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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 95 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02124798
The ClinicalTrials.gov registry entry for NCT02124798 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Belimumab autoinjector is the first listed.
NCT02124798 reports 0 study locations.
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.
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