708 patients tracked to uncover clues about spinal disease
NCT ID NCT01648907
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study followed 708 adults with early inflammatory back pain for up to 5 years. Researchers collected data to better understand how the disease progresses, what predicts joint damage, and how to improve diagnosis. The goal was to gather knowledge, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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708 people
The number who actually took part.
- Started
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Oct 2007
- Finished
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Feb 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients presenting early inflammatory back pain of more than 3 months and less than 3 years
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, Methotrexate or Azathioprine. However any history of treatment with biotherapy including anti-TNF therapy defined exclusion criteria * Corticosteroid intake was permitted only in case of a dose lower than 10 mg prednisoneper day and stable for at least 4 weeks prior baseline * MRI contraindication * No affiliation to the French National Social Security System
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Rheumatology, Cochin Hospital
Paris, 75014, France