[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psoriasis-arthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psoriasis-arthritis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,75,97,120,147,173,195,216],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100625081","a-study-of-clinical-and-immune-responses-to-sequential-biologic-therapies-in-psoriatic-arthritis-100625081",false,"NCT07417995","A Study of Clinical and Immune Responses to Sequential Biologic Therapies in Psoriatic Arthritis","STRIDE-PsA: A Study of Treatment Response and Immunogenicity in Sequential Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drug (b\u002FtsDMARD) Exposure in Psoriatic Arthritis","STRIDE-PsA","Inclusion Criteria:\n\n* Age ≥18 years\n* Clinical diagnosis of PsA meeting CASPAR criteria\n* Starting a new b\u002FtsDMARD, irrespective of line of therapy\n\nExclusion Criteria:\n\n* Switching b\u002FtsDMARD therapy for psoriasis or spondyloarthritis alone, without active psoriatic arthritis.\n* Previous treatment with the same b\u002FtsDMARD being started at baseline.\n* Inability or unwillingness to provide informed consent.","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate how well advanced therapies work in adults with psoriatic arthritis (PsA) who are starting a biologic or targeted synthetic disease-modifying antirheumatic drug (b\u002FtsDMARD) as part of routine care.\n\nThe main questions are:\n\n* Do treatment responses differ according to the number of previous advanced therapies?\n* Can anti-drug antibodies (ADAs) or blood drug levels help predict treatment effectiveness?\n\nResearchers will compare participants receiving earlier-line versus later-line advanced therapies to assess differences in treatment response and antibody development.\n\nParticipants will allow collection of routine clinical assessment data, complete questionnaires on symptoms and quality of life, and provide blood samples before treatment and at 12 weeks.",[25],"Psoriasis Arthritis",[27,28,29,30],"Anti-drug antibody","Biologic therapies","Immunogenicity","Targeted Synthetic DMARDs","NOT_YET_RECRUITING","2026-05-12",{"date":34,"type":35},"2026-05-13","ACTUAL",{"date":37,"type":21},"2026-06",{"date":39,"type":21},"2027-06",{"name":41,"class":42},"Royal United Hospitals Bath NHS Foundation Trust","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":43},"100627415","psoriasis-comorbidities-at-hospital-caldern-guardia-100627415","NCT07448337","Psoriasis Comorbidities at Hospital Calderón Guardia","Prevalence of Metabolic Comorbidities, Atherosclerotic Arterial Disease, and Psoriatic Arthritis in Patients With Psoriasis and Their Association With Clinical Severity and Therapeutic Profile Among Patients Treated at Hospital Rafael Ángel Calderón Guardia During 2024-2025","Inclusion Criteria:\n\n* Patients evaluated in outpatient clinics during the period 2024-2025.\n* Patients receiving systemic therapy and\u002For phototherapy.\n* Patients aged 12 years or older, of any sex.\n* Availability of sufficient clinical information to assess psoriasis severity, metabolic comorbidities, atherosclerotic cardiovascular disease, and psoriatic arthritis.\n* At least one dermatologic or rheumatologic evaluation recorded in the Electronic Health Record (EHR-EDUS) during the study period.\n* Confirmed diagnosis of psoriasis documented in the Electronic Health Record (EHR-EDUS) of Hospital Calderón Guardia.\n\nExclusion Criteria:\n\n* Clinical records insufficient to evaluate psoriasis severity, comorbidities, or therapeutic profile.\n* Patients managed exclusively with topical therapies.\n* Duplicate or inconsistent records, preventing accurate patient classification.\n* Cutaneous conditions not compatible with psoriasis.","12 Years",{"count":53,"type":21},350,"The goal of this observational study is to characterize the epidemiologic, clinical, severity, and therapeutic features of patients with psoriasis treated in Costa Rica between 2024 and 2025. The main questions it aims to answer are:\n\nWhat are the demographic and clinical characteristics and severity profiles of psoriasis patients?\n\nWhat treatments are used in routine clinical practice, and how are they associated with disease severity and outcomes?\n\nPatients with psoriasis receiving dermatologic care during the study period will be included. Data will be obtained retrospectively from electronic medical records and clinical registries without intervention or modification of treatment.",[56,25,57,58],"Psoriasis","Psoriasis (PsO)","Psoriasis Patients",[60,61,56,62,63,64],"Comorbidities","Costa Rica","Real-world data","Disease severity","Epidemiology","2026-04-02",{"date":67,"type":35},"2026-04-08",{"date":69,"type":21},"2026-05",{"date":71,"type":21},"2027-05",{"name":73,"class":74},"Caja Costarricense de Seguro Social","OTHER_GOV",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":82,"targetDuration":84,"studyType":22,"phases":4,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":96,"locationsCount":43},"100627420","costa-rican-registry-of-il-23-inhibitors-in-psoriatic-disease-100627420","NCT07448402","Costa Rican Registry of IL-23 Inhibitors in Psoriatic Disease","National Registry of Patients With Psoriatic Disease Receiving Interleukin-23 Inhibitor Therapy Within the Costa Rican Social Security System","Inclusion Criteria:\n\n* Confirmed diagnosis of psoriatic disease, including psoriasis (any clinical variant) and\u002For psoriatic arthritis based on rheumatologic criteria.\n* Receiving IL-23 inhibitor therapy (guselkumab or risankizumab).\n* Treated within participating Costa Rican public health centers.\n* Availability of sufficient clinical records to complete registry data (history, follow-up, labs).\n* Age ≥12 years, any sex.\n\nExclusion Criteria:\n\n* None specified (all patients meeting inclusion criteria are eligible).",{"count":83,"type":21},50,"5 Years","The goal of this observational registry study is to evaluate the real-world effectiveness and safety of IL-23 inhibitors in patients with psoriatic disease (psoriasis and\u002For psoriatic arthritis) treated in Costa Rica. The main questions it aims to answer are:\n\n* Do IL-23 inhibitors (guselkumab or risankizumab) improve disease severity and quality of life in patients with psoriatic disease in routine clinical practice?\n* What is the safety profile and treatment persistence of IL-23 inhibitors in this population?\n* Patients receiving IL-23 inhibitors as part of their usual medical care will be followed longitudinally using standardized clinical measures (e.g., PASI, DLQI, DAPSA\u002FBASDAI) and adverse-event reporting through a national registry.",[56,25,57],[56,88,89,61],"IL-23","Registry","2026-03-06",{"date":92,"type":35},"2026-03-09",{"date":69,"type":21},{"date":95,"type":21},"2031-05",{"name":73,"class":74},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100612282","phase-4-glp-1-receptor-agonists-in-non-diabetic-patients-with-psoriatic-arthritis-100612282","NCT07251556","GLP-1 Receptor Agonists in Non-diabetic Patients With Psoriatic Arthritis","Effect of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists on Subclinical Atherosclerosis in Non-diabetic Patients With Psoriatic Arthritis - a Proof-of-concept Randomized Study","Inclusion Criteria:\n\n1. fulfill the ClASsification criteria for Psoriatic Arthritis,\n2. are rheumatoid factor negative,\n3. BMI \\>=25 kg\u002Fm2,\n4. are over 18 years old and\n5. Chinese subjects\n\nExclusion Criteria:\n\n1. have prior therapy with GLP-1 receptor agonists during the last 24 weeks,\n2. have pre-existing diabetes,\n3. have liver or renal impairment,\n4. have known or symptoms suggestive of CVD,\n5. have chronic or previous acute pancreatitis,\n6. have current malignancy,\n7. are pregnant, breastfeeding or of childbearing potential, or\n8. are unable to give written informed consent.",{"count":105,"type":21},40,"INTERVENTIONAL",[108],"PHASE4","Background Psoriatic arthritis (PsA) patients are at increased risk of cardiovascular disease. Glucagon-Like Peptide-1 (GLP-1) receptor agonists are cardiovascular protective in diabetics. They have also anti-inflammatory properties. It is hypothesized GLP-1 receptor agonists can prevent the progression of atherosclerosis due to the combination of metabolic factors and disease activity control in non-diabetic PsA patients.\n\nObjectives To investigate the vascular effects of GLP-1 receptor agonists in PsA patients without diabetes. Their metabolic and anti-inflammatory roles will also be examined.\n\nDesign and subjects This is a pilot randomized open-labelled trial. We plan to enroll 40 non-diabetic patients with PsA. Participants will be randomized 1:1 to either GLP-1 receptor agonist (semaglutide) or control group.\n\nStudy instruments Subclinical carotid artherosclerosis is assessed by high-resolution ultrasound. Arterial stiffness is measured using pulse wave velocity by a tonometry system, and augmentation index by the SphygmoCor device. These assessments will be done at baseline and 24 weeks. Drug adversities will also be documented. Anthropometric measurements, sugar metabolism and lipid levels as well as the PsA disease activity will be monitored.",[25],"2025-11-25",{"date":113,"type":35},"2025-12-02",{"date":115,"type":21},"2025-12-01",{"date":117,"type":21},"2027-01-01",{"name":119,"class":42},"Chinese University of Hong Kong",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":17,"minAge":18,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":106,"phases":130,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":146},"100604459","phase-4-a-multi-center-rct-clinical-trial-on-personalized-precision-medicine-for-patients-with-psoriasis-and-psoriatic-arthritis-and-investigation-on-cardiovascular-biomarkers-100604459","NCT07149792","A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers","SMILE","Inclusion Criteria:\n\n* Healthy subjects\n* Psoriasis patients\n* Psoriatic arthritis patients\n* Agree to provide a blood sample\n\nExclusion Criteria:\n\n* A current history of cancer,\n* Recent hospitalization for infection or current antibiotic treatment\n* HIV infection.",true,"75 Years",{"count":83,"type":21},[108],"The inclusion criteria for this study were patients aged 18 to 75 years with a confirmed diagnosis of psoriasis by a dermatologist or psoriatic arthritis by a rheumatologist. Patients with active infections or suspected malignancies were excluded.\n\nA total of 40 patients with psoriasis, with or without psoriatic arthritis, were enrolled from multiple centers in Taiwan. All participants were recruited from the outpatient clinics of either the Department of Allergy, Immunology, and Rheumatology or the Department of Dermatology in tertiary hospitals across Taiwan.\n\nParticipants were randomly assigned to one of two groups:\n\nPrescreen Strategy-Based Biologics Selection Group\n\nStandard-Based Biologics Selection Group\n\nPatients will be followed up at weeks 4, 8, 12, 24, 32, 40, 48, 56, 64, and 72. Follow-up may be extended up to 3 years if necessary.\n\nClinical assessments will include:\n\nPrimary endpoints: PASI (Psoriasis Area and Severity Index), painful joint count, swollen joint count, and DAPSA (Disease Activity in Psoriatic Arthritis) score.\n\nSecondary endpoints: DLQI (Dermatology Life Quality Index), BSA (Body Surface Area), pruritus score, and internal carotid artery thickness measured at 6 months, 1 year, and 2 years.",[56,25,133],"Biologics",[135],"Prescreen, Biologics, Psoriasis, Strategic selection, Psoriatic arthritis","RECRUITING","2025-08-24",{"date":139,"type":35},"2025-09-02",{"date":141,"type":35},"2025-07-29",{"date":143,"type":21},"2028-06-01",{"name":145,"class":42},"Taichung Veterans General Hospital",2,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":155,"targetDuration":157,"studyType":22,"phases":4,"briefSummary":151,"conditions":158,"keywords":161,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":43},"100603116","molecular-inflammation-board-at-the-center-for-personalized-medicine-100603116","NCT07132333","Molecular Inflammation Board at the Center for Personalized Medicine","The Molecular Inflammation Board at the Centers for Personalized Medicine at the University Hospitals of Freiburg, Heidelberg, Tübingen and Ulm - A Multicenter Prospective Observational Study","MEB@ZPM","Inclusion Criteria:\n\n* Chronic inflammatory disorder (PsO, PsA, SpA, IBD)\n* Given informed consent\n* 18 years of age\n\nExclusion Criteria:\n\n* No capacity to consent",{"count":156,"type":21},3000,"14 Months",[57,25,159,160],"Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)","Spondylarthropathies",[162,163],"chronic inflammatory diseases","personalized medicine","2025-08-19",{"date":166,"type":35},"2025-08-20",{"date":168,"type":35},"2022-11-16",{"date":170,"type":21},"2032-11",{"name":172,"class":42},"University Hospital Tuebingen",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":43},"100599600","typological-study-of-sleep-pathologies-during-psoriatic-rheumatism-and-sapho-syndrome-prospective-study-within-the-paris-saint-joseph-hospital-group-100599600","NCT07086599","Typological Study of Sleep Pathologies During Psoriatic Rheumatism and SAPHO Syndrome: Prospective Study Within the Paris Saint-Joseph Hospital Group\"","SleepSO2","Inclusion Criteria:\n\n* Patient aged 18 years or older\n* Patient diagnosed with psoriatic arthritis or SAPHO syndrome and followed at Paris Saint-Joseph Hospital\n* Patient presenting sleep disorders warranting hospitalization for further -investigation of these disorders\n* French-speaking patient\n* Patient who does not oppose participation in the research protocol\n\nExclusion Criteria:\n\n* Patient already followed for a sleep disorder\n* Patient who underwent polysomnography in the last 2 years\n* End-of-life patient\n* Patient under guardianship or curatorship\n* Patient deprived of liberty\n* Patient under legal protection",{"count":181,"type":21},100,"Chronic inflammatory rheumatisms (CIR) are a source of motor disability and various comorbidities, particularly cardiovascular and metabolic. They also significantly impact patients' quality of life, including sleep disturbances. Among CIRs, psoriatic arthritis is a chronic inflammatory arthropathy associated with psoriasis, typically seronegative for rheumatoid factor. This heterogeneous disease affects peripheral and\u002For axial joints and can include extra-articular manifestations such as uveitis and chronic inflammatory bowel diseases. Its prevalence is estimated between 0.3% and 1% in the general population.\n\nSAPHO syndrome, similar to psoriatic arthritis, is characterized by specific bone involvement with a hypertrophic tendency, often affecting the axial skeleton and the anterior thoracic wall. Pain and inflammation are closely linked to sleep quality, creating a vicious cycle where pain disrupts sleep and poor sleep amplifies pain perception. Analgesic treatments, such as opioids, can also cause nocturnal respiratory pathologies, further disrupting sleep.\n\nInflammatory processes are regulated by sleep, influencing plasma concentrations of CRP, IL6, and TNF production. Patients with psoriatic arthritis or SAPHO syndrome share common risk factors with Obstructive Sleep Apnea Syndrome (OSAS), such as obesity, hypertension, and metabolic syndrome.\n\nSleep disorders are common in the general population and likely underdiagnosed in these patients. Several studies suggest a link between sleep disorders and these rheumatic conditions, affecting quality of life and exacerbating symptoms. Questionnaires like the Epworth and Pichot scales provide a more precise evaluation of these symptoms. However, objective sleep exploration through polysomnography has never been conducted in these patients.\n\nIn summary, CIRs, particularly psoriatic arthritis and SAPHO syndrome, significantly impact patients' quality of life and sleep, necessitating appropriate evaluation and management of associated sleep disorders.",[25,184,185],"SAPHO Syndrome","Sleep Apnea Syndromes","2025-07-18",{"date":188,"type":35},"2025-07-25",{"date":190,"type":35},"2023-11-13",{"date":192,"type":21},"2027-11-01",{"name":194,"class":42},"Fondation Hôpital Saint-Joseph",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":146},"100591966","a-prospective-study-to-assess-the-efficacy-of-il-17-inhibitors-on-subclinical-enthesitis-in-patients-with-moderate-to-severe-psoriasis-based-on-power-doppler-pd-ultrasonography-pdus-100591966","NCT06987292","A Prospective Study to Assess the Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler (PD) Ultrasonography (PDUS)","Efficacy of IL-17 Inhibitors on Subclinical Enthesitis in Patients With Moderate to Severe Psoriasis Based on Power Doppler (PD) Ultrasonography (PDUS): a Single-center, Prospective, Exploratory, Open-label Study","Inclusion Criteria:\n\n1. Adult patients ( ≥ 18 years of age) with chronic plaque-type psoriasis\n2. Meet one of the following conditions: Psoriasis Area and Severity Index \\[PASI\\] score \\> 6, or scalp involvement, or nail involvement.\n3. Inflammatory changes on ultrasound consistent with OMERACT definition at least at one peripheral attachment point at screening, defined as thickening and\u002For abnormal echogenicity of tendons or ligaments at the site of their insertion into the bone (within 2 mm of the talar cortex), and active Doppler signals that may indicate structural damage such as bone erosion, syndesmophytes\u002Fcalcifications\n4. Psoriasis is inadequately controlled by current topical therapy or phototherapy\n5. Able to sign the informed consent\n\nExclusion Criteria:\n\n1. Diagnosis of PsA2 according to CASPAR\n2. Any known rheumatic disease, positive rheumatoid factor\u002Fanti-citrullinated protein antibodies, prior treatment with anti-rheumatic drugs\n3. Treatment with systemic corticosteroids within 12 weeks or 5 half-lives of screening\n4. Obesity impeded ultrasound examination\n5. Pregnant or lactating women or women with plan for conception 5 months before or after treatment\n6. Participated in other clinical trials\n7. Concurrent significant medical problems, including but not limited to the following: uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 95 mmHg), congestive heart failure (NYHA class III or IV), total white blood cell count \\\u003C 2500\u002Fμl, or platelets \\\u003C 100,000\u002Fμl or neutrophils \\\u003C 1500\u002Fμl or hemoglobin \\\u003C 8.5 g\u002FdL at screening.\n8. Any liver function abnormality: aspartate aminotransferase (AST) \\> 2xULN, alanine aminotransferase (ALT) \\> 2xULN, total bilirubin (TBIL) \\> 2xULN\n9. Abnormal renal function: serum creatinine \\> 2.0 mg\u002Fdl\n10. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection, defined as a positive PPD skin test or Mycobacterium tuberculosis interferon-gamma release assay (IGRA) test.\n11. Current or relevant history of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.\n12. History of lymphoproliferative disease, or any known malignancy, or history of malignancy of any organ system within the past 5 years\n13. Unable or unwilling to undergo repeated venipuncture\n14. History of alcohol or drug abuse or evidence of abuse within 6 months prior to baseline\n15. History of hypersensitivity to any component of the study drug\n16. Did not accept live vaccines within 4 weeks prior to enrollment, do not have plan of vaccination program during the study, and no live vaccines are planned \\> 6 months after the last dose of the study (herpes zoster vaccine \\> 12 months)",{"count":83,"type":21},"It is an observational, single-center, prospective, exploratory, open-label study to assess the efficacy and safety of IL-17 inhibitors on subclinical enthesitis in patients with moderate to severe psoriasis with subclinical enthesitis based on Power Doppler (PD) Ultrasonography (PDUS)",[57,205,25,206],"Enthesitis","Secukinumab","2025-05-15",{"date":209,"type":35},"2025-05-23",{"date":211,"type":35},"2025-05-01",{"date":213,"type":21},"2027-12-31",{"name":215,"class":42},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":106,"phases":227,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":43},"100590980","phase-4-potential-role-of-guselkumab-in-modulating-pain-perception-and-related-gene-pathways-a-proof-of-concept-study-100590980","NCT06974474","Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study.","Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study","GUPAIN","Inclusion Criteria:\n\n* A man or a woman at least 18 and no more than 80 years of age;\n* Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months the enrolment and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening;\n* Inadequate response or intolerance of standard treatment (namely, methotrexate and\u002For TNF inhibitors);\n* At least 3 months of non-biologic DMARDs (limited to methotrexate ≤25 mg\u002Fweek, sulfasalazine ≤3 g\u002Fday, hydroxychloroquine ≤400 mg\u002Fday, and leflunomide ≤20mg\u002Fday) or at least 4 weeks of NSDAIDs for psoriatic arthritis;\n* Patient eligible for Guselkumab (both monotherapy or combination therapy with methotrexate) treatment according to international recommendations, national and regional regulatory authorities, and EMA datasheet;\n* VAS pain major than 15 mm at the enrolment;\n* DAPSA major than 14 at the enrolment;\n* Have at least 1 of the PsA subsets: oligoarticular or polyarticular PsA subset, distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, spondylitis with peripheral arthritis;\n* Peripheral tender joints ≥ 1\n* Peripheral swollen joints ≥ 1\n* C-reactive protein ≥ 0.3 mg\u002FdL\n* Involvement (namely, swollen joint) of wrists or knees;\n* Subjects naïve to bDMARDs or previously treated with up to 2 anti-tumor necrosis factor (TNFα) agents, discontinued for lack of benefit to an anti-TNFα therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar) and\u002For at least a 14-week dosage regimen (i.e., at least 4 doses) of infliximab (or biosimilar). Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity; Intolerance to an anti-TNFα biologic therapy, as assessed by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab (or biosimilars); If no intolerance or lack of benefit, the reason for discontinuation must be documented;\n* If currently using non-biologic DMARDs (limited to methotrexate \\[MTX\\], sulfasalazine \\[SSZ\\], hydroxychloroquine \\[HCQ\\], or leflunomide \\[LEF\\]), subjects should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before the first administration of study agent and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using a MTX, SSZ, or HCQ, must have not received for at least 4 weeks before the first administration of study agent. If currently not using LEF, must not have received for at least 12 weeks before the first administration of study agent. If using MTX, the route of administration and dose must be stable and the dose must be ≤25 mg\u002Fweek. If receiving SSZ, the dose must be ≤ 3g\u002Fday. If receiving HCQ, the dose must be ≤400 mg\u002Fday. If receiving LEF, the dose must be ≤20 mg\u002Fday.\n* If currently using NSAIDs or other analgesics for PsA, subjects must be on a stable dose for at least 2 weeks before the first administration of study agent. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks before the first administration of study agent;\n* Are willing to refrain from the use of complementary therapies for PsA or psoriasis including ayurvedic medicine, traditional Taiwanese, Korean, or Chinese medications, and acupuncture within 2 weeks before the first study agent administration and through Week 52;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of fibromyalgia according to ACR 2016 criteria;\n* Subjects with inflammatory diseases that might confound the evaluations of benefit of Guselkumab therapy, including but not limited to RA, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease;\n* Patients who received more than 2 anti-TNFα agents; - Has received an anti-TNF agent within the following timeframes: Infliximab (or its biosimilars) or golimumab (intravenous) within 8 weeks before the first administration Guselkumab; Golimumab (subcutaneous), adalimumab (or its biosimilars) or certolizumab pegol within 6 weeks before the first administration of study agent; Etanercept (or its biosimilars) within 4 weeks before the first administration of study agent;\n* Has previously been treated with Guselkumab; - Diagnosis of psychiatric disorder according to DSM-V; - Pregnancy or lactation;\n* Systemic or intra-articular glucocorticoids in the last 3 months;\n* Has previously received any biologic treatment (other than anti-TNFα agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment;\n* Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor, as well as apremilast;\n* Has previously received any systemic immunosuppressants (e.g., azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent;\n* Has received non-biologic DMARDs (other than MTX, SSZ, HCQ, LEF) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent;\n* Is currently receiving 2 or more allowed non-biologic DMARDs at baseline;\n* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), genitourinary, or metabolic disturbances;\n* Has unstable cardiovascular disease, defined as a recent clinical deterioration (e.g., unstable angina, rapid atrial fibrillation, or transient ischemic attack) in the last 3 months prior to screening or a cardiac hospitalization within the last 3 months prior to screening;\n* Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study agent administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first Guselkumab administration);\n* Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative diseases, such as lymphadenopathy or splenomegaly;\n* Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (e.g., bronchiectasis), recurrent urinary tract infection (e.g., recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (e.g., mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers;\n* Has a transplanted organ (with exception of a corneal transplant \\>3 months before the first administration of the study agent);\n* Has a history of an infected joint prosthesis, or has ever received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced;\n* Has or has had a serious infection (e.g., sepsis, pneumonia, or pyelonephritis) or has been hospitalized or received IV antibiotics for an infection within 2 months before screening;\n* Has or has had a herpes zoster infection within 2 months before screening;\n* Is pregnant, nursing, or planning a pregnancy (both men and women) within 12 weeks after receiving the last administration of the study agent;\n* Has received, or is expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of the study agent;\n* Has had a BCG vaccination within 12 months of screening;\n* Has known intolerance or hypersensitivity to any biologic medication, or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies, or antibody fragments;\n* Subject has known allergies, hypersensitivity, or intolerance to Guselkumab or its excipients;\n* Has a history of active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening;\n* Has a chest radiograph within 3 months prior to the first administration of the study agent that shows an abnormality suggestive of a malignancy, significant cardiovascular or pulmonary disease, or current active infection, including TB;\n* Has ever had a nontuberculous mycobacterial infection or opportunistic infection (e.g., cytomegalovirus, pneumocystosis, aspergillosis);\n* Is infected with human immunodeficiency virus (HIV, a confirmed positive serology for HIV antibody);\n* Tests positive for hepatitis B virus (HBV) infection at screening; - Is seropositive for antibodies to hepatitis C virus (HCV) at screening, unless the subject had 2 negative HCV ribonucleic acid (RNA) test results at least 6 months apart prior to screening and has a third negative HCV RNA test result at screening;\n* Has had major surgery (e.g., requiring general anesthesia and hospitalization) within 8 weeks before the screening, or will not have fully recovered from such surgery, or has such major surgery planned during the time the subject is expected to participate in the study; NOTE: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.","80 Years",{"count":226,"type":21},26,[108],"Psoriatic arthritis (PsA) is a chronic musculoskeletal disease that affects 0.1%-1% of the general population and about 20% of patients with psoriasis. Patients with PsA have a multifaceted pain experience, which depends on various factors, including joint inflammation, as well as peripheral and central pain sensitization. Although chronic pain is the most common symptom of PsA, few is known about the mechanisms driving it. From this point of view, the interactions between immune cells and nociceptors in the context of inflammation-related pain are emerging as a hot topic. Many studies suggested that IL-23\u002FIL-17 pathway may play a pivotal role in this regard. This is consistent with data currently available regarding Guselkumab in PsA. Indeed, according to DISCOVER 1 and DISCOVER 2, two randomized phase III trials, patients receiving Guselkumab achieved, among others, minimal disease activity state, significant improvement in the SF-36 physical component score, and visual analog scale of pain. This study proposal aims to evaluate the potential role of Guselkumab in modulating pain perception in PsA patients from a molecular, cellular, and electrophysiological point of view.",[25],[231],"Guselkumab","2025-05-07",{"date":234,"type":35},"2025-05-16",{"date":236,"type":35},"2024-06-18",{"date":238,"type":21},"2027-05-27",{"name":240,"class":42},"Fondazione Policlinico Universitario Campus Bio-Medico"]