Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease (NCT05799378)
A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California, Los Angeles — Los Angeles, California
Age range: 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- University of California, Los Angeles — Los Angeles, California
- University of California: San Diego — San Diego, California
- Emory University School of Medicine — Atlanta, Georgia
- Hackensack Meridian Health — Hackensack, New Jersey
- VA NY Harbor Healthcare System — New York, New York
- NYC Health + Hospitals/Bellevue — New York, New York
- NYU Langone Health — New York, New York
- Hospital for Special Surgery — New York, New York
- Columbia University Irving Medical Center/New York Presbyterian — New York, New York
- Montefiore Medical Center/Albert Einstein College of Medicine — The Bronx, New York
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma
- Penn State MS Hershey Medical Center — Hershey, Pennsylvania
📞 Contact the Study Coordinator
Phone: (212) 263-0372
Email: Mala.Masson@nyulangone.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Systemic Lupus Erythematosus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.