Effect of MTX Discontinuation on Shingrix Response in RA

Last updated: August 25, 2024
Sponsor: Konkuk University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Rheumatoid Arthritis

Treatment

Methotrexate

Clinical Study ID

NCT06574594
2024-02-038
  • Ages > 19
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • fulfill 2010 ACR/EULAR classification criteria for rheumatoid arthritis

  • age over 19 years

  • methotrexate user

  • agree for vaccination with shingrix

Exclusion

Exclusion Criteria:

  • have other form of inflammatory arthritis or autoimmune-mediated disease

  • malignancy, current infection, pregnancy

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Methotrexate
Phase:
Study Start date:
August 22, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Konkuk University Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

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