Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study

Sacroiliitis Clinical Trial

Official title:

Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05203926
• Other study ID #: 21-00955
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to further define and characterize imaging findings of possible sacroiliitis in Crohn's Disease patients by recalling subjects who had findings of possible sacroiliitis on prior MRE and assess the natural history and outcome of these cases by using standard magnetic resonance imaging (MRI) and x-ray of the sacroiliac joints.

Description:

When axial spondyloarthritis (SpA) occurs in Crohn's disease (CD) is an important clinical and research question that has not been fully answered. Magnetic resonance enterography (MRE), routinely obtained in Crohn's disease (CD) patients, can be utilized to assess sacroiliac joints (SIJ); currently published literature shows that it could be a valuable tool to detect active inflammation of sacroiliitis in CD patients. Only a small fraction of CD patients with MRE evidence of sacroiliitis is referred to rheumatologists for further evaluation. The proposed project aims to further define MRE features of sacroiliitis in CD by recalling subjects who had prior positive findings and assess the natural history and outcome of these cases by standard magnetic resonance imaging (MRI) of sacroiliac joints and SIJ X-ray. 37 CD subjects who were already found to have sacroiliitis in the previous MRE study will be recalled. Subjects will undergo standard MRI of SIJ, plain X-ray of SIJ and the rheumatologist will obtain detailed history and examine patients for evaluation of possible axial SpA. Other details pertaining to CD, CD therapy and activity, will also be obtained to help clarify a correlation between CD and axial SpA. This pilot study will allow better characterization of imaging features of sacroiliitis on MRE, provide useful information on clinical significance of these lesions in CD patients, and potentially establish MRE as a screening tool for early detection of sacroiliitis in CD patients.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 27
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Evidence of sacroiliitis on earlier standard of care MRE between 2014 and 2018.
• Confirmed diagnosis of Crohn's Disease
• Known HLA-B27 status at time of enrollment and most recent clinical ESR and CRP results from chart (from day of visit or within past 4 weeks of study visit)
• Adults >18 years of age

Exclusion Criteria:

• History of other inflammatory arthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout).
• Contraindication to MRI.
• History of malignancy <5 years in remission, (except for non-melanomatous skin cancer).
• Inability to comply with study protocol.
• Critically ill patients.
• Pregnant patients.
• Non-English speaking patients (as the questionnaires used in this study are not validated in other languages)

Related Conditions & MeSH terms

• Crohn Disease
• Sacroiliitis

Intervention

Procedure:
• MRI scan
Subjects will undergo T1 and STIR sequence MRI of sacroiliac joints (SIJ ) (pelvis MRI) as well as SIJ plain X-ray for assessment of radiographic sacroiliitis. The study will utilize 3 Tesla with phased array coil to maximize signal to noise ratio for image quality. This is a single procedure, which takes about 60 minutes. 1 radiologists, blinded to all clinical information, will evaluate for presence of acute and structural lesions. Images will be scored for presence or absence of acute and/or structural lesions in a global manner.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Spondyloarthritis Research and Treatment Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)	The MRI scans will establish significance of sacroiliitis features/lesions seen on MRE.	Intervention Visit 1 (Day 1)
Primary	Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)	The X-ray exams will establish significance of sacroiliitis features/lesions seen on MRE.	Intervention Visit 1 (Day 1)
Secondary	Measurement of Ankylosing Spondylitis Disease Activity	ASDAS- Ankylosing Spondylitis Disease Activity Score will assesses patient-perceived symptoms and current disease activity through serum markers. The higher the score the higher the disease activity.	Intervention Visit 1 (Day 1)
Secondary	Measurement of Bath Ankylosing Spondylitis Disease Activity Index	BASDAI- Bath Ankylosing Spondylitis Disease Activity Index assesses Ankylosing Spondylitis Disease activity and current symptoms. The BASDAI sum score is calculated by the sum of questions 1-4 plus mean of questions 5 and 6, the total then divided by 5. The sum score ranges from 0 to 10, higher values indicate more active disease.	Intervention Visit 1 (Day 1)
Secondary	Measurement of Bath Ankylosing Spondylitis Functional Index	BASFI- Bath Ankylosing Spondylitis Functional Index assesses functional limitation in patients with Ankylosing Spondylitis. The patient rates his/her ability to perform tasks (BASFI) by marking a vertical line on a 100 mm horizontal line. It consists of ten tasks lines to assess the degree of difficulty of performing each task. The total BASFI score is calculated by adding all ten scores and dividing by 10.	Intervention Visit 1 (Day 1)
Secondary	Measurement of HBI- Harvey-Bradshaw Index	HBI- Harvey-Bradshaw Index measures clinical activity of Crohn's Disease. The categorical HBI score was also used as an independent variable in all analyses. Specifically, HBI < 5 was defined as clinical remission, HBI between 5 and 7 as mild disease, HBI between 8 and 16 as moderate disease, and HBI > 16 as severe disease.	Intervention Visit 1 (Day 1)
Secondary	Measurement of CDAI- Crohn's Disease Activity Index	CDAI- Crohn's Disease Activity Index determines current severity of Crohn's Disease. CDAI scores range from 0 to 600. A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease.	Intervention Visit 1 (Day 1)