French Cohort of Undifferentiated Spondyloarthritis (DESIR)
|ClinicalTrials.gov Identifier: NCT01648907|
Recruitment Status : Active, not recruiting
First Posted : July 24, 2012
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment|
|EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES||Other: Imaging exams|
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|
|Actual Enrollment :||708 participants|
|Official Title:||French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis|
|Actual Study Start Date :||October 15, 2007|
|Primary Completion Date :||June 20, 2016|
|Estimated Study Completion Date :||April 20, 2020|
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 :
- Radiological sacroiliitis [ Time Frame: 5 years ]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
- Predictive biomarker(s) of structural radiographic or IRM progression in SpA [ Time Frame: 5 years ]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
- Changes of level of biomarkers in the disease in 5 years [ Time Frame: 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
- Changes of level of biomarkers in the disease in 2 years [ Time Frame: 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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648907
|Department of Rheumatology, Cochin Hospital|
|Paris, France, 75014|
|Principal Investigator:||Maxime DOUGADOS, MD||Cochin Hospital, India|