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NCT02124798 · ClinicalTrials.gov registry record · Phase 2
A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
NCT02124798: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT02124798 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02124798, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DEVICE Belimumab autoinjector
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2014-05-20 |
| Est. Completion | 2015-04-13 |
| Phase | Phase 2 |
What the finished NCT02124798 record still lists
NCT02124798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 1 intervention - of which Belimumab autoinjector is the first listed.
NCT02124798 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02124798 about?
NCT02124798 is a clinical study titled "A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector". 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 asse...
What is the current status of trial NCT02124798?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2014-05-20. Estimated completion is 2015-04-13.
What interventions are being tested in trial NCT02124798?
The interventions under investigation include: Belimumab autoinjector (DEVICE).
Who is sponsoring clinical trial NCT02124798?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02124798's enrollment target sits among peer trials
95 759th of 2000 higher than 1,237 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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