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Completed

NCT Number: NCT05203926

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

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.

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Key information

Conditions

Sacroiliitis Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MRI scan

Procedure

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.

Primary outcomes

  1. Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)

    Time frame: Intervention Visit 1 (Day 1)

    The MRI scans will establish significance of sacroiliitis features/lesions seen on MRE.

  2. Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)

    Time frame: Intervention Visit 1 (Day 1)

    The X-ray exams will establish significance of sacroiliitis features/lesions seen on MRE.

Secondary outcomes

  1. Measurement of Ankylosing Spondylitis Disease Activity

    Time frame: Intervention Visit 1 (Day 1)

    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.

  2. Measurement of Bath Ankylosing Spondylitis Disease Activity Index

    Time frame: Intervention Visit 1 (Day 1)

    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.

  3. Measurement of Bath Ankylosing Spondylitis Functional Index

    Time frame: Intervention Visit 1 (Day 1)

    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.

  4. Measurement of HBI- Harvey-Bradshaw Index

    Time frame: Intervention Visit 1 (Day 1)

    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.

  5. Measurement of CDAI- Crohn's Disease Activity Index

    Time frame: Intervention Visit 1 (Day 1)

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Spondyloarthritis Research and Treatment Network

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 24, 2022
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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