One or Two Week Methotrexate Discontinuation on Efficacy of Influenza Vaccination in Rheumatoid Arthritis.

Seoul National University

Status and phase

Completed

Phase 3

Conditions

Influenza

Vaccine Reaction

Autoimmune Diseases

Rheumatoid Arthritis

Treatments

Drug: MTX-hold

Study type

Interventional

Funder types

Other

Identifiers

NCT05069714

2109-020-1252

Details and patient eligibility

About

This is a multi-center, randomized, single-blinded, prospective, parallel group intervention study to investigate whether methotrexate (MTX) discontinuation for 1 week is non-inferior to MTX discontinuation for 2 weeks in regard to satisfactory vaccination response to a seasonal influenza.

Enrollment

184 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Males or females ≥ 19 years of age at time of consent
Have a diagnosis of RA per ACR criteria
Must understand and voluntarily sign an informed consent form including writing consent for data protection
Stable doses of methotrexate over the preceding 6 weeks

Exclusion criteria

Pregnant or lactating females
Previous anaphylactic response to vaccine components or to egg.
Acute infection with T >38°C at the time of vaccination
History of Guillain-Barre syndrome or demyelinating syndromes
Blood transfusion within 6 months
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