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Effect of Methotrexate Discontinuation on Immunogenicity of 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Patients With Autoimmune Rheumatic Diseases

Status: Recruiting

Location: See location...

Intervention Type: Biological

Study Type: Interventional

Study Phase: Phase 4

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?

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 100

Healthy Volunteers: f

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• 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).

Locations

Other Locations

Brazil

Reumatology division of Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

RECRUITING

São Paulo

Contact Information

Primary

Clovis A Silva, Full Professor

vacina.reumatousp@gmail.com

(11) 2661-6105

Time Frame

Start Date: 2026-06-22

Estimated Completion Date: 2028-12-30

Participants

Target number of participants: 192

Treatments

Experimental: MTX suspension

Participants randomized to this arm will receive one dose of the 20-valent pneumococcal conjugate vaccine (PCV20) at baseline (D0). They will be instructed to discontinue methotrexate (MTX) for 2 weeks following vaccination, then resume their regular MTX regimen. Prednisone up to 5 mg/day and other stable background therapies will be maintained. Blood samples will be collected at baseline (D0), 4 weeks post-vaccination (D28), and 6 months post-vaccination (D180).

Active_comparator: MTX

Participants randomized to this arm will receive one dose of the 20-valent pneumococcal conjugate vaccine (PCV20) at baseline (D0). They will continue MTX therapy without interruption during the vaccination period, maintaining their stable immunosuppressive regimen. Prednisone up to 5 mg/day and other stable background therapies will also be maintained. Blood samples will be collected at baseline (D0), 4 weeks post-vaccination (D28), and 6 months post-vaccination (D180).

Related Therapeutic Areas

Diphtheria

Strep Throat

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