Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age55+
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Age ≥ 55 years at time of enrollment

Normal OCT and VF assessment within 6 months of screening visit

Disqualifiers

Any patient that does not attain stable disease status by DORIS

Ophthalmologic evidence of retinopathy (these patients would be advised to discontinue HCQ and therefore unethical to randomize for this study)

Clinical SLEDAI > 0

Taking > 5 mg/day prednisone

Trial design

Treatments tested in this trial

  • Hydroxychloroquine
  • Placebo

Treatment groups

330 Participants
are divided into 2 treatment groups

Sponsors and collaborators

NYU Langone Health

Lead sponsor

National Institutes of Health (NIH)

Collaborator