MTX Hold During Covid-19 Booster
- Registration Number
- NCT05313061
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MTX 1 week hold MTX Group will continue MTX for 1 week after vaccination MTX continue MTX Group will continue MTX after vaccination
- Primary Outcome Measures
Name Time Method Covid-19 antibody titer before and after Covid-19 vacciation 2 weeks Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of