MTX Hold During Covid-19 Booster

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital

Criteria

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