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

Primary Purpose

Sacroiliitis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI scan
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sacroiliitis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Crohn's disease (CD) subjects

Arm Description

These subjects will then undergo T1 and STIR sequence MRI of SI joints (pelvis MRI) as well as SIJ plain X-ray for assessment of radiographic sacroiliitis.

Outcomes

Primary Outcome Measures

Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)
The MRI scans will establish significance of sacroiliitis features/lesions seen on MRE.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
December 23, 2021
Last Updated
January 11, 2023
Sponsor
NYU Langone Health
Collaborators
Spondyloarthritis Research and Treatment Network
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1. Study Identification

Unique Protocol Identification Number
NCT05203926
Brief Title
Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study
Official Title
Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Spondyloarthritis Research and Treatment Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crohn's disease (CD) subjects
Arm Type
Experimental
Arm Description
These subjects will then undergo T1 and STIR sequence MRI of SI joints (pelvis MRI) as well as SIJ plain X-ray for assessment of radiographic sacroiliitis.
Intervention Type
Procedure
Intervention Name(s)
MRI scan
Intervention Description
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 Outcome Measure Information:
Title
Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)
Description
The MRI scans will establish significance of sacroiliitis features/lesions seen on MRE.
Time Frame
Intervention Visit 1 (Day 1)
Title
Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)
Description
The X-ray exams will establish significance of sacroiliitis features/lesions seen on MRE.
Time Frame
Intervention Visit 1 (Day 1)
Secondary Outcome Measure Information:
Title
Measurement of Ankylosing Spondylitis Disease Activity
Description
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.
Time Frame
Intervention Visit 1 (Day 1)
Title
Measurement of Bath Ankylosing Spondylitis Disease Activity Index
Description
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.
Time Frame
Intervention Visit 1 (Day 1)
Title
Measurement of Bath Ankylosing Spondylitis Functional Index
Description
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.
Time Frame
Intervention Visit 1 (Day 1)
Title
Measurement of HBI- Harvey-Bradshaw Index
Description
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.
Time Frame
Intervention Visit 1 (Day 1)
Title
Measurement of CDAI- Crohn's Disease Activity Index
Description
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.
Time Frame
Intervention Visit 1 (Day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fardina Malik, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data collected from this study include anthropomorphic and blood draw data that will be uploaded to the participants' EHR and questionnaire data that will only be used for study-related purposes

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

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