CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 708 enrolled
Drug / intervention
Imaging examsother
Likely dose
Not stated in record
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Search/NCT01648907
NCT01648907N/ACompleted

French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis

Assistance Publique - Hôpitaux de Paris·observational·Posted Jul 24, 2012·Updated Mar 10, 2026

In Brief

An observational study evaluating Imaging exams for EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES. Completed, enrolled 708 participants across 1 site.

Detailed Summary

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 Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 24, 2012
Enrollment StartOct 15, 2007
Primary CompletionJun 20, 2016
Study CompletionFeb 23, 2022
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 13.9 years ago

Interventions

Imaging examsother

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.