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In China, Belimumab (GSK1550188) will be developed for a dosing regimen of once-monthly intravenous (IV) infusion for the treatment of SLE. This open-label, single dose study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of belimumab in Chinese SLE subjects. A total of approximately 20 subjects will be enrolled to receive IV infusion of 10 milligrams per kilogram (mg/kg) GSK1550188 on Day 0 for the treatment of SLE. Subjects will be followed for 84 days after the administration of drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab 10 mg/kg | Experimental | In this open label study, a single dose of 10 mg/kg Belimumab will be administered intravenously in Chinese subjects with systemic lupus erythematosus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab | Drug | Belimumab will be provided as white uniform lyophilized cake in vials with unit dose strength of 400 mg/vial plus excipients (citric acid/sodium citrate/sucrose/polysorbate) for reconstitution in 4.8 milliliter sterile water for injection (SWFI). Belimumab will be administered as 10 mg/kg intravenous infusion for over 1 hour on Day 0. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Belimumab | Blood samples were collected at the indicated timepoints to calculate Cmax of belimumab. | 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 |
| 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 | Blood samples were collected at the indicated timepoints to calculate AUC (0 to t) and AUC (0 to inf) of belimumab. | 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 |
| Terminal Phase Half-life (t1/2) of Belimumab | Blood samples were collected at the indicated time points to calculate t1/2 of belimumab. | 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 |
| Terminal Phase Rate Constant (Lambda z) of Belimumab | Blood samples were collected at the indicated time points to calculate lambda z of belimumab. | 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 |
| Systemic Clearance (CL) of Belimumab | Blood samples were collected at the indicated time points to calculate CL of belimumab. | 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 |
| Volume of Distribution (Vz) of Belimumab |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 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. | Baseline (pre-dose on Day 0) to Day 84 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Shanghai | China | ||||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31953740 | Background | Zhang J, Wan W, Miao L, Wu J, Dong J, Shen Y, Xiong C, Li C, Xue Y, Cao G, Ma P. Pharmacokinetics, Pharmacodynamics and Safety of Belimumab in Chinese Patients with Systemic Lupus Erythematosus: A Phase I, Open-Label Study. Rheumatol Ther. 2020 Mar;7(1):191-200. doi: 10.1007/s40744-020-00193-9. Epub 2020 Jan 17. | |
| 34741731 | Derived |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population which comprised of all the participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Belimumab 10 mg/kg | Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Concentration (Cmax) of Belimumab | Blood samples were collected at the indicated timepoints to calculate Cmax of belimumab. | Pharmacokinetic (PK) Parameter Population, which comprised of all those participants who received a dose of belimumab and for whom PK parameters could be calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | 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 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Belimumab 10 mg/kg | Eligible participants received a single dose of belimumab 10 mg per kg as intravenous infusion for over an hour on Day 0. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2017 | Aug 13, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 2, 2017 | Aug 13, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C511911 | belimumab |
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|
Blood samples were collected at the indicated time points to calculate Vz of belimumab.
| 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 |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | 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. | Up to Day 84 |
| Change From Baseline to Day 84 in Vital Sign- Pulse Rate | 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. | Baseline (pre-dose on Day 0) to Day 84 |
| Change From Baseline to Day 84 in Vital Sign- Temperature | 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. | Baseline (pre-dose on Day 0) to Day 84 |
| Number of Participants With Abnormal-clinically Significant 12-lead Electrocardiogram (ECG) Findings | 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. | Up to Day 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 | 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. | Baseline (pre-dose on Day 0) to Day 84 |
| Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | 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. | Baseline (pre-dose on Day 0) to Day 84 |
| Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | 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. | Baseline (pre-dose on Day 0) to Day 84 |
| Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | 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. | Baseline (pre-dose on Day 0) to Day 84 |
| Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | 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. | Baseline (pre-dose on Day 0) to Day 84 |
| Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes | 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. | Baseline (pre-dose on Day 0) to Day 84 |
| Change From Baseline to Day 84 in Hematology Parameter- Hematocrit | 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. | Baseline (pre-dose on Day 0) to Day 84 |
| Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin | 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. | Baseline (pre-dose on Day 0) to Day 84 |
| Number of Participants With Positive Urinalysis Dipstick Results | 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. | Day 0 (24 hours), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 |
| Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | 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. | Baseline (pre-dose on Day 0) to Day 84 |
| Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | 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]. | Baseline (pre-dose on Day 0) to Day 84 |
| 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 | 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]. | Baseline (pre-dose on Day 0) to Day 84 |
| Suzhou |
| 215004 |
| China |
| Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6. |
| 34628605 | Derived | Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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 | Blood samples were collected at the indicated timepoints to calculate AUC (0 to t) and AUC (0 to inf) of belimumab. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Day*micrograms/milliliter | 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 |
|
|
|
| Primary | Terminal Phase Half-life (t1/2) of Belimumab | Blood samples were collected at the indicated time points to calculate t1/2 of belimumab. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Days | 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 |
|
|
|
| Primary | Terminal Phase Rate Constant (Lambda z) of Belimumab | Blood samples were collected at the indicated time points to calculate lambda z of belimumab. | PK Parameter Population. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/day | 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 |
|
|
|
| Primary | Systemic Clearance (CL) of Belimumab | Blood samples were collected at the indicated time points to calculate CL of belimumab. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | (Milliliters/day)/kilogram | 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 |
|
|
|
| Primary | Volume of Distribution (Vz) of Belimumab | Blood samples were collected at the indicated time points to calculate Vz of belimumab. | PK Parameter Population | Posted | Geometric Mean | Geometric Coefficient of Variation | Milliliters/kilogram | 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 |
|
|
|
| Primary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | 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. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 84 |
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|
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| Secondary | Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | 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. | Safety Population | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Change From Baseline to Day 84 in Vital Sign- Pulse Rate | 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. | Safety Population. | Posted | Mean | Standard Deviation | Beats per minute | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Change From Baseline to Day 84 in Vital Sign- Temperature | 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. | Safety Population. | Posted | Mean | Standard Deviation | Celsius | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Number of Participants With Abnormal-clinically Significant 12-lead Electrocardiogram (ECG) Findings | 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. | Safety Population. | Posted | Count of Participants | Participants | Up to Day 84 |
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| Secondary | 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 | 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. | Safety Population. | Posted | Mean | Standard Deviation | International units per Liter (IU/L) | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein | 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. | Safety Population. | Posted | Mean | Standard Deviation | Grams per liter (g/L) | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate | 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. | Safety Population. | Posted | Mean | Standard Deviation | Micromoles per Liter (µmol/L) | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose | 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. | Safety Population. | Posted | Mean | Standard Deviation | Millimoles per Liter (mmol/L) | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets | 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. | Safety Population. | Posted | Mean | Standard Deviation | 10^9 cells/Liter | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes | 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. | Safety Population. | Posted | Mean | Standard Deviation | 10^12 cells/Liter | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Change From Baseline to Day 84 in Hematology Parameter- Hematocrit | 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. | Safety Population | Posted | Mean | Standard Deviation | Proportion of red blood cells in blood | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin | 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. | Safety Population. | Posted | Mean | Standard Deviation | Grams per Liter (g/L) | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Number of Participants With Positive Urinalysis Dipstick Results | 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. | Safety Population. | Posted | Count of Participants | Participants | Day 0 (24 hours), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 |
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| Secondary | Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment | 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. | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles. | Posted | Mean | Standard Deviation | Percent change | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment | 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]. | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles. | Posted | Mean | Standard Deviation | Percent change | Baseline (pre-dose on Day 0) to Day 84 |
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| Secondary | 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 | 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]. | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles. | Posted | Mean | Standard Deviation | Percent change | Baseline (pre-dose on Day 0) to Day 84 |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| 11 |
| 20 |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Bone infarction | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Balanoposthitis | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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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.
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| DBP: Day 0 (24 hours post-dose) |
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| DBP: Day 1 |
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| DBP: Day 7 |
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| DBP: Day 14 |
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| DBP: Day 21 |
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| DBP: Day 28 |
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| DBP: Day 42 |
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| DBP: Day 56 |
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| DBP: Day 84 |
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| SBP: Day 0 (5 minutes post-dose) |
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| SBP: Day 0 (1 hour post-dose) |
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| SBP: Day 0 (6 hours post-dose) |
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| SBP: Day 0 (24 hours post-dose) |
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| SBP: Day 1 |
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| SBP: Day 7 |
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| SBP: Day 14 |
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| SBP: Day 21 |
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| SBP: Day 28 |
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| SBP: Day 42 |
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| SBP: Day 56 |
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| SBP: Day 84 |
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| Title | Measurements |
|---|---|
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| Day 0 (24 hours post-dose) |
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| Day 1 |
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| Day 7 |
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| Day 14 |
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| Day 21 |
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| Day 28 |
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| Day 42 |
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| Day 56 |
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| Day 84 |
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| Title | Measurements |
|---|---|
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| Day 0 (24 hours post-dose) |
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| Day 1 |
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| Day 7 |
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| Day 14 |
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| Day 21 |
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| Day 28 |
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| Day 42 |
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| Day 56 |
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| Day 84 |
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| Title | Measurements |
|---|---|
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| ALT: Day 56 |
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| ALT: Day 84 |
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| ALP: Day 0 (24 hours) |
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| ALP: Day 14 |
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| ALP: Day 28 |
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| ALP: Day 56 |
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| ALP: Day 84 |
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| AST: Day 0 (24 hours) |
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| AST: Day 14 |
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| AST: Day 28 |
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| AST: Day 56 |
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| AST: Day 84 |
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| GGT: Day 0 (24 hours) |
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| GGT: Day 14 |
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| GGT: Day 28 |
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| GGT: Day 56 |
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| GGT: Day 84 |
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| Lactate dehydrogenase: Day 0 (24 hours) |
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| Lactate dehydrogenase: Day 14 |
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| Lactate dehydrogenase: Day 28 |
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| Lactate dehydrogenase: Day 56 |
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| Lactate dehydrogenase: Day 84 |
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| Title | Measurements |
|---|---|
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| Albumin: Day 56 |
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| Albumin: Day 84 |
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| Protein: Day 0 (24 hours) |
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| Protein: Day 14 |
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| Protein: Day 28 |
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| Protein: Day 56 |
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| Protein: Day 84 |
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| Title | Measurements |
|---|---|
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| Bilirubin: Day 56 |
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| Bilirubin: Day 84 |
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| Creatinine: Day 0 (24 hours) |
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| Creatinine: Day 14 |
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| Creatinine: Day 28 |
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| Creatinine: Day 56 |
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| Creatinine: Day 84 |
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| Direct bilirubin: Day 0 (24 hours) |
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| Direct bilirubin: Day 14 |
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| Direct bilirubin: Day 28 |
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| Direct bilirubin: Day 56 |
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| Direct bilirubin: Day 84 |
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| Indirect bilirubin: Day 0 (24 hours) |
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| Indirect bilirubin: Day 14 |
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| Indirect bilirubin: Day 28 |
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| Indirect bilirubin: Day 56 |
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| Indirect bilirubin: Day 84 |
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| Urate: Day 0 (24 hours) |
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| Urate: Day 14 |
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| Urate: Day 28 |
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| Urate: Day 56 |
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| Urate: Day 84 |
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| Title | Measurements |
|---|---|
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| Calcium: Day 56 |
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| Calcium: Day 84 |
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| Calcium Corrected: Day 0 (24 hours) |
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| Calcium Corrected: Day 14 |
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| Calcium Corrected: Day 28 |
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| Calcium Corrected: Day 56 |
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| Calcium Corrected: Day 84 |
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| Carbon dioxide: Day 0 (24 hours) |
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| Carbon dioxide: Day 14 |
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| Carbon dioxide: Day 28 |
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| Carbon dioxide: Day 56 |
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| Carbon dioxide: Day 84 |
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| Chloride: Day 0 (24 hours) |
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| Chloride: Day 14 |
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| Chloride: Day 28 |
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| Chloride: Day 56 |
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| Chloride: Day 84 |
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| Magnesium: Day 0 (24 hours) |
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| Magnesium: Day 14 |
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| Magnesium: Day 28 |
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| Magnesium: Day 56 |
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| Magnesium: Day 84 |
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| Phosphate: Day 0 (24 hours) |
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| Phosphate: Day 14 |
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| Phosphate: Day 28 |
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| Phosphate: Day 56 |
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| Phosphate: Day 84 |
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| Potassium: Day 0 (24 hours) |
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| Potassium: Day 14 |
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| Potassium: Day 28 |
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| Potassium: Day 56 |
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| Potassium: Day 84 |
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| Sodium: Day 0 (24 hours) |
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| Sodium: Day 14 |
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| Sodium: Day 28 |
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| Sodium: Day 56 |
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| Sodium: Day 84 |
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| Urea: Day 0 (24 hours) |
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| Urea: Day 14 |
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| Urea: Day 28 |
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| Urea: Day 56 |
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| Urea: Day 84 |
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| Glucose: Day 0 (24 hours) |
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| Glucose: Day 14 |
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| Glucose: Day 28 |
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| Glucose: Day 56 |
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| Glucose: Day 84 |
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| Title | Measurements |
|---|---|
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| Basophils: Day 56 |
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| Basophils: Day 84 |
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| Eosinophils: Day 0 (24 hours) |
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| Eosinophils: Day 14 |
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| Eosinophils: Day 28 |
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| Eosinophils: Day 56 |
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| Eosinophils: Day 84 |
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| Leukocytes: Day 0 (24 hours) |
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| Leukocytes: Day 14 |
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| Leukocytes: Day 28 |
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| Leukocytes: Day 56 |
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| Leukocytes: Day 84 |
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| Lymphocytes: Day 0 (24 hours) |
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| Lymphocytes: Day 14 |
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| Lymphocytes: Day 28 |
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| Lymphocytes: Day 56 |
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| Lymphocytes: Day 84 |
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| Monocytes: Day 0 (24 hours) |
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| Monocytes: Day 14 |
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| Monocytes: Day 28 |
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| Monocytes: Day 56 |
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| Monocytes: Day 84 |
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| Neutrophils: Day 0 (24 hours) |
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| Neutrophils: Day 14 |
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| Neutrophils: Day 28 |
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| Neutrophils: Day 56 |
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| Neutrophils: Day 84 |
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| Platelets: Day 0 (24 hours) |
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| Platelets: Day 14 |
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| Platelets: Day 28 |
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| Platelets: Day 56 |
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| Platelets: Day 84 |
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| Title | Measurements |
|---|---|
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| Day 56 |
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| Day 84 |
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| Title | Measurements |
|---|---|
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| Day 56 |
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| Day 84 |
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| Title | Measurements |
|---|---|
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| Day 56 |
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| Day 84 |
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| Title | Measurements |
|---|---|
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| Glucose: Day 28, 1+ or 1/4 g/L |
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| Glucose: Day 56, 1+ or 1/4 g/L |
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| Occult Blood: Day 0 (24 hours), Trace |
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| Occult Blood: Day 0 (24 hours), 1+ |
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| Occult Blood: Day 0 (24 hours), 3+ |
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| Occult Blood: Day 14, Trace |
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| Occult Blood: Day 14, 1+ |
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| Occult Blood: Day 14, 2+ |
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| Occult Blood: Day 21*a, Trace |
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| Occult Blood: Day 28, Trace |
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| Occult Blood: Day 28, 2+ |
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| Occult Blood: Day 56, Trace |
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| Occult Blood: Day 56, 1+ |
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| Occult Blood: Day 56, 2+ |
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| Occult Blood: Day 84, Trace |
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| Occult Blood: Day 84, 1+ |
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| Occult Blood: Day 84, 2+ |
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| Protein: Day 0 (24 hours), 2+ |
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| Protein: Day 14, Trace |
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| Protein: Day 14, 1+ |
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| Protein: Day 28, 2+ |
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| Protein: Day 42*b, Trace |
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| Protein: Day 56, Trace |
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| Protein: Day 84, Trace |
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| Protein: Day 84, 2+ |
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| CD19: Day 42, n=19 |
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| CD19: Day 56, n=20 |
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| CD19: Day 84, n=20 |
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| CD20+: Day 14, n=20 |
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| CD20+: Day 28, n=20 |
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| CD20+: Day 42, n=19 |
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| CD20+: Day 56, n=20 |
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| CD20+: Day 84, n=20 |
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| CD20+/27+ memory: Day 42, n=19 |
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| CD20+/27+ memory: Day 56, n=20 |
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| CD20+/27+ memory: Day 84, n=20 |
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| CD20+/27-naïve: Day 14, n=20 |
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| CD20+/27-naïve: Day 28, n=20 |
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| CD20+/27-naïve: Day 42, n=19 |
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| CD20+/27-naïve: Day 56, n=20 |
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| CD20+/27-naïve: Day 84, n=20 |
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| Norm CD19+/27Br/38Br SLE subset: Day 42, n=19 |
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| Norm CD19+/27Br/38Br SLE subset: Day 56, n=20 |
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| Norm CD19+/27Br/38Br SLE subset: Day 84, n=20 |
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| Norm CD20+/138+plasmacytoid: Day 14, n=19 |
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| Norm CD20+/138+plasmacytoid: Day 28, n=19 |
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| Norm CD20+/138+plasmacytoid: Day 42, n=18 |
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| Norm CD20+/138+plasmacytoid: Day 56, n=19 |
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| Norm CD20+/138+plasmacytoid: Day 84, n=19 |
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| Norm CD20+/69+activated: Day 14, n=19 |
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| Norm CD20+/69+activated: Day 28, n=19 |
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| Norm CD20+/69+activated: Day 42, n=18 |
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| Norm CD20+/69+activated: Day 56, n=19 |
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| Norm CD20+/69+activated: Day 84, n=19 |
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| Norm CD20-/CD138+plasma cells: Day 14, n=20 |
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| Norm CD20-/CD138+plasma cells: Day 28, n=20 |
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| Norm CD20-/CD138+plasma cells: Day 42, n=19 |
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| Norm CD20-/CD138+plasma cells: Day 56, n=20 |
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| Norm CD20-/CD138+plasma cells: Day 84, n=20 |
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