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Clinical trialNCT05799378RecruitingPhase 3Interventional

Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

SponsorNYU Langone HealthEnrollment330Systemic Lupus Erythematosus
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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 \>=55 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 3 months for one year to assess disease activity and flares.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of California, Los Angeles

    Los Angeles, California, United States

    Recruiting
  • University of California: San Diego

    San Diego, California, United States

    Recruiting
  • Emory University School of Medicine

    Atlanta, Georgia, United States

    Recruiting
  • Hackensack Meridian Health

    Hackensack, New Jersey, United States

    Recruiting
  • Columbia University Irving Medical Center/new York Presbyterian

    New York, New York, United States

    Recruiting
  • Hospital for Special Surgery

    New York, New York, United States

    Recruiting
  • Nyc Health + Hospitals/bellevue

    New York, New York, United States

    Recruiting
  • Nyu Langone Health

    New York, New York, United States

    Recruiting
  • Va Ny Harbor Healthcare System

    New York, New York, United States

    Recruiting
  • Montefiore Medical Center/albert Einstein College of Medicine

    The Bronx, New York, United States

    Completed
  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, United States

    Recruiting
  • Penn State Ms Hershey Medical Center

    Hershey, Pennsylvania, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
27 Jun 2024
Primary completion
31 Dec 2028
Completion
30 Jun 2029
Last update posted
20 Aug 2026
Registered enrollment
330
Registry id
NCT05799378

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.