Condition: Systemic Lupus Erythematosus · Sponsor: NYU Langone Health
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.
This description comes directly from the study's public registry record.
Mala Masson · (212) 263-0372 · Mala.Masson@nyulangone.org
Always discuss trial participation with your own doctor first.
| University of California, Los Angeles | Los Angeles, California, United States | Recruiting |
| Hackensack Meridian Health | Hackensack, New Jersey, United States | Recruiting |
| VA NY Harbor Healthcare System | 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 |
| Hospital for Special Surgery | New York, New York, United States | Recruiting |
| Columbia University Irving Medical Center/New York Presbyterian | New York, New York, United States | Recruiting |
| Montefiore Medical Center/Albert Einstein College of Medicine | The Bronx, New York, United States | Recruiting |
| Oklahoma Medical Research Foundation | Oklahoma City, Oklahoma, United States | Recruiting |
| Penn State MS Hershey Medical Center | Hershey, Pennsylvania, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05799378