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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT05269069
Eligibility Criteria:
Inclusion Criteria:
Subjects:
Males and females of age (age ≥ 18 years). Patients with RA according to American College of Rheumatology/EULAR 2010 criteria, Patients who have signed the informed consent
Controls:
Males and females of age (age ≥ 18 years). subjects who have signed the informed consent
Exclusion Criteria:
* Patients who have received more than three anti-TNFinhibitors
* Patients who have previously received a Janus kinase (JAK) inhibitor
* Patients with concomitant therapies as described below :
A combination with methotrexate is allowed if methotrexate is started ≥3 months before the start of the study and at a stable dosage (≤25 mg/week) for ≥4 weeks.
A combination to conventional synthetic DMARDs (csDMARDs) other than methotrexate is not allowed within 4 weeks before and/or during the clinical trial
* Corticosteroid therapy \>10mg/d prednisolone equivalent is not allowed
* Intra-articular injections of corticosteroids are allowed if their number is less than or equal to 4
* Intravenous corticosteroid infusions are not allowed
* Immunosuppressants other than methotrexate are not allowed
* History or discovery of an osteoporotic fracture AND/OR T-score ≤-3 if ≥50 years old AND/OR Z-score ≤-3 if \<50 years old during the screening phase,
* Corticosteroid therapy ≥ 10mg/d prednisolone equivalent,
* Pathologies or treatments affecting bone metabolism (breast cancer with antiaromatase, digestive malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism...),
* History of radiotherapy on the lumbar spine or the hip studied,
* Patients undergoing hormone replacement therapy (HRT) or patients already under anti-osteoporotic treatment (bisphosphonates, strontium ranelate, teriparatide or denosumab) apart from calcium and/or vitamin D supplementation, Chronic renal failure with creatinine clearance (CKD-EPI formula) ≤ 30 ml/min,
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05269069
Study Brief:
Protocol Section:
NCT05269069