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NCT Number: NCT06574594

Effect of MTX Discontinuation on Shingrix Response in RA

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.

Recruiting

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases DNA Virus Infections Herpes Zoster Herpesviridae Infections Immune System Diseases Infections Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Varicella Zoster Virus Infection Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. , 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Ki Min, MD, PhD

CONTACT

[email protected]

+82-10-9977-5455

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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