NCT05799378 Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
| NCT ID | NCT05799378 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | NYU Langone Health |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2024-06-27 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 330 participants in total. It began in 2024-06-27 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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)
Contact & Investigator
Peter Izmirly
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05799378 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05799378 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 330 participants.
Is NCT05799378 currently recruiting?
Yes, NCT05799378 is actively recruiting participants. Contact the research team at Mala.Masson@nyulangone.org for enrollment information.
Where is the NCT05799378 trial being conducted?
This trial is being conducted at Los Angeles, United States, Hackensack, United States, New York, United States, New York, United States and 6 additional locations.
Who is sponsoring the NCT05799378 clinical trial?
NCT05799378 is sponsored by NYU Langone Health. The principal investigator is Peter Izmirly at NYU Langone Health. The trial plans to enroll 330 participants.
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