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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT06577350
Eligibility Criteria:
Inclusion Criteria:
Patient group:
* Participants with a diagnosis of AxSpA: Participants with diagnosis of Ankylosing Spondylitis according to the modified New York criteria and participants with diagnosis of non-radiographic Spondyloarthritis (SpA) according to the Assessment of SpondyloArthritis International Society (ASAS) 2009 criteria.
* Aged 18-65 years
* Who gave consent to participate in the study
Healthy control group:
* Age- and gender-matched healthy participants (age 18-65)
* Who gave consent to participate in the study
Exclusion Criteria:
1. Systemic high-dose steroid use (\>5mg/day of prednisone for more than 3 months)
2. Possible other causes of secondary sarcopenia (uncontrolled diabetes, chronic heart failure, thyroid/parathyroid disease, chronic renal failure, chronic liver failure)
3. Hand-related disorders/diseases that could affect the healthy assessment of grip strength
4. Use of any medication that could potentially affect the bone metabolism (bisphosphonates, teriparatide, anticonvulsants, heparin, and anticoagulants)
5. Psoriasis, inflammatory bowel disease
6. Infection in the thigh area where ultrasonographic evaluation will be performed
7. Body weight over 100 kg (contraindication to be positioned in the BMD device)
8. Presence of malnutrition (individuals scoring 11 or below on the Mini Nutritional Assessment-Short Form (MNA))
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06577350
Study Brief:
Protocol Section:
NCT06577350