Effect of MTX Discontinuation on Shingrix Response in RA

NCT ID: NCT06574594

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-22

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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MTX discontinuation

methotrexate stop for 2 weeks after each shingrix vaccination

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

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

MTX continuation

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

methotrexate continuation group : keep methotrexate

Interventions

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Methotrexate

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

Intervention Type DRUG

Methotrexate

methotrexate continuation group : keep methotrexate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hong Ki Min

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Ki Min, MD, PhD

Role: STUDY_CHAIR

Konkuk University Medical Center

Locations

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Konkuk University Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hong Ki Min, MD, PhD

Role: CONTACT

+82-10-9977-5455

Facility Contacts

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Hong Ki Min, MD, PhD

Role: primary

+82-10-9977-5455

Other Identifiers

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2024-02-038

Identifier Type: -

Identifier Source: org_study_id

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