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This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to characterize the pharmacokinetic profile and safety profile of 200 mg single dose of belimumab, administered either intravenously or subcutaneously via auto-injector. Each subject will be randomized in a 1:2 ratio to receive a single dose of either intravenous (IV) or subcutaneous (SC) administration of belimumab 200 mg. The total study duration will be approximately 13 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab SC | Experimental | Subjects will be administered a single dose of belimumab 200 mg via the SC route. The dose will be administered in the front of the thigh via auto-injector device. |
|
| Belimumab IV | Experimental | Subjects will be administered a single dose of belimumab 200 mg via the IV route administered over approximately 1 hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab for IV | Drug | Belimumab will be available as white to off-white lyophilized cake at a unit dose strength of 400 mg to be reconstituted and diluted in normal saline to obtain 200 mg per dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Belimumab Following Intravenous Administration | Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following intravenous administration. Pharmacokinetic Population comprised of all safety participants (all randomized participants who received at least one dose of study treatment) for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. | Pre-dose (prior to start of belimumab IV infusion), 30 minutes (after the start of infusion), 0 hour (end of infusion); at 1, 6, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344 and 1680 hours after end of infusion |
| Serum Concentration of Belimumab Following Subcutaneous Administration | Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following subcutaneous administration. | Pre-dose and at 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 240 hours, 336 hours, 504 hours, 672 hours, 1008 hours, 1344 hours and 1680 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Vital Signs | Vital signs were measured in a semi-supine position after five minutes of rest and included tympanic temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. The normal ranges were: temperature (35.0-38.0 degrees celsius), SBP (85-160 millimeters of mercury [mmHg]), DBP (45-100 mmHg), heart rate (60-90 beats per minute). Number of participants with abnormality in any vital signs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment. |
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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 | 201508 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34554352 | Derived | Meng X, Wang Q, Wu S, Pu D, Zhang A, Fang S, Zhou X, Lu H. Pharmacokinetics and Safety of Intravenous and Subcutaneous Auto-injector Single-dose Belimumab in Healthy Chinese Volunteers: A phase 1, Randomized, Open-label Study. Rheumatol Ther. 2021 Dec;8(4):1711-1724. doi: 10.1007/s40744-021-00366-0. Epub 2021 Sep 23. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
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 171 participants were screened and 36 participants were enrolled and randomized in the study.
This was an open-label, randomized, parallel group, single dose study to evaluate safety and pharmacokinetics (PK) of belimumab, administered either intravenously (IV) or subcutaneously (SC) via an auto-injector in healthy Chinese participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belimumab 200 mg IV | Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour. |
| FG001 | Belimumab 200 mg SC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jun 27, 2019 | Sep 22, 2020 |
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Subjects will be randomized in a 1:2 ratio to receive one treatment of either IV or SC administration of belimumab 200 mg.
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| Belimumab for SC | Drug | Belimumab will be available as clear to opalescent, colorless to pale yellow sterile solution at unit dose strength of 200 mg/milliliter (mg/mL) for SC injection in a single-use, prefilled syringe contained within an auto-injector device. |
|
| Up to Day 71 |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Twelve-lead ECGs were recorded with the participants in a semi-supine position, after 5 minutes of rest using an ECG machine. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with clinically significant and not clinically significant abnormal ECG findings have been presented. | Up to Day 71 |
| Number of Participants With Abnormal Clinical Chemistry Parameters | Blood samples were collected for the assessment of clinical chemistry parameters. The normal ranges were: alanine aminotransferase(7-40 international units per liter[IU/L]), albumin(40-55 grams per liter[g/L]), alkaline phosphatase(35-100 IU/L), amylase(25-125 units per liter), aspartate aminotransferase(13-35 IU/L), bilirubin(Bil.)(3.4-20.5 micromoles per liter [µmol/L]), calcium(2.1-2.55 millimoles per liter[mmol/L]), chloride(99-110 mmol/L), cholesterol(Chol.)(0-5.17 mmol/L), creatine kinase(29-168 IU/L), creatinine(41-73 µmol/L), direct Bil.(0-8.6 µmol/L), gamma glutamyl transferase(7-45 IU/L), glucose(3.9-6.1 mmol/L), high density Chol.(1.04-1.55 mmol/L), low density Chol.(2.59-4.11 mmol/L), lactate dehydrogenase(120-250 IU/L), phosphate(0.74-1.52 mmol/L), potassium(3.5-5.3 mmol/L), protein(65-85 g/L), sodium(137-147 mmol/L), triglycerides(0-1.69 mmol/L), urate(150-350 µmol/L), urea(2.6-7.5 mmol/L). Number of participants with abnormal clinical chemistry parameters are presented. | Up to Day 71 |
| Number of Participants With Abnormal Hematology Parameters | Blood samples were collected for the assessment of hematology parameters. The normal ranges for the parameters were: basophil count ([0.00-0.06]*10^9 cells per liter [cells/L]), eosinophil count ([0.02-0.52]*10^9 cells/L), erythrocyte count ([3.8-5.1]*10^12 cells/L), hematocrit (0.35-0.45 proportion of red blood cells in blood), hemoglobin (115-150 g/L), leukocyte count ([3.5-9.5]*10^9 cells/L), lymphocyte count ([1.1-3.2]*10^9 cells/L), monocyte count ([0.1-0.6]*10^9 cells/L), neutrophil count ([1.8-6.3]*10^9 cells/L), platelet count ([125-350]*10^9 cells/L). Number of participants with abnormal hematology parameters are presented. | Up to Day 71 |
| Number of Participants With Abnormal Urinalysis Parameters | Urine samples were analyzed for glucose, ketones, occult blood and protein by dipstick method. The dipstick test results are read as Negative, Trace, 1+, 2+, 3+, 4+ indicating proportional concentrations in the urine sample. Normal range for dipstick test results are 'negative' results. Urine potential of hydrogen (pH) and specific gravity were also analyzed. pH is measured on a numeric scale of 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Urine specific gravity is a measure of the concentration of solutes in the urine and indicated as ratio of urine density to water density. The normal ranges for pH: 4.8 to 7.4; and for specific gravity: 1.003 to 1.03. Number of participants with abnormal results in any urinalysis parameters are presented. | Up to Day 71 |
| Number of Participants With Injection Site Reaction | Local tolerability as measured by injection site reaction example: induration, erythema, edema, rash, pruritis or pain. Number of participants with any injection site reaction are presented. | Up to Day 71 |
| Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants who had SAEs and non-SAEs are presented. | Up to Day 71 |
Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device.
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Belimumab 200 mg IV | Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour. |
| BG001 | Belimumab 200 mg SC | Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Serum Concentration of Belimumab Following Intravenous Administration | Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following intravenous administration. Pharmacokinetic Population comprised of all safety participants (all randomized participants who received at least one dose of study treatment) for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Nanograms per milliliter | Pre-dose (prior to start of belimumab IV infusion), 30 minutes (after the start of infusion), 0 hour (end of infusion); at 1, 6, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344 and 1680 hours after end of infusion |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Serum Concentration of Belimumab Following Subcutaneous Administration | Blood samples were collected at indicated time points for measurement of serum concentrations of belimumab following subcutaneous administration. | Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Nanograms per milliliter | Pre-dose and at 6 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 240 hours, 336 hours, 504 hours, 672 hours, 1008 hours, 1344 hours and 1680 hours post-dose |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Vital Signs | Vital signs were measured in a semi-supine position after five minutes of rest and included tympanic temperature, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. The normal ranges were: temperature (35.0-38.0 degrees celsius), SBP (85-160 millimeters of mercury [mmHg]), DBP (45-100 mmHg), heart rate (60-90 beats per minute). Number of participants with abnormality in any vital signs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment. | Safety Population | Posted | Count of Participants | Participants | Up to Day 71 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Twelve-lead ECGs were recorded with the participants in a semi-supine position, after 5 minutes of rest using an ECG machine. Abnormal findings were categorized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with clinically significant and not clinically significant abnormal ECG findings have been presented. | Safety Population | Posted | Count of Participants | Participants | Up to Day 71 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Clinical Chemistry Parameters | Blood samples were collected for the assessment of clinical chemistry parameters. The normal ranges were: alanine aminotransferase(7-40 international units per liter[IU/L]), albumin(40-55 grams per liter[g/L]), alkaline phosphatase(35-100 IU/L), amylase(25-125 units per liter), aspartate aminotransferase(13-35 IU/L), bilirubin(Bil.)(3.4-20.5 micromoles per liter [µmol/L]), calcium(2.1-2.55 millimoles per liter[mmol/L]), chloride(99-110 mmol/L), cholesterol(Chol.)(0-5.17 mmol/L), creatine kinase(29-168 IU/L), creatinine(41-73 µmol/L), direct Bil.(0-8.6 µmol/L), gamma glutamyl transferase(7-45 IU/L), glucose(3.9-6.1 mmol/L), high density Chol.(1.04-1.55 mmol/L), low density Chol.(2.59-4.11 mmol/L), lactate dehydrogenase(120-250 IU/L), phosphate(0.74-1.52 mmol/L), potassium(3.5-5.3 mmol/L), protein(65-85 g/L), sodium(137-147 mmol/L), triglycerides(0-1.69 mmol/L), urate(150-350 µmol/L), urea(2.6-7.5 mmol/L). Number of participants with abnormal clinical chemistry parameters are presented. | Safety Population | Posted | Count of Participants | Participants | Up to Day 71 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Hematology Parameters | Blood samples were collected for the assessment of hematology parameters. The normal ranges for the parameters were: basophil count ([0.00-0.06]*10^9 cells per liter [cells/L]), eosinophil count ([0.02-0.52]*10^9 cells/L), erythrocyte count ([3.8-5.1]*10^12 cells/L), hematocrit (0.35-0.45 proportion of red blood cells in blood), hemoglobin (115-150 g/L), leukocyte count ([3.5-9.5]*10^9 cells/L), lymphocyte count ([1.1-3.2]*10^9 cells/L), monocyte count ([0.1-0.6]*10^9 cells/L), neutrophil count ([1.8-6.3]*10^9 cells/L), platelet count ([125-350]*10^9 cells/L). Number of participants with abnormal hematology parameters are presented. | Safety Population | Posted | Count of Participants | Participants | Up to Day 71 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Urinalysis Parameters | Urine samples were analyzed for glucose, ketones, occult blood and protein by dipstick method. The dipstick test results are read as Negative, Trace, 1+, 2+, 3+, 4+ indicating proportional concentrations in the urine sample. Normal range for dipstick test results are 'negative' results. Urine potential of hydrogen (pH) and specific gravity were also analyzed. pH is measured on a numeric scale of 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Urine specific gravity is a measure of the concentration of solutes in the urine and indicated as ratio of urine density to water density. The normal ranges for pH: 4.8 to 7.4; and for specific gravity: 1.003 to 1.03. Number of participants with abnormal results in any urinalysis parameters are presented. | Safety Population | Posted | Count of Participants | Participants | Up to Day 71 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Injection Site Reaction | Local tolerability as measured by injection site reaction example: induration, erythema, edema, rash, pruritis or pain. Number of participants with any injection site reaction are presented. | Safety Population | Posted | Count of Participants | Participants | Up to Day 71 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events | An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Number of participants who had SAEs and non-SAEs are presented. | Safety Population | Posted | Count of Participants | Participants | Up to Day 71 |
|
|
Serious adverse events (SAEs) and non-serious adverse events were collected from the start of study treatment (Day 1) up to Day 71
SAEs and non-serious adverse events were reported for the Safety Population which comprised of all randomized participants who received at least one dose of study treatment.
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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 200 mg IV | Healthy Chinese participants were administered a single IV infusion of belimumab at a dose of 200 milligram (mg), infused over approximately 1 hour. | 0 | 12 | 0 | 12 | 11 | 12 |
| EG001 | Belimumab 200 mg SC | Healthy Chinese participants were administered a single SC dose of belimumab 200 mg in the front of the thigh via an auto-injector device. | 0 | 24 | 0 | 24 | 24 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Lip blister | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Tongue ulceration | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site hypoaesthesia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood immunoglobulin M decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Occult blood positive | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Urine ketone body present | Investigations | MedDRA 22.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA 22.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2020 | Sep 22, 2020 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C511911 | belimumab |
Not provided
Not provided
Not provided
| Male |
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| 1hour after end of infusion |
|
| 6 hours after end of infusion |
|
| 24 hours after end of infusion |
|
| 48 hours after end of infusion |
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| 72 hours after end of infusion |
|
| 96 hours after end of infusion |
|
| 168 hours after end of infusion |
|
| 336 hours after end of infusion |
|
| 504 hours after end of infusion |
|
| 672 hours after end of infusion |
|
| 1008 hours after end of infusion |
|
| 1344 hours after end of infusion |
|
| 1680 hours after end of infusion |
|
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| Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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