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

Primary Purpose

Peripheral Entheses

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BLOOD SAMPLES
Radiographs of the sacroiliac joints
Radiographs of heels
SCAN
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Entheses

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

the patients with SpA

sports subjects

control subjects

Arm Description

Outcomes

Primary Outcome Measures

enthesitis detection
Number of subject having at least an enthesitis in every group of subjects

Secondary Outcome Measures

MASEI scores

Full Information

First Posted
August 1, 2013
Last Updated
June 10, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02038426
Brief Title
Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not
Official Title
Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Entheses

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the patients with SpA
Arm Type
Experimental
Arm Title
sports subjects
Arm Type
Experimental
Arm Title
control subjects
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
BLOOD SAMPLES
Intervention Type
Device
Intervention Name(s)
Radiographs of the sacroiliac joints
Intervention Type
Device
Intervention Name(s)
Radiographs of heels
Intervention Type
Device
Intervention Name(s)
SCAN
Primary Outcome Measure Information:
Title
enthesitis detection
Description
Number of subject having at least an enthesitis in every group of subjects
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MASEI scores
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LOIC MONDOLONI
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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