Stopping Hydroxychloroquine in Elderly Patients with Lupus
A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
This study is testing if older adults with stable lupus can safely stop taking hydroxychloroquine without making their condition worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | rituximab, belimumab, methotrexate, cyclophosphamide, prednisone |
| Locations | 10 sites (Los Angeles, California and 9 other locations) |
| Trial ID | NCT05799378 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 60 and older with stable systemic lupus erythematosus who have been on hydroxychloroquine for at least seven years.
Not a fit: Patients who have had moderate or severe lupus flares in the year prior to screening or those not meeting the stability criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer treatment approach for elderly lupus patients by minimizing the risk of retinal damage while maintaining disease control.
How similar studies have performed: Other studies have explored the safety of discontinuing hydroxychloroquine, but this specific approach in elderly patients with stable SLE is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≥ 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 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 this trial is running
Los Angeles, California and 9 other locations
- University of California, Los Angeles — Los Angeles, California, 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)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
- Columbia University Irving Medical Center/New York Presbyterian — New York, New York, United States (Recruiting)
- Montefiore Medical Center/Albert Einstein College of Medicine — The Bronx, New York, United States (Recruiting)
- Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States (Recruiting)
- Penn State MS Hershey Medical Center — Hershey, Pennsylvania, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.