Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not

Peripheral Entheses Clinical Trial

Official title:

Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038426
• Other study ID #: 2013-A00759-36
• Secondary ID: 2013-27
• Status: Completed
• Phase: N/A
• First received: August 1, 2013
• Last updated: June 10, 2016
• Start date: November 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Purpose:

• Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects, athletes or not

• Comparison of the ultrasound semiology of enthesitis in the 3 populations

• Comparison of the MASEI scores in the 3 populations

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• - Axial spondyloarthritis according to the ASAS classification criteria

• 18-45 years old

• Athletes are defined by sport activities greater than or equal to 6 hours per week

• Non athletes are defined by sport activities lesser than or equal to 1 hour per week

Exclusion Criteria:

• - History of heel or ankle surgery

• Recent corticosteroid infiltration of the heel or the ankle

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Peripheral Entheses
• Spondylarthritis

Intervention

Biological:
• BLOOD SAMPLES

Device:
• Radiographs of the sacroiliac joints

• Radiographs of heels

• SCAN

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	enthesitis detection	Number of subject having at least an enthesitis in every group of subjects	12 months	No
Secondary	MASEI scores		12 months	No