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Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Study acronym: SHIELD
StatusRecruiting
PhasePhase 3
Started2024-06-27
View on ClinicalTrials.gov ↗

Amendment history

2026-08-18
minor
Study Status, Study Description, Eligibility v7
Eligibility criteriarevised
[...] edures and availability for the duration of the study Age ≥ 6055 years at time of enrollment Normal OCT and VF assessment wi [...]
2026-08-03
minor
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v6
Study sites10→12
2026-02-23
minor
2 amendments v4-v5
2 re-verifications since 2025-04-22, no change to tracked fields
2024-06-27
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-06-30→2028-12-31
Completion date2028-12-21→2029-06-30
Start dateestimated 2024-04→confirmed 2024-06-27
Study sitesdetails revised at 10 of 10 sites
2024-02-22
minor
Study Status v2
Start date2023-10→2024-04
2023-07-13
minor
Study Status v1
Start date2023-06-01→2023-10
2023-03-23
minor
Original filing
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 \>=55 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 3 months for one year to assess disease activity and flares.
Trial Details
NCT Number NCT05799378
Lead Sponsor NYU Langone Health
Collaborators: National Institutes of Health (NIH)
Conditions Systemic Lupus Erythematosus
Enrollment 330 participants
Start Date 2024-06-27
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-20