Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT05313061
Eligibility Criteria:
Inclusion Criteria:
* Males or females ≥ 19 years of age at time of consent
* Have a diagnosis of RA per ACR criteria
* Require methotrexate for RA treatment
* Subject to a Covid-19 booster vaccination
* Must understand and voluntarily sign an informed consent form including writing consent for data protection
Exclusion Criteria:
* Pregnant or lactating females
* Previous anaphylactic response to the vaccine components
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05313061
Study Brief:
Protocol Section:
NCT05313061