Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease — SHIELD  

Systemic Lupus Erythematosus Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

• NCT number: NCT05799378
• Study type: Interventional
• Source: NYU Langone Health
• Contact: Mala Masson
• Phone: (212) 263-0372
• Email: Mala.Masson@nyulangone.org
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2024
• Completion date: December 21, 2028