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The primary objective of this study is to assess the suitability of the autoinjector for self-administration of belimumab by subjects with SLE in real-life conditions. The study will assess the use of the autoinjector inside the clinic setting and outside the clinic setting. The study will also assess the safety and tolerability of belimumab administered subcutaneously (SC) via the autoinjector. Subjects will self-administer belimumab SC into the thigh or abdomen using the autoinjector device for 8 weekly doses. Subjects will return for a follow-up visit 4 weeks after the last SC dose of belimumab. All injections will be assessed by the investigators for success based on direct observation and/or the subject diary. A total of 118 subjects (treated with at least one dose of study drug) are planned to be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Subjects will self-administer belimumab SC into thigh or abdomen using the autoinjector device for 8 weekly doses; 4 of the doses will be administered under observation in the clinic and 4 of the doses will be administered outside the clinic and without observation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab autoinjector | Device | Single use, disposable autoinjector assembled with the prefilled syringe containing the drug product belimumab with unit dose strength of 200mg/mL and 1 mL will be given as a once weekly SC dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Successfully Able to Self-administer Their Observed First and Second Doses in Weeks 1 and 2 (Inside Clinic) | The primary objective was to assess the suitability of the auto injector for self-administration of belimumab. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included. | Weeks 1 and 2 (Inside clinic) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Successfully Able to Self-administer Their Observed Doses in Weeks 4 and 8 (Inside Clinic) | The main objective was to assess the suitability of the auto injector for self-administration of belimumab by participants with SLE. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included. |
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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 | Birmingham | Alabama | 35249 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 200339 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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A total of 119 participants were screened out of which only 95 were enrolled to the study treatment. 25 were screen failures the reasons for which were did not meet inclusion/exclusion criteria (23), lost to follow up (1), withdrew consent (1).
This was a study in participants with Systemic Lupus Erythematosus (SLE). The study was conducted at 27 centers in the United States from 20 May 2014 to 13 April 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total | Eligible participants self administered once weekly dose of 200 milligram per milliliter (mg/mL), of belimumab subcutaneously (SC) into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Weeks 4 and 8 (Inside clinic) |
| Number of Participants Who Reported They Were Successfully Able to Self-administer Their Doses Outside the Clinic Setting in Weeks 3, 5, 6, and 7 (Outside Clinic) | Assessment was performed for suitability of the auto injector for self-administration of belimumab by participant with SLE outside the clinic setting. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections outside of the clinic without assistance were included. | Weeks 3, 5, 6, and 7 (Outside clinic) |
| Tuscaloosa |
| Alabama |
| 35406 |
| United States |
| GSK Investigational Site | Gilbert | Arizona | 85234 | United States |
| GSK Investigational Site | Mesa | Arizona | 85202 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85032 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85037 | United States |
| GSK Investigational Site | San Leandro | California | 94578 | United States |
| GSK Investigational Site | Tustin | California | 92780 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Lawrenceville | Georgia | 30045 | United States |
| GSK Investigational Site | Lansing | Michigan | 48917 | United States |
| GSK Investigational Site | Flowood | Mississippi | 39232 | United States |
| GSK Investigational Site | Brooklyn | New York | 11203 | United States |
| GSK Investigational Site | Smithtown | New York | 11787 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27514 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28210 | United States |
| GSK Investigational Site | Greenville | North Carolina | 27834 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27617 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| GSK Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| GSK Investigational Site | Wyomissing | Pennsylvania | 19610 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29406 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29601 | United States |
| GSK Investigational Site | Houston | Texas | 77034 | United States |
| GSK Investigational Site | Houston | Texas | 77084 | United States |
| GSK Investigational Site | Webster | Texas | 77598 | United States |
| GSK Investigational Site | Beckley | West Virginia | 25801 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 200339 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200339 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200339 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200339 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200339 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 200339 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Belimumab 200mg Auto Injector | Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7). |
| Units | Counts |
|---|---|
| Participants |
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| 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 (NIH/OMB) | 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 | Number of Participants Successfully Able to Self-administer Their Observed First and Second Doses in Weeks 1 and 2 (Inside Clinic) | The primary objective was to assess the suitability of the auto injector for self-administration of belimumab. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included. | The intention-to-treat (ITT) population was defined as all participants who were enrolled and treated with at least 1 dose of belimumab. Only those participants with data available at the indicated time points were analyzed. | Posted | Number | Participants | Weeks 1 and 2 (Inside clinic) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Successfully Able to Self-administer Their Observed Doses in Weeks 4 and 8 (Inside Clinic) | The main objective was to assess the suitability of the auto injector for self-administration of belimumab by participants with SLE. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included. | ITT population. Only those participants with data available at the indicated time points were analyzed. | Posted | Number | Participants | Weeks 4 and 8 (Inside clinic) |
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| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Reported They Were Successfully Able to Self-administer Their Doses Outside the Clinic Setting in Weeks 3, 5, 6, and 7 (Outside Clinic) | Assessment was performed for suitability of the auto injector for self-administration of belimumab by participant with SLE outside the clinic setting. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections outside of the clinic without assistance were included. | ITT population. Only those participants with data available at the indicated time points were analyzed. | Posted | Number | Participants | Weeks 3, 5, 6, and 7 (Outside clinic) |
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From start of treatment (Day 0, week 1) up to week 12
All adverse events (AEs) and serious AEs (SAEs) were collected from the first dosing day (Day 0) to Week 12. The ITT population was used for analysis.
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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 200mg Auto Injector | Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7). | 0 | 95 | 4 | 95 | 28 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Postoperative abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| 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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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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