Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs
Eligible age
18–100 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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?
Sponsor: University of Sao Paulo General Hospital
You may qualify if…
- ✓ 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).
You may not qualify if…
- ✕ 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.
Source: ClinicalTrials.gov · NCT07242092 · last updated 2026-07-20