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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT05683769
Eligibility Criteria:
Inclusion Criteria:
For EHOA group:
* Diagnosis of EHOA according to the American College of Rheumatology (ACR) criteria and to the presence of the classical central erosion in at least two IP joints.
* Availability of plain radiography of both hands performed in the previous 6 months. Plain radiographs of both hands were collected and scored by two readers according to Kallman's classificationin a blind observation.
For PsA group:
* Diagnosis of PsA following the CASPAR classification guidelines
* peripheral arthritis pattern
* concomitant diagnosis of psoriasis confirmed by an expert dermatologist
* Naive to conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) or have withdrawn any DMARDs for at least three months, because of inadequate response or intolerance.
For control group:
* Healthy volunteers age-and sex-matched to study patients recruited among the hospital staff
* no symptoms or signs attributable to OA, psoriasis, as well as to autoimmune disorders and systemic inflammatory arthropathies.
Exclusion Criteria:
For all subjects:
* other rheumatic and not rheumatic diseases which can affect the functionality of the peripheral joints, as tendinopathies, carpal tunnel syndrome, Dupuytren's contractures, collagen diseases, neurological disorders or arthroplasty of the upper and lower limbs, recent trauma, or surgery of the concerned joints
* presence of inflammatory bowel diseases, liver or kidney diseases, acute or chronic infectious disorders, malignancy in the previous 5 years, pregnancy and breastfeeding.
* treatment with systemic or intra-articular (i.a.) corticosteroids, or with i.a. hyaluronic acid during the last three months.
* treatment with intra-muscular or intra-venous bisphosphonates in the previous 6 months
For EHOA group:
\- therapy with Symptomatic Slow Acting Drugs for Osteoarthritis (SYSADOAs) during the previous 6 months.
For PsA group:
\- PsA with pure axial involvement on the basis of inflammatory spinal pain and/or sacroiliac syndrome with spinal or sacroiliac radiographic changes and mixed involvement.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
73 Years
Study:
NCT05683769
Study Brief:
Protocol Section:
NCT05683769