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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT05570656
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65
* BMI between 18.5 and 30
* Written informed consent
* Same gender and age within +/- 3 years compared to an unmatched AS patient
Inclusion criteria specific to the AS group:
* Age 18-65
* BMI between 18.5 and 30
* Written informed consent
* AS meeting the ASAS (Assessment of Spondylo Arthritis International Society) criteria, i.e. with spinal pain ≥ 3 months old, with an age of diagnosis \< 45 years, with:
* Sacroiliitis on imaging AND ≥ 1 sign of spondylarthritis. OR
* HLA-B27 (human leukocyte antigen-B27) positive AND ≥ 2 other signs of spondylarthritis
Exclusion Criteria:
* Traumatic, tumoral or infectious low back pain
* History of spinal fracture
* History of lumbar, pelvis, hips, ankles, and/or knees surgery
* Severe scoliosis defined by a Cobb angle \> 50°
* Severe impairment of uncorrected visual acuity
* Concomitant pathology responsible for ataxia
* Lumbar arthrodesis of two or more stages
* Pregnant or breastfeeding women
* Patient unable to give consent: patient under guardianship or curators, mentally retarded, dementia, language barrier
* Patient not affiliated to a social security plan
* Patient under legal protection
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05570656
Study Brief:
Protocol Section:
NCT05570656