Effect of MTX Discontinuation on Shingrix Response in RA

Not Applicable

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Methotrexate

• Registration Number: NCT06574594
• Lead Sponsor: Konkuk University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-21
• Study Start: 2024-08-22
• Study First Submitted QC: 2024-08-25
• Last Update Submitted: 2024-08-25
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTX discontinuation	Methotrexate	methotrexate stop for 2 weeks after each shingrix vaccination
MTX continuation	Methotrexate	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
, Humoral immunity (anti-VZV antibody, anti-gE antibody)	baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of