Trial Outcomes & Findings for Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus (NCT NCT02880852)
NCT ID: NCT02880852
Last Updated: 2020-03-27
Results Overview
Blood samples were collected at the indicated timepoints to calculate Cmax of belimumab.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose
Results posted on
2020-03-27
Participant Flow
A total of 20 participants with Systemic Lupus Erythematosus (SLE) were enrolled. The study was conducted at 2 centers in China from 23-Jan-2017 to 08-Sep-2017.
A total of 25 participants were screened, of which 5 participants were screen failures. The reason for screen failures were: did not meet inclusion/exclusion criteria (4 participants) and investigator discretion (1 participant).
Participant milestones
| Measure |
Belimumab 10 mg/kg
Eligible participants received a single dose of belimumab 10 milligrams (mg) per kilogram (kg) as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Age, Continuous
|
37.4 Years
STANDARD_DEVIATION 14.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dosePopulation: Pharmacokinetic (PK) Parameter Population, which comprised of all those participants who received a dose of belimumab and for whom PK parameters could be calculated.
Blood samples were collected at the indicated timepoints to calculate Cmax of belimumab.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Maximum Observed Concentration (Cmax) of Belimumab
|
221.3532 Micrograms per milliliter
Geometric Coefficient of Variation 12.8405
|
PRIMARY outcome
Timeframe: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dosePopulation: PK Parameter Population
Blood samples were collected at the indicated timepoints to calculate AUC (0 to t) and AUC (0 to inf) of belimumab.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0 to t]) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0 to Inf]) of Belimumab
AUC(0 to t)
|
2395.3030 Day*micrograms/milliliter
Geometric Coefficient of Variation 23.2924
|
|
Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0 to t]) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0 to Inf]) of Belimumab
AUC(0 to inf)
|
2461.8013 Day*micrograms/milliliter
Geometric Coefficient of Variation 24.7125
|
PRIMARY outcome
Timeframe: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dosePopulation: PK Parameter Population
Blood samples were collected at the indicated time points to calculate t1/2 of belimumab.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Terminal Phase Half-life (t1/2) of Belimumab
|
14.6283 Days
Geometric Coefficient of Variation 35.4339
|
PRIMARY outcome
Timeframe: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dosePopulation: PK Parameter Population.
Blood samples were collected at the indicated time points to calculate lambda z of belimumab.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Terminal Phase Rate Constant (Lambda z) of Belimumab
|
0.0474 1/day
Geometric Coefficient of Variation 35.4339
|
PRIMARY outcome
Timeframe: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dosePopulation: PK Parameter Population
Blood samples were collected at the indicated time points to calculate CL of belimumab.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Systemic Clearance (CL) of Belimumab
|
4.0621 (Milliliters/day)/kilogram
Geometric Coefficient of Variation 24.7125
|
PRIMARY outcome
Timeframe: Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dosePopulation: PK Parameter Population
Blood samples were collected at the indicated time points to calculate Vz of belimumab.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Volume of Distribution (Vz) of Belimumab
|
85.7265 Milliliters/kilogram
Geometric Coefficient of Variation 21.6704
|
PRIMARY outcome
Timeframe: Up to Day 84Population: Safety Population.
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. 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, or is a congenital anomaly/birth defect or is medically significant, or associated with liver injury and impaired liver function.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
AE
|
12 Participants
|
|
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
SAE
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Safety Population
Vital signs included SBP and DBP. SBP and DBP were measured with the participant in the sitting position. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 0 (5 minutes post-dose)
|
-0.5 Millimeters of mercury
Standard Deviation 6.35
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 0 (1 hour post-dose)
|
-1.5 Millimeters of mercury
Standard Deviation 12.51
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 0 (6 hours post-dose)
|
-2.1 Millimeters of mercury
Standard Deviation 8.57
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 0 (24 hours post-dose)
|
-0.1 Millimeters of mercury
Standard Deviation 7.95
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 1
|
2.2 Millimeters of mercury
Standard Deviation 8.37
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 7
|
1.1 Millimeters of mercury
Standard Deviation 7.91
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 14
|
0.5 Millimeters of mercury
Standard Deviation 8.65
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 21
|
0.1 Millimeters of mercury
Standard Deviation 6.91
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 28
|
0.2 Millimeters of mercury
Standard Deviation 8.86
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 42
|
-3.2 Millimeters of mercury
Standard Deviation 7.99
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 56
|
-0.8 Millimeters of mercury
Standard Deviation 8.85
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Day 84
|
-0.6 Millimeters of mercury
Standard Deviation 11.06
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 0 (5 minutes post-dose)
|
0.8 Millimeters of mercury
Standard Deviation 9.92
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 0 (1 hour post-dose)
|
-2.5 Millimeters of mercury
Standard Deviation 11.44
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 0 (6 hours post-dose)
|
-4.5 Millimeters of mercury
Standard Deviation 12.15
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 0 (24 hours post-dose)
|
-3.7 Millimeters of mercury
Standard Deviation 11.76
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 1
|
-2.4 Millimeters of mercury
Standard Deviation 10.92
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 7
|
0.7 Millimeters of mercury
Standard Deviation 10.65
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 14
|
-1.0 Millimeters of mercury
Standard Deviation 12.09
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 21
|
-4.4 Millimeters of mercury
Standard Deviation 12.05
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 28
|
-1.5 Millimeters of mercury
Standard Deviation 14.01
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 42
|
-7.4 Millimeters of mercury
Standard Deviation 9.26
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 56
|
-4.0 Millimeters of mercury
Standard Deviation 11.14
|
|
Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Day 84
|
-7.4 Millimeters of mercury
Standard Deviation 14.91
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Safety Population.
Vital signs included pulse rate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 0 (5 minutes post-dose)
|
-1.2 Beats per minute
Standard Deviation 11.13
|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 0 (1 hour post-dose)
|
-1.6 Beats per minute
Standard Deviation 8.43
|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 0 (6 hours post-dose)
|
2.6 Beats per minute
Standard Deviation 12.14
|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 0 (24 hours post-dose)
|
2.3 Beats per minute
Standard Deviation 11.08
|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 1
|
5.7 Beats per minute
Standard Deviation 11.09
|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 7
|
4.7 Beats per minute
Standard Deviation 11.82
|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 14
|
6.9 Beats per minute
Standard Deviation 10.55
|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 21
|
5.0 Beats per minute
Standard Deviation 8.90
|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 28
|
7.6 Beats per minute
Standard Deviation 10.02
|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 42
|
8.3 Beats per minute
Standard Deviation 12.06
|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 56
|
4.1 Beats per minute
Standard Deviation 10.80
|
|
Change From Baseline to Day 84 in Vital Sign- Pulse Rate
Day 84
|
3.2 Beats per minute
Standard Deviation 14.21
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Safety Population.
Vital signs included temperature. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 0 (5 minutes post-dose)
|
0.21 Celsius
Standard Deviation 0.485
|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 0 (1 hour post-dose)
|
0.17 Celsius
Standard Deviation 0.473
|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 0 (6 hours post-dose)
|
0.20 Celsius
Standard Deviation 0.552
|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 0 (24 hours post-dose)
|
0.40 Celsius
Standard Deviation 0.617
|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 1
|
0.24 Celsius
Standard Deviation 0.486
|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 7
|
0.40 Celsius
Standard Deviation 0.793
|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 14
|
0.40 Celsius
Standard Deviation 0.504
|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 21
|
0.41 Celsius
Standard Deviation 0.454
|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 28
|
0.37 Celsius
Standard Deviation 0.457
|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 42
|
0.53 Celsius
Standard Deviation 0.595
|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 56
|
0.52 Celsius
Standard Deviation 0.473
|
|
Change From Baseline to Day 84 in Vital Sign- Temperature
Day 84
|
0.38 Celsius
Standard Deviation 0.434
|
SECONDARY outcome
Timeframe: Up to Day 84Population: Safety Population.
ECG parameters included heart rate, PR interval, QRS interval, QT interval and corrected QT (QTc) interval. Number of participants with abnormal-clinically significant 12-lead ECG findings are presented.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Number of Participants With Abnormal-clinically Significant 12-lead Electrocardiogram (ECG) Findings
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Safety Population.
Clinical chemistry parameters included ALT, ALP, AST, GGT and lactate dehydrogenase. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
ALT: Day 0 (24 hours)
|
-1.6 International units per Liter (IU/L)
Standard Deviation 3.46
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
ALT: Day 14
|
-1.3 International units per Liter (IU/L)
Standard Deviation 11.93
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
ALT: Day 28
|
-3.2 International units per Liter (IU/L)
Standard Deviation 12.34
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
ALT: Day 56
|
-5.0 International units per Liter (IU/L)
Standard Deviation 12.18
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
ALT: Day 84
|
-5.5 International units per Liter (IU/L)
Standard Deviation 11.84
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
ALP: Day 0 (24 hours)
|
-3.9 International units per Liter (IU/L)
Standard Deviation 3.56
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
ALP: Day 14
|
-5.6 International units per Liter (IU/L)
Standard Deviation 10.72
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
ALP: Day 28
|
-3.4 International units per Liter (IU/L)
Standard Deviation 8.80
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
ALP: Day 56
|
-7.2 International units per Liter (IU/L)
Standard Deviation 9.26
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
ALP: Day 84
|
-7.3 International units per Liter (IU/L)
Standard Deviation 11.80
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
AST: Day 0 (24 hours)
|
-1.9 International units per Liter (IU/L)
Standard Deviation 2.48
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
AST: Day 14
|
-1.8 International units per Liter (IU/L)
Standard Deviation 8.58
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
AST: Day 28
|
-2.6 International units per Liter (IU/L)
Standard Deviation 8.46
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
AST: Day 56
|
-2.8 International units per Liter (IU/L)
Standard Deviation 6.15
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
AST: Day 84
|
-3.6 International units per Liter (IU/L)
Standard Deviation 6.86
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
GGT: Day 0 (24 hours)
|
-1.5 International units per Liter (IU/L)
Standard Deviation 2.33
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
GGT: Day 14
|
-0.5 International units per Liter (IU/L)
Standard Deviation 7.34
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
GGT: Day 28
|
0.5 International units per Liter (IU/L)
Standard Deviation 7.22
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
GGT: Day 56
|
-4.1 International units per Liter (IU/L)
Standard Deviation 6.08
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
GGT: Day 84
|
-3.3 International units per Liter (IU/L)
Standard Deviation 8.44
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
Lactate dehydrogenase: Day 0 (24 hours)
|
-8.1 International units per Liter (IU/L)
Standard Deviation 10.56
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
Lactate dehydrogenase: Day 14
|
-3.2 International units per Liter (IU/L)
Standard Deviation 18.88
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
Lactate dehydrogenase: Day 28
|
-1.4 International units per Liter (IU/L)
Standard Deviation 22.30
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
Lactate dehydrogenase: Day 56
|
1.3 International units per Liter (IU/L)
Standard Deviation 24.30
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase
Lactate dehydrogenase: Day 84
|
1.5 International units per Liter (IU/L)
Standard Deviation 20.68
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Safety Population.
Clinical chemistry parameters included albumin and protein. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Albumin: Day 0 (24 hours)
|
-1.4 Grams per liter (g/L)
Standard Deviation 1.88
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Albumin: Day 14
|
-1.1 Grams per liter (g/L)
Standard Deviation 3.08
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Albumin: Day 28
|
-0.6 Grams per liter (g/L)
Standard Deviation 2.68
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Albumin: Day 56
|
-0.5 Grams per liter (g/L)
Standard Deviation 3.14
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Albumin: Day 84
|
-0.6 Grams per liter (g/L)
Standard Deviation 3.10
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Protein: Day 0 (24 hours)
|
-3.8 Grams per liter (g/L)
Standard Deviation 2.67
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Protein: Day 14
|
-3.2 Grams per liter (g/L)
Standard Deviation 5.12
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Protein: Day 28
|
-3.3 Grams per liter (g/L)
Standard Deviation 4.47
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Protein: Day 56
|
-3.8 Grams per liter (g/L)
Standard Deviation 5.41
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein
Protein: Day 84
|
-3.8 Grams per liter (g/L)
Standard Deviation 4.23
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Safety Population.
Clinical chemistry parameters included bilirubin, creatinine, direct bilirubin, indirect bilirubin and urate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Bilirubin: Day 0 (24 hours)
|
-2.8 Micromoles per Liter (µmol/L)
Standard Deviation 3.07
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Bilirubin: Day 14
|
-2.4 Micromoles per Liter (µmol/L)
Standard Deviation 4.48
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Bilirubin: Day 28
|
-3.4 Micromoles per Liter (µmol/L)
Standard Deviation 4.55
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Bilirubin: Day 56
|
-3.2 Micromoles per Liter (µmol/L)
Standard Deviation 5.17
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Bilirubin: Day 84
|
-2.1 Micromoles per Liter (µmol/L)
Standard Deviation 4.83
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Creatinine: Day 0 (24 hours)
|
-0.18 Micromoles per Liter (µmol/L)
Standard Deviation 4.479
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Creatinine: Day 14
|
-0.80 Micromoles per Liter (µmol/L)
Standard Deviation 5.502
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Creatinine: Day 28
|
-0.43 Micromoles per Liter (µmol/L)
Standard Deviation 6.698
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Creatinine: Day 56
|
-0.25 Micromoles per Liter (µmol/L)
Standard Deviation 5.962
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Creatinine: Day 84
|
-0.18 Micromoles per Liter (µmol/L)
Standard Deviation 6.062
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Direct bilirubin: Day 0 (24 hours)
|
-0.4 Micromoles per Liter (µmol/L)
Standard Deviation 1.05
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Direct bilirubin: Day 14
|
0.1 Micromoles per Liter (µmol/L)
Standard Deviation 1.37
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Direct bilirubin: Day 28
|
-0.6 Micromoles per Liter (µmol/L)
Standard Deviation 1.14
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Direct bilirubin: Day 56
|
-0.6 Micromoles per Liter (µmol/L)
Standard Deviation 1.47
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Direct bilirubin: Day 84
|
-0.2 Micromoles per Liter (µmol/L)
Standard Deviation 1.28
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Indirect bilirubin: Day 0 (24 hours)
|
-2.4 Micromoles per Liter (µmol/L)
Standard Deviation 2.87
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Indirect bilirubin: Day 14
|
-2.5 Micromoles per Liter (µmol/L)
Standard Deviation 4.10
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Indirect bilirubin: Day 28
|
-2.8 Micromoles per Liter (µmol/L)
Standard Deviation 4.12
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Indirect bilirubin: Day 56
|
-2.6 Micromoles per Liter (µmol/L)
Standard Deviation 4.26
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Indirect bilirubin: Day 84
|
-1.9 Micromoles per Liter (µmol/L)
Standard Deviation 4.79
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Urate: Day 0 (24 hours)
|
-14.5 Micromoles per Liter (µmol/L)
Standard Deviation 21.88
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Urate: Day 14
|
-10.5 Micromoles per Liter (µmol/L)
Standard Deviation 34.41
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Urate: Day 28
|
-13.5 Micromoles per Liter (µmol/L)
Standard Deviation 47.49
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Urate: Day 56
|
-2.5 Micromoles per Liter (µmol/L)
Standard Deviation 49.93
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate
Urate: Day 84
|
-7.5 Micromoles per Liter (µmol/L)
Standard Deviation 50.67
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Safety Population.
Clinical chemistry parameters included calcium, calcium corrected, carbon dioxide, chloride, magnesium, phosphate, potassium, sodium, urea and glucose. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Carbon dioxide: Day 56
|
-0.1 Millimoles per Liter (mmol/L)
Standard Deviation 2.33
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Carbon dioxide: Day 84
|
-0.2 Millimoles per Liter (mmol/L)
Standard Deviation 1.64
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Chloride: Day 0 (24 hours)
|
1.3 Millimoles per Liter (mmol/L)
Standard Deviation 2.12
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Chloride: Day 14
|
0.3 Millimoles per Liter (mmol/L)
Standard Deviation 2.05
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Calcium: Day 0 (24 hours)
|
-0.040 Millimoles per Liter (mmol/L)
Standard Deviation 0.0599
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Calcium: Day 14
|
-0.020 Millimoles per Liter (mmol/L)
Standard Deviation 0.1049
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Calcium: Day 28
|
0.004 Millimoles per Liter (mmol/L)
Standard Deviation 0.0848
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Calcium: Day 56
|
-0.020 Millimoles per Liter (mmol/L)
Standard Deviation 0.1054
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Calcium: Day 84
|
-0.027 Millimoles per Liter (mmol/L)
Standard Deviation 0.0909
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Calcium Corrected: Day 0 (24 hours)
|
-0.010 Millimoles per Liter (mmol/L)
Standard Deviation 0.0466
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Calcium Corrected: Day 14
|
0.003 Millimoles per Liter (mmol/L)
Standard Deviation 0.0663
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Calcium Corrected: Day 28
|
0.017 Millimoles per Liter (mmol/L)
Standard Deviation 0.0578
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Calcium Corrected: Day 56
|
-0.007 Millimoles per Liter (mmol/L)
Standard Deviation 0.0694
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Calcium Corrected: Day 84
|
-0.016 Millimoles per Liter (mmol/L)
Standard Deviation 0.0501
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Carbon dioxide: Day 0 (24 hours)
|
-0.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.86
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Carbon dioxide: Day 14
|
-0.2 Millimoles per Liter (mmol/L)
Standard Deviation 2.32
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Carbon dioxide: Day 28
|
0.1 Millimoles per Liter (mmol/L)
Standard Deviation 2.09
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Chloride: Day 28
|
0.4 Millimoles per Liter (mmol/L)
Standard Deviation 1.53
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Chloride: Day 56
|
1.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.63
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Chloride: Day 84
|
1.2 Millimoles per Liter (mmol/L)
Standard Deviation 1.74
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Magnesium: Day 0 (24 hours)
|
-0.044 Millimoles per Liter (mmol/L)
Standard Deviation 0.0564
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Magnesium: Day 14
|
-0.046 Millimoles per Liter (mmol/L)
Standard Deviation 0.0623
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Magnesium: Day 28
|
-0.049 Millimoles per Liter (mmol/L)
Standard Deviation 0.0709
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Magnesium: Day 56
|
-0.029 Millimoles per Liter (mmol/L)
Standard Deviation 0.0750
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Magnesium: Day 84
|
-0.034 Millimoles per Liter (mmol/L)
Standard Deviation 0.0751
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Phosphate: Day 0 (24 hours)
|
-0.085 Millimoles per Liter (mmol/L)
Standard Deviation 0.1299
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Phosphate: Day 14
|
-0.132 Millimoles per Liter (mmol/L)
Standard Deviation 0.2104
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Phosphate: Day 28
|
-0.135 Millimoles per Liter (mmol/L)
Standard Deviation 0.2201
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Phosphate: Day 56
|
-0.140 Millimoles per Liter (mmol/L)
Standard Deviation 0.2037
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Phosphate: Day 84
|
-0.152 Millimoles per Liter (mmol/L)
Standard Deviation 0.1509
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Potassium: Day 0 (24 hours)
|
-0.10 Millimoles per Liter (mmol/L)
Standard Deviation 0.333
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Potassium: Day 14
|
-0.04 Millimoles per Liter (mmol/L)
Standard Deviation 0.355
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Potassium: Day 28
|
-0.11 Millimoles per Liter (mmol/L)
Standard Deviation 0.335
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Potassium: Day 56
|
-0.13 Millimoles per Liter (mmol/L)
Standard Deviation 0.370
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Potassium: Day 84
|
-0.29 Millimoles per Liter (mmol/L)
Standard Deviation 0.356
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Sodium: Day 0 (24 hours)
|
0.1 Millimoles per Liter (mmol/L)
Standard Deviation 2.24
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Sodium: Day 14
|
0.3 Millimoles per Liter (mmol/L)
Standard Deviation 1.59
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Sodium: Day 28
|
0.1 Millimoles per Liter (mmol/L)
Standard Deviation 1.28
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Sodium: Day 56
|
0.8 Millimoles per Liter (mmol/L)
Standard Deviation 1.68
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Sodium: Day 84
|
0.8 Millimoles per Liter (mmol/L)
Standard Deviation 1.67
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Urea: Day 0 (24 hours)
|
0.20 Millimoles per Liter (mmol/L)
Standard Deviation 0.733
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Urea: Day 14
|
0.38 Millimoles per Liter (mmol/L)
Standard Deviation 1.122
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Urea: Day 28
|
0.10 Millimoles per Liter (mmol/L)
Standard Deviation 1.382
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Urea: Day 56
|
-0.13 Millimoles per Liter (mmol/L)
Standard Deviation 0.793
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Urea: Day 84
|
-0.20 Millimoles per Liter (mmol/L)
Standard Deviation 1.152
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Glucose: Day 0 (24 hours)
|
0.98 Millimoles per Liter (mmol/L)
Standard Deviation 3.248
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Glucose: Day 14
|
1.66 Millimoles per Liter (mmol/L)
Standard Deviation 2.094
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Glucose: Day 28
|
0.33 Millimoles per Liter (mmol/L)
Standard Deviation 2.230
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Glucose: Day 56
|
0.19 Millimoles per Liter (mmol/L)
Standard Deviation 2.093
|
|
Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose
Glucose: Day 84
|
0.57 Millimoles per Liter (mmol/L)
Standard Deviation 2.749
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Safety Population.
Hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils: Day 0 (24 hours)
|
-0.006 10^9 cells/Liter
Standard Deviation 0.0110
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils: Day 14
|
-0.011 10^9 cells/Liter
Standard Deviation 0.0176
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils: Day 28
|
-0.013 10^9 cells/Liter
Standard Deviation 0.0186
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils: Day 56
|
-0.008 10^9 cells/Liter
Standard Deviation 0.0162
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Basophils: Day 84
|
-0.005 10^9 cells/Liter
Standard Deviation 0.0115
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils: Day 0 (24 hours)
|
-0.019 10^9 cells/Liter
Standard Deviation 0.0506
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils: Day 14
|
-0.024 10^9 cells/Liter
Standard Deviation 0.0564
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils: Day 28
|
-0.006 10^9 cells/Liter
Standard Deviation 0.0535
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils: Day 56
|
-0.022 10^9 cells/Liter
Standard Deviation 0.0595
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Eosinophils: Day 84
|
-0.028 10^9 cells/Liter
Standard Deviation 0.0670
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes: Day 0 (24 hours)
|
0.29 10^9 cells/Liter
Standard Deviation 0.899
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes: Day 14
|
0.09 10^9 cells/Liter
Standard Deviation 1.403
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes: Day 28
|
1.00 10^9 cells/Liter
Standard Deviation 1.589
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes: Day 56
|
0.54 10^9 cells/Liter
Standard Deviation 1.337
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Leukocytes: Day 84
|
-0.04 10^9 cells/Liter
Standard Deviation 1.754
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes: Day 0 (24 hours)
|
-0.068 10^9 cells/Liter
Standard Deviation 0.5214
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes: Day 14
|
-0.180 10^9 cells/Liter
Standard Deviation 0.6718
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes: Day 28
|
-0.364 10^9 cells/Liter
Standard Deviation 0.6746
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes: Day 56
|
-0.287 10^9 cells/Liter
Standard Deviation 0.5812
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Lymphocytes: Day 84
|
-0.257 10^9 cells/Liter
Standard Deviation 0.5697
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes: Day 0 (24 hours)
|
0.005 10^9 cells/Liter
Standard Deviation 0.1300
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes: Day 14
|
-0.025 10^9 cells/Liter
Standard Deviation 0.1575
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes: Day 28
|
-0.077 10^9 cells/Liter
Standard Deviation 0.2568
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes: Day 56
|
-0.076 10^9 cells/Liter
Standard Deviation 0.1574
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Monocytes: Day 84
|
-0.059 10^9 cells/Liter
Standard Deviation 0.1878
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils: Day 0 (24 hours)
|
0.389 10^9 cells/Liter
Standard Deviation 0.9085
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils: Day 14
|
0.332 10^9 cells/Liter
Standard Deviation 1.8713
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils: Day 28
|
1.464 10^9 cells/Liter
Standard Deviation 1.9750
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils: Day 56
|
0.932 10^9 cells/Liter
Standard Deviation 1.3943
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Neutrophils: Day 84
|
0.305 10^9 cells/Liter
Standard Deviation 1.7297
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets: Day 0 (24 hours)
|
-6.3 10^9 cells/Liter
Standard Deviation 12.68
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets: Day 14
|
2.1 10^9 cells/Liter
Standard Deviation 26.11
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets: Day 28
|
10.0 10^9 cells/Liter
Standard Deviation 30.14
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets: Day 56
|
1.0 10^9 cells/Liter
Standard Deviation 20.84
|
|
Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets
Platelets: Day 84
|
-4.1 10^9 cells/Liter
Standard Deviation 29.04
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Safety Population.
Hematology parameter included erythrocytes. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes
Day 0 (24 hours)
|
-0.12 10^12 cells/Liter
Standard Deviation 0.158
|
|
Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes
Day 14
|
-0.19 10^12 cells/Liter
Standard Deviation 0.246
|
|
Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes
Day 28
|
-0.13 10^12 cells/Liter
Standard Deviation 0.205
|
|
Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes
Day 56
|
-0.16 10^12 cells/Liter
Standard Deviation 0.239
|
|
Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes
Day 84
|
-0.18 10^12 cells/Liter
Standard Deviation 0.282
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Safety Population
Hematology parameter included hematocrit. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Change From Baseline to Day 84 in Hematology Parameter- Hematocrit
Day 0 (24 hours)
|
-0.0112 Proportion of red blood cells in blood
Standard Deviation 0.0170
|
|
Change From Baseline to Day 84 in Hematology Parameter- Hematocrit
Day 14
|
-0.0176 Proportion of red blood cells in blood
Standard Deviation 0.0272
|
|
Change From Baseline to Day 84 in Hematology Parameter- Hematocrit
Day 28
|
0.0006 Proportion of red blood cells in blood
Standard Deviation 0.0310
|
|
Change From Baseline to Day 84 in Hematology Parameter- Hematocrit
Day 56
|
-0.0060 Proportion of red blood cells in blood
Standard Deviation 0.0226
|
|
Change From Baseline to Day 84 in Hematology Parameter- Hematocrit
Day 84
|
-0.0126 Proportion of red blood cells in blood
Standard Deviation 0.0313
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Safety Population.
Hematology parameter included hemoglobin. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin
Day 0 (24 hours)
|
-3.7 Grams per Liter (g/L)
Standard Deviation 4.83
|
|
Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin
Day 14
|
-5.0 Grams per Liter (g/L)
Standard Deviation 7.14
|
|
Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin
Day 28
|
-4.0 Grams per Liter (g/L)
Standard Deviation 5.55
|
|
Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin
Day 56
|
-5.0 Grams per Liter (g/L)
Standard Deviation 8.04
|
|
Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin
Day 84
|
-5.7 Grams per Liter (g/L)
Standard Deviation 10.11
|
SECONDARY outcome
Timeframe: Day 0 (24 hours), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84Population: Safety Population.
Urinalysis was done by the dipstick method to detect the presence of protein, glucose, ketones and occult blood in urine. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood, urine protein and urine ketones can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample; results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per Liter (g/L), 2+ or 1/2 g/L, 3+ or 1 g/L and 4+ indicating proportional concentrations in the urine sample. \*a indicates two participants did not take the urinalysis test at Day 14 on scheduled date but took an unscheduled sample at the next visit (Day 21) and \*b indicates one participant did not take the urinalysis test at Day 28 on scheduled date but took an unscheduled sample at the next visit (Day 42). Only those participants with positive results have been presented.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 0 (24 hours), Trace
|
5 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Glucose: Day 14, 1+ or 1/4 g/L
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Glucose: Day 14, 2+ or 1/2 g/L
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Glucose: Day 14, Trace
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Glucose: Day 28, 1+ or 1/4 g/L
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Glucose: Day 56, 1+ or 1/4 g/L
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 0 (24 hours), 1+
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 0 (24 hours), 3+
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 14, Trace
|
4 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 14, 1+
|
2 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 14, 2+
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 21*a, Trace
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 28, Trace
|
6 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 28, 2+
|
2 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 56, Trace
|
5 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 56, 1+
|
2 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 56, 2+
|
2 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 84, Trace
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 84, 1+
|
3 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Occult Blood: Day 84, 2+
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Protein: Day 0 (24 hours), 2+
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Protein: Day 14, Trace
|
3 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Protein: Day 14, 1+
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Protein: Day 28, 2+
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Protein: Day 42*b, Trace
|
1 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Protein: Day 56, Trace
|
2 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Protein: Day 84, Trace
|
3 Participants
|
|
Number of Participants With Positive Urinalysis Dipstick Results
Protein: Day 84, 2+
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Immunoglobulin B cell subsets included CD19 and CD 20+. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by \[(Post-Baseline Visit Value minus Baseline) / Baseline\]. Pharmacodynamic population comprised of participants who received the study medication and for whom pharmacodynamic data was available.
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
CD19: Day 14, n=20
|
26.6444 Percent change
Standard Deviation 78.2275
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
CD19: Day 28, n=20
|
-4.1141 Percent change
Standard Deviation 49.0574
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
CD19: Day 42, n=19
|
-12.6852 Percent change
Standard Deviation 46.6312
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
CD19: Day 56, n=20
|
-20.4908 Percent change
Standard Deviation 44.2536
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
CD19: Day 84, n=20
|
-27.0912 Percent change
Standard Deviation 49.5965
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
CD20+: Day 14, n=20
|
35.3407 Percent change
Standard Deviation 100.7209
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
CD20+: Day 28, n=20
|
0.3444 Percent change
Standard Deviation 54.1435
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
CD20+: Day 42, n=19
|
-8.6327 Percent change
Standard Deviation 52.1804
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
CD20+: Day 56, n=20
|
-20.6313 Percent change
Standard Deviation 42.8535
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment
CD20+: Day 84, n=20
|
-23.7421 Percent change
Standard Deviation 62.8031
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Immunoglobulin B cell subset included CD20+/27+ memory and CD20+/27-naïve. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by \[(Post-Baseline Visit Value minus Baseline) / Baseline\].
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
CD20+/27+ memory: Day 14, n=20
|
186.4701 Percent change
Standard Deviation 199.5187
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
CD20+/27+ memory: Day 28, n=20
|
118.1433 Percent change
Standard Deviation 135.2351
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
CD20+/27+ memory: Day 42, n=19
|
91.2965 Percent change
Standard Deviation 125.1803
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
CD20+/27+ memory: Day 56, n=20
|
135.8139 Percent change
Standard Deviation 167.0084
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
CD20+/27+ memory: Day 84, n=20
|
70.6332 Percent change
Standard Deviation 108.1058
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
CD20+/27-naïve: Day 14, n=20
|
4.0530 Percent change
Standard Deviation 61.8752
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
CD20+/27-naïve: Day 28, n=20
|
-15.9190 Percent change
Standard Deviation 48.8363
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
CD20+/27-naïve: Day 42, n=19
|
-17.0090 Percent change
Standard Deviation 61.5514
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
CD20+/27-naïve: Day 56, n=20
|
-40.2078 Percent change
Standard Deviation 37.1774
|
|
Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment
CD20+/27-naïve: Day 84, n=20
|
-42.6608 Percent change
Standard Deviation 43.8690
|
SECONDARY outcome
Timeframe: Baseline (pre-dose on Day 0) to Day 84Population: Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.
Immunoglobulin B cell subset inlcuded Norm CD19+/27Br/38Br SLE subset, Norm CD20+/138+plasmacytoid, Norm CD20+/69+activated and Norm CD20-/CD138+plasma cell. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by \[(Post-Baseline Visit Value minus Baseline) / Baseline\].
Outcome measures
| Measure |
Belimumab 10 mg/kg
n=20 Participants
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD19+/27Br/38Br SLE subset: Day 14, n=20
|
5.3271 Percent change
Standard Deviation 85.7472
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD19+/27Br/38Br SLE subset: Day 28, n=20
|
-4.4623 Percent change
Standard Deviation 91.3321
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD19+/27Br/38Br SLE subset: Day 42, n=19
|
17.2492 Percent change
Standard Deviation 132.2146
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD19+/27Br/38Br SLE subset: Day 56, n=20
|
48.1481 Percent change
Standard Deviation 148.1877
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD19+/27Br/38Br SLE subset: Day 84, n=20
|
24.9838 Percent change
Standard Deviation 118.1567
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20+/138+plasmacytoid: Day 14, n=19
|
200.6464 Percent change
Standard Deviation 702.0072
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20+/138+plasmacytoid: Day 28, n=19
|
255.8559 Percent change
Standard Deviation 1010.9303
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20+/138+plasmacytoid: Day 42, n=18
|
2.7891 Percent change
Standard Deviation 145.0411
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20+/138+plasmacytoid: Day 56, n=19
|
20.1061 Percent change
Standard Deviation 220.7714
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20+/138+plasmacytoid: Day 84, n=19
|
-44.0743 Percent change
Standard Deviation 65.0501
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20+/69+activated: Day 14, n=19
|
-0.9711 Percent change
Standard Deviation 196.9956
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20+/69+activated: Day 28, n=19
|
106.5032 Percent change
Standard Deviation 379.9580
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20+/69+activated: Day 42, n=18
|
9.8018 Percent change
Standard Deviation 138.7995
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20+/69+activated: Day 56, n=19
|
15.6984 Percent change
Standard Deviation 132.7055
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20+/69+activated: Day 84, n=19
|
-18.3523 Percent change
Standard Deviation 120.1047
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20-/CD138+plasma cells: Day 14, n=20
|
24.3489 Percent change
Standard Deviation 151.0876
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20-/CD138+plasma cells: Day 28, n=20
|
21.4906 Percent change
Standard Deviation 180.2169
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20-/CD138+plasma cells: Day 42, n=19
|
-6.6055 Percent change
Standard Deviation 129.1377
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20-/CD138+plasma cells: Day 56, n=20
|
3.0692 Percent change
Standard Deviation 175.5913
|
|
Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment
Norm CD20-/CD138+plasma cells: Day 84, n=20
|
-51.0462 Percent change
Standard Deviation 38.0848
|
Adverse Events
Belimumab 10 mg/kg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Belimumab 10 mg/kg
n=20 participants at risk
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
Belimumab 10 mg/kg
n=20 participants at risk
Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
4/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Infections and infestations
Gingivitis
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
2/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone infarction
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Up to Day 84
Serious adverse events and non-serious adverse events were collected for the Safety Population which comprised of all the participants who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER