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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to measure the amount of belimumab in the blood when given as an injection under the skin (subcutaneously; SC) and to evaluate the safety and tolerability of multiple injections under the skin in healthy subjects.
This study is designed to evaluate the absolute bioavailability, pharmacokinetics, tolerability, and safety of a single dose (groups 1-4) or multiple doses (groups 5-6) of belimumab administered subcutaneously (SC) to healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab IV 240 mg | Active Comparator |
| |
| Belimumab SC 2 x 120 mg | Experimental |
| |
| Belimumab SC 1 x 240 mg | Experimental |
| |
| Belimumab SC 1 x 200 mg | Experimental |
| |
| Belimumab SC 2 x 120 mg weekly | Experimental |
| |
| Belimumab SC 1 x 200 mg weekly | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Dose Group: Belimumab IV 240 mg | Biological | Belimumab IV 240 mg administered on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC) | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 | |
| Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 | |
| Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC | AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile. | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 |
| Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC | Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half. | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 |
| Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC | Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection. | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 | |
| Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daytona Beach | Florida | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34741731 | Derived | 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Belimumab IV 240 mg | Belimumab IV 240 mg administered on Day 0 |
| FG001 | Belimumab SC 2 x 120 mg | Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Single Dose Group: Belimumab SC 2 x 120 mg | Biological | Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0 |
|
|
| Single Dose Group: Belimumab SC 1 x 240 mg | Biological | Belimumab SC 240 mg x 1 injection on Day 0 |
|
|
| Single Dose Group: Belimumab SC 1 x 200 mg | Biological | Belimumab SC 200 mg x 1 injection on Day 0 |
|
|
| Multiple Dose Group: Belimumab SC 2 x 120 mg weekly | Biological | Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21 |
|
|
| Multiple Dose Group: Belimumab SC 1 x 200 mg weekly | Biological | Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21 |
|
|
| Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 |
| Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab | AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile. | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 |
| Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab | Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half. | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 |
| Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab | Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections. | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 |
| Number of Participants Who Experienced Adverse Events | Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups). | Up to Day 119 |
| Evansville |
| Indiana |
| United States |
| Dallas | Texas | United States |
| Madison | Wisconsin | United States |
| 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. |
| FG002 | Belimumab SC 1 x 240 mg | Belimumab SC 240 mg x 1 injection on Day 0 |
| FG003 | Belimumab SC 1 x 200 mg | Belimumab SC 200 mg x 1 injection on Day 0 |
| FG004 | Belimumab SC 2 x 120 mg Weekly | Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21 |
| FG005 | Belimumab SC 1 x 200 mg Weekly | Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Belimumab IV 240 mg | Belimumab IV 240 mg administered on Day 0 |
| BG001 | Belimumab SC 2 x 120 mg | Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0 |
| BG002 | Belimumab SC 1 x 240 mg | Belimumab SC 240 mg x 1 injection on Day 0 |
| BG003 | Belimumab SC 1 x 200 mg | Belimumab SC 200 mg x 1 injection on Day 0 |
| BG004 | Belimumab SC 2 x 120 mg Weekly | Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21 |
| BG005 | Belimumab SC 1 x 200 mg Weekly | Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21 |
| BG006 | 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 |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC) | The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Median | Full Range | days | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab | The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC | The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC | AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile. | The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg∙day/mL | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC | Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half. | The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC | Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection. | The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | 90% Confidence Interval | percentage bioavailability | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab | The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab | AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile. | The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg∙day/mL | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab | Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half. | The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab | Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections. | The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | 90% Confidence Interval | percentage bioavailability | Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced Adverse Events | Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups). | Analyses were performed on the as-treated population, defined as the set of all participants who received at least 1 partial or full dose of treatment with the assignment to treatment group that was based on the actual treatment administered to the participants. | Posted | Number | participants | Up to Day 119 |
|
up to Day 119
Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Belimumab IV 240 mg | Belimumab IV 240 mg administered on Day 0 | 0 | 19 | 14 | 19 | ||
| EG001 | Belimumab SC 2 x 120 mg | Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0 | 0 | 20 | 11 | 20 | ||
| EG002 | Belimumab SC 1 x 240 mg | Belimumab SC 240 mg x 1 injection on Day 0 | 0 | 20 | 16 | 20 | ||
| EG003 | Belimumab SC 1 x 200 mg | Belimumab SC 200 mg x 1 injection on Day 0 | 0 | 19 | 14 | 19 | ||
| EG004 | Belimumab SC 2 x 120 mg Weekly | Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21 | 1 | 20 | 17 | 20 | ||
| EG005 | Belimumab SC 1 x 200 mg Weekly | Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21 | 1 | 20 | 19 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| External ear disorder | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lip blister | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lip pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lip ulceration | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injection site scab | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastritis viral | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Herpes zoster infection neurological | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Scratch | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Splinter | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lymph node palpable | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sleep talking | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ovulation pain | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hidradenitis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
For multi-center trials, no investigator will be authorized to publish study results from an individual center until the earlier of the multi-center trial results are published or 12 months after the end or termination of the multi-center trial at all sites. All manuscripts and abstracts must be submitted to the sponsor for review at least 30 days prior to submission for publication or for presentation at a scientific meeting. The sponsor may delay publication for up to 3 months.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C511911 | belimumab |
Not provided
Not provided
Not provided
| Male |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Belimumab SC 240 mg x 1 injection on Day 0 |
| OG003 | Belimumab SC 1 x 200 mg | Belimumab SC 200 mg x 1 injection on Day 0 |
|
|
Belimumab SC 200 mg x 1 injection on Day 0
|
|
| Belimumab SC 1 x 200 mg |
Belimumab SC 200 mg x 1 injection on Day 0 |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
| OG004 | Belimumab SC 2 x 120 mg Weekly | Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21 |
| OG005 | Belimumab SC 1 x 200 mg Weekly | Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21 |
|
|