Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
Start Date
6/27/2024
Completion Date
6/30/2029
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.
Eligibility Criteria
Age Range: 60 years to No maximum
Interventions
Hydroxychloroquine
Placebo
Conditions
Locations
University of California, Los Angeles
Los Angeles, California 90095
United States
Hackensack Meridian Health
Hackensack, New Jersey 07601
United States
VA NY Harbor Healthcare System
New York, New York 10010
United States
NYC Health + Hospitals/Bellevue
New York, New York 10016
United States
NYU Langone Health
New York, New York 10016
United States
Hospital for Special Surgery
New York, New York 10021
United States
Columbia University Irving Medical Center/New York Presbyterian
New York, New York 10032
United States
Montefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York 10461
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104
United States
Penn State MS Hershey Medical Center
Hershey, Pennsylvania 17033
United States