French Cohort of Undifferentiated Spondyloarthritis

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis

Conditions
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EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES

Intervention / Treatment
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* Other: Imaging exams


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SPONDYLARTHRITIS COHORT<br> | Other: Imaging exams<br>* 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.<br>* Other names: Biological tests;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological sacroiliitis | 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 | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive biomarker(s) of structural radiographic or IRM progression in SpA | 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 | 5 years | 
| Changes of level of biomarkers in the disease in 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 | 5 years | 
| Changes of level of biomarkers in the disease in 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 | 2 years | 
| Correlation and/or association between changes of biomarkers and structural damages at 2 and 5 years |  | 5 years | 
| Correlation and/or association between changes of biomarkers and disease activity at 2 and 5 years |  | 5 years | 
| Correlation and/or association between changes of biomarkers in patients with or without anti-TNF treatment |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DESIR, SPONDYLARTHRITIS, EARLY INFLAMMATORY RACHIIALGIA, BACK PAIN