NCT05313061UnknownPhase 3
Effect of One-week Discontinuation of Methotrexate on Immunogenicity of COVID-19 Booster Vaccination in Patients With Rheumatoid Arthritis: A Randomized Pilot Study
Seoul National University Hospital1 site in 1 country40 target enrollmentStarted: December 29, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Covid-19 antibody titer before and after Covid-19 vacciation
Study Overview
Brief Summary
To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
MTX continue
Active Comparator
Group will continue MTX after vaccination
Intervention: MTX (Drug)
MTX 1 week hold
Experimental
Group will continue MTX for 1 week after vaccination
Intervention: MTX (Drug)
Outcomes
Primary Outcomes
Covid-19 antibody titer before and after Covid-19 vacciation
Time Frame: 2 weeks
Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination
Secondary Outcomes
- T cell activation after vaccination(2, 4, 16 weeks)
- B cell activation after vaccination(2, 4, 16 weeks)
Investigators
Eun Bong Lee
Professor
Seoul National University Hospital
Study Sites (1)
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