2-week dc of MTX and Influenza Vaccination in RA

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate whether a transient discontinuation of methotrexate MTX for 2 weeks improves the vaccination response to a seasonal influenza.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Methotrexate; Vaccines

Criteria

Inclusion Criteria:

• Males or females ≥ 19 years and < 65 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

• Previous vaccination with any live vaccine 4 weeks before or any inactivated vaccine 2 weeks before the study

• Blood transfusion within 6 months

• Active rheumatoid arthritis necessitating a recent change in the drug regimen

• 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