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

Effect of One-week vs Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial

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.

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