Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy

Spondyloarthritis Clinical Trial

— EchoSpA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794404
• Other study ID #: GESPA
• Status: Completed
• Phase: N/A
• First received: November 19, 2008
• Last updated: October 28, 2016
• Start date: December 2004
• Est. completion date: December 2010

Study information

• Verified date: November 2008
• Source: Groupe Français d'Etude Génétique des Spondylarthropathies
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondyloarthitis
• Spondylarthritis
• Spondylarthropathies
• Spondylarthropathy
• Spondyloarthritis

Locations

Country	Name	City	State
France	Ambroise Paré Hospital	Boulogne Billancourt
France	Cavale Blanche Hospital	Brest
France	Cote de Nacre Hospital	Caen
France	South Hospital of Grenoble	Echirolles
France	Conception Hospital	Marseille
France	Nancy Brabois Hospital	VANDOEUVRE les NANCY

Sponsors (3)

Lead Sponsor	Collaborator
Dr Maria-Atonietta D'AGOSTINO	French Society of Rheumatology, Groupe Français d'Etude Génétique des Spondylarthropathies

Country where clinical trial is conducted

France,