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

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?

Timeline

Start

2026-06-22

Primary completion

2027-12-30

Completion

2028-12-30

Publications

• Background Frenck RW Jr, Gurtman A, Rubino J, Smith W, van Cleeff M, Jayawardene D, Giardina PC, Emini EA, Gruber WC, Scott DA, Schmole-Thoma B. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012 Aug;19(8):1296-303. doi: 10.1128/CVI.00176-12. Epub 2012 Jun 27.
• Background Chapman TJ, Pichichero ME, Kaur R. Comparison of pneumococcal conjugate vaccine (PCV-13) cellular immune responses after primary and booster doses of vaccine. Hum Vaccin Immunother. 2020 Dec 1;16(12):3201-3207. doi: 10.1080/21645515.2020.1753438. Epub 2020 May 13.
• Background Ribeiro AC, Guedes LK, Moraes JC, Saad CG, Aikawa NE, Calich AL, Franca IL, Carvalho JF, Sampaio-Barros PD, Goncalves CR, Borba EF, Timenetsky Mdo C, Precioso AR, Duarte A, Bonfa E, Laurindo IM. Reduced seroprotection after pandemic H1N1 influenza adjuvant-free vaccination in patients with rheumatoid arthritis: implications for clinical practice. Ann Rheum Dis. 2011 Dec;70(12):2144-7. doi: 10.1136/ard.2011.152983. Epub 2011 Aug 22.
• Background ten Wolde S, Breedveld FC, Hermans J, Vandenbroucke JP, van de Laar MA, Markusse HM, Janssen M, van den Brink HR, Dijkmans BA. Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis. Lancet. 1996 Feb 10;347(8998):347-52. doi: 10.1016/s0140-6736(96)90535-8.

Drugs

Indications