[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611554":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":28,"locations":27,"responsibleParty":35,"collaborators":37,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":27,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":67,"whyStopped":27,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":27},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MTX suspension","EXPERIMENTAL","Participants randomized to this arm will receive one dose of the 20-valent pneumococcal conjugate vaccine (PCV20) at baseline (D0). They will be instructed to discontinue methotrexate (MTX) for 2 weeks following vaccination, then resume their regular MTX regimen. Prednisone up to 5 mg\u002Fday and other stable background therapies will be maintained. Blood samples will be collected at baseline (D0), 4 weeks post-vaccination (D28), and 6 months post-vaccination (D180).",[13],"Biological: Pneumococcal Vaccine",{"label":15,"type":16,"description":17,"interventionNames":18},"MTX","ACTIVE_COMPARATOR","Participants randomized to this arm will receive one dose of the 20-valent pneumococcal conjugate vaccine (PCV20) at baseline (D0). They will continue MTX therapy without interruption during the vaccination period, maintaining their stable immunosuppressive regimen. Prednisone up to 5 mg\u002Fday and other stable background therapies will also be maintained. Blood samples will be collected at baseline (D0), 4 weeks post-vaccination (D28), and 6 months post-vaccination (D180).",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Pneumococcal Vaccine","All participants will receive a single intramuscular dose (0.5 mL) of PCV20 (Prevnar 20®, Pfizer), administered into the deltoid muscle at baseline (Day 0). PCV20 contains purified capsular polysaccharides of 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F), individually conjugated to the nontoxic diphtheria CRM197 carrier protein. The conjugation induces a T-cell dependent immune response, resulting in higher-affinity antibodies and immune memory compared to polysaccharide vaccines.",[15,9],[26],"20-valent Pneumococcal Conjugate Vaccine (PCV20)",null,[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Clovis A Silva, Full Professor","CONTACT","(11) 2661-6105","55","vacina.reumatousp@gmail.com",{"type":36,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[38],{"name":39,"class":40},"Insituto Adolfo Lutz","UNKNOWN","100611554","phase-4-influence-of-methotrexate-discontinuation-on-immunogenicity-after-pcv-20-vaccine-in-patients-ards-100611554",false,"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.","ALL","18 Years","100 Years",{"count":53,"type":54},192,"ESTIMATED","INTERVENTIONAL",[57],"PHASE4","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?",[60],"Autoimmune Rheumatic Diseases",[22,62,63,64,65,66],"Methotrexate","PCV20","Immunogenicity","Vaccination","Rheumatology","NOT_YET_RECRUITING","2026-03-19",{"date":70,"type":71},"2026-03-24","ACTUAL",{"date":73,"type":54},"2026-03-25",{"date":75,"type":54},"2028-12-30",{"name":5,"class":6}]