Effect of MTX Discontinuation on Shingrix Response in RA

Recruiting now · Not applicable

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT06574594

Run by

Konkuk University Medical Center

People needed

110

Starts

2024-08-22

Expected to finish

2025-12-31

Last updated by the study team

2024-08-28

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Konkuk University Medical Center — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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