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 range
18 Years – 50 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.