Clinical Trial

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

Study acronym: MTX-PCV20-ARD
Recruiting Phase 4
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Summary
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?
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-21
Trial Details
NCT Number NCT07242092
Lead Sponsor University of Sao Paulo General Hospital
Collaborators: Instituto Adolfo Lutz
Conditions Autoimmune Rheumatic Diseases
Enrollment 192 participants
Start Date 2026-06-22
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-20