Effect of MTX Discontinuation on Shingrix Response in RA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methotrexate, Methotrexate.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Methotrexate Discontinuation on Immunogenicity of Shingrix in Patients With Rheumatoid Arthritis
Overview
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.
Interventions
- Drug Methotrexate
methotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination - Drug Methotrexate
methotrexate continuation group : keep methotrexate
Primary outcome measures
- Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster) [Time frame: baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination]
Secondary outcome measures (1)
- , Humoral immunity (anti-VZV antibody, anti-gE antibody) [Time frame: baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
South Korea · 1 center
- Konkuk University Medical Center — Seoul
Identifiers
NCT: NCT06574594 · 2024-02-038