French Cohort of Undifferentiated Spondyloarthritis (NCT01648907) | Clinical Trial Compass
CompletedNot Applicable
French Cohort of Undifferentiated Spondyloarthritis
France708 participantsStarted 2007-10-15
Plain-language 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
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged over 18 and under 50 years
* Inflammatory back pain (buttock, lumbar or thoracic spine) fulfilling either the Calin orBerlin criteria :
* Calin criteria (at least 4 of 5 criteria must be met) (ref. 25):
* Insidious onset
* Onset before age 40
* Persistence since at least three months
* Morning stiffness 30 minutes
* Improvement with exercise
* Berlin criteria (at least 2 of 4 criteria must be met) (ref. 26):
* Morning stiffness 30 minutes
* Improvement with exercise and absence of improvement at rest
* Nocturnal pain in the second part of the night
* Alternating buttock pain
* Symptom duration more than 3 months and less than 3 years
* Symptoms suggestive of spondyloarthritis according to the local investigator's assessment(e.g. score ≥5 on a 0 to 10 numerical rating scale in which 0 = no suggestive and 10 = verysuggestive of spondyloarthritis)
* Realization of a prior medical examination (article L.1121-11 of the Code of the Public health)
* Informed consent Dated and signed voluntarily
Exclusion Criteria:
* Other spinal disease clearly defined (eg symptomatic mechanical discopathy)
* Pregnant woman
* History of alcoholism, drug addiction, psychological problems, severe co-morbidities which might interfere with the validity of the informed consent and/or prevent an optimal compliance of the patient to the cohort
* It was possible to include patients who have received or are receiving a thorough treatment such as Sulfasalazine, Methotrex…