MTX Hold During Covid-19 Booster

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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