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Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
NCT05799378 · View on ClinicalTrials.gov ↗
Study Summary
Hydroxychloroquine (HCQ) is a systemic lupus erythematosus (SLE) medication that has been very effective in reducing lupus disease activity and keeping patients stable with reduced symptoms. Despite a track record of safety with regard to infection compared to traditional immunosuppressive agents, the risk of HCQ retinal toxicity escalates with continued use. Evaluation using sensitive standard of care approaches suggests nearly a third of patients accrue retinal damage. Data are needed to accurately weigh the balance between accumulating ocular exposure of HCQ versus the risk of disease flare in a population that may have more inactive disease than younger patients. The purpose of this trial is to address the safety of withdrawal of HCQ in SLE patients =60 years old. The central hypothesis is that HCQ can be safely discontinued in stable/quiescent patients assessed by validated disease activity and flare instruments in the context of serologic, cytokine and transcriptomic profiling. Patients will be randomized to either the placebo or active arm and followed every 2 months for one year to assess disease activity and flares.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Hydroxychloroquine
Study Locations (10)
New York
- VA NY Harbor Healthcare System — New York
- NYC Health + Hospitals/Bellevue — New York
- NYU Langone Health — New York
- Hospital for Special Surgery — New York
- Columbia University Irving Medical Center/New York Presbyterian — New York
- Montefiore Medical Center/Albert Einstein College of Medicine — The Bronx
California
- University of California, Los Angeles — Los Angeles
New Jersey
- Hackensack Meridian Health — Hackensack
Oklahoma
- Oklahoma Medical Research Foundation — Oklahoma City
Pennsylvania
- Penn State MS Hershey Medical Center — Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2024-06-27 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05799378
The ClinicalTrials.gov registry entry for NCT05799378 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05799378 reports 10 study locations spanning 5 distinct geographic areas — top geographies include New York, California, New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05799378 about?
NCT05799378 is a clinical study titled "Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease". Hydroxychloroquine (HCQ) is a systemic lupus erythematosus (SLE) medication that has been very effective in reducing lupus disease activity and keeping patients stable with reduced symptoms. Despite a track record of safety with regard to infection compared to traditional immunosuppressive agents, t...
What is the current status of trial NCT05799378?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2024-06-27. Estimated completion is 2029-06-30.
What conditions does trial NCT05799378 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05799378?
The interventions under investigation include: Placebo (DRUG), Hydroxychloroquine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05799378?
This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05799378 being conducted?
This trial has 10 study locations across California, New Jersey, New York, Oklahoma, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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