Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs
Recruiting
Phase 4
Interventional Study
Autoimmune Rheumatic Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 192 (estimated)
- Sponsor
- University of Sao Paulo General Hospital · Other
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About This Trial
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 opso…
Trial Locations
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Eligibility Criteria
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 va…
Contacts