Not Yet RecruitingPhase 4

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

192 participantsStarted 2026-03-25

Plain-language 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?

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Seroconversion Rate After Vaccination

Timeframe: Day 28 (4 weeks post-vaccination).

Trial details

NCT IDNCT07242092

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Clovis A Silva, Full Professor

(11) 2661-6105 vacina.reumatousp@gmail.com

View on ClinicalTrials.gov More Autoimmune Rheumatic Diseases trials