RecruitingNot ApplicableNCT06574594

Effect of MTX Discontinuation on Shingrix Response in RA

Effect of Methotrexate Discontinuation on Immunogenicity of Shingrix in Patients With Rheumatoid Arthritis


Sponsor

Konkuk University Medical Center

Enrollment

110 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if methotrexate discontinuation affect on immunogeneity of shingrix in RA patients. The main questions it aims to answer are: Discontinuation of methotrexate after shingrix immunization increase efficacy of the vaccine in patients with RA ? Researchers will compare humoral and cell-mediated immunity against herpes zoster in RA patients who are vaccinated by shingrix, and compare these immunity between RA patients with MTX discontinuation and MTX continuation groups. Participants will: Vaccinated with shingrix twice. MTX continuation group will keep taking MTX after shingrix vaccination, whereas MTX discontinuation group will stop MTX for 2 weeks after shingrix vaccination. Visit the clinic at baseline (first shingrix vaccination), 2 months later for 2nd shingrix vaccination, then 3 \& 6 months later from baseline to achieve blood sample.


Eligibility

Min Age: 19 Years

Inclusion Criteria4

  • fulfill 2010 ACR/EULAR classification criteria for rheumatoid arthritis
  • age over 19 years
  • methotrexate user
  • agree for vaccination with shingrix

Exclusion Criteria2

  • have other form of inflammatory arthritis or autoimmune-mediated disease
  • malignancy, current infection, pregnancy

Interventions

DRUGMethotrexate

methotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination

DRUGMethotrexate

methotrexate continuation group : keep methotrexate


Locations(1)

Konkuk University Medical Center

Seoul, South Korea

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NCT06574594


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