Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

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

Keywords

Systemic Lupus Erythematosus, Hydroxychloroquine, elderly lupus disease, lupus, sle, plaquenil, Hydroxychloroquine (HCQ)

Eligibility

You can join if…

Open to people ages 60 years and up

  • 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 ≥ 60 years at time of enrollment
  • Normal OCT and VF assessment within 6 months of screening visit
  • Ability to take oral medication
  • Have established SLE (≥ 4 ACR criteria or SLICC criteria or ≥ 10 points by EULAR criteria, SLE diagnosed at least seven years ago)
  • Stable disease at screening visit by attaining DORIS remission (meeting all criterion listed below) and not on any immunosuppressants.
    • Criterion 1: Clinical SLEDAI= 0
    • Criterion 2: SELENA-SLEDAI PGA ≤ 0.5 (on a scale from 0-3, where 0 is no disease activity and 3 is maximum disease activity)
    • Criterion 3: Current prednisolone (or equivalent corticosteroid) dose ≤ 5 mg daily
  • No moderate or severe flares one year prior to screening
  • Taking ≥ 200 HCQ daily for ≥ 7 years

You CAN'T join if...

  • 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
  • Taking any immunosuppressive drugs or biological agents (including: methotrexate, azathioprine, mycophenolate mofetil, mycophenolic acid, leflunomide, cyclosporine, cyclophosphamide, tacrolimus, rituximab, and belimumab)
  • Any reason the treating rheumatologist is concerned about ongoing activity not captured by SLEDAI
  • HCQ level < 100 ng/ml as this would support noncompliance and less reliance on HCQ to control activity
  • Patient unwilling or unable to comply with study procedures for any reason
  • Any indications of potentially diminished capacity, such as a diagnosis of dementia or cognitive impairment (including, but not limited to stroke-related cognitive impairment)

Locations

  • University of California, Los Angeles
    Los Angeles California 90095 United States
  • Oklahoma Medical Research Foundation
    Oklahoma City Oklahoma 73104 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
NYU Langone Health
ID
NCT05799378
Phase
Phase 3 Lupus Research Study
Study Type
Interventional
Participants
Expecting 330 study participants
Last Updated