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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03110094
Eligibility Criteria:
Inclusion Criteria:
* Rheumatoid arthritis diagnosed according to EULAR 2010 criteria (European League Against Rheumatism);
* Active rheumatoid arthritis, defined by DAS 28\> 3.2;
* Corticotherapy systemic ≤ 15mg /day, stable for ≥ 15 days;
* Refractory or intolerant rheumatoid arthritis with at least one chemical background treatment;
* Previous biological treatment stopped for ≥ 3 months for monoclonal antibodies (except Rituximab) and 15 days for Etanercept;
* Patients who have given written informed consent.
* For healthy volunteers: subjects aged 18 coming to the French blood establishment of Rennes for a donation of blood
Exclusion Criteria:
* Patient minor;
* Presence of a contraindication to biological treatment;
* Previous treatment with Rituximab;
* Vaccination or surgery in the month preceding the study or planned within 3 months of inclusion;
* Patient not affiliated to social security;
* Major persons subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
* For healthy volunteers: Minor subject ; Subject not affiliated with social security ; Major persons subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03110094
Study Brief:
Protocol Section:
NCT03110094