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

Study acronym: MTX-PCV20-ARD
StatusRecruiting
PhasePhase 4
Started2026-06-22
View on ClinicalTrials.gov ↗

Amendment history

2026-07-17
Study Status, Contacts/Locations v2
Recruitment opened
Start dateestimated 2026-03-25→confirmed 2026-06-22
Study sites0→1
2026-03-19
Study Status, Study Description, Outcome Measures, Eligibility v1
Primary completion date2026-12-30→2027-12-30
Completion date2027-12-30→2028-12-30
Start date2026-01-01→2026-03-25
Eligibility criteria+6 characters
[...] decompensated CHF (NYHA III-IV), demyelinating disease. Live virus vaccine ≤4 weeks or inactivated vaccine ≤2 weeks before. Bl [...]
Secondary endpointsdetails revised at 2 of 11 entries
Study description-1 characters
[...] ected at baseline (D0), 4 weeks post-vaccination (D28), and 126 months post-vaccination (D180). Humoral immunogenicity will [...]
2025-11-18
Original filing
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?
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