ankylosing spondylitis axial spondyloarthritis rheumatic disease of the spine
Conditions
Interventions
None listed
Sponsors
Zuyderland
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: a) Male and female patients of at least 18 years b) Diagnosis of radiographic axial SpA according to the rheumatologist and fulfilling the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for radiographic axial SpA c) At least one syndesmophyte (cervical or lumbar) on CR (as assessed by the rheumatologist and local investigator)* d) Provide a written informed consent *All local investigators have expertise in the assessment of conventional radiographs and therefore this assessment functions as a type of central reading
Exclusion criteria
Exclusion criteria: a) A history of alcoholism, drug abuse, psychological or other emotional problems, severe co-morbidity that are likely to invalidate informed consent or limit the ability of the subject to comply with the protocol requirements. b) Pregnancy or an active desire to have children on the short-term c) Presence of >=18 syndesmophytes (i.e. less than 6 vertebral corners free of syndesmophytes) d) Spinal surgery with osteosynthesis material present in the spine (foreign material visible on the radiograph)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Validation of the CTSS and CTFASSS in an independent cohort, following the Outcome OMERACT filter (truth, discrimination, feasibility) | — |
Secondary
| Measure | Time frame |
|---|---|
| 8.1.2. Secondary study parameters/endpoints (if applicable) - Comparison of the psychometric properties (e.g. discrimination) between ldCT and CR in the assessment of progression of structural damage; - Comparison between an ldCT-score including syndesmophyte formation and facet joint ankylosis (CTFASSS, under development) and a score that only includes syndesmophytes (CTSS); - Estimation of the potential reduction in the sample size required in controlled trials when using an ldCT score instead of CR to assess progression of structural damage; - Reliability of structural progression on ldCT at 1 year; - Psychometric properties of structural progression on ldCT limited to the thoracic spine, with reduced radiation exposure compared to an ldCT score of the whole spine, compared to CR. 8.1.3. Other study parameters (if applicable) Beyond the main research questions of the study, additional questions can be addressed in AXIOMA. Examples are: - Assessment of the relationship between bone mineral densities using ldCT (Hounsfield units) and progression of structural damage; - Assessment of whether a syndesmophyte captured by ldCT is predictive of a syndesmophyte later visible on CR; - Assessment of whether progression of spinal damage in ldCT is associated with progression of damage at the sacro-iliac joints also assessed with ldCT; - Investigation of the relationship with major outcomes over time, e.g. longitudinal association of structural damage and spinal mobility or functional impairment, relationship between disease activity and structural progression as measured by ldCT. New objectives related to the 4-year extension of AXIOMA: - To gain insight into spinal and SIJ structural damage progression over time, as measured by ldCT, in patients with axSpA; - To analyse the predictive validity of MRI spinal and SIJ structural lesions (erosions, fatty lesions, ankylosis) using the ldCT structural lesions as the gold standard; - To investigate | — |
Countries
France, Germany, Netherlands, Spain, Turkey
Contacts
Public ContactMS Ramiro
Zuyderland
Outcome results
None listed