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Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy (EchoSpA)

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ClinicalTrials.gov Identifier: NCT00794404
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : October 31, 2016
Sponsor:
Collaborators:
Groupe Français d'Etude Génétique des Spondylarthropathies
French Society of Rheumatology
Information provided by (Responsible Party):
Dr Maria-Atonietta D'AGOSTINO, Groupe Français d'Etude Génétique des Spondylarthropathies

Brief Summary:
The purpose of this study is to evaluate the interest of enthesis sonography for the diagnosis of spondylarthritis, in patients with uncertain diagnosis consulting for clinical symptoms suggestive of spondylarthritis

Condition or disease
Spondylarthropathy Ankylosing Spondyloarthitis Spondyloarthritis

Detailed Description:
Spondylarthritis (SPA) are the second most frequent inflammatory rheumatic disorders and, because it starts early in life and has a chronic progressive course, the impact of this disease on health resources and patient's life quality can be important. Because the characteritic signs of SPA, like radiological evidence of sacro-iliitis, appear late in time, the lag time between the onset first signs of SPA for the patient and the confirmed diagnosis can be very long (up to 8 years). Previous studies proved that patients who are affected by SPA are showing abnormal vascularization of peripheral enthesis more frequently than patients affected by other rheumatic diseases. Ultrasonography in B mode combined with power Doppler (PDUS) is a non invasive and highly sensitive toll which can detect enthesitis and abnormal vsacularization even for the patients who are not showing yet the evidence of SPA's symptomatology. Using PDUS as a early diagnosis tool could lead to the improvement of diagnostic procedures and therapeutic management of SpA and reduce the cost of diagnosis for patient and health insurances.

Study Type : Observational
Actual Enrollment : 489 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy in Patients With Uncertain Diagnosis Consulting for Clinical Symptoms Suggestive of Spondylarthropathy
Study Start Date : December 2004
Actual Primary Completion Date : March 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a symptomatology which can lead to a SPA diagnosis but with no confirmed diagnosis yet for any rheumatic didease.
Criteria

Inclusion Criteria:

  • patients < 50 years old, consulting for spinal inflammatory symptoms > 3 months duration
  • patients consulting for arthritis or tenderness joints > 3 months duration
  • patients < 50 years old consulting for enthesitis or dactylitis > 3 months duration
  • patients with uveitis and HLA-B27 positivity
  • relatives of SpA patients consulting for symptoms suggestive of SpA

Exclusion Criteria:

  • patient with confirmed diagnosis of rheumatic disease (included SpA)
  • patient protected by law (patient <18 years old, pregnant woman)
  • patient who can't atempt the RMI
  • patient who will have difficulties to complete the two years of follow-up

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): NCT00794404


Locations
France
Ambroise Paré Hospital
Boulogne Billancourt, France, 92100
Cavale Blanche Hospital
Brest, France, 29200
Cote de Nacre Hospital
Caen, France, 14033
South Hospital of Grenoble
Echirolles, France, 38434
Conception Hospital
Marseille, France, 13005
Nancy Brabois Hospital
VANDOEUVRE les NANCY, France, 54511
Sponsors and Collaborators
Dr Maria-Atonietta D'AGOSTINO
Groupe Français d'Etude Génétique des Spondylarthropathies
French Society of Rheumatology
Investigators
Principal Investigator: D'AGOSTINO Maria-Antonietta, MCUPH Ambroise Paré Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Maria-Atonietta D'AGOSTINO, PU-PH, Groupe Français d'Etude Génétique des Spondylarthropathies
ClinicalTrials.gov Identifier: NCT00794404     History of Changes
Other Study ID Numbers: GESPA
First Posted: November 20, 2008    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: November 2008
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Spondylarthritis
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases