Discontinuing Methotrexate for 2 Weeks After PCV20 to See If Immunity Improves

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, controlled study will compare immune responses after PCV20 vaccination in patients with autoimmune rheumatic diseases who temporarily discontinue methotrexate for two weeks versus those who continue it. Primary focus is on humoral immunogenicity, with secondary measures including functional opsonophagocytic activity and cellular immunity. The study also monitors the risk of disease flare during methotrexate withdrawal and safety outcomes. Eligible participants are adults with stable methotrexate dosing and low disease activity who are vaccine-naïve to PCV20. The trial is conducted at a major Brazilian center with collaboration from a national institute and is sponsored by a university hospital.

Why it matters

Who can join: the full rules

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.

Where it's running

• Reumatology division of Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Clovis A Silva, Full Professor
• Email: vacina.reumatousp@gmail.com
• Phone: (11) 2661-6105

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.