Axial SpondyloarthritisSPA-THORAXNCT05779969
Comparison of CT Scan Between Patients With Axial Spondyloarthritis and Control Subjects
An observational study of Axial Spondyloarthritis, run by Hôpital NOVO at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Chest CT scan
- How many people
- 377 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2023to 13 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Rheumatology department - NOVO Hospital - Pontoise site
Pontoise, 95390
About this study
Official title: Comparison of CT Scan Aspects of the Manubriosternal Joint Between Patients With Axial Spondyloarthritis and Control Subjects
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.
Read the detailed description
Axial spondyloarthritis (axSpA) is, together with rheumatoid arthritis, one of the 2 major chronic inflammatory rheumatic diseases. While the lumbar spine and sacroiliac joints are at the forefront of the clinic and diagnosis of axSpA, clinical involvement of the rib cage is common and long-standing. It can lead to limitation of thoracic extension and respiratory consequences. Clinical involvement of the anterior chest wall was evaluated in the early 2010s in axSpA, especially in the newer forms.
Several anatomical structures of the thoracic cage can be the cause of pain and among these is the manubriosternal joint (MST). It is known to be a possible site of inflammatory involvement in axSpA and this is well demonstrated by MRI imaging. Bone CT scans allow precise analysis of changes in the MST joint, but unlike MRI, they do not analyse inflammation, which is itself the cause of structural changes. While inflammation is the main cause of pain, structural changes, particularly ankylosis, are the cause of potentially disabling sequelae. To date, there have been no studies of structural damage to the MST joint in patients with axSpA, including the radiographic form. Moreover, little is known about the CT scan data of the MST joint in healthy subjects. Apart from the interest in defining axSpA-related abnormalities for CT scan analysis of the MST joint in general, it is important to know the frequency and types of structural abnormalities of the MST joint in axSpA, not for early diagnosis, but in terms of assessing the severity of the disease.
The investigator's hypothesis is that there are structural abnormalities of the STD joint in the radiographic axSpA, the characteristics, prevalence and relationship to patient and disease characteristics of which must be determined. This should be analysed in the non-radiographic axSpA. This requires comparison with a control population, but as there are no validated criteria for assessing the pathological nature of the STD joint on CT, it is necessary to proceed in 2 steps:
- - To define the structural damage to the MST joint in radiographic axSpA by comparison with control subjects. This comparison should focus first on the various basic abnormalities known to be present in radiographic axSpA, and in particular in the sacroiliac joints, such as erosions, subchondral bone condensation, pinching of the joint space, and ankylosis, which should be compared to the fusion phenomena described in controls.
- - Study the characteristics of this structural damage in radiographic and non-radiographic axSpA.
- Conditions
- Axial Spondyloarthritis
- Being tested
- Chest CT scan
- Keywords
- Manubriosternal joint,, Axial spondyloarthritis,, Chest CT scan
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest CT scanOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Chest CT scan Patient | Identification of structural damage to the manubriosternal joint (MST) in a population of patients with radiographic axSpA Receives: 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. Receives: Other: Chest CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Structural damage to the manubriosternal joint will be assessed on the scans by a double radiologist/rheumatologist reading in the different populations using a review grid.
Measured: 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
Structural damage to the manubriosternal joint will be assessed on the scans by a double radiologist/rheumatologist reading in the different populations using a review grid.
Measured: 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
Structural damage to the manubriosternal joint will be assessed on the scans by a double radiologist/rheumatologist reading in the different populations using a review grid.
Measured: 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)
The phenotypic character of axSpA is assessed by clinical criteria defined by the rheumatologist
Measured: At the end of the study, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start9 Feb 2023
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Edouart Pertuiset, Principal investigator, Hospital NOVO - Pontoise site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779969
- Sponsor's protocol ID
- CHRD 2222
- Acronym
- SPA-THORAX
- Status last verified
- Dec 2024
- First submitted
- 7 Mar 2023
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27355535van 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.
PubMed 6231933Rudwaleit 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.
PubMed 19297344Elhai 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.
PubMed 22119315Wendling 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.
PubMed 23678156Weber 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.
PubMed 22226453Cameron HU, Fornasier VL. The manubriosternal joint--ananatomicoradiological survey. Thorax. 1974 Jul;29(4):472-4. doi: 10.1136/thx.29.4.472.
PubMed 4854943
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of CT Scan Aspects of the Manubriosternal Joint Between Patients With Axial Spondyloarthritis and Control Subjects
- ClinicalTrials.gov ID
- NCT05779969
- Acronym / sponsor ID
- SPA-THORAX / CHRD 2222
- Conditions
- Axial Spondyloarthritis
- Keywords
- Manubriosternal joint,, Axial spondyloarthritis,, Chest CT scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Axial spondyloarthritis (axSpA) is, together with rheumatoid arthritis, one of the 2 major chronic inflammatory rheumatic diseases. While the lumbar spine and sacroiliac joints are at the forefront of the clinic and diagnosis of axSpA, clinical involvement of the rib cage is common and long-standing. It can lead to limitation of thoracic extension and respiratory consequences. Clinical involvement of the anterior chest wall was evaluated in the early 2010s in axSpA, especially in the newer forms.
Several anatomical structures of the thoracic cage can be the cause of pain and among these is the manubriosternal joint (MST). It is known to be a possible site of inflammatory involvement in axSpA and this is well demonstrated by MRI imaging. Bone CT scans allow precise analysis of changes in the MST joint, but unlike MRI, they do not analyse inflammation, which is itself the cause of structural changes. While inflammation is the main cause of pain, structural changes, particularly ankylosis, are the cause of potentially disabling sequelae. To date, there have been no studies of structural damage to the MST joint in patients with axSpA, including the radiographic form. Moreover, little is known about the CT scan data of the MST joint in healthy subjects. Apart from the interest in defining axSpA-related abnormalities for CT scan analysis of the MST joint in general, it is important to know the frequency and types of structural abnormalities of the MST joint in axSpA, not for early diagnosis, but in terms of assessing the severity of the disease.
The investigator's hypothesis is that there are structural abnormalities of the STD joint in the radiographic axSpA, the characteristics, prevalence and relationship to patient and disease characteristics of which must be determined. This should be analysed in the non-radiographic axSpA. This requires comparison with a control population, but as there are no validated criteria for assessing the pathological nature of the STD joint on CT, it is necessary to proceed in 2 steps:
- - To define the structural damage to the MST joint in radiographic axSpA by comparison with control subjects. This comparison should focus first on the various basic abnormalities known to be present in radiographic axSpA, and in particular in the sacroiliac joints, such as erosions, subchondral bone condensation, pinching of the joint space, and ankylosis, which should be compared to the fusion phenomena described in controls.
- - Study the characteristics of this structural damage in radiographic and non-radiographic axSpA.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chest CT scan Patient | – | Other: Chest CT scanIdentification of structural damage to the manubriosternal joint (MST) in a population of patients with radiographic axSpA |
| Chest CT scan Control | – | Other: Chest CT scanIdentification of structural damage to the manubriosternal joint (MST) in a control population free of chronic inflammatory rheumatism on chest CT. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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.
- Adults aged 18 to 69 years,
Key exclusion criteria (9 listed)
- Peripheral spondyloarthritis,
- Unavailability of chest CT scan images in the hospital computer system,
- Unknown result of pelvic X-ray.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest CT scanComparison 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. | Other | Chest CT scan Control, Chest CT scan Patient |
Primary outcome
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
Time frame: At the end of the study, an average of 1 month
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.
4 secondary outcomes
Determination of the prevalence of structural damage to the manubriosternal joint (MST) in radiographic axSpA by comparing this population with the control population
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: At the end of the study, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Background: PubMed 27355535Taurog 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.
- Background: PubMed 6231933van 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.
- Background: PubMed 19297344Rudwaleit 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.
- Background: PubMed 22119315Elhai 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.
- Background: PubMed 23678156Wendling 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.
- Background: PubMed 22226453Weber 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.
- Background: PubMed 4854943Cameron HU, Fornasier VL. The manubriosternal joint--ananatomicoradiological survey. Thorax. 1974 Jul;29(4):472-4. doi: 10.1136/thx.29.4.472.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Edouart Pertuiset principal investigator
Hospital NOVO - Pontoise site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondyloarthritis, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At the end of the study, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05779969, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.