[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-gout\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-gout":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":4},"100640348","phase-1-a-study-of-in026-in-participants-with-refractory-gout-100640348",false,"NCT07587684","A Study of IN026 in Participants With Refractory Gout","A Clinical Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of IN026 in the Treatment of Refractory Gout","Inclusion Criteria:\n\n1. Can voluntarily sign the informed consent form (ICF) and comply with ICF and study protocol requirements.\n2. Male or female, 18-75 years old (inclusive) at screening.\n3. Meet 2015 ACR\u002FEULAR gout classification criteria, in the intercritical phase of gout or acute flare resolved ≥2 weeks at screening.\n4. Serum uric acid ≥420 μmol\u002FL (7 mg\u002Fdl) at screening.\n5. Meet the definition of refractory gout (poor uric acid control accompanied by severe gout symptoms)\n\nExclusion Criteria:\n\n1. Gout secondary to radiotherapy\u002Fchemotherapy, lead poisoning, organ transplantation, tumor, etc. at screening\u002Fbaseline.\n2. Rheumatoid arthritis, infectious\u002Fseptic arthritis, or other acute inflammatory arthritis at screening\u002Fbaseline.\n3. Glucose-6-phosphate dehydrogenase (G6PD) deficiency history, or G6PD level below normal lower limit.\n4. Positive HBsAg; HCV antibody positive is excluded except those with sustained HCV-RNA negativity after standard treatment; HIV antibody positive; active syphilis.\n5. Presence of chronic liver diseases including active hepatitis, cirrhosis and alcoholic liver disease.\n6. Participants with a history of any of the following: serious cardiovascular diseases within 6 months prior to screening; or serious diseases of the digestive, respiratory, urinary, musculoskeletal, neuropsychiatric, hematological, or immune systems within 3 months prior to screening.\n7. Prolonged QTcF at screening.\n8. Uncontrolled or untreated hypertension at screening.\n9. Participants who have received medications that may affect endpoint assessment, such as other urate-lowering therapies, mRNA-LNP vaccine, PEGylated drugs and uricase agents.\n10. History of severe allergy, or known allergy to IN026 or its components.\n11. Participation in other clinical trials within 30 days prior to screening.\n12. Participants with poor compliance, or those deemed otherwise unsuitable for this study by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical study is to learn if IN026 Injection is safe and works to lower uric acid levels in adults with refractory gout (gout that does not respond well to standard treatments). The main questions it aims to answer are:\n\n* What medical problems do participants have when taking IN026, such as changes in vital signs, blood tests, or heart rhythm?\n* How does the body absorb, process, and respond to IN026, and does it trigger an immune reaction?\n* Does IN026 lower uric acid levels in the blood and reduce tophi?\n\nInvestigator will start with lower doses of IN026 and slowly increase the dose to find the well-tolerated dose.\n\nParticipants will:\n\n* Receive IN026 through an intravenous (IV) drip into a vein at a set dose.\n* Complete a screening period of up to 4 weeks, followed by treatment and check-ups for up to 20 weeks.\n* Have blood and urine samples taken at set times to check safety and how the body responds to IN026.",[27],"Refractory Gout",[29,30,31,32,33,34,27,35,36,37,38,39,40,41,42,43],"Uricase","Gout","Uric acid","IN026","hyperuricemia","Metabolic Diseases","Safety","Pharmacokinetics","Pharmacodynamics","Efficacy","mRNA-LNP medicine","Rheumatic Diseases","Messenger RNA","Urate oxidase","immunogenicity","NOT_YET_RECRUITING","2026-05-07",{"date":47,"type":48},"2026-05-14","ACTUAL",{"date":50,"type":21},"2026-05",{"date":52,"type":21},"2028-05",{"name":54,"class":55},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100566323","study-on-the-efficacy-and-safety-of-thermotherapy-in-the-treatment-of-refractory-gout-100566323","NCT06653686","Study on the Efficacy and Safety of Thermotherapy in the Treatment of Refractory Gout","Study on the Efficacy and Safety of Extracorporeal High-Frequency Hyperthermia in the Treatment of Refractory Gout","Inclusion Criteria:\n\n1. Age between 18 and 80 years old;\n2. Meeting the diagnostic criteria for refractory gout, defined as fulfilling at least one of the following three conditions: 1) Blood uric acid remains ≥360 μmol\u002FL despite adequate doses and duration of urate-lowering drugs, either alone or in combination (adequate treatment is defined as single-drug therapy at standard doses for more than 6 months, or maximum doses for more than 3 months, with blood uric acid still ≥360 μmol\u002FL; combination therapy for more than 3 months with blood uric acid still ≥360 μmol\u002FL); 2) More than two gout flares per year despite standardized treatment; 3) Presence of multiple or progressive tophi;\n3. History of at least three gouty arthritis flares in the past 12 months prior to enrollment;\n4. Understanding the purpose and procedures of the study and providing signed informed consent.\n\nExclusion Criteria:\n\n1. Acute gout flare within 2 weeks prior to screening;\n2. Secondary gout due to hematological diseases, chemotherapy, radiotherapy, renal failure, or medications (e.g., diuretics such as furosemide, torsemide, hydrochlorothiazide, aspirin, niacin \\[vitamin B3\\], antituberculosis drugs, immunosuppressants such as cyclosporine);\n3. Other secondary joint pain (e.g., joint pain caused by rheumatoid arthritis or systemic lupus erythematosus) or joint pain of unknown cause;\n4. Patients with cardiac, pulmonary, hepatic, or renal insufficiency; active tuberculosis; mental illness or consciousness disorders;\n5. Patients with bone marrow hematopoietic insufficiency; leukemia; a tendency for major bleeding; or a history of malignant tumors;\n6. Polyarticular gouty arthritis involving more than four joints;\n7. Presence or suspicion of active or recurrent bacterial, fungal, or viral infections, including tuberculosis, HIV, or hepatitis B or C infections;\n8. Allergy to the study drugs; patients with heat insensitivity;\n9. Patients currently using mercaptopurine or azathioprine; patients taking CYP3A4 inhibitors or P-gp inhibitors;\n10. Major surgery within the last 3 months or unhealed surgical wounds;\n11. Presence of stents or metal implants;\n12. Local skin lesions or infections;\n13. Pregnant or breastfeeding women.","80 Years",{"count":65,"type":21},128,[67],"NA","Gout is a crystal-related arthropathy caused by purine metabolism disorder or decreased uric acid excretion. It can manifest as acute recurrent arthritis, tophus formation, tophaceous chronic arthritis, and urate nephropathy, with severe cases potentially leading to joint disability, renal insufficiency, and damage to other vital organs.Poor long-term control of uric acid levels may result in the progression of refractory gout in some patients, characterized by persistently elevated serum uric acid levels, recurrent acute arthritis, and multiple or progressive tophi, severely affecting quality of life and imposing a significant economic burden on patients.Currently, clinical research on refractory gout is relatively limited, and both domestic and international guidelines continue to recommend uric acid-lowering therapy to slow disease progression.However, due to poor adherence, intolerance to uric acid-lowering drugs, or dose limitations caused by coexisting chronic kidney disease, achieving target serum uric acid levels in these patients is often difficult, and their clinical symptoms are challenging to alleviate effectively.\n\nIn recent years, thermotherapy, as a non-pharmacological treatment modality, has garnered increasing attention for its effects in alleviating chronic pain, promoting blood circulation, and reducing inflammatory responses.Its primary mechanisms include: 1) increasing local temperature to influence the solubility of monosodium urate (MSU) crystals, promoting their dissolution, reducing gout attacks, and accelerating the resolution of gout flares;2) elevated local temperature promotes vasodilation and blood circulation, increasing the supply of oxygen and nutrients, facilitating the clearance of uric acid and inflammatory mediators;3) thermotherapy enhances local immune responses by boosting cellular phagocytic activity; 4) it may act as a stimulus transmitted to the central nervous system alongside pain impulses, disrupting pain transmission pathways and resulting in the attenuation or elimination of pain sensations. In recent years, thermotherapy has been widely used in clinical practice as a non-invasive, adjunctive treatment for various conditions, such as tumors, lumbar disc herniation, chronic prostatitis, pelvic inflammatory disease, endometriosis-associated dysmenorrhea, and osteoarthritis, due to its proven efficacy, non-invasive nature, and minimal adverse effects.A study from China demonstrated that thermotherapy has significant therapeutic effects on patients with acute gout attacks, effectively alleviating acute symptoms and reducing inflammatory responses. In this study, the overall clinical efficacy rate of the treatment group (thermotherapy combined with conventional therapy) was significantly higher at 90.0% compared to 72.5% in the control group. Moreover, on day 1 and day 3 post-treatment, the VAS scores of the treatment group (4.11±0.76, 3.23±0.53) were significantly lower than those of the control group (5.23±1.21, 4.23±0.76), and the treatment group had lower ESR and CRP levels than the control group after treatment (P\\\u003C0.05).Therefore, the primary aim of this study is to investigate the efficacy of thermotherapy in reducing gout attacks. However, there is currently no large-scale, multicenter clinical research evidence evaluating the clinical effectiveness of thermotherapy in patients with refractory gout.\n\nIn summary, considering the critical regulatory role of temperature in the formation and deposition of monosodium urate crystals and the fundamental principles of extracorporeal high-frequency thermotherapy, we hypothesize that extracorporeal high-frequency thermotherapy could reasonably reduce MSU crystal burden, lower uric acid levels, alleviate local inflammation, and decrease the frequency of gout attacks through its thermal effects.This study aims to evaluate the efficacy of extracorporeal high-frequency thermotherapy in patients with refractory gout through a randomized controlled trial, exploring its effects on reducing gout attack frequency, improving uric acid metabolism, and alleviating inflammation. Additionally, the study will assess the impact of thermotherapy on patients' quality of life, physical function, and metabolic parameters, with the goal of providing new effective strategies for the treatment of refractory gout in the future.",[27],"2024-10-20",{"date":72,"type":48},"2024-10-22",{"date":74,"type":21},"2024-11",{"date":76,"type":21},"2026-11",{"name":78,"class":55},"The First Hospital of Jilin University"]