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

NHS Foundation Trust

Status: Completed

Conditions: Axial Spondyloarthritis; Crohn Disease

Treatments: Diagnostic Test: Clinical assessment and dedicated MRI of the spine and pelvis; Diagnostic Test: MRE review for evidence of axSpA in SIJs

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03817983

A094864

Details and patient eligibility

About

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.

Full 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.

Enrollment: 259 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

259 participants in 3 patient groups

ProSpA-CD Screen Phase: MRE review for axSpA

Description:

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

Treatment:

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

Description:

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).

Treatment:

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

Description:

Clinical assessment and dedicated MRI of the spine and pelvis to assess for evidence of axSpA for participants with normal SIJs (controls) on MRE.

Treatment:

Diagnostic Test: Clinical assessment and dedicated MRI of the spine and pelvis