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NCT03543839 · ClinicalTrials.gov registry record · Phase 4
Trial of Belimumab in Early Lupus
A Phase 4 study of Lupus Erythematosus, Systemic and Lupus Erythematosus, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03543839 is a Phase 4 study of Lupus Erythematosus, Systemic and Lupus Erythematosus that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 30 participants, below the 202-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03543839, a Phase 4 study of Lupus Erythematosus, Systemic and Lupus Erythematosus, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to belimumab will be rerandomized to continue to receive belimumab or to receive placebo. The study will look at clinical effects as well as effects on the immune system.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Belimumab
- BIOLOGICAL Belimumab/Placebo
Study Locations (1)
New York
- Feinstein Institute - Manhasset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03543839
The ClinicalTrials.gov registry entry for NCT03543839 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 202-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (85% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03543839 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03543839 about?
NCT03543839 is a clinical study titled "Trial of Belimumab in Early Lupus". This two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to be...
What is the current status of trial NCT03543839?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2020-09-15. Estimated completion is 2026-12.
What conditions does trial NCT03543839 study?
This clinical trial studies the following conditions: Lupus Erythematosus, Systemic, Lupus Erythematosus.
What interventions are being tested in trial NCT03543839?
The interventions under investigation include: Placebo (OTHER), Belimumab (BIOLOGICAL), Belimumab/Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT03543839?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03543839 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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