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.
Systemic Lupus Erythematosus
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.
Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
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University of California, Los Angeles, Los Angeles, California, United States, 90095
Hackensack Meridian Health, Hackensack, New Jersey, United States, 07601
Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York, United States, 10461
VA NY Harbor Healthcare System, New York, New York, United States, 10010
NYC Health + Hospitals/Bellevue, New York, New York, United States, 10016
NYU Langone Health, New York, New York, United States, 10016
Hospital for Special Surgery, New York, New York, United States, 10021
Columbia University Irving Medical Center/New York Presbyterian, New York, New York, United States, 10032
Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States, 73104
Penn State MS Hershey Medical Center, Hershey, Pennsylvania, United States, 17033
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
60 Years to
ALL
No
NYU Langone Health,
Peter Izmirly, PRINCIPAL_INVESTIGATOR, NYU Langone Health
Jill Buyon, PRINCIPAL_INVESTIGATOR, NYU Langone Health
2029-06-30