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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT02903212
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of Rheumatoid arthritis
* Therapy failure with at least one biological agent from anti-TNF-alpha (etanercept, infliximab, adalimumab, certolizumab and golimumab; 3 months at optimal dose), anti-IL6 (tocilizumab; 3 months); T-cell costimulatory pathway inhibitor (abatacept; 3 months); anti-CD20 (rituximab; 6 months at optimal dose); Anti IL-1 (anakinra; 3 months)
* Disease Activity Score (DAS) DAS28 ≥ 3.2
* Subject has provided written informed consent
Exclusion Criteria:
* Pregnant or lactating women
* Inflammatory arthritis other than rheumatoid arthritis
* History of invasive cancer
* Immunodeficiency (HIV infection, Immunosuppressive therapy)
* Active bacterial or viral infections, in particular HCV or HBV.
* Surgery not older than 4 weeks.
* Unstable comorbidities: uncontrolled diabetes, heart disease, advanced renal or hepatic impairment.
* Contraindication to an apheresis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02903212
Study Brief:
Protocol Section:
NCT02903212