Last updated: December 14, 2022
Sponsor: Seoul National University Hospital
Overall Status: Completed
Phase
3
Condition
Influenza
Rheumatoid Arthritis
Connective Tissue Diseases
Treatment
N/AClinical Study ID
NCT05069714
2109-020-1252
Ages > 19 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 writingconsent for data protection
- Stable doses of methotrexate over the preceding 6 weeks
Exclusion
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 connectivetissue disease, dermatomyositis/polymyositis, and vasculitis except for secondarySjogren's disease
- Any condition including laboratory abnormality which places the subject atunacceptable risk
- Subjects who decline to participate
Study Design
Total Participants: 184
Study Start date:
October 01, 2021
Estimated Completion Date:
September 30, 2022
Connect with a study center
Seoul National Univ. Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
Korea, Republic ofSite Not Available
SMG-SNU Boramae Medical Center
Seoul, 156-707
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
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