Stopping Hydroxychloroquine in Elderly Patients with Lupus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety of discontinuing hydroxychloroquine (HCQ) in elderly patients aged 60 and above who have stable systemic lupus erythematosus (SLE). The study aims to evaluate whether stopping HCQ can be done without increasing the risk of disease flare, while also considering the potential for retinal toxicity associated with long-term HCQ use. Participants will be assessed using validated disease activity measures and undergo serologic, cytokine, and transcriptomic profiling to monitor their health status throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• University of California: San Diego
  San Diego, California, United States Recruiting
• Emory University School of Medicine
  Atlanta, Georgia, United States Recruiting
• Hackensack Meridian Health
  Hackensack, New Jersey, United States Recruiting
• VA NY Harbor Healthcare System
  New York, New York, United States Recruiting
• NYC Health + Hospitals/Bellevue
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Peter Izmirly — NYU Langone Health
• Study coordinator: Mala Masson
• Email: Mala.Masson@nyulangone.org
• Phone: (212) 263-0372

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.