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 @ 11:49 AM
Ignite Modification Date:
2025-12-24 @ 11:49 AM
NCT ID:
NCT02531061
Eligibility Criteria:
Inclusion Criteria:
* Initial medical examination performed,
* RA diagnosis according to the criteria of the ACR / EULAR 2010
* Low or moderate disease activity with a DAS28 ≤ 4 since at least for 6 months
* Patients with bDMARDs (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, ou Orencia®) since at least 6 months and no change planned by the investigator,
* Patient with at least one erosion on the head of the 2nd or 3rd metacarpal right or left,
* Stable corticosteroids dose since at least 3 months less than or equal to 10 mg of prednisone equivalent,
* Medical care and monitoring in the rheumatology department of the CHU of Saint-Etienne or the Edouard Herriot Hospital in Lyon,
* written consent of patient
Exclusion Criteria:
* Other diagnosis than RA,
* Intravenous or intra-articular injection at the 2nd or 3rd metacarpophalangeal left or right during the 3 months prior to inclusion,
* Surgery provided at the 2nd or 3rd metacarpophalangeal right or left within a year of inclusion,
* Concomitant treatment with zoledronic acid (Aclasta) or denosumab (Prolia®)
* Refusal of blood collection,
* Pregnancy or breastfeeding women,
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02531061
Study Brief:
Protocol Section:
NCT02531061