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Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
Sponsor: NYU Langone Health
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.
Official title: A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
330
Start Date
2024-06-27
Completion Date
2029-06-30
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Hydroxychloroquine
Hydroxychloroquine 200mg capsules. Administered orally.
Placebo
Hydroxychloroquine-matching placebo capsule. Administered orally.
Locations (10)
University of California, Los Angeles
Los Angeles, California, United States
Hackensack Meridian Health
Hackensack, New Jersey, United States
VA NY Harbor Healthcare System
New York, New York, United States
NYC Health + Hospitals/Bellevue
New York, New York, United States
NYU Langone Health
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
Columbia University Irving Medical Center/New York Presbyterian
New York, New York, United States
Montefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Penn State MS Hershey Medical Center
Hershey, Pennsylvania, United States