Rheumatoid Arthritis
Conditions
Keywords
herpes zoster, Shingrix, methotrexate
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.
Interventions
DRUGMethotrexate
methotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination
Sponsors
Konkuk University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| , Humoral immunity (anti-VZV antibody, anti-gE antibody) | baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination |
Countries
South Korea
Contacts
Primary ContactHong Ki Min, MD, PhD
Outcome results
None listed