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

• Status: Not yet recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

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