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French Cohort of Undifferentiated Spondyloarthritis (DESIR)

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ClinicalTrials.gov Identifier: NCT01648907
Recruitment Status : Unknown
Verified May 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : July 24, 2012
Last Update Posted : May 25, 2017
Sponsor:
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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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