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:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-25 @ 3:40 AM
NCT ID:
NCT04281602
Eligibility Criteria:
Inclusion Criteria for patients:
* Adult patients suffering from rheumatoid arthritis diagnosed according to American College of Rheumatology/European League Against Rheumatism 2010 criteria and requiring an anti-IL-6 therapy by intravenous or subcutaneous injection
* Non-opposition of the patient
Inclusion Criteria for healthy controls:
* Adult patients not suffering from acute or chronic inflammatory disease at inclusion (normal C-reactive protein and fibrinogen levels)
* Non-opposition of the subject
Exclusion Criteria for patients:
* Patient is already treated with anti-IL-6 therapy
* Pregnancy or breastfeeding women
* Person under judicial protection, guardianship
* Patient suffering from another chronic inflammatory disease
* Patient suffering from another acute inflammatory disease at inclusion
* Person not beneficiaries of the social security system
Exclusion Criteria for healthy controls:
* Pregnancy or breastfeeding women
* Person under judicial protection, guardianship
* Patient suffering from acute or chronic inflammatory disease at inclusion
* Previous history of chronic inflammatory disease
* Ongoing anti-inflammatory or immunosuppressive treatment, except aspirin and derivatives at anti-platelet aggregation dose, non-steroidal anti-inflammatory drugs stopped for 10 days or systemic steroids stopped for 1 month
* Person not beneficiaries of the social security system
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04281602
Study Brief:
Protocol Section:
NCT04281602