Number Analyzed 13 participants
1
Phosphorus; Week 12; to low; n= 13 Number Analyzed 13 participants
0
Phosphorus; Week 28; to high; n= 11 Number Analyzed 11 participants
2
Phosphorus; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Phosphorus; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Phosphorus; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Phosphorus; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Phosphorus; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Phosphorus;Week 104; to high; n= 10 Number Analyzed 10 participants
1
Phosphorus;Week 104; to low; n= 10 Number Analyzed 10 participants
1
Phosphorus; 16 week follow up; to high; n= 8 Number Analyzed 8 participants
0
Phosphorus; 16 week follow up; to low; n= 8 Number Analyzed 8 participants
0
Total protein; Week 12; to high; n= 12 Number Analyzed 12 participants
0
Total protein; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Total protein; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Total protein; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Total protein; Week 52; to high; n= 7 Number Analyzed 7 participants
0
Total protein; Week 52; to low; n= 7 Number Analyzed 7 participants
1
Total protein; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Total protein; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Total protein; Week 104; to high; n= 10 Number Analyzed 10 participants
0
Total protein; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Total protein; 16 Week follow up; to high; n= 8 Number Analyzed 8 participants
0
Total protein; 16 Week follow up; to low; n= 8 Number Analyzed 8 participants
0
BUN; Week 12; to high; n= 13 Number Analyzed 13 participants
2
BUN; Week 12; to low; n= 13 Number Analyzed 13 participants
0
BUN; Week 28; to high; n= 11 Number Analyzed 11 participants
0
BUN; Week 28; to low; n= 11 Number Analyzed 11 participants
0
BUN; Week 52; to high; n= 7 Number Analyzed 7 participants
2
BUN; Week 52; to low; n= 7 Number Analyzed 7 participants
0
BUN; Week 76; to high; n= 8 Number Analyzed 8 participants
2
BUN; Week 76; to low; n= 8 Number Analyzed 8 participants
0
BUN; Week 104; to high; n= 10 Number Analyzed 10 participants
0
BUN; Week 104; to low; n= 10 Number Analyzed 10 participants
0
BUN; 16 week follow up; to high; n= 8 Number Analyzed 8 participants
0
BUN; 16 week follow up; to low; n= 8 Number Analyzed 8 participants
0
Uric acid; Week 12; to high; n= 13 Number Analyzed 13 participants
2
Uric acid; Week 12; to low; n= 13 Number Analyzed 13 participants
2
Uric acid; Week 28; to high; n= 11 Number Analyzed 11 participants
1
Uric acid; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Uric acid; Week 52; to high; n= 7 Number Analyzed 7 participants
1
Uric acid; Week 52; to low; n= 7 Number Analyzed 7 participants
0
Uric acid; Week 76; to high; n= 8 Number Analyzed 8 participants
2
Uric acid; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Uric acid; Week 104; to high; n= 10 Number Analyzed 10 participants
2
Uric acid; Week 104; to low; n= 10 Number Analyzed 10 participants
0
Uric acid; 16 week follow up; to high; n= 8 Number Analyzed 8 participants
2
Uric acid; 16 week follow up; to low; n= 8 Number Analyzed 8 participants
0
Basophils; Week 12; to high; n= 12 Number Analyzed 12 participants
0
Basophils; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Basophils; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Basophils; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Basophils; Week 52; to high; n= 9 Number Analyzed 9 participants
0
Basophils; Week 52; to low; n= 9 Number Analyzed 9 participants
0
Basophils; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Basophils; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Basophils; Week 104; to high; n= 9 Number Analyzed 9 participants
0
Basophils; Week 104; to low; n= 9 Number Analyzed 9 participants
0
Basophils; 16 week follow up; to high; n= 9 Number Analyzed 9 participants
0
Basophils; 16 week follow up; to low; n= 9 Number Analyzed 9 participants
0
Eosinophils; Week 12; to high; n= 12 Number Analyzed 12 participants
1
Eosinophils; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Eosinophils; Week 28; to high; n= 11 Number Analyzed 11 participants
1
Eosinophils; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Eosinophils; Week 52; to high; n= 9 Number Analyzed 9 participants
0
Eosinophils; Week 52; to low; n= 9 Number Analyzed 9 participants
0
Eosinophils; Week 76; to high; n= 8 Number Analyzed 8 participants
1
Eosinophils; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Eosinophils; Week 104; to high; n= 9 Number Analyzed 9 participants
0
Eosinophils; Week 104; to low; n= 9 Number Analyzed 9 participants
0
Eosinophils; 16 week follow up; to high; n= 9 Number Analyzed 9 participants
0
Eosinophils; 16 week follow up; to low; n= 9 Number Analyzed 9 participants
0
Hemoglobin; Week 12; to high; n= 12 Number Analyzed 12 participants
0
Hemoglobin; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Hemoglobin; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Hemoglobin; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Hemoglobin; Week 52; to high; n= 9 Number Analyzed 9 participants
0
Hemoglobin; Week 52; to low; n= 9 Number Analyzed 9 participants
2
Hemoglobin; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Hemoglobin; Week 76; to low; n= 8 Number Analyzed 8 participants
1
Hemoglobin; Week 104; to high; n= 9 Number Analyzed 9 participants
0
Hemoglobin; Week 104; to low; n= 9 Number Analyzed 9 participants
1
Hemoglobin; 16 week follow up; to high; n= 9 Number Analyzed 9 participants
0
Hemoglobin; 16 week follow up; to low; n= 9 Number Analyzed 9 participants
1
Hematocrit; Week 12; to high; n= 12 Number Analyzed 12 participants
0
Hematocrit; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Hematocrit; Week 28; to high; n= 11 Number Analyzed 11 participants
1
Hematocrit; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Hematocrit; Week 52; to high; n= 9 Number Analyzed 9 participants
0
Hematocrit; Week 52; to low; n= 9 Number Analyzed 9 participants
1
Hematocrit; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Hematocrit; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Hematocrit; Week 104; to high; n= 9 Number Analyzed 9 participants
0
Hematocrit; Week 104; to low; n= 9 Number Analyzed 9 participants
1
Hematocrit; 16 week follow up; to high; n= 9 Number Analyzed 9 participants
0
Hematocrit; 16 week follow up; to low; n= 9 Number Analyzed 9 participants
1
Lymphocytes; Week 12; to high; n= 12 Number Analyzed 12 participants
0
Lymphocytes; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Lymphocytes; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Lymphocytes; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Lymphocytes; Week 52; to high; n= 9 Number Analyzed 9 participants
0
Lymphocytes; Week 52; to low; n= 9 Number Analyzed 9 participants
0
Lymphocytes; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Lymphocytes; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Lymphocytes; Week 104; to high; n= 9 Number Analyzed 9 participants
0
Lymphocytes; Week 104; to low; n= 9 Number Analyzed 9 participants
0
Lymphocytes; 16 week follow up; to high; n= 9 Number Analyzed 9 participants
0
Lymphocytes; 16 week follow up; to low; n= 9 Number Analyzed 9 participants
0
Monocytes; Week 12; to high; n= 12 Number Analyzed 12 participants
0
Monocytes; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Monocytes; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Monocytes; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Monocytes; Week 52; to high; n= 9 Number Analyzed 9 participants
0
Monocytes; Week 52; to low; n= 9 Number Analyzed 9 participants
0
Monocytes; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Monocytes; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Monocytes; Week 104; to high; n= 9 Number Analyzed 9 participants
0
Monocytes; Week 104; to low; n= 9 Number Analyzed 9 participants
0
Monocytes; 16 week follow up; to high; n= 9 Number Analyzed 9 participants
0
Monocytes; 16 week follow up; to low; n= 9 Number Analyzed 9 participants
0
Neutrophils; Week 12; to high; n= 12 Number Analyzed 12 participants
1
Neutrophils; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Neutrophils; Week 28; to high; n= 11 Number Analyzed 11 participants
0
Neutrophils; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Neutrophils; Week 52; to high; n= 9 Number Analyzed 9 participants
0
Neutrophils; Week 52; to low; n= 9 Number Analyzed 9 participants
0
Neutrophils; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Neutrophils; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Neutrophils; Week 104; to high; n= 9 Number Analyzed 9 participants
2
Neutrophils; Week 104; to low; n= 9 Number Analyzed 9 participants
0
Neutrophils; 16 week follow up; to high; n=9 Number Analyzed 9 participants
1
Neutrophils; 16 week follow up; to low; n= 9 Number Analyzed 9 participants
0
Platelet count; Week 12; to high; n= 12 Number Analyzed 12 participants
3
Platelet count; Week 12; to low; n= 12 Number Analyzed 12 participants
0
Platelet count; Week 28; to high; n= 11 Number Analyzed 11 participants
2
Platelet count; Week 28; to low; n= 11 Number Analyzed 11 participants
0
Platelet count; Week 52; to high; n= 9 Number Analyzed 9 participants
0
Platelet count; Week 52; to low; n= 9 Number Analyzed 9 participants
0
Platelet count; Week 76; to high; n= 8 Number Analyzed 8 participants
0
Platelet count; Week 76; to low; n= 8 Number Analyzed 8 participants
0
Platelet count; Week 104; to high; n= 9 Number Analyzed 9 participants
1
Platelet count; Week 104; to low; n= 9 Number Analyzed 9 participants
0
Platelet count; 16 week follow up; to high; n= 9 Number Analyzed 9 participants
0
Platelet count; 16 week follow up; to low; n= 9 Number Analyzed 9 participants
0
RBC; Week 12; to high; n= 12 Number Analyzed 12 participants
0
RBC; Week 12; to low; n= 12 Number Analyzed 12 participants
3
RBC; Week 28; to high; n= 11 Number Analyzed 11 participants
0
RBC; Week 28; to low; n= 11 Number Analyzed 11 participants
1
RBC; Week 52; to high; n= 9 Number Analyzed 9 participants
0
RBC; Week 52; to low; n= 9 Number Analyzed 9 participants
1
RBC; Week 76; to high; n= 8 Number Analyzed 8 participants
0
RBC; Week 76; to low; n= 8 Number Analyzed 8 participants
0
RBC; Week 104; to high; n= 9 Number Analyzed 9 participants
0
RBC; Week 104; to low; n= 9 Number Analyzed 9 participants
0
RBC; 16 week follow up; to high; n= 9 Number Analyzed 9 participants
0
RBC; 16 week follow up; to low; n= 9 Number Analyzed 9 participants
1
WBC; Week 12; to high; n= 12 Number Analyzed 12 participants
1
WBC; Week 12; to low; n= 12 Number Analyzed 12 participants
0
WBC; Week 28; to high; n= 11 Number Analyzed 11 participants
0
WBC; Week 28; to low; n= 11 Number Analyzed 11 participants
0
WBC; Week 52; to high; n= 9 Number Analyzed 9 participants
0
WBC; Week 52; to low; n= 9 Number Analyzed 9 participants
0
WBC; Week 76; to high; n= 8 Number Analyzed 8 participants
0
WBC; Week 76; to low; n= 8 Number Analyzed 8 participants
0
WBC; Week 104; to high; n= 9 Number Analyzed 9 participants
2
WBC; Week 104; to low; n= 9 Number Analyzed 9 participants
0
WBC; 16 week follow up; to high; n= 9 Number Analyzed 9 participants
1
WBC; 16 week follow up; to low; n= 9 Number Analyzed 9 participants
0
31.Secondary Outcome
Title Number of Participants With Urinalysis Dipstick Findings
Hide Description Urine samples were collected for urinalysis by dipstick method from Baseline up to Week 116/16 months follow up and number of participants with findings were presented for Baseline, Week 12, 28, 52, 76, 104/4 weeks post last-dose and Week 116/16 week follow up (WF). The urinalysis parameters included occult blood, glucose, ketones, protein. The findings were presented as trace or 1/10 g/100 milliliter (dL), trace, negative, 4+, 3+, 3+ or 1 g/dL, 2+ or 1/2 g/dL, 2+, 1+ or 1/4 g/dL and 1+. Only participants present at the specific time points were presented (represented by n=X in the category titles).
Time Frame Baseline and up to Week 116/16 Week follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
Week 12; occult blood; Trace or 1/10 g/DL; n= 12 Number Analyzed 12 participants
0
Week 12;Occult Blood; Trace; n= 12 Number Analyzed 12 participants
1
Week 12; Occult Blood; negative; n= 12 Number Analyzed 12 participants
2
Week 12; Occult Blood; 4+; n= 12 Number Analyzed 12 participants
0
Week 12; Occult Blood; 3+ OR 1 G/DL; n= 12 Number Analyzed 12 participants
0
Week 12; Occult Blood; 3+; n= 12 Number Analyzed 12 participants
2
Week 12; Occult Blood; 2+ OR 1/2 G/DL; n= 12 Number Analyzed 12 participants
0
Week 12; Occult Blood; 2+ ; n= 12 Number Analyzed 12 participants
6
Week 12; Occult Blood;1+ OR 1/4 G/DL; n= 12 Number Analyzed 12 participants
0
Week 12; Occult Blood; 1+; n= 12 Number Analyzed 12 participants
1
Week 12; glucose; Trace or 1/10 g/DL; n= 12 Number Analyzed 12 participants
3
Week 12;glucose; Trace; n= 12 Number Analyzed 12 participants
0
Week 12; glucose; negative; n= 12 Number Analyzed 12 participants
8
Week 12; glucose; 4+; n= 12 Number Analyzed 12 participants
0
Week 12; glucose; 3+ OR 1 G/DL; n= 12 Number Analyzed 12 participants
0
Week 12; glucose; 3+; n= 12 Number Analyzed 12 participants
0
Week 12; glucose; 2+ OR 1/2 G/DL; n= 12 Number Analyzed 12 participants
0
Week 12; glucose; 2+ ; n= 12 Number Analyzed 12 participants
0
Week 12; glucose;1+ OR 1/4 G/DL; n= 12 Number Analyzed 12 participants
1
Week 12; glucose; 1+; n= 12 Number Analyzed 12 participants
0
Week 12; ketones; Trace or 1/10 g/DL; n= 12 Number Analyzed 12 participants
0
Week 12; ketones; Trace; n= 12 Number Analyzed 12 participants
0
Week 12; ketones; negative; n= 12 Number Analyzed 12 participants
12
Week 12; ketones; 4+; n= 12 Number Analyzed 12 participants
0
Week 12; ketones; 3+ OR 1 G/DL; n= 12 Number Analyzed 12 participants
0
Week 12; ketones; 3+; n= 12 Number Analyzed 12 participants
0
Week 12; ketones; 2+ OR 1/2 G/DL; n= 12 Number Analyzed 12 participants
0
Week 12; ketones; 2+ ; n= 12 Number Analyzed 12 participants
0
Week 12; ketones;1+ OR 1/4 G/DL; n= 12 Number Analyzed 12 participants
0
Week 12; ketones; 1+; n= 12 Number Analyzed 12 participants
0
Week 12; protein; Trace or 1/10 g/DL; n= 12 Number Analyzed 12 participants
0
Week 12; Protein; Trace; n= 12 Number Analyzed 12 participants
0
Week 12; Protein; negative; n= 12 Number Analyzed 12 participants
0
Week 12; Protein; 4+; n= 12 Number Analyzed 12 participants
0
Week 12; Protein; 3+ OR 1 G/DL; n= 12 Number Analyzed 12 participants
0
Week 12; Protein; 3+; n= 12 Number Analyzed 12 participants
8
Week 12; Protein; 2+ OR 1/2 G/DL; n= 12 Number Analyzed 12 participants
0
Week 12; Protein; 2+ ; n= 12 Number Analyzed 12 participants
3
Week 12; Protein;1+ OR 1/4 G/DL; n= 12 Number Analyzed 12 participants
0
Week 12; Protein; 1+; n= 12 Number Analyzed 12 participants
1
Week 28; occult blood; Trace or 1/10 g/DL; n= 11 Number Analyzed 11 participants
0
Week 28;Occult Blood; Trace; n= 11 Number Analyzed 11 participants
2
Week 28; Occult Blood; negative; n= 11 Number Analyzed 11 participants
1
Week 28; Occult Blood; 4+; n= 11 Number Analyzed 11 participants
0
Week 28; Occult Blood; 3+ OR 1 G/DL; n= 11 Number Analyzed 11 participants
0
Week 28; Occult Blood; 3+; n= 11 Number Analyzed 11 participants
0
Week 28; Occult Blood; 2+ OR 1/2 G/DL; n= 11 Number Analyzed 11 participants
0
Week 28; Occult Blood; 2+ ; n= 11 Number Analyzed 11 participants
4
Week 28; Occult Blood;1+ OR 1/4 G/DL; n= 11 Number Analyzed 11 participants
0
Week 28; Occult Blood; 1+; n= 11 Number Analyzed 11 participants
4
Week 28; glucose; Trace or 1/10 g/DL; n= 11 Number Analyzed 11 participants
1
Week 28;glucose; Trace; n= 11 Number Analyzed 11 participants
0
Week 28; glucose; negative; n= 11 Number Analyzed 11 participants
9
Week 28; glucose; 4+; n= 11 Number Analyzed 11 participants
0
Week 28; glucose; 3+ OR 1 G/DL; n= 11 Number Analyzed 11 participants
0
Week 28; glucose; 3+; n= 11 Number Analyzed 11 participants
0
Week 28; glucose; 2+ OR 1/2 G/DL; n= 11 Number Analyzed 11 participants
0
Week 28; glucose; 2+ ; n= 11 Number Analyzed 11 participants
0
Week 28; glucose;1+ OR 1/4 G/DL; n= 11 Number Analyzed 11 participants
1
Week 28; glucose; 1+; n= 11 Number Analyzed 11 participants
0
Week 28; ketones; Trace or 1/10 g/DL; n= 11 Number Analyzed 11 participants
0
Week 28; ketones; Trace; n= 11 Number Analyzed 11 participants
0
Week 28; ketones; negative; n= 11 Number Analyzed 11 participants
11
Week 28; ketones; 4+; n= 11 Number Analyzed 11 participants
0
Week 28; ketones; 3+ OR 1 G/DL; n= 11 Number Analyzed 11 participants
0
Week 28; ketones; 3+; n= 11 Number Analyzed 11 participants
0
Week 28; ketones; 2+ OR 1/2 G/DL; n= 11 Number Analyzed 11 participants
0
Week 28; ketones; 2+ ; n= 11 Number Analyzed 11 participants
0
Week 28; ketones;1+ OR 1/4 G/DL; n= 11 Number Analyzed 11 participants
0
Week 28; ketones; 1+; n= 11 Number Analyzed 11 participants
0
Week 28; protein; Trace or 1/10 g/DL; n= 11 Number Analyzed 11 participants
0
Week 28; Protein; Trace; n= 11 Number Analyzed 11 participants
0
Week 28; Protein; negative; n= 11 Number Analyzed 11 participants
0
Week 28; protein; 4+; n= 11 Number Analyzed 11 participants
0
Week 28; Protein; 3+ OR 1 G/DL; n= 11 Number Analyzed 11 participants
0
Week 28; Protein; 3+; n= 11 Number Analyzed 11 participants
10
Week 28; Protein; 2+ OR 1/2 G/DL; n= 11 Number Analyzed 11 participants
0
Week 28; Protein; 2+ ; n= 11 Number Analyzed 11 participants
1
Week 28; Protein;1+ OR 1/4 G/DL; n= 11 Number Analyzed 11 participants
0
Week 28; Protein; 1+; n= 11 Number Analyzed 11 participants
0
Week 52; occult blood; Trace or 1/10 g/DL; n= 9 Number Analyzed 9 participants
0
Week 52;Occult Blood; Trace; n= 9 Number Analyzed 9 participants
2
Week 52; Occult Blood; negative; n= 9 Number Analyzed 9 participants
3
Week 52; Occult Blood; 4+; n= 9 Number Analyzed 9 participants
0
Week 52; Occult Blood; 3+ OR 1 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; Occult Blood; 3+; n= 9 Number Analyzed 9 participants
0
Week 52; Occult Blood; 2+ OR 1/2 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; Occult Blood; 2+ ; n= 9 Number Analyzed 9 participants
4
Week 52; Occult Blood;1+ OR 1/4 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; Occult Blood; 1+; n= 9 Number Analyzed 9 participants
0
Week 52; glucose; Trace or 1/10 g/DL; n= 9 Number Analyzed 9 participants
2
Week 52;glucose; Trace; n= 9 Number Analyzed 9 participants
0
Week 52; glucose; negative; n= 9 Number Analyzed 9 participants
7
Week 52; glucose; 4+; n= 9 Number Analyzed 9 participants
0
Week 52; glucose; 3+ OR 1 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; glucose; 3+; n= 9 Number Analyzed 9 participants
0
Week 52; glucose; 2+ OR 1/2 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; glucose; 2+ ; n= 9 Number Analyzed 9 participants
0
Week 52; glucose;1+ OR 1/4 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; glucose; 1+; n= 9 Number Analyzed 9 participants
0
Week 52; ketones; Trace or 1/10 g/DL; n= 9 Number Analyzed 9 participants
0
Week 52; ketones; Trace; n= 9 Number Analyzed 9 participants
0
Week 52; ketones; negative; n= 9 Number Analyzed 9 participants
9
Week 52; ketones; 4+; n= 9 Number Analyzed 9 participants
0
Week 52; ketones; 3+ OR 1 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; ketones; 3+; n= 9 Number Analyzed 9 participants
0
Week 52; ketones; 2+ OR 1/2 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; ketones; 2+ ; n= 9 Number Analyzed 9 participants
0
Week 52; ketones;1+ OR 1/4 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; ketones; 1+; n= 9 Number Analyzed 9 participants
0
Week 52; protein; Trace or 1/10 g/DL; n= 9 Number Analyzed 9 participants
0
Week 52; Protein; Trace; n= 9 Number Analyzed 9 participants
0
Week 52; Protein; negative; n= 9 Number Analyzed 9 participants
0
Week 52; protein; 4+; n= 9 Number Analyzed 9 participants
0
Week 52; Protein; 3+ OR 1 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; Protein; 3+; n= 9 Number Analyzed 9 participants
4
Week 52; Protein; 2+ OR 1/2 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; Protein; 2+ ; n= 9 Number Analyzed 9 participants
3
Week 52; Protein;1+ OR 1/4 G/DL; n= 9 Number Analyzed 9 participants
0
Week 52; Protein; 1+; n= 9 Number Analyzed 9 participants
2
Week 76; occult blood; Trace or 1/10 g/DL;n=7 Number Analyzed 7 participants
0
Week 76;Occult Blood; Trace; n= 7 Number Analyzed 7 participants
3
Week 76; Occult Blood; negative; n= 7 Number Analyzed 7 participants
3
Week 76; Occult Blood; 4+; n= 7 Number Analyzed 7 participants
0
Week 76; Occult Blood; 3+ OR 1 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; Occult Blood; 3+; n= 7 Number Analyzed 7 participants
0
Week 76; Occult Blood; 2+ OR 1/2 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; Occult Blood; 2+ ; n= 7 Number Analyzed 7 participants
0
Week 76; Occult Blood;1+ OR 1/4 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; Occult Blood; 1+; n= 7 Number Analyzed 7 participants
1
Week 76; glucose; Trace or 1/10 g/DL; n= 7 Number Analyzed 7 participants
2
Week 76;glucose; Trace; n= 7 Number Analyzed 7 participants
0
Week 76; glucose; negative; n= 7 Number Analyzed 7 participants
5
Week 76; glucose; 4+; n= 7 Number Analyzed 7 participants
0
Week 76; glucose; 3+ OR 1 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; glucose; 3+; n= 7 Number Analyzed 7 participants
0
Week 76; glucose; 2+ OR 1/2 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; glucose; 2+ ; n= 7 Number Analyzed 7 participants
0
Week 76; glucose;1+ OR 1/4 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; glucose; 1+; n= 7 Number Analyzed 7 participants
0
Week 76; ketones; Trace or 1/10 g/DL; n= 7 Number Analyzed 7 participants
0
Week 76; ketones; Trace; n= 7 Number Analyzed 7 participants
0
Week 76; ketones; negative; n= 7 Number Analyzed 7 participants
7
Week 76; ketones; 4+; n= 7 Number Analyzed 7 participants
0
Week 76; ketones; 3+ OR 1 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; ketones; 3+; n= 7 Number Analyzed 7 participants
0
Week 76; ketones; 2+ OR 1/2 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; ketones; 2+ ; n= 7 Number Analyzed 7 participants
0
Week 76; ketones;1+ OR 1/4 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; ketones; 1+; n= 7 Number Analyzed 7 participants
0
Week 76; protein; Trace or 1/10 g/DL; n= 7 Number Analyzed 7 participants
0
Week 76; Protein; Trace; n= 7 Number Analyzed 7 participants
0
Week 76; Protein; negative; n= 7 Number Analyzed 7 participants
1
Week 76; protein; 4+; n= 7 Number Analyzed 7 participants
0
Week 76; Protein; 3+ OR 1 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; Protein; 3+; n= 7 Number Analyzed 7 participants
1
Week 76; Protein; 2+ OR 1/2 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; Protein; 2+ ; n= 7 Number Analyzed 7 participants
4
Week 76; Protein;1+ OR 1/4 G/DL; n= 7 Number Analyzed 7 participants
0
Week 76; Protein; 1+; n= 7 Number Analyzed 7 participants
1
Week 104; occult blood; Trace or 1/10 g/DL;n=10 Number Analyzed 10 participants
0
Week 104;Occult Blood; Trace; n= 10 Number Analyzed 10 participants
0
Week 104; Occult Blood; negative; n= 10 Number Analyzed 10 participants
8
Week 104; Occult Blood; 4+; n= 10 Number Analyzed 10 participants
0
Week 104; Occult Blood; 3+ OR 1 G/DL; n= 10 Number Analyzed 10 participants
0
Week 104; Occult Blood; 3+; n= 10 Number Analyzed 10 participants
0
Week 104; Occult Blood; 2+ OR 1/2 G/DL; n= 10 Number Analyzed 10 participants
0
Week 104; Occult Blood; 2+ ; n=10 Number Analyzed 10 participants
1
Week 104; Occult Blood;1+ OR 1/4 G/DL; n= 10 Number Analyzed 10 participants
0
Week 104; Occult Blood; 1+; n= 10 Number Analyzed 10 participants
1
Week 104; glucose; Trace or 1/10 g/DL; n= 10 Number Analyzed 10 participants
2
Week 104 ;glucose; Trace; n= 10 Number Analyzed 10 participants
0
Week 104; glucose; negative; n= 10 Number Analyzed 10 participants
7
Week 104; glucose; 4+; n= 10 Number Analyzed 10 participants
0
Week 104; glucose; 3+ OR 1 G/DL; n= 10 Number Analyzed 10 participants
0
Week 104; glucose; 3+; n= 10 Number Analyzed 10 participants
0
Week 104; glucose; 2+ OR 1/2 G/DL; n= 10 Number Analyzed 10 participants
0
Week 104; glucose; 2+ ; n= 10 Number Analyzed 10 participants
0
Week 104; glucose;1+ OR 1/4 G/DL; n= 10 Number Analyzed 10 participants
1
Week 104; glucose; 1+; n= 10 Number Analyzed 10 participants
0
Week 104; ketones; Trace or 1/10 g/DL; n= 10 Number Analyzed 10 participants
0
Week 104; ketones; Trace; n= 10 Number Analyzed 10 participants
0
Week 104; ketones; negative; n= 10 Number Analyzed 10 participants
10
Week 104; ketones; 4+; n= 10 Number Analyzed 10 participants
0
Week 104; ketones; 3+ OR 1 G/DL; n= 10 Number Analyzed 10 participants
0
Week 104; ketones; 3+; n= 10 Number Analyzed 10 participants
0
Week 104; ketones; 2+ OR 1/2 G/DL; n= 10 Number Analyzed 10 participants
0
Week 104; ketones; 2+ ; n= 10 Number Analyzed 10 participants
0
Week 104; ketones;1+ OR 1/4 G/DL; n= 10 Number Analyzed 10 participants
0
Week 104; ketones; 1+; n= 10 Number Analyzed 10 participants
0
Week 104; protein; Trace or 1/10 g/DL; n= 10 Number Analyzed 10 participants
0
Week 104; Protein; Trace; n= 10 Number Analyzed 10 participants
0
Week 104; Protein; negative; n= 10 Number Analyzed 10 participants
1
Week 104; protein; 4+; n= 10 Number Analyzed 10 participants
0
Week 104; Protein; 3+ OR 1 G/DL; n= 10 Number Analyzed 10 participants
0
Week 104; Protein; 3+; n= 10 Number Analyzed 10 participants
3
Week 104; Protein; 2+ OR 1/2 G/DL; n= 10 Number Analyzed 10 participants
0
Week 104; Protein; 2+ ; n= 10 Number Analyzed 10 participants
6
Week 104; Protein;1+ OR 1/4 G/DL; n= 10 Number Analyzed 10 participants
0
Week 104; Protein; 1+; n= 10 Number Analyzed 10 participants
0
16 WF; Occult blood; TRACE OR 1/10 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Occult blood; TRACE; n= 9 Number Analyzed 9 participants
2
16 WF; Occult blood; NEGATIVE; n= 9 Number Analyzed 9 participants
6
16 WF; Occult blood; 4+; n= 9 Number Analyzed 9 participants
0
16 WF; Occult blood; 3+ OR 1 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Occult blood; 3+; n= 9 Number Analyzed 9 participants
0
16 WF; Occult blood; 2+ OR 1/2 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Occult blood; 2+; n= 9 Number Analyzed 9 participants
1
16 WF; Occult blood; 1+ OR 1/4 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Occult blood; 1+; n= 9 Number Analyzed 9 participants
0
16 WF; Glucose; TRACE OR 1/10 G/DL; n= 9 Number Analyzed 9 participants
1
16 WF; Glucose; TRACE; n= 9 Number Analyzed 9 participants
0
16 WF; Glucose; negative; n= 9 Number Analyzed 9 participants
7
16 WF; Glucose; 4+; n= 9 Number Analyzed 9 participants
0
16 WF; Glucose; 3+ OR 1 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Glucose; 3+; n= 9 Number Analyzed 9 participants
0
16 WF; Glucose; 2+ OR 1/2 G/DL; n= 9 Number Analyzed 9 participants
1
16 WF; Glucose; 2+; n= 9 Number Analyzed 9 participants
0
16 WF; Glucose; 1+ OR 1/4 G/DL; n=9 Number Analyzed 9 participants
0
16 WF; Glucose; 1+; n=9 Number Analyzed 9 participants
0
16 WF; Ketones; TRACE OR 1/10 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Ketones; TRACE; n= 9 Number Analyzed 9 participants
0
16 WF; Ketones; negative; n= 9 Number Analyzed 9 participants
9
16 WF; Ketones; 4+; n= 9 Number Analyzed 9 participants
0
16 WF; Ketones; 3+ OR 1 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Ketones; 3+; n= 9 Number Analyzed 9 participants
0
16 WF; Ketones; 2+ OR 1/2 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Ketones; 2+; n= 9 Number Analyzed 9 participants
0
16 WF; Ketones; 1+ OR 1/4 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Ketones; 1+; n= 9 Number Analyzed 9 participants
0
16 WF; Protein; TRACE OR 1/10 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Protein; TRACE; n= 9 Number Analyzed 9 participants
1
16 WF; Protein; negative; n= 9 Number Analyzed 9 participants
0
16 WF; Protein; 4+; n= 9 Number Analyzed 9 participants
0
16 WF; Protein; 3+ OR 1 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Protein; 3+; n= 9 Number Analyzed 9 participants
3
16 WF; Protein; 2+ OR 1/2 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Protein; 2+; n= 9 Number Analyzed 9 participants
4
16 WF; Protein; 1+ OR 1/4 G/DL; n= 9 Number Analyzed 9 participants
0
16 WF; Protein; 1+; n= 9 Number Analyzed 9 participants
1
32.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description SBP and DBP were measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week follow-up visit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and up to week 116/16 week follow-up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
Week 12; SBP; n= 12 Number Analyzed 12 participants
-4.2  (17.23)
Week 28; SBP; n= 11 Number Analyzed 11 participants
-5.8  (18.14)
Week 52; SBP; n= 9 Number Analyzed 9 participants
-1.9  (18.66)
Week 76; SBP; n= 8 Number Analyzed 8 participants
-1.3  (11.30)
4 Week post last dose; SBP; n= 10 Number Analyzed 10 participants
-12.2  (11.78)
16 Week follow up; SBP; n= 9 Number Analyzed 9 participants
-7.4  (15.72)
Week 104 withdrawn visit; SBP; n= 2 Number Analyzed 2 participants
-1.0  (5.66)
Week 12; DBP; n= 12 Number Analyzed 12 participants
3.8  (12.94)
Week 28; DBP; n= 11 Number Analyzed 11 participants
0.8  (10.75)
Week 52; DBP; n= 9 Number Analyzed 9 participants
1.2  (11.87)
Week 76; DBP; n= 8 Number Analyzed 8 participants
2.8  (9.68)
4 Week post last dose; DBP; n= 10 Number Analyzed 10 participants
-3.3  (9.87)
16 Week follow up; DBP; n= 9 Number Analyzed 9 participants
2.4  (14.98)
Week 104 withdrawn visit; DBP; n= 2 Number Analyzed 2 participants
5.5  (2.12)
33.Secondary Outcome
Title Change From Baseline in Pulse Rate
Hide Description Pulse rate was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and up to Week 116/16 week follow-up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Week 12; n= 12 Number Analyzed 12 participants
-0.7  (11.40)
Week 28; n= 11 Number Analyzed 11 participants
1.0  (7.90)
Week 52; n= 9 Number Analyzed 9 participants
-1.7  (13.11)
Week 76; n= 8 Number Analyzed 8 participants
-2.3  (15.77)
4 Week post last dose; n= 10 Number Analyzed 10 participants
-2.8  (15.33)
16 Week follow up; n= 9 Number Analyzed 9 participants
-0.9  (16.72)
Week 104 withdrawn visit; n= 2 Number Analyzed 2 participants
5.0  (7.07)
34.Secondary Outcome
Title Change From Baseline in Temperature
Hide Description Temperature was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and up to Week 116/16 week follow-up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: Celsius
Week 12; n= 12 Number Analyzed 12 participants
-0.09  (0.591)
Week 28; n= 11 Number Analyzed 11 participants
-0.00  (0.453)
Week 52; n= 9 Number Analyzed 9 participants
-0.11  (0.639)
Week 76; n= 8 Number Analyzed 8 participants
-0.17  (0.486)
4 Week post last dose; n= 8 Number Analyzed 8 participants
-0.06  (0.604)
16 Week follow up; n= 6 Number Analyzed 6 participants
0.30  (0.424)
Week 104 withdrawn visit; n= 2 Number Analyzed 2 participants
0.15  (0.353)
35.Secondary Outcome
Title Number of Participants With Positive Immunogenicity Findings
Hide Description Blood samples of participants were collected pre-dose on Weeks 0, 12, 28, 40, 52, 76, 4 week post last dose and 16 week post last dose visit for belimumab immunogenicity assay. No participants showed positive immunogenicity findings.
Time Frame Baseline and up to Week 116/16 week follow-up visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
0
36.Secondary Outcome
Title Urine Membrane Attack Complex (MAC) Levels
Hide Description Urine membrane attack complex was assayed quantitatively by ELISA method. Urine MAC samples were collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results were normalized using urine creatinine concentration to adjust for urine dilution. Endpoint was moved to ‘Exploratory’ in Protocol amendment 5 as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed
Time Frame Baseline and up to 4 week post last dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV
Hide Arm/Group Description:
Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
37.Secondary Outcome
Title Change From Baseline in Urine Membrane Attack Complex (MAC)
Hide Description Urine membrane attack complex will be assayed quantitatively by ELISA method. Urine MAC samples are being collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results will be normalized using urine creatinine concentration to adjust for urine dilution, before calculation of the ratio as value at time point divided by value at Baseline (Day 0). Endpoint was changed to 'exploratory' as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed.
Time Frame Baseline and up to 4 week post last dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Belimumab 10 mg/kg IV