Back to search results

Stopping Hydroxychloroquine in Elderly Lupus Disease

This study is looking at what happens when older adults (age 60 and up) with Systemic Lupus Erythematosus (SLE), a long-term autoimmune disease, stop taking Hydroxychloroquine. Hydroxychloroquine helps manage lupus symptoms, but long-term use can harm your eyes. Researchers want to see if stopping this medication is safe for older patients, who might have less active lupus. You would either continue taking Hydroxychloroquine or switch to a placebo (an inactive pill that looks like the real medicine). The main goal is to see how many people develop a moderate or severe lupus flare within 12 months. The study plans to enroll 330 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment (either Hydroxychloroquine or a placebo). The study plans to enroll 330 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months to see if they develop a lupus flare.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05799378

Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Recruiting
PHASE3Ages 55+InterventionalTreatment
NYU Langone Health
~330 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:HydroxychloroquinePlacebo

At a glance

Recruiting sites
11 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI)
Measured over Up to Month 12

Conditions

Systemic Lupus Erythematosus

Explore related trials

Systemic Lupus Erythematosus

Where it's being run

12 sites across 6 states
New York6
California2
Georgia1
New Jersey1
Oklahoma1
Pennsylvania1

Study leadership

  • Peter Izmirly · PRINCIPAL_INVESTIGATOR · NYU Langone Health
  • Jill Buyon · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Mala Masson
[email protected]
(212) 263-0372
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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

Exclusion

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)

What this trial measures

  • Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI)Up to Month 12

    Number of participants who experience moderate or severe flares as defined by the rSFI.