NCT00794404

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
489

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

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

Study Start

First participant enrolled

December 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 31, 2016

Status Verified

November 1, 2008

Enrollment Period

5.2 years

First QC Date

November 19, 2008

Last Update Submit

October 28, 2016

Conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ambroise Paré Hospital

Boulogne-Billancourt, 92100, France

Location

Cavale Blanche Hospital

Brest, 29200, France

Location

Cote de Nacre Hospital

Caen, 14033, France

Location

South Hospital of Grenoble

Échirolles, 38434, France

Location

Conception Hospital

Marseille, 13005, France

Location

Nancy Brabois Hospital

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (1)

  • Devauchelle-Pensec V, D'Agostino MA, Marion J, Lapierre M, Jousse-Joulin S, Colin D, Chary-Valckenaere I, Marcelli C, Loeuille D, Aegerter P, Guis S, Gaudin P, Breban M, Saraux A; Study Group of Spondylarthritis. Computed tomography scanning facilitates the diagnosis of sacroiliitis in patients with suspected spondylarthritis: results of a prospective multicenter French cohort study. Arthritis Rheum. 2012 May;64(5):1412-9. doi: 10.1002/art.33466.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

SpondylarthropathiesSpondylarthritis

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Officials

  • D'AGOSTINO Maria-Antonietta, MCUPH

    Ambroise Paré Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PU-PH

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 20, 2008

Study Start

December 1, 2004

Primary Completion

March 1, 2010

Study Completion

December 1, 2010

Last Updated

October 31, 2016

Record last verified: 2008-11

Data Sharing

IPD Sharing
Will not share

Locations