MRE as a Screening Tool for axSpA in IBD (ProSpA-CD)

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Axial Spondyloarthritis
• Intervention / Treatment: Diagnostic test: MRE review for evidence of axSpA in SIJs; Diagnostic test: Clinical assessment and dedicated MRI of the spine and pelvis

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 Type: Observational
• Enrollment (Actual): 259

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Rheumatology Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

1. Subjects who are willing and able to give informed consent for participation in the study.
2. Male and female subjects aged 18 years or above.
3. Diagnosed by the gastroenterology team with Crohn's disease.
4. MRE imaging since 2015 for their Crohn's disease.

Exclusion Criteria:

1. Subjects unwilling or unable to give informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ProSpA-CD Screen Phase: MRE review for axSpA; Review of MRE scan for evidence of axSpA in Crohn's disease patients	Diagnostic test: MRE review for evidence of axSpA in SIJs; Screening for evidence of axSpA on the MRE scan of patients with Crohn's disease
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).	Diagnostic test: 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
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.	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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).	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).	12 months

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Deepak R Jadon, MBBCh PhD, CUH NHSFT

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Actual): August 8, 2020
• Study Completion (Actual): August 8, 2020

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 12, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Bone Diseases, Infectious; Spinal Diseases; Spondylarthropathies; Ankylosis; Gastroenteritis; Inflammatory Bowel Diseases; Axial Spondyloarthritis; Spondylitis; Spondylarthritis; Crohn Disease
• Other Study ID Numbers: A094864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No