MTX Hold During Covid-19 Booster

Seoul National University

Status and phase: Enrolling; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: MTX

Study type: Interventional

Funder types: Other

Identifiers

NCT05313061

H-2112-019-1279

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

MTX continue

Active Comparator group

Description:

Group will continue MTX after vaccination

Treatment:

Drug: MTX

MTX 1 week hold

Experimental group

Description:

Group will continue MTX for 1 week after vaccination

Treatment:

Drug: MTX