Status:
UNKNOWN
MTX Hold During Covid-19 Booster
Lead Sponsor:
Seoul National University Hospital
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05313061
Start Date
December 29 2021
End Date
December 30 2022
Last Update
April 6 2022
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080