French Cohort of Undifferentiated Spondyloarthritis

EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES Clinical Trial

— DESIR  

Official title:

French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01648907
• Other study ID #: P070302
• Secondary ID: IDRCB 2007-A0060
• Status: Completed
• Start date: October 15, 2007
• Est. completion date: February 23, 2022

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 708
• Est. completion date: February 23, 2022
• Est. primary completion date: June 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES
• Spondylarthritis
• Spondylarthropathies
• Spondylitis

Intervention

Other:
• Imaging exams
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.

Locations

Country	Name	City	State
France	Department of Rheumatology, Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Dougados M, d'Agostino MA, Benessiano J, Berenbaum F, Breban M, Claudepierre P, Combe B, Dargent-Molina P, Daurès JP, Fautrel B, Feydy A, Goupille P, Leblanc V, Logeart I, Pham T, Richette P, Roux C, Rudwaleit M, Saraux A, Treluyer JM, van der Heijde D, W — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Correlation and/or association between changes of biomarkers and structural damages at 2 and 5 years		5 years
Secondary	Correlation and/or association between changes of biomarkers and disease activity at 2 and 5 years		5 years
Secondary	Correlation and/or association between changes of biomarkers in patients with or without anti-TNF treatment		5 years