Systemic Lupus ErythematosusPhase 3SHIELDNCT05799378
Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
A Phase 3 study testing Hydroxychloroquine in people with Systemic Lupus Erythematosus, run by NYU Langone Health at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 12 sitesUnited States
- Study dates
- 27 Jun 2024to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 11 recruiting
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30322
- Recruiting
Hackensack Meridian Health
Hackensack, New Jersey, 07601
- Recruiting
Penn State MS Hershey Medical Center
Hershey, Pennsylvania, 17033
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
- Recruiting
VA NY Harbor Healthcare System
New York, New York, 10010
- Recruiting
NYC Health + Hospitals/Bellevue
New York, New York, 10016
- Recruiting
NYU Langone Health
New York, New York, 10016
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
- Recruiting
Columbia University Irving Medical Center/New York Presbyterian
New York, New York, 10032
- Recruiting
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
- Recruiting
University of California: San Diego
San Diego, California, 92093
- Completed
Montefiore Medical Center/Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the 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 >=55 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Hydroxychloroquine, Placebo
- Keywords
- Hydroxychloroquine, systemic lupus erythematosus, elderly lupus disease, lupus, sle, plaquenil
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine 200mg capsules. Administered orally.
PlaceboDrug
Hydroxychloroquine-matching placebo capsule. Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine (HCQ) | Experimental | 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. Receives: Drug: Hydroxychloroquine |
| HCQ-Matching Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI)
Number of participants who experience moderate or severe flares as defined by the rSFI.
Measured: Up to Month 12
Secondary outcomes (10)
Number of Participants who Develop Moderate Flare based on rSFI
Number of participants who experience moderate flares as defined by the rSFI.
Measured: Up to Month 12
Physician Global Assessment (PGA) Score at 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.
Measured: Month 12
Number of Participants who Begin Prednisone Treatment
Measured: Up to Month 12
Number of Participants who Increase Prednisone Use
Measured: Up to Month 12
Number of Participants who Experience Thromboembolic Event
Thromboembolic event includes, but is not limited to, venous thrombosis.
Measured: Up to Month 12
Number of Participants who Experience Cardiovascular Event
Measured: Up to Month 12
Number of Participants with New-Onset Diabetes
Measured: Up to Month 12
Number of Participants with New Retinal Toxicity
Measured: Up to Month 12
Change in 36-Item Short Form Survey Instrument (SF-36) Score
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.
Measured: Baseline, Month 12
Change in 29-Question Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score
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.
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start27 Jun 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Peter Izmirly, Principal investigator, NYU Langone HealthJill Buyon, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799378
- Sponsor's protocol ID
- 23-00071
- Acronym
- SHIELD
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared with investigators whose proposed use of the data has been approved by the co-PIs, Dr. Peter M. Izmirly and Dr. Jill P. Buyon, beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Peter.Izmirly@nyulangone.org and Jill.Buyon@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. A copy of an informed consent form will also be made available.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
- ClinicalTrials.gov ID
- NCT05799378
- Acronym / sponsor ID
- SHIELD / 23-00071
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Hydroxychloroquine, systemic lupus erythematosus, elderly lupus disease, lupus, sle, plaquenil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 >=55 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine (HCQ) | Experimental | Drug: HydroxychloroquinePatients 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. |
| HCQ-Matching Placebo | Placebo comparator | Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineHydroxychloroquine 200mg capsules. Administered orally. | Drug | Hydroxychloroquine (HCQ) |
| PlaceboHydroxychloroquine-matching placebo capsule. Administered orally. | Drug | HCQ-Matching Placebo |
Primary outcome
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.
10 secondary outcomes
Number of Participants who Develop Moderate Flare based on rSFI
Time frame: Up to Month 12
Physician Global Assessment (PGA) Score at Month 12
Time frame: Month 12
Number of Participants who Begin Prednisone Treatment
Time frame: Up to Month 12
Number of Participants who Increase Prednisone Use
Time frame: Up to Month 12
Number of Participants who Experience Thromboembolic Event
Time frame: Up to Month 12
Number of Participants who Experience Cardiovascular Event
Time frame: Up to Month 12
Number of Participants with New-Onset Diabetes
Time frame: Up to Month 12
Number of Participants with New Retinal Toxicity
Time frame: Up to Month 12
Change in 36-Item Short Form Survey Instrument (SF-36) Score
Time frame: Baseline, Month 12
Change in 29-Question Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score
Time frame: Baseline, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared with investigators whose proposed use of the data has been approved by the co-PIs, Dr. Peter M. Izmirly and Dr. Jill P. Buyon, beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Peter.Izmirly@nyulangone.org and Jill.Buyon@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. A copy of an informed consent form will also be made available.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Izmirly principal investigator
NYU Langone Health
Jill Buyon principal investigator
NYU Langone Health
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine in people with Systemic Lupus Erythematosus, run by NYU Langone Health at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mala Masson ((212) 263-0372, Mala.Masson@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Develop Moderate or Severe Flare based on the Revised SELENA SLEDAI Flare Index (rSFI) (time frame: Up to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.