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Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Study 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 2 months for one year to assess disease activity and flares.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 60 Years and Over
Gender All
More 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05799378
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 NYU Langone Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Peter IzmirlyJill Buyon
Principal Investigator Affiliation NYU Langone HealthNYU Langone Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Systemic Lupus Erythematosus
Arms & Interventions

Arms

Experimental: Hydroxychloroquine (HCQ)

Patients will receive a 90-day supply of HCQ at their screening visit, at 2 months, 4 months, 6 months, 8 months, and 10 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.

Placebo Comparator: HCQ-Matching Placebo

Patients will receive a 90-day supply of HCQ-matching placebo at their screening visit, at 2 months, 4 months, 6 months, 8 months, and 10 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.

Interventions

Drug: - Hydroxychloroquine

Hydroxychloroquine 200mg capsules. Administered orally.

Drug: - Placebo

Hydroxychloroquine-matching placebo capsule. Administered orally.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, Los Angeles, Los Angeles, California

Status

Address

University of California, Los Angeles

Los Angeles, California, 90095

Hackensack Meridian Health, Hackensack, New Jersey

Status

Address

Hackensack Meridian Health

Hackensack, New Jersey, 07601

Bronx, New York

Status

Address

Montefiore Medical Center/Albert Einstein College of Medicine

Bronx, New York, 10461

VA NY Harbor Healthcare System, New York, New York

Status

Address

VA NY Harbor Healthcare System

New York, New York, 10010

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

Status

Address

NYC Health + Hospitals/Bellevue

New York, New York, 10016

NYU Langone Health, New York, New York

Status

Address

NYU Langone Health

New York, New York, 10016

Hospital for Special Surgery, New York, New York

Status

Address

Hospital for Special Surgery

New York, New York, 10021

New York, New York

Status

Address

Columbia University Irving Medical Center/New York Presbyterian

New York, New York, 10032

Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma

Status

Address

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104

Penn State MS Hershey Medical Center, Hershey, Pennsylvania

Status

Address

Penn State MS Hershey Medical Center

Hershey, Pennsylvania, 17033

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