French Cohort of Undifferentiated Spondyloarthritis (DESIR)

• ClinicalTrials.gov Identifier: NCT01648907
• Recruitment Status: Unknown
• First Posted: July 24, 2012
• Last Update Posted: May 25, 2017
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: July 20, 2012
• First Posted Date: July 24, 2012
• Last Update Posted Date: May 25, 2017
• Actual Study Start Date: October 15, 2007
• Actual Primary Completion Date: June 20, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 20, 2012)

Radiological sacroiliitis [ Time Frame: 5 years ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 23, 2017)

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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: French Cohort of Undifferentiated Spondyloarthritis
• Official Title: French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis
• Brief 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

Detailed 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

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients presenting early inflammatory back pain of more than 3 months and less than 3 years
• Condition: EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES

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.

Other Names:

• Radiological examinations
• Bone densitometry
• Enthesis ultrasound
• Biological tests

Study Groups/Cohorts

SPONDYLARTHRITIS COHORT

Intervention: Other: Imaging exams

Publications *

• 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, Wendling D. The DESIR cohort: a 10-year follow-up of early inflammatory back pain in France: study design and baseline characteristics of the 708 recruited patients. Joint Bone Spine. 2011 Dec;78(6):598-603. doi: 10.1016/j.jbspin.2011.01.013. Epub 2011 Mar 31.
• Descamps E, Molto A, Borderie D, Lories R, Richard CM, Pons M, Roux C, Briot K. Changes in bone formation regulator biomarkers in early axial spondyloarthritis. Rheumatology (Oxford). 2020 Sep 5. pii: keaa296. doi: 10.1093/rheumatology/keaa296. [Epub ahead of print]
• López-Medina C, Molto A, Claudepierre P, Dougados M. Clinical manifestations, disease activity and disease burden of radiographic versus non-radiographic axial spondyloarthritis over 5 years of follow-up in the DESIR cohort. Ann Rheum Dis. 2020 Feb;79(2):209-216. doi: 10.1136/annrheumdis-2019-216218. Epub 2019 Nov 29.
• Ruyssen-Witrand A, Luxembourger C, Cantagrel A, Nigon D, Claudepierre P, Degboe Y, Constantin A. Association between IL23R and ERAP1 polymorphisms and sacroiliac or spinal MRI inflammation in spondyloarthritis: DESIR cohort data. Arthritis Res Ther. 2019 Jan 15;21(1):22. doi: 10.1186/s13075-018-1807-5.
• Dougados M, Maksymowych WP, Landewé RBM, Moltó A, Claudepierre P, de Hooge M, Lambert RG, Bonin R, Bukowski JF, Jones HE, Logeart I, Pedersen R, Szumski A, Vlahos B, van der Heijde D. Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis. Ann Rheum Dis. 2018 Feb;77(2):221-227. doi: 10.1136/annrheumdis-2017-212008. Epub 2017 Sep 29.
• Ruyssen-Witrand A, Jamard B, Cantagrel A, Nigon D, Loeuille D, Degboe Y, Constantin A. Relationships between ultrasound enthesitis, disease activity and axial radiographic structural changes in patients with early spondyloarthritis: data from DESIR cohort. RMD Open. 2017 Sep 7;3(2):e000482. doi: 10.1136/rmdopen-2017-000482. eCollection 2017.
• Ez-Zaitouni Z, Hilkens A, Gossec L, Berg IJ, Landewé R, Ramonda R, Dougados M, van der Heijde D, van Gaalen F. Is the current ASAS expert definition of a positive family history useful in identifying axial spondyloarthritis? Results from the SPACE and DESIR cohorts. Arthritis Res Ther. 2017 May 31;19(1):118. doi: 10.1186/s13075-017-1335-8.
• Molto A, Tezenas du Montcel S, Wendling D, Dougados M, Vanier A, Gossec L. Disease activity trajectories in early axial spondyloarthritis: results from the DESIR cohort. Ann Rheum Dis. 2017 Jun;76(6):1036-1041. doi: 10.1136/annrheumdis-2016-209785. Epub 2016 Nov 25.
• Canouï-Poitrine F, Poulain C, Molto A, Le Thuaut A, Lafon C, Farrenq V, Ferkal S, Le Corvoisier P, Ghaleh B, Bastuji-Garin S, Fautrel B, Dougados M, Claudepierre P. Early tumor necrosis factor α antagonist therapy in everyday practice for inflammatory back pain suggesting axial spondyloarthritis: results from a prospective multicenter french cohort. Arthritis Care Res (Hoboken). 2014 Sep;66(9):1395-402. doi: 10.1002/acr.22330.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: July 20, 2012): 708
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: April 20, 2020
• Actual Primary Completion Date: June 20, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01648907
• Other Study ID Numbers: P070302; IDRCB 2007-A00608-45 ( Other Identifier: ANSM )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Not Provided

Investigators

• Principal Investigator: Maxime DOUGADOS, MD; Cochin Hospital

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: May 2017