Axial SpondyloarthritisProSpA-CDNCT03817983
MRE as a Screening Tool for axSpA in IBD
An observational study of Axial Spondyloarthritis and Crohn Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to assess the effectiveness (specificity and sensitivity) of using magnetic resonance enterography (MRE) as a screening tool for axial spondyloarthritis (axSpA) in patients with Crohns disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Axial Spondyloarthritis, Crohn Disease
- What is being tested?
- MRE review for evidence of axSpA in SIJs and Clinical assessment and dedicated MRI of the spine and pelvis
- How many people
- 259 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2019to 8 Aug 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Crohn's disease (aged more than 18 years) who have had a MRE scan performed between January 1st 2015 and January 1st 2019
Who may be able to join
- Subjects who are willing and able to give informed consent for participation in the study.
- Male and female subjects aged 18 years or above.
- Diagnosed by the gastroenterology team with Crohn's disease.
- MRE imaging since 2015 for their Crohn's disease.
Who cannot join
- 1. Subjects unwilling or unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rheumatology Research Unit
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: Magnetic Resonance Enterography as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease: A Prospective Single-center Cross-sectional Observational Study Using MRE Screening Followed by Clinical Assessment
This study aims to assess the effectiveness (specificity and sensitivity) of using magnetic resonance enterography (MRE) as a screening tool for axial spondyloarthritis (axSpA) in patients with Crohns disease. Patients with evidence of axSpA on MRE imaging will be assessed clinically for axSpA (including a dedicated axial magnetic resonance imaging scan of the spine and sacroiliac joints) and will be compared to a group of age and sex-matched control participants with Crohn's disease but with no evidence of axSpA on MRE imaging.
Read the detailed description
Spondyloarthritis (SpA) is a term that encompasses psoriatic arthritis with axial disease, ankylosing spondylitis and non-radiological axial spondyloarthritis. The prevalence of SpA in the general population is estimated to be between 0.01%-2.5%. SpA patients have a high burden of inflammatory bowel disease (IBD), which primarily includes Crohn's disease (CD) and Ulcerative colitis (UC), with an estimated prevalence of 10%-12%. However, few studies have investigated the converse; the presence of IBD cases with undiagnosed SpA. Untreated SpA may lead to a significant impact on general health and quality of life; therefore early diagnosis and treatment is crucial. Most CD patients will have had a MRE assessment for their CD, which also captures the axial skeleton and can therefore be used to screen for evidence of axial SpA (axSpA). In this study, MRE images from consenting CD subjects will be reviewed for evidence of axSpA. CD patients with evidence of axSpA will then be reviewed in a rheumatology clinic to assess more specifically for SpA. This will include completion of patient reported outcome measures, clinical examination, routine blood tests, human leucocyte antigen (HLA)-B27 genotyping and a dedicated axial magnetic resonance imaging (MRI) scan. The patients will also be consented to participate in the second part of the study which will be to compare these 'cases' statistically to a 'control' group of age- and sex-matched CD subjects without MRE evidence of axSpA.
This study aims to: (i) determine the validity, sensitivity and specificity of MRE as a screening tool for axSpA in CD patients using dedicated axial MRI scans with clinical assessment as the gold standard; (ii) devise an algorithm of clinical indices that can be used as a screening tool for axSpA in CD cases.
- Conditions
- Axial Spondyloarthritis, Crohn Disease
- Being tested
- MRE review for evidence of axSpA in SIJs, Clinical assessment and dedicated MRI of the spine and pelvis
- Medical subject headings
- Axial Spondyloarthritis, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRE review for evidence of axSpA in SIJsDiagnostic test
Screening for evidence of axSpA on the MRE scan of patients with Crohn's disease
Clinical assessment and dedicated MRI of the spine and pelvisDiagnostic test
Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA
| Study group | Role | What they receive |
|---|---|---|
| ProSpA-CD Screen Phase: MRE review for axSpA | Review of MRE scan for evidence of axSpA in Crohn's disease patients Receives: Diagnostic Test: MRE review for evidence of axSpA in SIJs | |
| ProSpA-CD Assess Phase (cases): Clinical assessment and dedicated MRI of the spine and pelvis | Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with abnormalities identified in the sacroiliac joints (SIJs) on MRE (cases). Receives: Diagnostic Test: Clinical assessment and dedicated MRI of the spine and pelvis | |
| ProSpA-CD Assess Phase (controls): Clinical assessment and dedicated MRI of the spine and pelvis | Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with normal SIJs (controls) on MRE. Receives: Diagnostic Test: Clinical assessment and dedicated MRI of the spine and pelvis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease
We assessed the SIJs on MRE imaging of patients with Crohn's disease (CD) for abnormalities potentially consistent with axial spondyloarthritis (axSpA), using a novel SIJ scoring system of 0-10 (0 = normal SIJs, 1-10 = abnormal SIJs). These patients were then assessed for evidence of axSpA using the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axSpA, including a dedicated axial MRI of the spine and pelvis. This primary outcome measure assessed the true positive rate (sensitivity) and true negative rate (specificity) of using MRE imaging of patients with CD to identify axSpA. A receiver operating characteristic (ROC) curve was generated using the novel SIJ scoring system of 0-10 and a 'diagnosis of axSpA' or 'no diagnosis of axSpA'. The ROC curve illustrated the true positive rate and true negative rate of using MRE as a screening tool for axSpA for each unit score (0-10) of the SIJ scoring system. This was performed using Stata 16 (2019).
Measured: 12 months
Secondary outcomes (6)
The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the 2009 ASAS Criteria for Axial Spondyloarthritis.
Patients with Crohn's disease are at increased risk of developing axial spondyloarthritis (axSpA). MRE imaging is used to assess the extent of Crohn's disease in the small bowel and also captures the sacroiliac joints (SIJs), which are commonly affected in axSpA. The MRE images of participants with Crohn's disease were reviewed for abnormalities in the SIJs potentially consistent with axSpA. These participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). This included a clinical history and examination, blood tests (including HLA-B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. Radiographs of the SIJs, hands and feet were reviewed if available. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA (CASPAR) criteria were then used to classify patients with axSpA, AS and PsA respectively.
Measured: 12 months
The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the Modified New York Criteria for Ankylosing Spondylitis
Patients with Crohn's disease are at increased risk of developing axial spondyloarthritis (axSpA). MRE imaging is used to assess the extent of Crohn's disease in the small bowel and also captures the sacroiliac joints (SIJs), which are commonly affected in axSpA. The MRE images of participants with Crohn's disease were reviewed for abnormalities in the SIJs potentially consistent with axSpA. These participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). This included a clinical history and examination, blood tests (including HLA-B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. Radiographs of the SIJs, hands and feet were reviewed if available. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA (CASPAR) criteria were then used to classify patients with axSpA, AS and PsA respectively.
Measured: 12 months
The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the CASPAR Criteria for Psoriatic Arthritis
Patients with Crohn's disease are at increased risk of developing axial spondyloarthritis (axSpA). MRE imaging is used to assess the extent of Crohn's disease in the small bowel and also captures the sacroiliac joints (SIJs), which are commonly affected in axSpA. The MRE images of participants with Crohn's disease were reviewed for abnormalities in the SIJs potentially consistent with axSpA. These participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). This included a clinical history and examination, blood tests (including HLA-B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. Radiographs of the SIJs, hands and feet were reviewed if available. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA (CASPAR) criteria were then used to classify patients with axSpA, AS and PsA respectively.
Measured: 12 months
The Number (and Percentage) of Participants Fulfilling the 2009 ASAS Criteria for axSpA Proceeding to Non-pharmacological and Pharmacological Treatment of Their axSpA, as a Surrogate Measure of Change in Clinical Care as a Result of MRE Screening.
This outcome measure focuses on the group of participants who fulfilled the 2009 ASAS classification criteria for axial spondyloarthritis in the ProSpA-CD Assess cases group. A total of 22 participants in the cases group fulfilled the 2009 ASAS classification criteria for axial spondyloarthritis (n=22/90).
Measured: 12 months
The Predictive Value of Specific Extra-articular Features With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease
The MRE images of participants with Crohn's disease (CD) were reviewed for abnormalities in the SIJs potentially consistent with axSpA. The participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). The clinical assessment included age, sex, smoking status, alcohol consumption, occupation, site of CD, CD disease duration, history of extra-articular manifestations/ features, patient reported outcome measures, blood tests (including HLA B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA criteria were then used to classify patients with axSpA, AS and PsA respectively. Logistic regression analyses were performed to assess the association of extra-articular features and site of CD with a diagnosis of axSpA in CD, using Stata 16 (2019).
Measured: 12 months
The Predictive Value of a Particular Site of Crohn's Disease (Colon, Ileum Etc) With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease
The MRE images of participants with Crohn's disease (CD) were reviewed for abnormalities in the SIJs potentially consistent with axSpA. The participants were then clinically assessed for axSpA, ankylosing spondylitis (AS) and psoriatic arthritis (PsA). The clinical assessment included age, sex, smoking status, site of CD, CD disease duration, history of extra-articular manifestations/ features, blood tests (including HLA B27 and inflammatory markers) and a dedicated axial MRI of the spine and pelvis. The 2009 ASAS (Assessment of Spondyloarthritis International Society) classification criteria for axSpA, modified New York criteria for AS and classification for PsA criteria were then used to classify patients with axSpA, AS and PsA respectively. Logistic regression analyses were performed to assess the association of extra-articular features and site of CD with a diagnosis of axSpA in CD, using Stata 16 (2019).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start4 Mar 2019
- Primary completion8 Aug 2020
- Study completion8 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Prospective
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Jobie Evans, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Deepak R Jadon, MBBCh PhD, Principal investigator, CUH NHSFT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817983
- Sponsor's protocol ID
- A094864
- Acronym
- ProSpA-CD
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2019
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Enterography as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease: A Prospective Single-center Cross-sectional Observational Study Using MRE Screening Followed by Clinical Assessment
- ClinicalTrials.gov ID
- NCT03817983
- Acronym / sponsor ID
- ProSpA-CD / A094864
- Conditions
- Axial Spondyloarthritis, Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 8 Aug 2020 (actual)
- Study completion
- 8 Aug 2020 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the effectiveness (specificity and sensitivity) of using magnetic resonance enterography (MRE) as a screening tool for axial spondyloarthritis (axSpA) in patients with Crohns disease. Patients with evidence of axSpA on MRE imaging will be assessed clinically for axSpA (including a dedicated axial magnetic resonance imaging scan of the spine and sacroiliac joints) and will be compared to a group of age and sex-matched control participants with Crohn's disease but with no evidence of axSpA on MRE imaging.
Detailed description
Spondyloarthritis (SpA) is a term that encompasses psoriatic arthritis with axial disease, ankylosing spondylitis and non-radiological axial spondyloarthritis. The prevalence of SpA in the general population is estimated to be between 0.01%-2.5%. SpA patients have a high burden of inflammatory bowel disease (IBD), which primarily includes Crohn's disease (CD) and Ulcerative colitis (UC), with an estimated prevalence of 10%-12%. However, few studies have investigated the converse; the presence of IBD cases with undiagnosed SpA. Untreated SpA may lead to a significant impact on general health and quality of life; therefore early diagnosis and treatment is crucial. Most CD patients will have had a MRE assessment for their CD, which also captures the axial skeleton and can therefore be used to screen for evidence of axial SpA (axSpA). In this study, MRE images from consenting CD subjects will be reviewed for evidence of axSpA. CD patients with evidence of axSpA will then be reviewed in a rheumatology clinic to assess more specifically for SpA. This will include completion of patient reported outcome measures, clinical examination, routine blood tests, human leucocyte antigen (HLA)-B27 genotyping and a dedicated axial magnetic resonance imaging (MRI) scan. The patients will also be consented to participate in the second part of the study which will be to compare these 'cases' statistically to a 'control' group of age- and sex-matched CD subjects without MRE evidence of axSpA.
This study aims to: (i) determine the validity, sensitivity and specificity of MRE as a screening tool for axSpA in CD patients using dedicated axial MRI scans with clinical assessment as the gold standard; (ii) devise an algorithm of clinical indices that can be used as a screening tool for axSpA in CD cases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ProSpA-CD Screen Phase: MRE review for axSpA | – | Diagnostic Test: MRE review for evidence of axSpA in SIJsReview of MRE scan for evidence of axSpA in Crohn's disease patients |
| ProSpA-CD Assess Phase (cases): Clinical assessment and dedicated MRI of the spine and pelvis | – | Diagnostic Test: Clinical assessment and dedicated MRI of the spine and pelvisClinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with abnormalities identified in the sacroiliac joints (SIJs) on MRE (cases). |
| ProSpA-CD Assess Phase (controls): Clinical assessment and dedicated MRI of the spine and pelvis | – | Diagnostic Test: Clinical assessment and dedicated MRI of the spine and pelvisClinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with normal SIJs (controls) on MRE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Crohn's disease (aged more than 18 years) who have had a MRE scan performed between January 1st 2015 and January 1st 2019
Key inclusion criteria (4 listed)
- Subjects who are willing and able to give informed consent for participation in the study.
- Male and female subjects aged 18 years or above.
- Diagnosed by the gastroenterology team with Crohn's disease.
- MRE imaging since 2015 for their Crohn's disease.
Key exclusion criteria (1 listed)
- 1. Subjects unwilling or unable to give informed consent.
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 |
|---|---|---|
| MRE review for evidence of axSpA in SIJsScreening for evidence of axSpA on the MRE scan of patients with Crohn's disease | Diagnostic test | ProSpA-CD Screen Phase: MRE review for axSpA |
| Clinical assessment and dedicated MRI of the spine and pelvisClinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA | Diagnostic test | ProSpA-CD Assess Phase (cases): Clinical assessment and dedicated MRI of the spine and pelvis, ProSpA-CD Assess Phase (controls): Clinical assessment and dedicated MRI of the spine and pelvis |
Primary outcome
The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease
Time frame: 12 months
We assessed the SIJs on MRE imaging of patients with Crohn's disease (CD) for abnormalities potentially consistent with axial spondyloarthritis (axSpA), using a novel SIJ scoring system of 0-10 (0 = normal SIJs, 1-10 = abnormal SIJs). These patients were then assessed for evidence of axSpA using the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axSpA, including a dedicated axial MRI of the spine and pelvis. This primary outcome measure assessed the true positive rate (sensitivity) and true negative rate (specificity) of using MRE imaging of patients with CD to identify axSpA. A receiver operating characteristic (ROC) curve was generated using the novel SIJ scoring system of 0-10 and a 'diagnosis of axSpA' or 'no diagnosis of axSpA'. The ROC curve illustrated the true positive rate and true negative rate of using MRE as a screening tool for axSpA for each unit score (0-10) of the SIJ scoring system. This was performed using Stata 16 (2019).
6 secondary outcomes
The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the 2009 ASAS Criteria for Axial Spondyloarthritis.
Time frame: 12 months
The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the Modified New York Criteria for Ankylosing Spondylitis
Time frame: 12 months
The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the CASPAR Criteria for Psoriatic Arthritis
Time frame: 12 months
The Number (and Percentage) of Participants Fulfilling the 2009 ASAS Criteria for axSpA Proceeding to Non-pharmacological and Pharmacological Treatment of Their axSpA, as a Surrogate Measure of Change in Clinical Care as a Result of MRE Screening.
Time frame: 12 months
The Predictive Value of Specific Extra-articular Features With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease
Time frame: 12 months
The Predictive Value of a Particular Site of Crohn's Disease (Colon, Ileum Etc) With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Deepak R Jadon, MBBCh PhD principal investigator
CUH NHSFT
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 and Crohn Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 1 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 14 Jan 2025. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2025.