Effect of MTX Discontinuation on Shingrix Response in RA

Konkuk University Medical Center

Status: Enrolling

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT06574594

2024-02-038

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

MTX discontinuation

Experimental group

Description:

methotrexate stop for 2 weeks after each shingrix vaccination

Treatment:

Drug: Methotrexate

Drug: Methotrexate

MTX continuation

Active Comparator group

Treatment:

Drug: Methotrexate

Drug: Methotrexate