Rheumatoid Arthritis
Conditions
Brief summary
To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.
Interventions
DRUGMTX
MTX continuation
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females ≥ 19 years of age at time of consent * Have a diagnosis of RA per ACR criteria * Require methotrexate for RA treatment * Subject to a Covid-19 booster vaccination * Must understand and voluntarily sign an informed consent form including writing consent for data protection
Exclusion criteria
* Pregnant or lactating females * Previous anaphylactic response to the vaccine components * Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease * Any condition including laboratory abnormality which places the subject at unacceptable risk * Subjects who decline to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Covid-19 antibody titer before and after Covid-19 vacciation | 2 weeks | Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T cell activation after vaccination | 2, 4, 16 weeks | Percentage of activated T cells after vaccination |
| B cell activation after vaccination | 2, 4, 16 weeks | Percentage of activated b cells after vaccination |
Countries
South Korea
Outcome results
None listed