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Lupus drug may be stopped in seniors without flare risk, study tests

NCT ID NCT05799378

Disease control Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study looks at whether people aged 60 and older with stable lupus can safely stop taking hydroxychloroquine, a common medication that can cause eye damage over time. About 330 participants will either continue the drug or switch to a placebo and be monitored for one year. The goal is to see if stopping the drug leads to disease flares, helping doctors balance the risks of eye side effects against lupus symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Irving Medical Center/New York Presbyterian

    RECRUITING

    New York, New York, 10032, United States

  • Emory University School of Medicine

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Hackensack Meridian Health

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hospital for Special Surgery

    RECRUITING

    New York, New York, 10021, United States

  • Montefiore Medical Center/Albert Einstein College of Medicine

    COMPLETED

    The Bronx, New York, 10461, United States

  • NYC Health + Hospitals/Bellevue

    RECRUITING

    New York, New York, 10016, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Oklahoma Medical Research Foundation

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Penn State MS Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California: San Diego

    RECRUITING

    San Diego, California, 92093, United States

  • VA NY Harbor Healthcare System

    RECRUITING

    New York, New York, 10010, United States

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