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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT02116504
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients of more than 18 years old diagnosed with RA according to 2010 ACR/EULAR criteria Or Male and female patients Age \> 2 years and \<18 years, diagnosed with JIA according to the Internal League Against Rheumatism (ILAR) classification criteria.
* Patient for whom the Treating Physician has decided to prescribe in the usual manner in accordance with the terms of the marketing authorization and independently from entry into this study:
* etanercept, adalimumab, infliximab, infliximab Biosimilar, rituximab OR tocilizumab in first line or after failure with other biotherapy. In case of previous rituximab, inclusion may be possible at least 6 months after the last rituximab infusion therapy or,
* Subcutaneous form of Tocilizumab, either as first line or after switch from infusion tocilizumab form is allowed.
* Having given written informed consent prior to undertaking any study-related procedures. For JIA patients, written informed consent signed by parents or legal representative and assent of the minor child
* Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
Exclusion Criteria:
* Under any administrative or legal supervision.
* Patients having previously anti-TNF if they are going to receive another anti-TNF therapy
* Patients having previously received rituximab in the past 6 months.
* Conditions/situations such as:
* Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint
* Impossibility to meet specific protocol requirements (e.g. blood sampling)
* Patient is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
* Uncooperative or any condition that could make the patient potentially non-compliant to the study procedures
* Pregnant or breast-feeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT02116504
Study Brief:
Protocol Section:
NCT02116504