French Cohort of Undifferentiated Spondyloarthritis (DESIR)
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
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis|
- Radiological sacroiliitis [ Time Frame: 5 years ] [ Designated as safety issue: No ]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
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||May 2021|
|Estimated Primary Completion Date:||May 2020 (Final data collection date for primary outcome measure)|
Other: Imaging exams
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 :
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648907
|Department of Rheumatology, Cochin Hospital|
|Paris, France, 75014|
|Principal Investigator:||Maxime DOUGADOS, MD||Cochin Hospital|