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Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs

RecruitingPhase 4Ages 18 Years - 100 YearsAllUniversity of Sao Paulo General Hospital
NCT07242092 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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). Key questions: * Does suspending MTX for 2 weeks after PCV20 enhance humoral immunogenicity? * What is the impact of MTX discontinuation on functional opsonophagocytic activity (OPA) and cellular immunity? * What is the risk of disease flaring with MTX withdrawal?

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults (\>=18 years ) with confirmed ARD diagnosis (e.g., RA, PsA, axial SpA, primary Sjögren's, SLE, IIM, SSc, MCTD). * Stable MTX dose ≥12 weeks. * Prednisone ≤5 mg/day. * Low disease activity/remission according to specific disease activity criteria. * Eligible for PCV20 vaccination (no prior PCV20). Exclusion Criteria: * Anaphylaxis to vaccine components. * Acute febrile illness. * Guillain-Barré, decompensated CHF (NYHA III-IV), demyelinating disease. * Live virus vaccine ≤4 weeks or inactivated vaccine ≤2 weeks before. * Blood products in last 6 months. * Severe infection in last month (including pneumococcal). * Hospitalization at enrollment. * Refusal to participate or inability to complete study procedures.
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What it tests

  • Pneumococcal Vaccine
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Where

1 site
Reumatology division of Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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