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NCT Number: NCT05799378

Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hydroxychloroquine

Drug

Hydroxychloroquine 200mg capsules. Administered orally.

Placebo

Drug

Hydroxychloroquine-matching placebo capsule. Administered orally.

Primary outcomes

  1. Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI)

    Time frame: Up to Month 12

    Number of participants who experience moderate or severe flares as defined by the rSFI.

Secondary outcomes

  1. Number of Participants who Develop Moderate Flare based on rSFI

    Time frame: Up to Month 12

    Number of participants who experience moderate flares as defined by the rSFI.

  2. Physician Global Assessment (PGA) Score at Month 12

    Time frame: Month 12

    The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. The score ranges from +4 to (-4), where 4 = Markedly Improved, 0 = No change, and (-4) = markedly worse.

  3. Number of Participants who Begin Prednisone Treatment

    Time frame: Up to Month 12

  4. Number of Participants who Increase Prednisone Use

    Time frame: Up to Month 12

  5. Number of Participants who Experience Thromboembolic Event

    Time frame: Up to Month 12

    Thromboembolic event includes, but is not limited to, venous thrombosis.

  6. Number of Participants who Experience Cardiovascular Event

    Time frame: Up to Month 12

  7. Number of Participants with New-Onset Diabetes

    Time frame: Up to Month 12

  8. Number of Participants with New Retinal Toxicity

    Time frame: Up to Month 12

  9. Change in 36-Item Short Form Survey Instrument (SF-36) Score

    Time frame: Baseline, Month 12

    The SF-36 is 36-item self-rated measure of quality of life. A scoring algorithm is used to convert the raw scores into a range from zero (the respondent has the worst possible health) to 100 where the respondent is in the best possible health.

  10. Change in 29-Question Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score

    Time frame: Baseline, Month 12

    PROMIS-29 consists of 29 questions rated on a scale from 1-5. The raw score is converted to a final T-score metric with a mean T-score of 50 and a standard deviation of 10. The final score ranges from 0 (worst possible outcome) to 100 (best possible outcome). The questionnaire assesses seven domains - depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities.

Study contacts

Contact information is provided by the study sponsor or research team.

Mala Masson

CONTACT

[email protected]

(212) 263-0372

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Acronym: SHIELD

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Apr 5, 2023
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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