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Effect of MTX Discontinuation on Shingrix Response in RA

NCT06574594 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-08-28

No results posted yet for this 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.

Conditions

Interventions

DRUG

Methotrexate

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

DRUG

Methotrexate

methotrexate continuation group : keep methotrexate

Sponsors & Collaborators

  • Konkuk University Medical Center

    lead OTHER

Principal Investigators

  • Hong Ki Min, MD, PhD · Konkuk University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-22
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06574594 on ClinicalTrials.gov