Clinical trial NCT03817983: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Axial Spondyloarthritis
Crohn Disease
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-01-28
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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, 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.

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.

Primary outcomes:
measure: The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease
timeFrame: 12 months
Secondary outcomes:
measure: The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the 2009 ASAS Criteria for Axial Spondyloarthritis.
timeFrame: 12 months
measure: The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the Modified New York Criteria for Ankylosing Spondylitis
timeFrame: 12 months
measure: The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the CASPAR Criteria for Psoriatic Arthritis
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: The Predictive Value of Specific Extra-articular Features With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease
timeFrame: 12 months
measure: The Predictive Value of a Particular Site of Crohn's Disease (Colon, Ileum Etc) With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease
timeFrame: 12 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Rheumatology Research Unit
state: Cambridgeshire
Study officials:
affiliation: CUH NHSFT
name: Deepak R Jadon, MBBCh PhD
role: PRINCIPAL_INVESTIGATOR
References: