SacroiliitisNCT05203926
Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study
A study testing MRI scan in people with Sacroiliitis, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sacroiliitis
- What is being tested?
- MRI scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 4 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Sacroiliitis
- Being tested
- MRI scan
- Medical subject headings
- Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease (CD) subjects | Experimental | 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. Receives: Procedure: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)
The MRI scans will establish significance of sacroiliitis features/lesions seen on MRE.
Measured: Intervention Visit 1 (Day 1)
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.
Measured: Intervention Visit 1 (Day 1)
Secondary outcomes (5)
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.
Measured: Intervention Visit 1 (Day 1)
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.
Measured: Intervention Visit 1 (Day 1)
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.
Measured: Intervention Visit 1 (Day 1)
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.
Measured: Intervention Visit 1 (Day 1)
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.
Measured: Intervention Visit 1 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start14 Mar 2022
- Primary completion4 Nov 2023
- Study completion4 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SacroiliitisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Spondyloarthritis Research and Treatment Network
- Responsible party
- Sponsor
- Investigators
- Fardina Malik, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203926
- Sponsor's protocol ID
- 21-00955
- Status last verified
- Jun 2024
- First submitted
- 23 Dec 2021
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT05203926
- Acronym / sponsor ID
- 21-00955
- Conditions
- Sacroiliitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Spondyloarthritis Research and Treatment Network
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 4 Nov 2023 (actual)
- Study completion
- 4 Nov 2023 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease (CD) subjects | Experimental | Procedure: MRI scanThese 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanSubjects 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. | Procedure or surgery | Crohn's disease (CD) subjects |
Primary outcome
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.
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.
5 secondary outcomes
Measurement of Ankylosing Spondylitis Disease Activity
Time frame: Intervention Visit 1 (Day 1)
Measurement of Bath Ankylosing Spondylitis Disease Activity Index
Time frame: Intervention Visit 1 (Day 1)
Measurement of Bath Ankylosing Spondylitis Functional Index
Time frame: Intervention Visit 1 (Day 1)
Measurement of HBI- Harvey-Bradshaw Index
Time frame: Intervention Visit 1 (Day 1)
Measurement of CDAI- Crohn's Disease Activity Index
Time frame: Intervention Visit 1 (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No. 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
Related trials for Sacroiliitis
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Active, not recruitingObservational study
Post-Market Clinical Study on a Modular SI Joint Fusion System
Sacroiliitis, Sacroiliac Joint Dysfunction
Active, not recruitingPhase 4
A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
Non-radiographic Axial Spondyloarthritis
Enrolling by invitationObservational study
Sacroiliac Joint Fusion Intervention For Mobility, Pain Relief, and Lasting Improvement in Functional Recovery "SIMPLIFY"
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Sacroiliitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fardina Malik, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan in people with Sacroiliitis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE) (time frame: Intervention Visit 1 (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.