This study is a large national multicenter, longitudinal, prospective follow-up of patients presenting with early inflammatory back pain in order to set up a database to facilitate several investigations on diagnosis, prognosis, epidemiology, pathogenesis and medico-economics in the field of early inflammatory back pain and spondyloarthritis
This large national multicenter, longitudinal, prospective follow-up of patients presenting with early inflammatory back pain in order to set up a database to facilitate several investigations on diagnosis, prognosis, epidemiology, pathogenesis and medico-economics in the field of early inflammatory back pain and spondyloarthritis. The Patients were recruited if they had inflammatory back pain of more than 3months and less than 3years. Patients will be followed every 6months during the first 2years then every year during at least 5years. Apart from information collected on a Case Report Form (demographics, disease activity, severity, co-morbidities, socio-economics, treatments, radiological and MRI evaluation of the spine and the pelvis according to the local investigators, and for some centers bone densitometry and ultrasonography of entheses), the digital X-rays and MRI of the spine and pelvis are stored using a specific software (Carestream) and the biological samples (DNA, RNA, sera, urines) are centralized at the Biological Resources Center (Bichat Hospital). This large cohort should facilitate the conduct of researches in different areas (clinical, medico-economics, translational) in order to improve our knowledge on the pathogenesis and natural history of axial spondyloarthritis
Study Type
OBSERVATIONAL
Enrollment
708
Radiological examinations: * Standard x-ray: they include an x-ray of the cervical, thoracic, and lumbar spine (side-on), of the lumbar spine from the front and an x-ray of the pelvis from the front * MRI scan: are taken of the cervical, thoracic and lumbar spine and sacroiliac joints. Bone densitometry: evaluation of bone densitometry of the lumbar spine and femoral neck. Enthesis ultrasound: bilateral evaluation of entheseal insertions for the Achilles tendon, patella tendons and epicondyle tendons. Biological tests : * Genetic test : DNA will be collected at the first visit from all centers. RNA will be collected at the inclusion visit in AP-HP centres only. * Serum will be collected by all centres at the initial visit, then in M6, M12 and M24 for the first two years of the study, then in M60. * Urine will be collected by all centres at the initial visit, then in M24 for the first two years of the study, then in M60.
Department of Rheumatology, Cochin Hospital
Paris, France
Radiological sacroiliitis
Percentage of patients after 5 years of evolution, that will have a radiological sacroiliitis according to the presence or absence of the sacroiliac inflammatory abnormalities of the sacroiliac joints at study entry on MRI
Time frame: 5 years
Predictive biomarker(s) of structural radiographic or IRM progression in SpA
To identify biomarker(s) of bone formation (DKK-1, sclérostin, BMP-7, périostin) which are predictive of structural radiographic progression and in IRM at 5 years
Time frame: 5 years
Changes of level of biomarkers in the disease in 5 years
To assess the 5-year changes in of serum periostin, serum sclerostin, DKK-1 and BMP-7 in a large population of early axial SpA
Time frame: 5 years
Changes of level of biomarkers in the disease in 2 years
To assess the 2-year changes in of serum periostin, serum sclerostin, DKK-1 and BMP-7 in a large population of early axial SpA
Time frame: 2 years
Correlation and/or association between changes of biomarkers and structural damages at 2 and 5 years
Time frame: 5 years
Correlation and/or association between changes of biomarkers and disease activity at 2 and 5 years
Time frame: 5 years
Correlation and/or association between changes of biomarkers in patients with or without anti-TNF treatment
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.