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Trial record 1 of 1 for:    NCT01648907
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French Cohort of Undifferentiated Spondyloarthritis (DESIR)

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ClinicalTrials.gov Identifier: NCT01648907
Recruitment Status : Completed
First Posted : July 24, 2012
Last Update Posted : October 31, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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

Condition or disease Intervention/treatment
EARLY UNDIFFERENTIATED SPONDYLARTHROPATHIES Other: Imaging exams

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 Design
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Study Type : Observational
Actual Enrollment : 708 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: French Cohort on Outcome of Recent Undifferentiated Spondyloarthritis
Actual Study Start Date : October 15, 2007
Actual Primary Completion Date : June 20, 2016
Actual Study Completion Date : February 23, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Correlation and/or association between changes of biomarkers and structural damages at 2 and 5 years [ Time Frame: 5 years ]
  5. Correlation and/or association between changes of biomarkers and disease activity at 2 and 5 years [ Time Frame: 5 years ]
  6. Correlation and/or association between changes of biomarkers in patients with or without anti-TNF treatment [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting early inflammatory back pain of more than 3 months and less than 3 years
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648907


Locations
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France
Department of Rheumatology, Cochin Hospital
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Maxime DOUGADOS, MD Cochin Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01648907    
Other Study ID Numbers: P070302
IDRCB 2007-A00608-45 ( Other Identifier: ANSM )
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: October 31, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
DESIR
SPONDYLARTHRITIS
EARLY INFLAMMATORY RACHIIALGIA
BACK PAIN
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Spondylarthropathies
Bone Diseases, Infectious
Infections
 Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases