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Purpose

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 3 months for one year to assess disease activity and flares.

Condition

Eligibility

Eligible Ages
Over 55 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Hydroxychloroquine (HCQ) 		Patients will receive a 90-day supply of HCQ at their screening visit and at 3 months, 6 months, 9 months and 12 months. All patients will return their current supply along with a completed dosing diary at each visit and receive a new supply in exchange. The HCQ dose administered will match each patient's dosage of HCQ at enrollment.
  • Drug: Hydroxychloroquine
    Hydroxychloroquine 200mg capsules. Administered orally.
Placebo Comparator
HCQ-Matching Placebo 		Patients will receive a 90-day supply of HCQ-matching placebo at their screening visit and at 3 months, 6 months, 9 months and 12 months. All patients will return their current supply along with a completed dosing diary at each visit and receive a new supply in exchange. The HCQ-matching placebo dose administered will match each patient's dosage of HCQ at enrollment.
  • Drug: Placebo
    Hydroxychloroquine-matching placebo capsule. Administered orally.

Recruiting Locations

University of California, Los Angeles
Los Angeles, California 90095

University of California: San Diego
San Diego, California 92093

Emory University School of Medicine
Atlanta, Georgia 30322

Hackensack Meridian Health
Hackensack, New Jersey 07601

VA NY Harbor Healthcare System
New York, New York 10010

NYC Health + Hospitals/Bellevue
New York, New York 10016

NYU Langone Health
New York, New York 10016

Hospital for Special Surgery
New York, New York 10021

Columbia University Irving Medical Center/New York Presbyterian
New York, New York 10032

Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104

Penn State MS Hershey Medical Center
Hershey, Pennsylvania 17033

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

Mala Masson
(212) 263-0372
Mala.Masson@nyulangone.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.