French Cohort of Undifferentiated Spondyloarthritis (DESIR)

October 28, 2022 updated by: Assistance Publique - Hôpitaux de Paris

French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

708

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Department of Rheumatology, Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting early inflammatory back pain of more than 3 months and less than 3 years

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SPONDYLARTHRITIS COHORT
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
5 years
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
2 years
Correlation and/or association between changes of biomarkers and structural damages at 2 and 5 years
Time Frame: 5 years
5 years
Correlation and/or association between changes of biomarkers and disease activity at 2 and 5 years
Time Frame: 5 years
5 years
Correlation and/or association between changes of biomarkers in patients with or without anti-TNF treatment
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Maxime DOUGADOS, MD, Cochin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2007

Primary Completion (Actual)

June 20, 2016

Study Completion (Actual)

February 23, 2022

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 20, 2012

First Posted (Estimate)

July 24, 2012

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P070302
  • IDRCB 2007-A00608-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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