A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector
Public ClinicalTrials.gov record NCT02124798. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Single-Arm Study to Evaluate the Reliability of an Autoinjector That Administers Belimumab Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02124798
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 95 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 20, 2014 (Actual)
- Primary completion
- Apr 13, 2015 (Actual)
- Completion
- Apr 13, 2015 (Actual)
- Last update posted
- Apr 11, 2018
2014 – 2015
United States locations
- U.S. sites
- 27
- U.S. states
- 14
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35249 | — |
| GSK Investigational Site | Tuscaloosa | Alabama | 35406 | — |
| GSK Investigational Site | Gilbert | Arizona | 85234 | — |
| GSK Investigational Site | Mesa | Arizona | 85202 | — |
| GSK Investigational Site | Phoenix | Arizona | 85032 | — |
| GSK Investigational Site | Phoenix | Arizona | 85037 | — |
| GSK Investigational Site | San Leandro | California | 94578 | — |
| GSK Investigational Site | Tustin | California | 92780 | — |
| GSK Investigational Site | Orlando | Florida | 32806 | — |
| GSK Investigational Site | Lawrenceville | Georgia | 30045 | — |
| GSK Investigational Site | Lansing | Michigan | 48917 | — |
| GSK Investigational Site | Flowood | Mississippi | 39232 | — |
| GSK Investigational Site | Brooklyn | New York | 11203 | — |
| GSK Investigational Site | Smithtown | New York | 11787 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | 27514 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28210 | — |
| GSK Investigational Site | Greenville | North Carolina | 27834 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27617 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | — |
| GSK Investigational Site | Duncansville | Pennsylvania | 16635 | — |
| GSK Investigational Site | Wyomissing | Pennsylvania | 19610 | — |
| GSK Investigational Site | Charleston | South Carolina | 29406 | — |
| GSK Investigational Site | Greenville | South Carolina | 29601 | — |
| GSK Investigational Site | Houston | Texas | 77034 | — |
| GSK Investigational Site | Houston | Texas | 77084 | — |
| GSK Investigational Site | Webster | Texas | 77598 | — |
| GSK Investigational Site | Beckley | West Virginia | 25801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02124798, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 11, 2018 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02124798 live on ClinicalTrials.gov.