[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-rheumatic-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-rheumatic-diseases":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,75,104],{"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":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100614129","phase-4-antibiotic-prophylaxis-after-simple-tooth-extraction-in-immunosuppressed-patients-with-autoimmune-rheumatic-diseases-100614129",false,"NCT07275580","Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases","Effectiveness of Short-Course Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases","PRO-EXOD","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed diagnosis of an ARD: SLE, RA, JIA, AS, PsA, IIM, systemic vasculitis, primary Sjögren's syndrome, or SSc\n* Under immunosuppressive or biologic therapy ≥3 months\n* Indication for simple extraction of tooth with chronic odontogenic focus\n* Provided informed consent\n\nExclusion Criteria:\n\n* Individuals who do not agree to participate in the study will be excluded.\n* Patients who require more technically complex extractions, such as impacted or impacted third molars.\n* Patients with local and systemic changes that require more extensive antibiotic coverage, such as cases with clinical signs of acute infections, anticoagulated patients, heart patients, patients who have undergone radiotherapy or are undergoing treatment for neoplasms.\n* Patients allergic to amoxicillin.","ALL","18 Years",{"count":20,"type":21},352,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This randomized, double-blind, placebo-controlled clinical trial aims to evaluate whether single-dose amoxicillin prophylaxis administered prior to simple tooth extraction reduces postoperative infection rates in immunosuppressed patients with autoimmune rheumatic diseases (ARDs).\n\nAlthough antibiotic prophylaxis is not recommended for healthy individuals undergoing simple extractions, immunosuppressed ARD patients frequently receive antibiotics despite limited evidence supporting this practice.\n\nSecondary objectives include assessing infection severity, postoperative complications, and the impact of ARD diagnosis and immunosuppressive treatment on infection risk.",[27,28,29,30],"Autoimmune Rheumatic Diseases","Tooth Extraction","Infection Prevention","Antibiotic Prophylaxis",[27,28,29,32,33],"Amoxicillin","Antibiotic Stewardship","NOT_YET_RECRUITING","2026-04-14",{"date":37,"type":38},"2026-04-15","ACTUAL",{"date":40,"type":21},"2026-06-01",{"date":42,"type":21},"2029-12-30",{"name":44,"class":45},"University of Sao Paulo General Hospital","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100611554","phase-4-influence-of-methotrexate-discontinuation-on-immunogenicity-after-pcv-20-vaccine-in-patients-ards-100611554","NCT07242092","Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs","Effect of Methotrexate Discontinuation on Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Patients With Autoimmune Rheumatic Diseases","MTX-PCV20-ARD","Inclusion Criteria:\n\n* Adults (\\>=18 years ) with confirmed ARD diagnosis (e.g., RA, PsA, axial SpA, primary Sjögren's, SLE, IIM, SSc, MCTD).\n* Stable MTX dose ≥12 weeks.\n* Prednisone ≤5 mg\u002Fday.\n* Low disease activity\u002Fremission according to specific disease activity criteria.\n* Eligible for PCV20 vaccination (no prior PCV20).\n\nExclusion Criteria:\n\n* Anaphylaxis to vaccine components.\n* Acute febrile illness.\n* Guillain-Barré, decompensated CHF (NYHA III-IV), demyelinating disease.\n* Live virus vaccine ≤4 weeks or inactivated vaccine ≤2 weeks before.\n* Blood products in last 6 months.\n* Severe infection in last month (including pneumococcal).\n* Hospitalization at enrollment.\n* Refusal to participate or inability to complete study procedures.","100 Years",{"count":56,"type":21},192,[24],"This clinical trial aims to evaluate the effect of temporary methotrexate (MTX) discontinuation on the humoral immunogenicity of the 20-valent pneumococcal conjugate vaccine (PCV20) in adult patients with autoimmune rheumatic diseases (ARDs).\n\nKey questions:\n\n* Does suspending MTX for 2 weeks after PCV20 enhance humoral immunogenicity?\n* What is the impact of MTX discontinuation on functional opsonophagocytic activity (OPA) and cellular immunity?\n* What is the risk of disease flaring with MTX withdrawal?",[27],[61,62,63,64,65,66],"Pneumococcal Vaccine","Methotrexate","PCV20","Immunogenicity","Vaccination","Rheumatology","2026-03-19",{"date":69,"type":38},"2026-03-24",{"date":71,"type":21},"2026-03-25",{"date":73,"type":21},"2028-12-30",{"name":44,"class":45},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100614526","phase-4-recombinant-herpes-zoster-vaccine-in-patients-with-autoimmune-rheumatic-diseases-under-immunomodulators-100614526","NCT07280741","Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators","Efficacy, Immunogenicity, and Safety of the Recombinant Herpes Zoster Vaccine (RZV) in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators","IMUNO-RZV","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosis of an autoimmune rheumatic disease (such as rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, psoriatic arthritis, systemic sclerosis, Sjögren syndrome, idiopathic inflammatory myopathies, or primary systemic vasculitis) according to validated classification criteria.\n* Clinical stability at the time of enrollment, defined as no change in disease-modifying therapy or corticosteroid dose in the preceding four weeks and no evidence of infection or disease flare.\n* Current use of hydroxychloroquine or sulfasalazine in monotherapy for at least three months prior to inclusion.\n* Can be under prednisone use of 5mg\u002Fweek.\n* Ability and willingness to comply with study procedures and follow-up visits.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Previous vaccination with recombinant zoster vaccine (RZV).\n* History of herpes zoster or varicella infection within 12 months before enrollment.\n* Concomitant use of systemic immunosuppressive therapy including but not limited to methotrexate, mycophenolate mofetil, azathioprine, cyclophosphamide, biologics, or JAK inhibitors.\n* Use of glucocorticoids \\>5mg\u002Fweek.\n* Acute febrile illness or active infection at the time of vaccination.\n* Pregnancy or breastfeeding.\n* Known hypersensitivity to any component of the recombinant zoster vaccine.\n* History of Guillain-Barré syndrome.\n* Any condition that, in the investigators' judgment, could interfere with study participation or interpretation of results.",{"count":84,"type":21},200,[24],"This interventional phase IV clinical trial will evaluate the efficacy, immunogenicity and safety of the adjuvanted recombinant herpes zoster vaccine (RZV) in adults with autoimmune rheumatic diseases (ARDs) receiving immunomodulatory monotherapy. Humoral immune response will be quantified by anti-glycoprotein E (anti-gE) antibody titers. Patients will receive two doses of RZV. Outcomes include seroconversion and geometric mean titers six weeks after completion of the vaccination schedule, persistence of antibody titers at one year, and incidence of confirmed herpes zoster during follow-up.",[27],[64,89,90,91,92,93],"Hepers Zoster","Vaccine","Safety","Immunomodulators","Inflammation","RECRUITING","2026-03-06",{"date":97,"type":38},"2026-03-11",{"date":99,"type":38},"2025-12-02",{"date":101,"type":21},"2028-07-30",{"name":44,"class":45},1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100619189","phase-4-prevention-of-recurrence-of-herpes-simplex-in-autoimmune-rheumatic-diseases-100619189","NCT07341386","Prevention of Recurrence of Herpes Simplex in Autoimmune Rheumatic Diseases","Prevention of Recurrence of Herpes Simplex in Patients With Autoimmune Rheumatic Diseases","PRoHerpARD","Inclusion Criteria\n\n* Eligible participants must be \\>12 years old\n* Any sex\n* Have a confirmed diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted classification criteria, including: rheumatoid arthritis (ACR\u002FEULAR 2010), juvenile idiopathic arthritis (ILAR), axial spondyloarthritis (ASAS 2009), psoriatic arthritis (CASPAR 2012), systemic lupus erythematosus (SLICC 2012), systemic sclerosis (ACR 2013), dermatomyositis\u002Fpolymyositis (Bohan \\& Peter), systemic vasculitis (Takayasu arteritis, granulomatosis with polyangiitis, polyarteritis nodosa), primary Sjögren's syndrome (ACR\u002FEULAR 2016), mixed connective tissue disease (Alarcón-Segovia or Kasukawa criteria), chronic recurrent multifocal osteomyelitis (Jansson et al., 2007), sarcoidosis (ATS\u002FERS\u002FWASOG 2020 statement) and behçet's syndrome (International Study Group, 1990).\n* Present serologic evidence of prior HSV infection (complement fixation titer ≥ 1:8)\n* A clinical history of recurrent oral or genital herpes simplex virus infection, defined as at least four episodes in the past 12 months.\n\nExclusion Criteria\n\n-Participants will be excluded if they have a known hypersensitivity to acyclovir or any component of the study medication.","12 Years",{"count":114,"type":21},62,[24],"The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate the effectiveness and safety of oral suppressive therapy with acyclovir in preventing herpes simplex virus (HSV) reactivation in patients with autoimmune rheumatic diseases (ARDs) who have a history of recurrent HS episodes.\n\nThe main questions this study aims to answer are:\n\nDoes continuous oral acyclovir reduce the frequency of HSV reactivation in ARD patients compared to placebo? What is the safety profile of prolonged acyclovir use in this population? What are the main risk factors (clinical and treatment-related) associated with HSV reactivation in immunosuppressed patients.\n\nParticipants will:\n\nBe randomly assigned (1:1) to receive oral acyclovir (400 mg BID) or placebo for 12 months; Be followed for a total of 24 months, with regular clinical evaluations (every 3 months) and laboratory monitoring (every 3 months); Be assessed for HSV recurrence based on clinical symptoms, detection of HSV DNA by polymerase chain reaction (PCR) in mucocutaneous swabs in doubtful cases, and standardized reporting forms; Undergo disease activity assessments and adverse event monitoring at regular intervals.\n\nThe study includes adult and pediatric patients with confirmed diagnoses of one of the following ARDs: systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), dermatomyositis\u002Fpolymyositis (DM\u002FPM), systemic sclerosis (SSc), systemic vasculitis, primary Sjögren's syndrome, Mixed connective tissue disease (MCTD), Chronic recurrent multifocal osteomyelitis (CRMO), Sarcoidosis and Behçet's Syndrome. All participants must have a documented history of recurrent HSV (oral and\u002For genital) before inclusion.",[27,118,119],"Recurrent Herpes Simplex","Prevention",[121,122,27,66,123,124,125],"Herpes Simplex Virus","Acyclovir","Pediatric Rheumatology","Antiviral Suppressive Therapy","Infectious Disease Prevention","2026-03-03",{"date":128,"type":38},"2026-03-05",{"date":130,"type":21},"2026-04-01",{"date":132,"type":21},"2028-04-01",{"name":44,"class":45}]