[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gout\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gout":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,41,74,105,129,152,173,203,230,256,286,309,334,354,399,423,446,468,491,522,548,570,592,613,633],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100641420","phase-4-the-impact-of-initiating-dotinurad-urate-lowering-therapy-at-different-time-windows-on-gout-flare-resolution-time-100641420",false,"NCT07661030","The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time","The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time: A Multicenter, Randomized, Parallel-Controlled Study","Inclusion Criteria:\n\n* Male or female individuals aged 18-70 years old.\n* Meet the 2015 ACR\u002FEULAR diagnostic criteria of gout.\n* With an onset of acute gout flares within 7 days.\n* With gout experiencing gout flares ≥2 times; or with gout experiencing gout flares 1 time and is younger than 40 years old; or with gout experiencing gout flares 1 time and has a serum uric acid level greater than 480 μmol\u002FL and\u002For has co-morbidities (renal function impairment, hypertension,).\n* Provide a signed written informed consent form.\n\nExclusion Criteria:\n\n* Has secondary hyperuricemia.\n* Serum uric acid level \\\u003C 360 μmol\u002FL.\n* Used IL-1β inhibitors within 6 months before screening.\n* Used uric acid-lowering drugs within 1 month before screening.\n* Used anti-inflammatory drugs within 14 days before screening.\n* Comorbidities with nephrolithiasis or clinical urinary calculi\n* History of kidney transplantation or dialysis.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m².\n* AST or ALT \\> 2 times the upper limit of normal.\n* Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg during the screening period.\n* White blood cell count \\\u003C 3.5 × 10⁹\u002FL, or platelet count \\\u003C 100 × 10⁹\u002FL, or hemoglobin \\\u003C 90 g\u002FL.\n* Currently in the treatment period of malignant tumors, or within 6 months after the end of the treatment period.\n* Congestive heart failure (New York Heart Association \\[NYHA\\] cardiac function classification II-IV), confirmed ischemic heart disease, peripheral artery disease and\u002For cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty).\n* Hypersensitivity to the study drugs or their excipients, or all of urine alkalinizer (potassium citrate\u002Fsodium citrate hydrate compound preparations).\n* Have active gastrointestinal ulcers\u002Fbleeding, or have had a recurrence of ulcers\u002Fbleeding in the past.","ALL","18 Years","70 Years",{"count":21,"type":22},142,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","To confirm that initiating Dotinurad for uric acid uric acid lowering during the acute phase of gout is non-inferior to initiating it after the acute phase of gout has subsided, and to analyze whether initiating Dotinurad treatment during the acute phase will increase the pain level, the recurrence rate of gout, and the inflammatory level of patients.",[28],"Gout","NOT_YET_RECRUITING","2026-06-16",{"date":32,"type":33},"2026-06-22","ACTUAL",{"date":35,"type":22},"2026-07-30",{"date":37,"type":22},"2027-07-30",{"name":39,"class":40},"First Affiliated Hospital of Wenzhou Medical University","OTHER",{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100641054","musculoskeletal-ultrasound-for-differentiating-rheumatoid-and-gouty-arthritis-100641054","NCT07657156","Musculoskeletal Ultrasound for Differentiating Rheumatoid and Gouty Arthritis","Role of Musculoskeletal Ultrasound in Differentiation of Rheumatoid Arthritis and Gouty Arthritis Using Semi-Quantitative Scoring","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Either sex.\n* Patients with clinically suspected or confirmed rheumatoid arthritis.\n* Patients with clinically suspected or confirmed gouty arthritis.\n* Patients referred for musculoskeletal ultrasound assessment of painful, swollen, or inflamed joints.\n* Patients able and willing to provide informed consent.\n* Patients whose final diagnosis is established by clinical assessment, laboratory testing, and\u002For relevant imaging or synovial fluid analysis when available.\n\nExclusion Criteria:\n\n* Patients younger than 18 years.\n* Patients with septic arthritis or suspected joint infection.\n* Patients with traumatic joint injury involving the target joint.\n* Patients with other inflammatory arthropathies such as psoriatic arthritis, reactive arthritis, or systemic lupus erythematosus if they may confound imaging interpretation.\n* Patients with advanced osteoarthritis in the scanned joint if it markedly limits Faculty of Medicine Institutional Review Board (IRB) Assiut Medical School Research Proposal Form 5 interpretation.\n* Patients with incomplete clinical records or insufficient ultrasound windows.\n* Patients who refuse consent.\n* Patients whose diagnosis remains uncertain after clinical workup.",{"count":49,"type":22},100,"OBSERVATIONAL","Rheumatoid arthritis (RA) and gouty arthritis (GA) are two common forms of joint inflammation that can present with very similar physical symptoms, making them difficult to tell apart early in the disease process. Accurate and early differentiation is crucial because the treatment strategies and long-term management for the two conditions are substantially different.\n\nThe primary purpose of this observational study is to evaluate the diagnostic performance of musculoskeletal ultrasound (MSUS) in distinguishing between RA and GA. Ultrasound is a safe, radiation-free imaging tool that can visualize joint inflammation and structural changes in real-time. This study utilizes a structured semi-quantitative scoring system (graded on a scale of 0 to 3) to systematically measure the severity of joint lining thickness (synovial hypertrophy) and active blood flow (power Doppler signal). It also checks for crystal-related deposits, such as tophi or the double contour sign, which are highly suggestive of gout.\n\nParticipants aged 18 and older with suspected or confirmed RA or GA who are referred for joint assessment at Assiut University Hospitals will undergo a standard clinical evaluation, routine laboratory testing, and an ultrasound examination of specific target joints (such as the wrists, hands, knees, and ankles). By comparing the ultrasound scores and specific structural findings between the two patient groups, the study aims to establish a reliable, standardized imaging approach to help physicians make faster, more confident diagnoses and initiate the correct disease-specific therapies sooner.",[53,54,28,55],"Rheumatoid Arthritis (RA)","Gouty Arthritis (GA)","Inflammatory Arthritis",[57,58,59,60,61,62,63,64],"Musculoskeletal Ultrasound","Semi-quantitative Scoring","Ultrasonography","Synovitis","Power Doppler","Double Contour Sign","Tophi","Diagnostic Imaging","2026-06-14",{"date":67,"type":33},"2026-06-18",{"date":69,"type":22},"2026-07",{"date":71,"type":22},"2027-08",{"name":73,"class":40},"Assiut University",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":5},"100614481","phase-2-a-study-to-investigate-the-clinical-effect-and-the-safety-of-prx-115-infused-intravenously-at-different-dosing-regimens-with-and-without-methotrexate-versus-placebo-in-adults-gout-patients-release-100614481","NCT07280156","A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Assessing the Efficacy, Safety, and Dosing Regimen Selection of Multiple Intravenous Infusions of PRX-115 With and Without Methotrexate Versus Placebo in Adult Patients With Gout (RELEASE)","RELEASE","Inclusion Criteria:\n\n1. Males or females ≥18 years of age.\n2. Weight within the range of 50.0 - 150.0 kg.\n3. Gout patients who failed to normalize sUA (\\\u003C7 mg\u002FdL) with or without xanthine oxidase inhibitors or uricosuric agent or have contraindications to these drugs.\n4. Willing to discontinue any oral ULT\n5. Females who are sterile, postmenopausal, or non-pregnant and using birth control methods.\n\nExclusion Criteria:\n\n1. Any condition known to have arthritis as a clinical manifestation.\n2. Positive testing for HBV,HCV, or HIV.\n3. The patient is a pregnant or lactating female or plans to become pregnant during the study period.\n4. Known allergy or sensitivity to the injected proteins, including pegylated products.\n5. Prior exposure to any experimental or marketed uricase.\n6. Patient treated with a medication known to have an influence on urate metabolism or clearance such as ULTs.\n7. History of anaphylaxis, severe allergic reactions, or severe atopy.\n8. G6PD deficiency or known catalase deficiency.\n9. History of significant hematologic or autoimmune disorders within 5 years of Screening and\u002For patient is immunocompromised or treated with immunosuppressive medications.\n10. Non-compensated CHF or hospitalization for CHF (Stage 3-4 NYHA Functional Class) within 3 months of the Screening Visit, uncontrolled arrhythmia, treatment for acute coronary syndrome (myocardial infarction or unstable angina), or uncontrolled BP (\\>160\u002F100 mmHg) at screening and prior to randomization at Week -4 (Visit 1).\n11. Current liver disease, as determined by ALT or AST levels above upper limit of normal at Screening Visit.\n12. Chronic liver disease.\n13. Hemoglobin \\\u003C11 g\u002FdL, neutrophil count \\\u003C1500 \u002Fµl, or platelet count \\\u003C100,000 \u002Fµl.\n14. Known severe pulmonary fibrosis, bronchiectasis or interstitial pneumonitis.\n15. eGFR ≤ 40 mL\u002Fmin\u002F1.73m2 tested at Screening Visit. Kidney transplant or requires dialysis.\n16. Known intolerance and\u002For known contraindication to MTX treatment or MTX treatment considered inappropriate\n17. Has uncontrolled type 2 diabetes at Screening with HbA1c ≥8.5%. Patients with type 1 diabetes will be excluded.\n18. Has known latent autoimmune diabetes of adult.\n19. Immunocompromised state, regardless of etiology.\n20. History or treatment of malignancy in the last 5 years, excluding localized, nonmelanoma skin cancers (e.g. basal or squamous cell)",{"count":83,"type":22},150,[85],"PHASE2","This is a multicenter, randomized, double-blind, placebo-controlled phase II study assessing the efficacy, safety, and dosing regimen selection of multiple IV infusions of PRX-115 over 24 weeks, with or without MTX, versus the respective placebos in adult patients with gout.",[28],[89,90,91,92,93],"gout","uricase","uric acid","hyperuricemia","PRX-115","RECRUITING","2026-06-10",{"date":97,"type":33},"2026-06-11",{"date":99,"type":33},"2025-12-22",{"date":101,"type":22},"2028-06",{"name":103,"class":104},"Protalix","INDUSTRY",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":126,"locationsCount":128},"100634080","phase-2-a-phase-2-trial-of-dotinurad-in-xanthine-oxidase-inhibitor-xoi-intoleranturicase-failure-gout-participants-100634080","NCT07535034","A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant\u002FUricase Failure Gout Participants","A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad in Adult Participants With Gout Who Are Intolerant to Xanthine Oxidase Inhibitors or Failed Uricase Treatment","Inclusion Criteria:\n\n1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.\n2. Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year and has at least 1 of the following:\n\n   * History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat.\n   * Failed uricase treatment (eg, an sUA level \\>6.0 mg\u002FdL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment).\n3. sUA level \\>6.0 and \\\u003C10.5 mg\u002FdL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit).\n4. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -28 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.\n5. Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of trial drug.\n\nExclusion Criteria:\n\n1. History of or presence of kidney stones within 1 year prior to Screening.\n2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.\n3. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.\n4. Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening.\n5. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or trial compliance or may confound interpretation of trial results.","75 Years",{"count":114,"type":22},90,[85],"The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.",[28],[119,120],"Dotinurad","Xanthine Oxidase Inhibitors","2026-06-08",{"date":95,"type":33},{"date":124,"type":33},"2026-05-08",{"date":71,"type":22},{"name":127,"class":104},"Crystalys Therapeutics",17,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":49},"100599852","phase-3-a-study-of-dotinurad-versus-allopurinol-in-participants-with-gout-100599852","NCT07089875","A Study of Dotinurad Versus Allopurinol in Participants With Gout","A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With Gout","Inclusion Criteria:\n\n1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.\n2. Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year.\n3. Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant's medical records).\n4. Participant must be on a stable background allopurinol dose of ≥300 mg\u002Fday (200 mg\u002Fday for those with moderate renal impairment as documented in the participant's medical history) up to 600 mg\u002Fday for at least 3 months prior to Screening and remain on their dosing regimen until Day 1.\n5. sUA level ≥6.5 mg\u002FdL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).\n6. Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.\n7. Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. History of or presence of kidney stones within 1 year prior to Screening.\n2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.\n3. Hypersensitivity or intolerance to dotinurad or to both colchicine and nonsteroidal anti-inflammatory drugs.\n4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.\n5. Known history of or positive results for human immunodeficiency virus, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening.\n6. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or study compliance or may confound interpretation of study results.",{"count":137,"type":22},500,[139],"PHASE3","The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.",[28],[119,143,144],"Allopurinol","Hyperuricemia","2026-06-04",{"date":121,"type":33},{"date":148,"type":33},"2025-08-01",{"date":150,"type":22},"2027-11-29",{"name":127,"class":104},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100447707","phase-3-immediate-prescription-of-a-hypouricemic-treatment-febuxostat-compared-to-its-delayed-administration-100447707","NCT05109936","Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration","Non-inferiority Study of a New Therapeutic Strategy for Gout: Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration - FEFACRIGOU Trial","FEFACRIGOU","Inclusion Criteria:\n\n1. Patients with an attack of gout, diagnosed immediately or less than 5 days old. Gout is defined according to American-European criteria (Appendix 3).\n2. Attack of gout affecting one (or more) peripheral joint (s) whatever (s) it (s):\n\n   * Either a first crisis,\n   * Either a new attack of a gout not treated with a hypo-uricemic or for which the hypo-uricemic treatment has not been taken for at least 6 months.\n3. Uricemia ≥ 420 µmol \u002F l, including under a diuretic (dosage carried out within 10 days before inclusion),\n4. Age ≥ 18 years old,\n5. Patient with a creatinine clearance ≥ 30 ml \u002F min (dosage carried out within 10 days before inclusion),\n6. Patient having read and understood the information letter and signed the consent form,\n7. Affiliation to a social security scheme,\n8. Woman of childbearing potential with effective contraception according to WHO definition (estrogen-progestins or intrauterine device or tubal ligation for more than 1 month and to be continued for at least 5 weeks after the last dose of the drug. ) and a negative urine pregnancy test on inclusion and throughout the duration of the study Where Postmenopausal woman: amenorrhea not medically induced for at least 12 months before the inclusion visit.\n\nExclusion Criteria:\n\n1. Patients under the age of 18,\n2. Stop taking a hypouricemic agent for less than 6 months,\n3. Known contraindication to ADENURIC 80 mg film-coated tablet: hypersensitivity to the active substance (febuxostat) or to one of the excipients,\n4. Renal failure defined by creatinine clearance \\\u003C30 ml \u002F min,\n5. Hepatic disease defined by an increase to more than 2 times the normal of transaminases, alkaline phosphatases, to more than 3 times the normal of gamma-GT,\n6. Non-weaned alcoholism,\n7. Crisis more than 5 days old,\n8. Patient who has received an organ or marrow transplant,\n9. Person on Naproxen, mercaptopurine, azathioprine, Glycuronidation inhibitors and inducers, theophylline, macrolides, HMG Co-A reductase inhibitors and \u002F or diuretic in combination with an ACE inhibitor or ARAII,\n10. Person with rare hereditary disorders of galactose intolerance, lactase deficiency or glucose \u002F galactose malabsorption\n11. Poor understanding of the project due to neurological disease or lack of French practice,\n12. Pregnant woman or likely to be in the absence of effective contraception (Women of childbearing age should have a negative urine pregnancy test),\n13. Breastfeeding woman\n14. Any history of pre-existing major cardiovascular disease (myocardial infarction, stroke, unstable angina, etc.), metabolic, endocrine, psychiatric or cancerous in uncontrolled development,\n15. Person deprived of liberty by an administrative or judicial decision,\n16. Person placed under judicial protection, guardianship or curatorship,\n17. Participating patient who participated in the month preceding inclusion in another interventional drug trial.",{"count":161,"type":22},128,[139],"Gout, the most common inflammatory rheumatism in France, is a complication of chronic hyperuricemia (\\> 360umol \u002F l). The resulting urate crystals are deposited in many tissues, especially the skeletal or kidneys. It appears in the form of spontaneously regressive inflammatory joint attacks in 5 to 7 days but recurrent. Gout turns into a chronic disease if uric acidemia is not reduced, and is responsible for joint destruction. It becomes a vector of renal failure and is associated with cardiovascular morbidity and a reduction in life expectancy. It is cured if a long-term treatment such as febuxostat leading to the normalization of the uric acidemia is administered.\n\nHowever, the frequency of this disease is increasing in industrialized or emerging countries. The causes are numerous, particularly food, but also related to flaws in therapeutic care. Studies show that this treatment is not taken in particular because, after the acute attack, the patient who has become asymptomatic again no longer consults. Currently, in a traditional way and according to European recommendations, it is not prescribed until several weeks after the acute attack in order to avoid early relapses, which would then be more numerous. Nevertheless, even if the hypouricemic agent is prescribed late , the attacks can be repeated and become rare for several months after obtaining a uricemia below 360umol \u002F l; they eventually disappear. Lack of knowledge of this disease largely affects the hazards of disease-modifying treatment, which alone can prevent the progression to chronic inflammatory disease and its cardiovascular and renal impact and on mortality. One of the causes of not taking a hypouricemic agent is its delayed administration.\n\nThis study is proposed to assess the relevance of early initiation versus delayed administration of such treatment.",[28],{"date":121,"type":33},{"date":167,"type":33},"2023-08-02",{"date":169,"type":22},"2027-01-01",{"name":171,"class":40},"University Hospital, Rouen",6,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100630657","the-remote-monitoring-of-gout-feasibility-study-in-primary-care-100630657","NCT07490522","The Remote Monitoring of Gout Feasibility Study in Primary Care","The Self-management App 'MinUrinsyregikt' for Patients With Gout. The ReMonit Gout Feasibility Study in Primary Care","ReMonit Gout","Patients are eligible to be included in the study only if all the following criteria apply:\n\n* Adults ≥18 years of age at screening\n* Patients with a clinical diagnosis of gout\n* Serum urate level \\>360 µmol\u002FL at inclusion\n* Indication for urate lowering therapy assessed by medical doctor\n* Having a smartphone\u002Ftablet\n\nPatients are excluded from the study if any of the following criteria apply:\n\n* Pregnant or breastfeeding\n* Contraindication for urate lowering therapy\n* Does not understand Norwegian language\n* Major co-morbidities (e.g., malignancies, severe chronic kidney disease, severe mental disorders)",{"count":182,"type":22},50,[184],"NA","The goal of this feasibility study is to determine the feasibility of a patient self-management app (MinUrinsyregikt) for patients with gout. The primary objectives of the study are:\n\n1. To determine the feasibility of a patient self-management app for patients with gout receiving GP follow-up.\n2. To determine the feasibility of conducting a future randomised controlled trial to test the effectiveness of the app for patients with gout in primary care.\n\nParticipants will be asked to test the self-management app for 3 months. Data will be collected from the participants and their GPs.",[28],[28,188,189,190,191,192],"Feasibility study","E-health","Primary care","Digital health","Urate-lowering Therapy (ULT)","2026-04-27",{"date":195,"type":33},"2026-04-30",{"date":197,"type":22},"2026-04",{"date":199,"type":22},"2027-12",{"name":201,"class":40},"Diakonhjemmet Hospital",1,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":211,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":202},"100563933","phase-4-the-effects-of-febuxostat-dose-tapering-in-gout-patients-optimally-controlled-for-5-years-or-more-100563933","NCT06622603","the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More","A Prospective, Multicenter, Randomized Investigator Initiative Clinical Trial Study on the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More","TARGET","* Inclusion Criteria:\n\n  1. Adult gout patients aged ≥19 but \\\u003C80 years.\n  2. Gout patients treated with urate-lowering therapy (either allopurinol or febuxostat monotherapy, or a combination of two agents) for at least the past 5 years.\n  3. Patients who have at least five serum urate level measurements over the past 5 years and meet one of the following criteria:\n\n     All serum urate levels measured in the past 5 years have been maintained below 6.0 mg\u002FdL; or the area under the curve (AUC) of serum urate levels over time for the past 5 years is less than 33.0 mg\u002FdL x year\n  4. Patients without palpable or visible tophi on physical examination (evaluated at pre-defined 18 joint sites and the ears).\n  5. Patients without acute gouty attack or history of nephrolithiasis in the past 12 months\n  6. Patients with an estimated glomerular filtration rate (eGFR) of 60 mL\u002Fmin\u002F1.73m² or higher, based on the Cockcroft-Gault formula.\n  7. Patients who voluntarily provide written informed consent to participate.\n* Exclusion Criteria:\n\n  1. Subjects who continuously require prophylactic low-dose colchicine\u002FNSAIDs.\n  2. Subjects already having taken low-dose urate-lowering agents. The low-dose urate-lowering agents are defined as allopurinol ≤200 mg\u002Fday or febuxostat ≤20 mg\u002Fday. But patients on a combination of low-dose allopurinol and febuxostat are eligible.\n  3. Subjects taking medications that could affect serum uric acid levels and uric acid fractional excretion rates, such as benzbromarone, fenofibrate, loop diuretics, thiazide or thiazide-like diuretics, and losartan.\n  4. Subjects classified as having high-risk alcohol use according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA):\n\n     For men \\\u003C65 years: more than 14 drinks per week or for men ≥65 years or women: more than 7 drinks per week\n  5. Subjects with a history of hypersensitivity to febuxostat or allopurinol\n  6. Subjects with unstable cardiovascular conditions, who require adjustment of urgent their therapy\n  7. Subjects taking mercaptopurine or azathioprine\n  8. Subjects with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n  9. Subjects with moderate or severe liver dysfunction (AST or ALT levels greater than 3 times the upper normal limit)\n  10. Subjects for whom investigators anticipate that a change in a urate-lowering agent dose could present significant risks or that any factor could severely impact drug adherence, complicating study registration.","19 Years","79 Years",{"count":214,"type":22},59,[25],"The goal of this clinical trial is to compare the changes in serum urate levels and symptom recurrence after reducing or suspending urate-lowering agents in well-controlled gout patients (the 'after dishes are clean' state in the Dirty Dish hypothesis)\n\nResearchers will compare three randomized groups: the reducing group takes febuxostat 20 mg once daily for 12 months, the discontinuing group takes a placebo once daily for 6 months, followed by febuxostat 20 mg once daily for the next 6 months, and the maintaining group continues their pre-study urate-lowering agents for 12 months, serving as an observational reference group.\n\nDuring the 12-month study period, participants will visit every 3 months for laboratory evaluations including serum urate levels, and for checking symptomatic status using questionnaires and diaries. Additionally, musculoskeletal ultrasonography and serum sample collection will be performed at baseline to study predictors for maintaining serum urate levels \\\u003C7.0 mg\u002FdL after reducing or suspending urate-lowering therapy.",[28,218],"Uric Acid",[220,143],"Febuxostat","2026-04-23",{"date":223,"type":33},"2026-04-29",{"date":225,"type":33},"2025-09-10",{"date":227,"type":22},"2027-08-19",{"name":229,"class":40},"Seoul National University Hospital",{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":241,"conditions":242,"keywords":245,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":202},"100621234","phase-1-drug-drug-interaction-study-of-abp-671-in-gout-patients-100621234","NCT07367971","Drug-Drug Interaction Study of ABP-671 in Gout Patients","Open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients","Inclusion Criteria:\n\n* Adults 18-75 years with clinical diagnosis of gout.\n* Stable Allopurinol therapy QD for ≥14 days prior to Day 1.\n* Cohort N: Normal renal function.\n* Cohort R: Moderate renal impairment.\n\nExclusion Criteria:\n\n* Clinically significant hepatic impairment.\n* History of Allopurinol hypersensitivity.\n* Pregnancy or breastfeeding.",{"count":238,"type":22},20,[240],"PHASE1","This is a open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients. Pharmacokinetic (PK) interaction between ABP-671 and Allopurinol will be evaluated in participants who are on stable Allopurinol therapy.",[243,28,244],"Gout Chronic","DDI (Drug-Drug Interaction)",[89,243,246],"ABP-671","2026-04-12",{"date":249,"type":33},"2026-04-14",{"date":251,"type":33},"2026-01-23",{"date":253,"type":22},"2026-08-31",{"name":255,"class":104},"Atom Therapeutics Co., Ltd",{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":273,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":202},"100583770","dose-response-of-exercise-for-arthritis-management-100583770","NCT06880653","Dose Response of Exercise for Arthritis Management","Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes","DREAM","Inclusion Criteria:\n\n* 18 years or older\n* Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have any contraindications to exercise (besides arthritis)\n* Engage in \\>45 min\u002Fweek of Actigraph assessed moderate to vigorous intensity activity\n* Are pregnant, breastfeeding, or planning to become pregnant in the next year\n* Are planning to relocate out of the Columbia, SC area in the next 12 months,\n* Do not have a device compatible with Fitbit\n* Have uncontrolled hypertension (e.g., systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg)\n* Plan to have a surgery that affects mobility in the next 12 months\n* Have a serious cognitive impairment.\n* Not willing to be randomized to any of the 3 conditions, do not believe they could adhere to the goals, or do not believe they could achieve the highest dose of activity (150 minutes\u002Fweek).",{"count":265,"type":22},285,[184],"The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes\u002Fweek, 90 minutes\u002Fweek, or 150 minutes\u002Fweek) on arthritis symptoms.",[269,53,28,270,271,272],"Arthritis","Fibromyalgia (FM)","Osteoarthritis","Lupus Erythematosus, Systemic",[274,275,276],"arthritis","exercise","physical activity","2026-04-02",{"date":279,"type":33},"2026-04-03",{"date":281,"type":33},"2025-03-28",{"date":283,"type":22},"2029-04-30",{"name":285,"class":40},"University of South Carolina",{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":296,"briefSummary":297,"conditions":298,"keywords":299,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":202},"100478265","tight-control-of-gouty-arthritis-compared-to-usual-care-100478265","NCT05507723","Tight Control of Gouty Arthritis Compared to Usual Care","Effect of Tight Urate Control in Gouty Arthritis Compared to Usual Care (TICOGA), a Randomised Clinical Trial","TICOGA","Inclusion Criteria:\n\n* Provision of informed consent.\n* Age ≥18 years.\n* Patient has sustained at least one flare of gout in the previous 12 months.\n* Confirmed clinical diagnosis of gout as per ACR\u002FEULAR criteria\n* Serum urate \\>0.36mm\u002FL.\n* Patient has a smart phone and is able to install GoutSMART application.\n\nExclusion Criteria:\n\n* Subject unable to provide consent\n* Patient on maximum urate lowering therapy or where therapy cannot be escalated further due to intolerance\u002Fadverse reaction to either allopurinol or febuxostat.\n* End stage renal failure\u002Ftransplant\n* Current prescription of medication known to interact with xanthine oxidase inhibitors such as azathioprine or mercapto-purine.",{"count":295,"type":22},125,[184],"Gout is caused by a reaction to urate crystals that results in attacks of severe joint pain. Medicines that lower urate levels can prevent gout flares, however it takes time for this benefit to be felt, and paradoxically starting treatment with large doses of urate lowering treatment risks provoking attacks of gout. Medical guidelines disagree on the best way to overcome these challenges with many recommending medicine dose adjustment based on regular urate testing but a general practice guideline suggesting more simply increasing the medicine dose in those patients that continue to suffer flares. In reality most patients are not treated at all, and many of those that are treated never receive an effective dose of treatment. We have developed a supported self-management approach to gout in which patients monitor their own urate levels using a finger prick test, and then receive advice on adjusting their treatment dose to achieve target urate levels through a smartphone app (Gout SMART). A trial of this approach has shown that it results in much better control of urate levels after 6 months than usual care, and suggests that it also leads to fewer flares. We would now like to confirm that this approach is effective in reducing flares of gout over 2 years by randomising patients to either treatment-to-target urate using our self-monitoring approach, or to usual care.",[28],[300,89],"treat-to-target",{"date":302,"type":33},"2026-04-08",{"date":304,"type":33},"2025-06-12",{"date":306,"type":22},"2028-12-31",{"name":308,"class":40},"University of Edinburgh",{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":202},"100631704","the-orienting-study-100631704","NCT07504146","The Orienting Study","The Natural History Of Calcium Pyrophosphate Deposition And Gout: An Observational Clinical And Imaging Study - The Orienting Study","ORIENTING","The inclusion criteria for CPPD patients are:\n\n* Patients diagnosed with CPPD disease according to the ACR\u002FEULAR 2023 classification criteria.\n* Patients with evidence of asymptomatic CPPD on US or X-rays (not meeting the classification criteria) according to validated imaging definitions.\n* Aged older than 18 years.\n* Able to provide informed consent, according to requirements of local IRB\u002Fethics committee.\n\nThe inclusion criteria for gout patients are:\n\n* Patients diagnosed with gout according to the ACR\u002FEULAR 2015 classification criteria.\n* Aged older than 18 years.\n* Able to provide informed consent, according to requirements of local IRB\u002Fethics committee.\n\nThe inclusion criteria for disease controls are:\n\n* A diagnosis of OA according to ACR classification criteria\n* No evidence of uric acid or calcium pyrophosphate deposits on US\n* Uric acid \\\u003C 6 mg\u002FdL\n* Aged older than 18 years.\n* Able to provide informed consent, according to requirements of local IRB\u002Fethics committee\n\nThe exclusion criteria for gout\u002FCPPD patients are:\n\n* Known history of other inflammatory arthropathies\n* Unable to provide informed consent, according to requirements of local IRB\u002Fethics committee.\n\nThe exclusion criteria for disease controls are:\n\n* Known history of other inflammatory arthropathies\n* Unable to provide informed consent, according to requirements of local IRB\u002Fethics committee.",{"count":318,"type":22},450,"This study at IRCCS Galeazzi - Sant'Ambrogio Hospital involves patients with gout, CPPD, and osteoarthritis as a control group. Patients will receive routine care with regular clinical, laboratory, and imaging assessments every six months, alongside urgent visits as needed. The study aims to understand crystal deposits in joints and blood vessels and monitor their progression over time, assessing how these deposits respond to standard treatments and if they are associated with cardiovascular complications. Data will be collected from medical records over a follow-up period of up to 10 years, offering long-term insights into disease impact and treatment effectiveness.",[321,28],"CPPD - Calcium Pyrophosphate Deposition Disease",[323,28,271,324],"CPPD","Ultrasound","2026-03-25",{"date":327,"type":33},"2026-03-31",{"date":329,"type":33},"2024-10-30",{"date":331,"type":22},"2039-10-30",{"name":333,"class":40},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":202},"100624804","phase-3-tigulixostat-ibi128-vs-febuxostat-in-gout-100624804","NCT07414394","Tigulixostat (IBI128) vs Febuxostat in Gout","A Randomized, Double-Blind, Double-Dummy, Multi-Center, Phase III Study Comparing the Efficacy and Safety of Tigulixostat (IBI128) and Febuxostat in Chinese Subjects With Gout","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\n1. Age ≥ 18 years, male or female.\n2. Body mass index (BMI) between 18 and 40 kg\u002Fm².\n3. Diagnosed with gout according to the 2015 ACR\u002FEULAR classification criteria.\n4. Serum uric acid (sUA) at screening:\n\n   ≥ 480 μmol\u002FL for subjects without comorbidities;\n\n   ≥ 420 μmol\u002FL for subjects with at least one concurrent condition (e.g., ≥ 2 gout attacks\u002Fyear, tophi, chronic gouty arthritis, hypertension, diabetes, dyslipidemia, age of onset \\\u003C 40 years).\n5. Voluntarily sign the informed consent form and agree to strictly follow the protocol requirements.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. History of allergy or intolerance to any component of febuxostat or Tigulixostat, or previous evidence of poor response to febuxostat treatment (e.g., sUA \\> 420 μmol\u002FL after ≥ 6 weeks of febuxostat ≥ 40 mg).\n2. Acute gout attack within 4 weeks prior to screening or from screening to first dose.\n3. Use of uric acid-lowering drugs (e.g., allopurinol, febuxostat, probenecid, benzbromarone, dotinurad, recombinant uricase; excluding sodium bicarbonate) within 2 weeks before screening.\n4. Hyperuricemia caused by secondary gout (e.g., myeloproliferative disease, tumor, organ transplantation, enzyme deficiency, renal tubular dysfunction, lead poisoning, psoriasis, medications), excluding hyperuricemia due to renal insufficiency.\n5. Use of the following medications or therapies prior to screening or planned during the study:\n\n(1)Prior urate oxidase treatment; (2)Concomitant medications affecting uric acid levels within 4 weeks before screening with dose adjustments (e.g., losartan, calcium channel blockers, diuretics, fenofibrate, atorvastatin, α-glucosidase inhibitors, insulin sensitizers, DPP4 inhibitors, SGLT2 inhibitors, metformin, GLP-1 receptor agonists, pyrazinamide, aspirin); (3)Long-term drugs dependent on xanthine oxidase metabolism (e.g., azathioprine, mercaptopurine); (4)Oral corticosteroids ≥ 10 consecutive days, or intramuscular\u002Fintravenous\u002Fintra-articular corticosteroid injection within 4 weeks before screening; (5)Biologics (e.g., TNF-α inhibitors, IL-1 inhibitors, IL-6 inhibitors) within 12 weeks before screening.\n\n6\\. History or evidence of any of the following diseases:\n\n1. Xanthinuria, Lech-Nyhan syndrome, 5-phosphoribosyl-1-pyrophosphate synthetase superactivity, congenital myogenic hyperuricemia, rhabdomyolysis;\n2. Uncontrolled severe pain not caused by gout;\n3. Cardiovascular events or conditions within 6 months (e.g., acute MI, ACS, unstable angina, CABG, PCI, TIA, cerebrovascular accident, severe arrhythmia, NYHA class III\u002FIV heart failure);\n4. QTcF ≥ 480 ms or history of prolonged QTc interval;\n5. Poorly controlled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) or recent adjustment of antihypertensive drugs;\n6. Poorly controlled diabetes (HbA1c ≥ 9.0%);\n7. Autoimmune or inflammatory diseases requiring systemic immunosuppressive treatment;\n8. Active peptic ulcer or GI bleeding within 1 month;\n9. Diseases affecting drug absorption (e.g., IBS, IBD);\n10. Active hepatitis B, C, HIV, or syphilis infection;\n11. Active or untreated malignancy within 5 years, except specified low-risk cancers;\n12. Thyroid dysfunction requiring treatment. 7. Laboratory abnormalities:\n\n(1)total bilirubin \\> 2×ULN, ALT or AST \\> 3×ULN; (2)eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m². 8. Pregnant or lactating women, or participants unwilling to use effective contraception during the study and for 8 weeks after study end.\n\n9\\. History of alcohol or drug abuse (weekly alcohol \\> 21 units for males, \\> 14 units for females).\n\n10\\. Blood donation or loss ≥ 400 mL within 3 months, or prior blood transfusion.\n\n11\\. Participation in another interventional clinical trial within 3 months or 5 half-lives of prior investigational drug.\n\n12\\. Major surgery within 3 months, incomplete recovery, or planned major surgery during study.\n\n13\\. Presence of mental illness deemed inappropriate for study participation by the investigator.\n\n14\\. Any other condition judged by the investigator to potentially affect study efficacy or safety evaluation.",{"count":342,"type":22},600,[139],"The primary purpose of this study is to compare the efficacy of Tigulixostat (IBI128) versus Febuxostat on the proportion of Chinese adults with gout achieving a serum uric acid (sUA) level \\\u003C 360 μmol\u002FL at Week 24. The study also evaluates safety, gout attacks, kidney function, inflammation, and quality of life over 52 weeks of treatment. Approximately 600 eligible participants will be randomized to receive either Tigulixostat or Febuxostat.",[28],"2026-03-24",{"date":325,"type":33},{"date":349,"type":33},"2026-03-17",{"date":351,"type":22},"2027-10-30",{"name":353,"class":104},"Innovent Biologics Technology Limited (Shanghai R&D Center)",{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":371,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":398},"100489857","phase-2-study-of-dapansutrile-tablets-in-subjects-with-an-acute-gout-flare-100489857","NCT05658575","Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare","A Multi-Center Phase 2\u002F3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Safety and Efficacy Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare","Inclusion Criteria:\n\n* Male and female subjects age 18 or older\n* Clinical diagnosis of gout according to the 2015 ACR\u002FEULAR Gout Classification Criteria:\n\nA) Diagnosis of gout must be confirmed in the target joint as indicated by either the presence of monosodium urate (MSU) crystals by microscopic evaluation of synovial fluid from the target joint or bursa OR by imaging evidence of urate deposition in the target joint or bursa at the Screening\u002FBaseline Visit\u002FStudy Day 1, or\n\nB) Documented history in the target joint or bursa ; or documented history of 2 or more gout flares in the previous 18 months\n\n* Confirmation of a gout flare in the target joint that began within 96 hours prior to the Screening\u002FBaseline Visit\n* Provide written informed consent and understand and comply with all trial requirements\n\nExclusion Criteria:\n\n* Presence of any palpable and visible tophi by physical examination\n* Has ≥ 4 joints with an acute gout flare at Screening\u002FBaseline\n* Presence of active rheumatoid arthritis or other acute inflammatory arthritis\n* Evidence\u002Fsuspicion of infectious\u002Fseptic arthritis\n* Clinically significant general pain or non-gout-related joint pain that would interfere with the subject's ability to accurately assess pain in the target joint\n* Known diagnosis of chronic kidney disease or known history of renal impairment\n* Positive test for severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) infection, if tested, within 4 weeks of the Screening\u002FBaseline\n* Active malignancy or recent malignancy with any systemic anti-cancer treatment\n* Has a hypersensitivity or allergy to OLT1177® or other drugs in its class\n* Hypersensitivity or allergy to paracetamol\u002Facetaminophen\n* Use of any prohibited concomitant medications\u002Ftherapies over the periods defined in the protocol or planned use of any prohibited concomitant medications\u002Ftherapies during the Treatment Period (including the use of paracetamol\u002Facetaminophen within 4 hours prior to the Screening\u002FBaseline Visit or other pain medications within 12 hours prior to the Screening\u002F Baseline Visit\n* Use of any product containing paracetamol\u002Facetaminophen within 4 hours prior to the Screening\u002FBaseline Visit or planned use during the Treatment Period (with the exception of study-provided Rescue Medication \\[paracetamol\u002Facetaminophen\\], which is permitted after completion of the first target joint pain assessment on Study Day 4",{"count":362,"type":22},300,[85,139],"The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.",[366,367,368,369,28,269,370],"Acute Gout Flare","Gout Attack","Gout Flare","Gouty Arthritis","Joint Pain",[89,372,373,374,375,376,377,378,379,380,381,382,383,384,92,385,386,387,388],"gouty arthritis","mono-articular arthritis","NLRP3","NLRP3 inhibitor","dapansutrile","OLT1177","joint pain","inflammation","gouty Inflammation","inflammasomes","IL-1 beta","IL-1 inflammation","autoinflammatory conditions","uric acid crystal","flare","small-molecule","therapeutic","2026-03-09",{"date":391,"type":33},"2026-03-11",{"date":393,"type":33},"2023-01-06",{"date":395,"type":22},"2027-01-31",{"name":397,"class":104},"Olatec Therapeutics LLC",40,{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":422},"100584293","pharmacist-led-treat-to-target-urate-lowering-therapy-in-patients-with-gout-100584293","NCT06887452","Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients With Gout","Pharmacist-Led Treat-to-Target Urate Lowering Therapy in Patients in Gout (Pharm-UP) Study","Pham-UP","Inclusion Criteria:\n\n* US Veterans over the age of 18 years with physician-diagnosed\n* Documented hyperuricemia (SU \\>6.8 mg\u002FdL)\n* Satisfy ACR\u002FEULAR gout classification criteria\n* Report 1 or more flares in the prior 6 months\n* Receipt of a new ULT prescription (allopurinol or febuxostat) initiated by a primary care provider or longer term ULT but otherwise satisfy the flare\u002FSU criteria\n\nExclusion Criteria:\n\n* Any patient intolerant or unable to take ULTs (allopurinol or febuxostat)\n* Patients with a rheumatology encounter within the prior 3 months",{"count":408,"type":22},310,[184],"This study will compare two different approaches to manage medications that lower uric acid levels. This study will be conducted at five VA medical centers across the United States and will take 4-5 years to complete. Individual participation will last up to two years.",[28,369],"2026-02-17",{"date":414,"type":33},"2026-02-19",{"date":416,"type":22},"2026-10-01",{"date":418,"type":22},"2031-03-30",{"name":420,"class":421},"VA Office of Research and Development","FED",5,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":433,"conditions":434,"keywords":435,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":202},"100567500","time-required-to-dissolve-urate-deposits-100567500","NCT06669000","Time Required to Dissolve Urate Deposits","Time Required to Dissolve Urate Deposits in Patients With Gout","ReViGoRe 40","Inclusion Criteria:\n\n* Age over 18 years\n* Gout according to the ACR\u002FEular 2015 criteria\n* SUA levels greater than 60 mg\u002FL\n* US score (MTP1s, knees) ≥2\u002F24\n* Informed consent Dated and signed voluntarily\n\nExclusion Criteria:\n\n* Ongoing urate lowering therapy\n* Severe and uncontrolled diseases such as cancer, cardiovascular or neurovegetative diseases\n* Pregnant or breast-feeding women\n* No affiliation to the French National Social Security System",{"count":432,"type":22},250,"Gout is characterized by episodes of acute arthritis of the lower limbs due to intermittent activation of innate immunity in the joints where urate crystals have formed. These crystals occur when serum urate (SUA) levels have been above 70 mg\u002FL for many years. They can be dissolved by lowering SUA levels to at least 60 mg\u002FL (treat-to-target - T2T - strategy). Once the crystals are dissolved, patients are no longer symptomatic and are considered to be in remission (treat-to-dissolve - T2D - strategy).\n\nThe presence of crystals and their dissolution during treatment can be monitored by repeated ultrasound (US) scans of the feet and knees.\n\nThe time required for complete dissolution varies from patient to patient. ReViGore40 is a cohort designed to i) determine the time to complete dissolution of urate deposits in joints when SUA levels are maintained below 40 mg\u002FL, ii) determine the factors (clinical, biological, genetic) associated with the time required for complete dissolution of urate deposits within joints.",[28],[28,436,63,437,438,324,143,220],"Flares","Urate levels","Urate deposits",{"date":414,"type":33},{"date":441,"type":33},"2024-09-24",{"date":443,"type":22},"2032-09-24",{"name":445,"class":40},"Assistance Publique - Hôpitaux de Paris",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":202},"100619550","phase-4-purified-cortrophin-gel-efficacy-and-safety-study-of-2-dose-levels-in-patients-with-acute-gout-flares-100619550","NCT07346079","Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares","A Randomized, Multicenter, Double-blind, Efficacy and Safety Study of 2 Dose Levels of Purified Cortrophin® Gel in Patients With Acute Gouty Arthritis Flares","Inclusion Criteria:\n\n* Signed informed consent to participate in this study\n* Male and female patients, aged 18-85 years\n* Meeting the 2015 Gout classification criteria of the ACR\u002FEULAR collaborative initiative\n* Onset of current acute gout flare within 5 days prior to study entry\n* Body mass index of less than or equal to 45 kg\u002Fm2\n* Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)\n* History of ≥ 1 gout flares within the 12 months prior to study entry\n* The patient meets at least one of the following criteria for both NSAIDs and colchicine treatment options:\n* Minimum of one episode of being intolerant, or unresponsive to the treatment, see Appendices 2-4.\n* The investigator deems the patient is either contraindicated or inappropriate for the treatment. Inappropriateness could be due to anticipated changes in patient status (i.e., such as worsening of comorbidities or use of concomitant medication), see Appendices 2-4.\n* Patients must be willing and capable of using an electronic device (e.g., cellphone) and must have access to a cellphone to be able to complete surveys.\n\nExclusion Criteria:\n\n* Patients with scleroderma, osteoporosis, active or recurrent bacterial, fungal or viral infections, ocular herpes simplex, recent surgery (within 2 weeks prior to randomization or have an unhealed operation wound(s)), history of or the presence of a peptic ulcer, uncontrolled congestive heart failure, uncontrolled hypertension, uncontrolled diabetes type 1 or 2, or sensitivity to proteins derived from porcine sources.\n* Patients with primary adrenocortical insufficiency or adrenocortical hyperfunction.\n* Rheumatoid arthritis, evidence or suspicion of infectious\u002Fseptic arthritis, or other acute inflammatory arthritis.\n* Polyarticular gouty arthritis involving more than 4 joints.\n* Participation in another concurrent investigational study within 30 days of randomization or has taken an investigational drug within five times the half-life of that investigational drug has passed.\n* Previous inclusion in this study.\n* Presence of severe renal function impairment: estimated creatinine clearance \\\u003C30 mL\u002Fmin\u002F1.73m2 (CKD stages 4 and 5).\n* Uncontrolled clinically significant hematologic, CNS, hepatic, pulmonary, gastrointestinal, metabolic, or endocrine disease as deemed by the investigator.\n* Presence of any medical or psychological condition or laboratory result that might create risk to the patients (or interfere with the patient's ability to comply with the protocol requirements, or to complete the study) in the opinion of the investigator.\n* Prior or current treatment with any ACTH product.\n* Pregnant or nursing (lactating) women. Women of childbearing age are required to be using an acceptable method of contraception.\n* Patients taking urate-lowering therapy had to be on a stable dose and regimen for ≥2 weeks before entering the study and remain on a stable dosage and regimen for at least 1 week after Purified Cortrophin® Gel.\n* Use of specified pain relief medications or biologics (including glucocorticoids, narcotics, paracetamol\u002Facetaminophen, NSAIDs, colchicine, IL-blockers and tumor necrosis factor \\[TNF\\] inhibitors) within specified periods (see Appendix 5) prior to randomization.\n\n  * Vaccination within 30 days prior to study enrollment and during the study period.","90 Years",{"count":83,"type":22},[25],"This is a randomized, multicenter, double-blind, single administration study to investigate the efficacy and safety of 2 dosing regimens of Purified Cortrophin® Gel in the treatment of an acute gouty arthritis flare.\n\nThe study consists of three periods: an optional pre-screening period, a double-blind treatment period, and a 7-day follow-up period.\n\nThe treatment period is double-blind, and the patients will be randomized to treatment with 40 U Purified Cortrophin® Gel or 80 U Purified Cortrophin® Gel in a 1:1 ratio. Purified Cortrophin® Gel will be administered once (either subcutaneously or intramuscularly) on the first visit (Day 0; Visit 1) and surveyed after 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3; Visit 2) as well as on Day 7.",[458,368,28],"Gout Arthritis","2026-01-15",{"date":461,"type":33},"2026-01-20",{"date":463,"type":33},"2025-12-20",{"date":465,"type":22},"2027-08-31",{"name":467,"class":40},"Massachusetts General Hospital",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":476,"enrollmentInfo":477,"targetDuration":4,"studyType":23,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":202},"100557164","improving-gout-care-after-an-ed-visit-100557164","NCT06534554","Improving Gout Care After an ED Visit","Improving Gout Care After an Emergency Department Visit for Acute Gout","CARE-Gout","Inclusion Criteria:\n\n* ≥ 18 years old\n* Able to communicate and understand English or Spanish\n* Confirmed acute gout flare by EMR review at ED visit\n\nExclusion Criteria:\n\n* Enrollment in an ongoing RCT (NCT04075903) testing a behavioral intervention employing \"storytelling\".","99 Years",{"count":478,"type":22},200,[184],"The prevalence of gout has been steadily increasing over several decades and is correlated with the rising burden of obesity, chronic cardiac and renal disease; all conditions overrepresented in the Southeastern U.S. - particularly in African Americans. Through a novel post-emergency department visit intervention, we aim to improve the care patients with gout receive, both during acute exacerbations and long-term. A secondary goal of the project is to concurrently enhance participation of minorities in biomedical research in the Deep South.",[28],"2026-01-14",{"date":484,"type":33},"2026-01-16",{"date":486,"type":33},"2024-06-18",{"date":488,"type":22},"2027-06-01",{"name":490,"class":40},"University of Alabama at Birmingham",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":499,"targetDuration":4,"studyType":23,"phases":501,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":202},"100618070","orlistat-and-weight-management-for-uric-acid-control-in-obese-gout-a-rct-100618070","NCT07326839","Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCT","Optimization of Blood Uric Acid Control in Obese Gout Patients by Orlistat-Mediated Metabolic Remodeling and Intensive Weight Management: A Randomized Controlled Trial","OWMUAC","Inclusion Criteria:\n\n1. Meeting the 2015 ACR\u002FEULAR classification criteria for gout.\n2. Age 18-70 years.\n3. BMI ≥28 kg\u002Fm².\n4. Serum uric acid ≥480 μmol\u002FL.\n5. Willing and able to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Contraindications to orlistat or other gout medications.\n2. Severe hepatic or renal dysfunction.\n3. History of severe allergy or adverse reactions to study drugs.\n4. Pregnant or lactating women.\n5. Malignancy.\n6. Secondary gout.\n7. Poor compliance or inability to cooperate.\n8. Participation in other clinical trials within the last 3 months.",{"count":500,"type":22},120,[184],"A total of 120 obese gout patients were included in a 24-week double-blind randomized controlled design. The intervention group received orlistat 120 mg tid + UTL + individualized diet-exercise-behavioral reinforcement weight loss program, while the control group received a placebo + UTL + standard recommendations. The primary endpoint was the rate of achieving serum uric acid levels \\\u003C360 μmol\u002FL at 24 weeks; secondary endpoints included the proportion of weight loss ≥5%, frequency of gout attacks, and inflammatory indicators such as CRP and IL-1β; the activity of AMPK in PBMCs and the expression of HIF1α and NLRP3 inflammasome-related proteins were also assessed.",[28,504],"Obesity",[506,28,507,508,509,510,511,512,374],"Obese","Orlistat","Metabolic Reprogramming","Weight Control","Uric acid","AMPK","HIF1","2026-01-07",{"date":515,"type":33},"2026-01-08",{"date":517,"type":22},"2025-12-10",{"date":519,"type":22},"2027-11-09",{"name":521,"class":40},"XueMei Guo",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":534,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":202},"100538994","phase-1-a-phase-ib-clinical-trial-of-peguricase-for-injection-with-methotrexate-in-patients-with-uncontrolled-gout-100538994","NCT06298071","A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.","A Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics, and Initial Efficacy of Single and Multiple Dosing of Peguricase for Injection With Methotrexate in Patients With Gout.","Inclusion Criteria:\n\n* Willing and able to give informed consent.\n* Male and female aged between 18 and 70 years old , regardless of gender.\n* Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) in the range of (19-30) kg\u002Fm2 (including 19 and 30)；\n* The clinical diagnosis of gout met the criteria of American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) in 2015，patients were in non-acute attack at screening or at least 2 weeks after complete remission of acute attack, and sUA ≥420 μmol\u002FL at screening；\n* Patients whose serum uric acid level could not reach the target after standard treatment with conventional uric acid-lowering drugs or who were contraindicated or intolerant to conventional uric acid-lowering drugs；\n* Patients who were willing to stop taking any uric-acid-lowering drug at least 7 days before using methotrexate during the run-in period;\n* Could tolerate the prescribed dose of methotrexate during the run-in period;\n* Patients were able to attend and complete the visit on time.\n\nExclusion Criteria:\n\n* Patients had active systemic infection within 2 weeks before enrollment，including an infection for which treatment was being received；\n* Having a chronic or recurrent infection, such as recurrent pneumonia or chronic bronchitis; Patients with active or severe lung disease or pulmonary insufficiency on chest imaging, or current pulmonary fibrosis or bronchiectasis；\n* Patients who are on anti-TB treatment or have active TB；\n* Diagnosis of osteomyelitis；\n* Ongoing or long-term use of immune system modulating drugs, such as methotrexate, mercaptopurine, mycophanolate, long-term use (≥3 months) of prednisone ≥10 mg\u002F day or equivalent dose of corticosteroids; Or have a history of transplant surgery requiring long-term immunotherapy; Or a known history of autoimmune disease, allergic disease;\n* Known allergy to recombinant proteins or porcine products, or history of allergy to uricase, pegylated products, corticosteroids and antihistamines, or known intolerance to methotrexate, fexofenadine, acetaminophen or contraindications to methotrexate, fexofenadine, acetaminophen;\n* Patients who are known to be intolerant to all gout attack management regiments (participants must be able to tolerate at least one: Colchicine and\u002For Nsaids and\u002For Prednisone 0.5 mg\u002Fkg daily；\n* Patients who have previously been treated with pegyluricase or other recombinant uricase, or who have been treated with other pegylated biological products;\n* Participation in other clinical study with a drug intervention within 4 weeks before initiation of methotrexate or the drug was still in the elimination phase before screening (within 5 half-lives), whichever is older;\n* Patients with chronic liver disease such as hepatitis, cirrhosis, alcoholic liver disease;\n* Patients have unstable angina, severe arrhythmias requiring drug intervention, congestive heart failure (NYHA grade≥Ⅱ), uncontrolled hypertension (over 150\u002F95 mmHg), poor glycemic control in diabetics ( HbA1c≥7%), acute stroke, Severe or chronic hemorrhagic digestive disease, pleural and abdominal effusion;\n* A history of hypoxanthine-guanine phosphoribosyltransferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome;\n* Glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD test values below the lower limit of normal;\n* Estimated glomerular filtration rate (eGFR) ≤40 mL\u002Fmin\u002F1.73m2, or currently receiving dialysis, or end-stage renal disease (CKD4-5);\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal value or albumin below the lower limit of normal value during screening (before methotrexate treatment);\n* Use of any blood component, short-acting or long-acting growth factor drugs within 14 days prior to screening, or white blood cell count \\\u003C 4×109\u002FL, hematopoietic volume \\\u003C 32%, or platelet count \\\u003C 75×109\u002FL;\n* Receiving anticoagulant therapy or international normalized ratio (INR) \\> 1.5×ULN or activated partial thromboplastin time (APTT) \\> 1.5×ULN before enrollment;\n* Receiving systemic or local radiotherapy for tumors, or history of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix;\n* Any acute illness that was considered by the investigator to be likely to affect the study occurred within 1 month before screening;\n* Donated (or lost) blood and donated (or lost) ≥400 mL or received blood transfusion within 3 months before screening;\n* If any one of the five serological tests of hepatitis B was positive except for hepatitis B surface antibody, or hepatitis C antibody positive, treponema pallidum antibody positive or HIV antibody positive in serum virology examination;\n* History of drug or substance abuse, or a positive drug screening test;\n* History of alcohol abuse in the 3 months before screening \\[drinking more than 14 units of alcohol per week (1 unit ≈360 mL of beer)\\] or 45 mL of 40% spirits or 150 mL of wine)\\]; or positive alcohol breath test on admission;\n* Lactating women, as well as male participants (or their partners) or female participants 30 days before the study to the end of the study, who have plans for pregnancy or sperm or egg donation within 6 months and are unwilling to take effective contraceptive measures;\n* Patients have serious mental and psychological disorders, cognitive disorders and the existence of a history of mental illness.\n* The investigator considered it inappropriate to participate in the study.",{"count":530,"type":22},36,[240],"To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.",[28],[535,536,537,538,539],"Uncontrolled gout","Peguricase for injection","Safety","Tolerability","Efficacy","2026-01-06",{"date":515,"type":33},{"date":543,"type":33},"2023-03-03",{"date":545,"type":22},"2026-12-30",{"name":547,"class":104},"Shanghai Institute Of Biological Products",{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":453,"enrollmentInfo":556,"targetDuration":4,"studyType":23,"phases":558,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":569},"100429717","phase-4-treat-to-target-serum-urate-versus-treat-to-avoid-symptoms-in-gout-100429717","NCT04875702","Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout","Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial","TRUST","To be eligible to be enrolled in the study, each patient must:\n\n1. Provide signed written or electronic informed consent.\n2. Be between 18 and 90 years old.\n3. Be in a participating primary care practice with at least one visit in the previous 36 months.\n4. Be diagnosed with gout by the 2015 ACR\u002FEULAR criteria, with 8 or more points on the 2015 ACR\u002FEULAR criteria scoring algorithm.\n5. Have experienced at least one gout flare attributed in the previous 12 months.\n6. Have a baseline inter-critical serum urate (SU) ≥ 6.0 mg\u002FdL (at screening or in the 30 days before screening)\n7. Be able to swallow pills.\n8. Agree to practice effective measures of birth control if of reproductive potential.\n\nExclusion Criteria\n\nCandidates who meet any of the following criteria will be excluded from the study:\n\n1. Diagnosis of CKD Stage 3B or worse (eGFR \\\u003C 45 mL\u002Fmin\u002F 1.73 m2) at screening\n2. More than one subcutaneous tophus on clinical examination at screening\n3. Two or more episodes of renal colic in the past 5 years\n4. Unable to provide informed consent.\n5. AST\u002FALT \\> 3 × upper limit of normal (ULN) (within 6 months of entry).\n6. Pregnancy, planning pregnancy, or breastfeeding.\n7. Patients who have been treated with thiopurines (mercaptopurine (PURINETHOL®), azathioprine (IMURAN®), or thioguanine) in the past 12 months or currently being treated with thiopurines are not eligible for the study. Usage of the thiopurines (azathioprine and mercaptopurine) with allopurinol has been shown to cause a significant drug-drug interaction.\n8. Unlikely to survive 2 years because of comorbidities.\n9. Currently taking \\> 200 mg of allopurinol per day or any dose of febuxostat. Patients taking 200 mg or less of allopurinol daily may participate, provided they meet the eligibility criteria for flares and current SU, and they have not had a dose escalation in their allopurinol in the previous 6 months.\n10. Patients with known allergic or hypersensitive reactions to allopurinol and not willing to initiate febuxostat if urate lowering is indicated.\n11. Subjects that test positive for HLA-B\\*5801 allele, a genetic marker for severe cutaneous adverse reactions caused by allopurinol and are unwilling to initiate febuxostat if urate lowering is indicated by the study. Subjects of higher risk, including Black\u002FAfrican American, Asian (except Japanese), native Hawaiian, or Pacific Islander descent will be tested at screening.",{"count":557,"type":22},650,[25],"The TRUST study is a randomized, controlled multicenter study to evaluate the management of gout by comparing two commonly used treatment strategies for gout (TTT vs TTASx) to determine the most beneficial for a patient-centered gout outcomes, as well as relevant cardiovascular-metabolic-renal endpoints.",[28],"2025-09-22",{"date":563,"type":33},"2025-09-25",{"date":565,"type":33},"2024-02-22",{"date":567,"type":22},"2028-10-31",{"name":467,"class":40},7,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":577,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":202},"100587151","phase-2-metformin-in-safety-and-efficacy-in-gouty-patients-100587151","NCT06924658","Metformin in Safety and Efficacy in Gouty Patients","the Impact of Metformin Use on Clinical Outcomes in Gouty Patients","Inclusion Criteria:\n\n* Gouty patients clinically diagnosed as gouty arthritis based on the American College of Rheumatology\u002FEuropean League Against Rheumatism criteria of gout.\n\nExclusion Criteria:\n\n* Systemic disorders such as cardiovascular, neurological, coronary artery disease.\n* Hypertension, hyperlipidemia, diabetes mellitus, active infections.\n* Other inflammatory or autoimmune diseases.\n* Patients on biologics,\n* Cases with hypersensitivity to metformin and those with impaired liver and kidney functions.","60 Years",{"count":579,"type":22},70,[85],"The most frequent crystal arthropathy is gout, which is also the most prevalent cause of inflammatory arthritis. Gouty Patients frequently have excruciating pain and swelling in their joints. Gout is linked to decreased health-related quality of life and functional disability. Gout and its associated diseases have been shown to have a significant impact on patients mortality and morbidities. Metformin, a biguanide, is used to manage diabetes by reducing insulin resistance and preventing comorbidities such as cerebrovascular and coronary artery disease, as well as providing renal protection to diabetic nephropathy patients",[28],"2025-06-25",{"date":585,"type":33},"2025-06-27",{"date":587,"type":33},"2025-04-20",{"date":589,"type":22},"2026-11-20",{"name":591,"class":40},"Mostafa Bahaa",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":599,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":202},"100592585","phase-2-comparative-clinical-and-biochemical-study-evaluating-the-effectiveness-of-metformin-versus-febuxostat-on-gouty-obese-non-diabetic-patients-100592585","NCT06995339","Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients","Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostate on Gouty Obese Non-Diabetic Patients","Inclusion Criteria:\n\n* Males or females aged \\\u003C 18 years.\n* All patients are diagnosed to have gout with serum uric acid \\\u003C 7 mg\u002Fdl.\n* All patients are diagnosed to have obesity with body mass index (BMI) ≥ 30 kg\u002Fm2.\n\nExclusion Criteria:\n\n* The presence of any type of diabetes mellitus.\n* Patients with drug-induced hyperuriceamia (those taking anti-TB agents, low dose aspirin, cytotoxic chemotherapy, diuretics, immunosuppressants, fructose, lactate infusion, testosterone or xylitol).\n* Non-obese patients with BMI \\>30 kg\u002Fm2.\n* Pregnant or lactating women.","65 Years",{"count":601,"type":22},60,[85],"Gout is a systemic disease that results from the deposition of monosodium urate crystals (MSU) in tissues. Increased serum uric acid (SUA) above a specific threshold (\\>6.8 mg\u002Fdl) is a requirement for the formation of uric acid crystals. MSU crystals can be deposited in all tissues mainly in and around the joints forming tophi. Early presentation of gout is an acute joint inflammation that is quickly relieved by non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine. Lowering SUA levels below deposition threshold either by dietary modification or using serum uric acid lowering drugs is the main goal in management of gout. This results in dissolution of MSU crystals preventing further attacks",[28],"2025-06-21",{"date":607,"type":33},"2025-06-24",{"date":609,"type":33},"2025-05-30",{"date":611,"type":22},"2026-12-20",{"name":591,"class":40},{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":599,"enrollmentInfo":620,"targetDuration":4,"studyType":23,"phases":621,"briefSummary":622,"conditions":623,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":202},"100564453","phase-1-safety-tolerability-and-pharmacokinetic-characteristics-of-sss11-in-patients-with-gout-and-hyperuricemia-100564453","NCT06629376","Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia","Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacological Studies of SSS11 in Patients With Gout and Hyperuricemia After Multiple Administrations, Dose Escalation, Randomized Double-blind, Placebo-controlled Trials","Inclusion Criteria:\n\n* A patient with clinical diagnosis of gout (according to the 2015 ACR\u002FEULAR gout classification criteria), non acute attack phase, and hyperuricemia {under normal purine diet, blood uric acid\\>420 µ mol\u002FL (7 mg\u002Fdl) not tested twice on an empty stomach on the same day}。\n* Screening period blood uric acid\\>420 µ mol\u002FL (7mg\u002Fdl)。\n\nExclusion Criteria:\n\n* Within 14 days prior to enrollment (or within 5 half lives of the drug, whichever is longer), medication that lowers uric acid levels or affects uric acid levels and related drugs (allopurinol, febuxostat, benzbromarone, probenecid, benzenesulfonazolone, Tongyifengning tablets, etc.) must be taken, or during the study period, other drugs that lower uric acid levels or affect uric acid levels and related drugs other than experimental drugs must not be discontinued。\n* Patients with acute gout attacks within 14 days prior to enrollment。\n* Previously received uric acid oxidase or treated with similar drugs such as pegolase or rabulidase。\n* Individuals with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD enzyme activity levels below the lower limit of normal。\n* Individuals with a history of catalase deficiency or evidence that meets the diagnostic criteria for catalase deficiency。\n* Malignant tumor patients (whether treated or not)。",{"count":601,"type":22},[240],"This is a safety, tolerability, pharmacokinetics, and preliminary pharmacological study of multiple administration, dose escalation, randomized double-blind, placebo-controlled.The main purpose of this experiment is to evaluate the safety and tolerability of multiple injections of PEGylated recombinant Candida urate oxidase (test drug code: SSS11) in patients with gout and hyperuricemia.The experimental period includes a screening period of 4 weeks, a treatment period of 4 or 8 weeks, and an observation period of 4 weeks。",[28,144],"2025-05-26",{"date":626,"type":33},"2025-05-28",{"date":628,"type":33},"2023-11-20",{"date":630,"type":22},"2027-08-08",{"name":632,"class":104},"Shenyang Sunshine Pharmaceutical Co., LTD.",{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":641,"conditions":642,"keywords":643,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":651,"locationsCount":202},"100481253","prevalence-of-abnormalities-in-ultrasonography-of-joint-and-tendons-in-patients-with-gout-100481253","NCT05546593","Prevalence of Abnormalities in Ultrasonography of Joint and Tendons in Patients With Gout","EchoGoutte","Inclusion Criteria:\n\nInclusion criteria were adult patients with a diagnosis of gout according to ACR\u002FEULAR 2015 criteria and able to give informed consent. Exclusion criteria were the presence of other chronic inflammatory rheumatic diseases and patients without French social insurance.\n\nExclusion Criteria:\n\n\\-",{"count":478,"type":22},"Gout is the most frequent inflammatory arthritis in men after 40 years, with a prevalence of 0.9% in France. This disease is characterized by deposits of sodium urate crystals in joints, tendons and soft tissues, which can be detected by ultrasound examination. To date, there was no study assessing inflammatory, structural and deposit lesions due to gout in joints and tendons, since the standardization of ultrasound definitions of gout by the OMERACT (Outcome Measures in Rheumatology) in 2015. The objective of this study is t estimate the prevalence and severity of ultrasound inflammatory lesions (synovitis, tenosynovitis, soft tissues abnormalities), structural lesions (osteophytes, erosions) and abnormalities due to sodium urate deposits (double contour, aggregates, tophi) in patients with gout.",[28],[28,324,644],"Microcrystal disease","2025-03-17",{"date":647,"type":33},"2025-03-19",{"date":649,"type":33},"2022-08-24",{"date":197,"type":22},{"name":445,"class":40}]