[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05799378":3,"trial-entities:NCT05799378":201,"trial-summary:NCT05799378":204},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":45,"secondary_outcomes":50,"sex":78,"minimum_age":79,"maximum_age":17,"healthy_volunteers":80,"eligibility_criteria":81,"std_ages":106,"locations":109,"central_contacts":187,"overall_officials":193,"references":199,"see_also_links":200},"NCT05799378","23-00071","Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease","A Phase III, Randomized, Double-Blind Placebo-Controlled, Non-Inferiority, Multi-Center Study of the Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease","RECRUITING","2029-06-30","2026-08","2026-08-20","2024-06-27","NYU Langone Health","OTHER",true,"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\u002Fquiescent 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.",null,[19],"Systemic Lupus Erythematosus",[21,22,23,24,25,26],"Hydroxychloroquine","systemic lupus erythematosus","elderly lupus disease","lupus","sle","plaquenil","INTERVENTIONAL","TREATMENT",[30],"PHASE3",{"count":32,"type":33},330,"ESTIMATED",[35,40],{"type":36,"name":21,"description":37,"armGroupLabels":38},"DRUG","Hydroxychloroquine 200mg capsules. Administered orally.",[39],"Hydroxychloroquine (HCQ)",{"type":36,"name":41,"description":42,"armGroupLabels":43},"Placebo","Hydroxychloroquine-matching placebo capsule. Administered orally.",[44],"HCQ-Matching Placebo",[46],{"measure":47,"description":48,"timeFrame":49},"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.","Up to Month 12",[51,54,58,60,62,65,67,69,71,75],{"measure":52,"description":53,"timeFrame":49},"Number of Participants who Develop Moderate Flare based on rSFI","Number of participants who experience moderate flares as defined by the rSFI.",{"measure":55,"description":56,"timeFrame":57},"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.","Month 12",{"measure":59,"timeFrame":49},"Number of Participants who Begin Prednisone Treatment",{"measure":61,"timeFrame":49},"Number of Participants who Increase Prednisone Use",{"measure":63,"description":64,"timeFrame":49},"Number of Participants who Experience Thromboembolic Event","Thromboembolic event includes, but is not limited to, venous thrombosis.",{"measure":66,"timeFrame":49},"Number of Participants who Experience Cardiovascular Event",{"measure":68,"timeFrame":49},"Number of Participants with New-Onset Diabetes",{"measure":70,"timeFrame":49},"Number of Participants with New Retinal Toxicity",{"measure":72,"description":73,"timeFrame":74},"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.","Baseline, Month 12",{"measure":76,"description":77,"timeFrame":74},"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.","ALL","55 Years",false,{"inclusion":82,"exclusion":95,"raw_text":105},[83,84,85,86,87,88,89,90,91,92,93,94],"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",[96,97,98,99,100,101,102,103,104],"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\u002Fday 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 \\\u003C 100 ng\u002Fml 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)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Age ≥ 55 years at time of enrollment\n* Normal OCT and VF assessment within 6 months of screening visit\n* Ability to take oral medication\n* Have established SLE (≥ 4 ACR criteria or SLICC criteria or ≥ 10 points by EULAR criteria, SLE diagnosed at least seven years ago)\n* Stable disease at screening visit by attaining DORIS remission (meeting all criterion listed below) and not on any immunosuppressants.\n\n  * Criterion 1: Clinical SLEDAI= 0\n  * 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)\n  * Criterion 3: Current prednisolone (or equivalent corticosteroid) dose ≤ 5 mg daily\n* No moderate or severe flares one year prior to screening\n* Taking ≥ 200 HCQ daily for ≥ 7 years\n\nExclusion Criteria:\n\n* Any patient that does not attain stable disease status by DORIS\n* Ophthalmologic evidence of retinopathy (these patients would be advised to discontinue HCQ and therefore unethical to randomize for this study)\n* Clinical SLEDAI \\> 0\n* Taking \\> 5 mg\u002Fday prednisone\n* Taking any immunosuppressive drugs or biological agents (including: methotrexate, azathioprine, mycophenolate mofetil, mycophenolic acid, leflunomide, cyclosporine, cyclophosphamide, tacrolimus, rituximab, and belimumab)\n* Any reason the treating rheumatologist is concerned about ongoing activity not captured by SLEDAI\n* HCQ level \\\u003C 100 ng\u002Fml as this would support noncompliance and less reliance on HCQ to control activity\n* Patient unwilling or unable to comply with study procedures for any reason\n* Any indications of potentially diminished capacity, such as a diagnosis of dementia or cognitive impairment (including, but not limited to stroke-related cognitive impairment)",[107,108],"ADULT","OLDER_ADULT",[110,119,126,134,142,149,153,155,159,163,171,179],{"facility":111,"status":8,"city":112,"state":113,"zip":114,"country":115,"geoPoint":116},"University of California, Los Angeles","Los Angeles","California","90095","United States",{"lat":117,"lon":118},34.05223,-118.24368,{"facility":120,"status":8,"city":121,"state":113,"zip":122,"country":115,"geoPoint":123},"University of California: San Diego","San Diego","92093",{"lat":124,"lon":125},32.71571,-117.16472,{"facility":127,"status":8,"city":128,"state":129,"zip":130,"country":115,"geoPoint":131},"Emory University School of Medicine","Atlanta","Georgia","30322",{"lat":132,"lon":133},33.749,-84.38798,{"facility":135,"status":8,"city":136,"state":137,"zip":138,"country":115,"geoPoint":139},"Hackensack Meridian Health","Hackensack","New Jersey","07601",{"lat":140,"lon":141},40.88593,-74.04347,{"facility":143,"status":8,"city":144,"state":144,"zip":145,"country":115,"geoPoint":146},"VA NY Harbor Healthcare System","New York","10010",{"lat":147,"lon":148},40.71427,-74.00597,{"facility":150,"status":8,"city":144,"state":144,"zip":151,"country":115,"geoPoint":152},"NYC Health + Hospitals\u002FBellevue","10016",{"lat":147,"lon":148},{"facility":13,"status":8,"city":144,"state":144,"zip":151,"country":115,"geoPoint":154},{"lat":147,"lon":148},{"facility":156,"status":8,"city":144,"state":144,"zip":157,"country":115,"geoPoint":158},"Hospital for Special Surgery","10021",{"lat":147,"lon":148},{"facility":160,"status":8,"city":144,"state":144,"zip":161,"country":115,"geoPoint":162},"Columbia University Irving Medical Center\u002FNew York Presbyterian","10032",{"lat":147,"lon":148},{"facility":164,"status":165,"city":166,"state":144,"zip":167,"country":115,"geoPoint":168},"Montefiore Medical Center\u002FAlbert Einstein College of Medicine","COMPLETED","The Bronx","10461",{"lat":169,"lon":170},40.84985,-73.86641,{"facility":172,"status":8,"city":173,"state":174,"zip":175,"country":115,"geoPoint":176},"Oklahoma Medical Research Foundation","Oklahoma City","Oklahoma","73104",{"lat":177,"lon":178},35.46756,-97.51643,{"facility":180,"status":8,"city":181,"state":182,"zip":183,"country":115,"geoPoint":184},"Penn State MS Hershey Medical Center","Hershey","Pennsylvania","17033",{"lat":185,"lon":186},40.28592,-76.65025,[188],{"name":189,"role":190,"phone":191,"email":192},"Mala Masson","CONTACT","(212) 263-0372","Mala.Masson@nyulangone.org",[194,197],{"name":195,"affiliation":13,"role":196},"Peter Izmirly","PRINCIPAL_INVESTIGATOR",{"name":198,"affiliation":13,"role":196},"Jill Buyon",[],[],{"nct_id":4,"conditions":202,"biomarkers":203},[19],[],{"nct_id":4,"found":15,"summary":205,"prompt_version":215},{"design":206,"status":207,"heading":208,"summary":209,"follow_up":210,"word_count":211,"commitments":212,"compensation":213,"drugs_mentioned":214},"This is an interventional study, meaning participants will receive a specific treatment (either Hydroxychloroquine or a placebo). The study plans to enroll 330 participants.","completed","Stopping Hydroxychloroquine in Elderly Lupus Disease","This study is looking at what happens when older adults (age 60 and up) with Systemic Lupus Erythematosus (SLE), a long-term autoimmune disease, stop taking Hydroxychloroquine. Hydroxychloroquine helps manage lupus symptoms, but long-term use can harm your eyes. Researchers want to see if stopping this medication is safe for older patients, who might have less active lupus. You would either continue taking Hydroxychloroquine or switch to a placebo (an inactive pill that looks like the real medicine). The main goal is to see how many people develop a moderate or severe lupus flare within 12 months. The study plans to enroll 330 participants.","Participants will be followed for up to 12 months to see if they develop a lupus flare.",103,"Not specified in the trial record.","Not stated in the trial record.",[21,41],"v2"]