Effect of MTX Discontinuation on Shingrix Response in RA

NCT06574594 | Recruiting DMC

• 1 other identifier: 2024-02-038
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Rheumatoid Arthritis

Keywords

herpes zoster; Shingrix; methotrexate

Outcome Measures

Primary Outcomes (1)

• Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster)

  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)

  baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination

Study Arms (2)

MTX discontinuation

EXPERIMENTAL

methotrexate stop for 2 weeks after each shingrix vaccination

Drug: Methotrexate

MTX continuation

ACTIVE COMPARATOR

Drug: Methotrexate

Interventions

Methotrexate DRUG

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

MTX discontinuation

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Herpes Zoster

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hong Ki Min, MD, PhD

  Konkuk University Medical Center

  STUDY CHAIR

Central Study Contacts

Hong Ki Min, MD, PhD

CONTACT

+82-10-9977-5455; alsghdrl1921@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 28, 2024
• Study Start: August 22, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)