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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
95
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
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Tuscaloosa, Alabama, United States
GSK Investigational Site
Gilbert, Arizona, United States
GSK Investigational Site
Mesa, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
San Leandro, California, United States
GSK Investigational Site
Tustin, California, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Lawrenceville, Georgia, United States
...and 17 more locations
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.
Time frame: Weeks 1 and 2 (Inside clinic)
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.
Time frame: 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.
Time frame: Weeks 3, 5, 6, and 7 (Outside clinic)
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