NCT05779969

Brief Summary

The aim of this study is to define structural damage to the manubriosternal joint (MST) in axial spondyloarthritis (axSpA) by comparing its CT scan aspects between a population of patients with radiographic (axSpA) and a control population free of chronic inflammatory rheumatism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
377

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

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

Study Start

First participant enrolled

February 9, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2024

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

March 7, 2023

Last Update Submit

December 30, 2024

Conditions

Keywords

Manubriosternal joint,Axial spondyloarthritis,Chest CT scan

Outcome Measures

Primary Outcomes (1)

  • To define the structural damage of the manubriosternal joint (MST) in axSpA by comparing its Chest CT scan aspects between a population of patients with radiographic axSpA and a control population free of chronic inflammatory rheumatism

    Assessment of the various aspects of the manubriosternal joint on the CT scan. These different elements of analysis are grouped in an evaluation grid. Assessment of the various aspects of the manubriosternal joint on the CT scan. These different elements of analysis are grouped in an evaluation grid. The prevalence of each unit anomaly (e.g. "erosions") will be compared between the radiographic axSpA population and the control population.

    At the end of the study, an average of 1 month

Secondary Outcomes (4)

  • Determination of the prevalence of structural damage to the manubriosternal joint (MST) in radiographic axSpA by comparing this population with the control population

    At the end of the study, an average of 1 month

  • Determination of the prevalence of structural damage to the manubriosternal joint (MST) in non-radiographic axSpA by comparing this population with the control population

    At the end of the study, an average of 1 month

  • Determination of the prevalence of structural damage to the manubriosternal joint (MST) between radiographic axSpA and non- radiographic axSpA

    At the end of the study, an average of 1 month

  • Search for a significant association between a phenotypic feature of axSpA and the existence of structural damage to the manubriosternal joint (MST)

    At the end of the study, an average of 1 month

Study Arms (2)

Chest CT scan Patient

Identification of structural damage to the manubriosternal joint (MST) in a population of patients with radiographic axSpA

Other: Chest CT scan

Chest CT scan Control

Identification of structural damage to the manubriosternal joint (MST) in a control population free of chronic inflammatory rheumatism on chest CT.

Other: Chest CT scan

Interventions

Comparison of structural damage to the manubriosternal joint (MST) between a population of patients with radiographic axSpA and a control population free of chronic inflammatory rheumatism on chest CT.

Chest CT scan ControlChest CT scan Patient

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having a Chest CT scan (as part of a conventional hospitalization or Day hospitalization) between 01/01/2015 and 30/10/2022 for a population of patients with radiographic axSpA and a control population free of chronic inflammatory rheumatism

You may qualify if:

  • axSpA population:
  • Adults aged 18 to 69 years,
  • Diagnosis of axSpA according to the ASAS 2009 criteria,
  • Hospitalized in the Rheumatology Department of the NOVO Hospital (Pontoise site) from 01/01/2015 to 30/10/2022 and had a Chest CT scan with images available in the hospital's computer system,
  • Informed of the study and did not object.
  • Control population:
  • Adults aged 18 to 69 years,
  • Day hospitalization in the pneumology department of the NOVO Hospital (Pontoise site) from 01/01/2015 to 30/10/2022 and having had a lung scan on this occasion,
  • Informed of the study and did not object.

You may not qualify if:

  • axSpA population:
  • Peripheral spondyloarthritis,
  • Unavailability of chest CT scan images in the hospital computer system,
  • Unknown result of pelvic X-ray.
  • Control population:
  • Lung cancer or suspected lung cancer
  • Any of the following conditions: spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, SAPHO syndrome, chest wall bone disease, tumour bone disease, severe scoliosis, malformative syndrome
  • History of thoracic trauma or thoracic surgery,
  • Unavailability of chest CT scan images in the hospital computer system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology department - NOVO Hospital - Pontoise site

Pontoise, 95390, France

Location

Related Publications (7)

  • Taurog JD, Chhabra A, Colbert RA. Ankylosing Spondylitis and Axial Spondyloarthritis. N Engl J Med. 2016 Jun 30;374(26):2563-74. doi: 10.1056/NEJMra1406182. No abstract available.

    PMID: 27355535BACKGROUND
  • van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum. 1984 Apr;27(4):361-8. doi: 10.1002/art.1780270401.

    PMID: 6231933BACKGROUND
  • Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.

    PMID: 19297344BACKGROUND
  • Elhai M, Paternotte S, Burki V, Durnez A, Fabreguet I, Koumakis E, Meyer M, Payet J, Roure F, Dougados M, Gossec L. Clinical characteristics of anterior chest wall pain in spondyloarthritis: an analysis of 275 patients. Joint Bone Spine. 2012 Oct;79(5):476-81. doi: 10.1016/j.jbspin.2011.10.003. Epub 2011 Nov 25.

    PMID: 22119315BACKGROUND
  • Wendling D, Prati C, Demattei C, Loeuille D, Richette P, Dougados M. Anterior chest wall pain in recent inflammatory back pain suggestive of spondyloarthritis. data from the DESIR cohort. J Rheumatol. 2013 Jul;40(7):1148-52. doi: 10.3899/jrheum.121460. Epub 2013 May 15.

    PMID: 23678156BACKGROUND
  • Weber U, Lambert RG, Rufibach K, Maksymowych WP, Hodler J, Zejden A, Duewell S, Kissling RO, Filipow PL, Jurik AG. Anterior chest wall inflammation by whole-body magnetic resonance imaging in patients with spondyloarthritis: lack of association between clinical and imaging findings in a cross-sectional study. Arthritis Res Ther. 2012 Jan 6;14(1):R3. doi: 10.1186/ar3551.

    PMID: 22226453BACKGROUND
  • Cameron HU, Fornasier VL. The manubriosternal joint--ananatomicoradiological survey. Thorax. 1974 Jul;29(4):472-4. doi: 10.1136/thx.29.4.472.

    PMID: 4854943BACKGROUND

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • Dr Edouart Pertuiset

    Hospital NOVO - Pontoise site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 22, 2023

Study Start

February 9, 2023

Primary Completion

December 13, 2024

Study Completion

December 13, 2024

Last Updated

December 31, 2024

Record last verified: 2024-12

Locations