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

• ClinicalTrials.gov Identifier: NCT03817983
• Recruitment Status: Completed
• First Posted: January 28, 2019
• Last Update Posted: March 15, 2022
• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborator: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Jobie Evans, Cambridge University Hospitals NHS Foundation Trust

Tracking Information

• First Submitted Date: January 18, 2019
• First Posted Date: January 28, 2019
• Last Update Posted Date: March 15, 2022
• Actual Study Start Date: March 4, 2019
• Actual Primary Completion Date: August 8, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 23, 2019): The sensitivity and specificity of MRE as a screening tool for axial spondyloarthritis in Crohn's disease [ Time Frame: 12 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 23, 2019)

• The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the 2009 ASAS criteria for axial Spondyloarthritis. [ Time Frame: 12 months ]
  ASAS (Assessment of Spondyloarthritis International Society)
• The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the modified New York criteria for Ankylosing spondylitis [ Time Frame: 12 months ]
• The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the CASPAR criteria for psoriatic arthritis [ Time Frame: 12 months ]
  CASPAR (Classification Criteria for Psoriatic Arthritis)
• The proportion of these patients (expressed as a percentage) proceeding to non-pharmacological and pharmacological treatment of their axial Spondyloarthritis, 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MRE as a Screening Tool for axSpA in IBD
• 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
• Brief 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. 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, 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
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

All subjects (cases and controls) will be asked to consent to provide research samples, including whole blood and stool, for storage and future analysis (serum for biomarker analysis, plasma for proteomic analysis, DNA for genotyping, and stool for microbiome analysis).

• 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

Condition

• Axial Spondyloarthritis
• Crohn Disease

Intervention

Diagnostic Test: MRE review for axSpA

Screening for evidence of axSpA on the MRE scan of patients with Crohn's disease followed by clinical and MRI assessment

Study Groups/Cohorts

MRE review for axSpA

Review of MRE scan for evidence of axSpA in Crohn's disease patients

Intervention: Diagnostic Test: MRE review for axSpA

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 6, 2022): 261
• Original Estimated Enrollment (submitted: January 23, 2019): 445
• Actual Study Completion Date: August 8, 2020
• Actual Primary Completion Date: August 8, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03817983
• Other Study ID Numbers: A094864
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Jobie Evans, Cambridge University Hospitals NHS Foundation Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Original Study Sponsor: Same as current
• Collaborators: Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: Deepak R Jadon, MBBCh PhD; CUH NHSFT

• PRS Account: Cambridge University Hospitals NHS Foundation Trust
• Verification Date: March 2022