NCT02038426

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 13, 2016

Status Verified

June 1, 2016

Enrollment Period

9 months

First QC Date

August 1, 2013

Last Update Submit

June 10, 2016

Conditions

Peripheral Entheses

Outcome Measures

Primary Outcomes (1)

  • enthesitis detection

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

    12 months

Secondary Outcomes (1)

  • MASEI scores

    12 months

Study Arms (3)

the patients with SpA

EXPERIMENTAL
Biological: BLOOD SAMPLESDevice: Radiographs of the sacroiliac jointsDevice: Radiographs of heelsDevice: SCAN

sports subjects

EXPERIMENTAL
Biological: BLOOD SAMPLESDevice: Radiographs of the sacroiliac jointsDevice: Radiographs of heelsDevice: SCAN

control subjects

OTHER
Biological: BLOOD SAMPLESDevice: Radiographs of the sacroiliac jointsDevice: Radiographs of heelsDevice: SCAN

Interventions

BLOOD SAMPLESBIOLOGICAL
control subjectssports subjectsthe patients with SpA
Radiographs of the sacroiliac jointsDEVICE
control subjectssports subjectsthe patients with SpA
Radiographs of heelsDEVICE
control subjectssports subjectsthe patients with SpA
SCANDEVICE
control subjectssports subjectsthe patients with SpA

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Axial spondyloarthritis according to the ASAS classification criteria
  • 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

You may not qualify if:

  • \- History of heel or ankle surgery
  • Recent corticosteroid infiltration of the heel or the ankle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • LOIC MONDOLONI

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2013

First Posted

January 16, 2014

Study Start

November 1, 2013

Primary Completion

August 1, 2014

Study Completion

January 1, 2015

Last Updated

June 13, 2016

Record last verified: 2016-06

Locations

FR(1)