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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: Recruiting Phase 4 study of Lupus Erythematosus, Systemic and Lupus Erythematosus, sponsored by Northwell Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The frequency of autoreactive B cells in the naïve subset will be identified by flow cytometry.
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 |
What NCT03543839 shows while recruiting
NCT03543839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 202-participant average among 29 other Lupus Erythematosus, Systemic trials with a reported enrollment target (85% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03543839's enrollment target sits among peer trials
30 25th of 29 higher than 4 of 29 other Lupus Erythematosus, Systemic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Erythematosus, Systemic 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.
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