Effect of MTX Discontinuation on Shingrix Response in RA

August 25, 2024 updated by: Hong Ki Min, Konkuk University Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MTX discontinuation
methotrexate stop for 2 weeks after each shingrix vaccination
Drug: Methotrexate
methotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination
Drug: Methotrexate
methotrexate continuation group : keep methotrexate
Active Comparator: MTX continuation
Drug: Methotrexate
methotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination
Drug: Methotrexate
methotrexate continuation group : keep methotrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster)
Time Frame: baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination
baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
, Humoral immunity (anti-VZV antibody, anti-gE antibody)
Time Frame: baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination
baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Investigators

  • Study Chair: Hong Ki Min, MD, PhD, Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 22, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 25, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-02-038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD can be shared with reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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