SacroiliitisNCT06034808
Frequency of Sacroiliitis in Inflammatory Bowel Disease Patients Using MRI
An observational study of Sacroiliitis, run by Assiut University.
Trial summary
1. to determine the overall frequency of Inflammatory sacroiliitis among patients with Inflammatory bowel disease using magnetic resonance imaging 2. identify the association of sacroliitis in IBD patients clinical and laboratory markers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sacroiliitis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Dec 2024
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients were selected from outpatient clinic of IBD of Elraghi hospital.
Who may be able to join
- subjects between 18 and 65 years.
- subjects met clinical, pathological or radiological criteria of IBD.
Who cannot join
- Patients who refuse enter the study
- Patients who not diagnosed as IBD
- other inflammatory arthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic or reactive arthritis)
- co-existent autoimmune diseases (e.g. celiac disease, Behcets disease)
- malignancy less than 5 years in remission .
- having a contraindication to MRI.
Trial locations and contacts
No sites are listed yet.
About this study
- to determine the overall frequency of Inflammatory sacroiliitis among patients with Inflammatory bowel disease using magnetic resonance imaging
- identify the association of sacroliitis in IBD patients clinical and laboratory markers
Read the detailed description
INFLAMMATORY BOWEL DISEASE (IBD) is a disorder in which an inappropriate response to an unknown antigen, combined with genetic and environmental factors, result in inflammation of the small bowel and colon . The two main forms of IBD are Crohn's disease (CD) and ulcerative colitis (UC) which are both associated with spondyloarthropathy (SpA), an inflammatory arthritis characterized by sacroiliitis and inflammatory back pain .
Articular manifestations of inflammatory bowel disease(IBD), comprising Crohn's disease (CD) and ulcerative colitis (UC), were first described in 1930 and have been considered as spondylarthropathies since 1978. They include peripheral arthritis and inflammatory axial involvement.
Extra-intestinal musculoskeletal manifestations associated with Inflammatory bowel disease, can be divided into axial and peripheral arthropathy, which can be a cause of significant morbidity that can adversely affect the quality of life in these patients. Peripheral arthropathy represent the most frequent (40%) extra-intestinal manifestation in IBD. These manifestations occur more frequently in patients with Crohn's disease.
Sacroiliitis (SI) is considered one of the common axial arthropathies with an estimated prevalence of around 10% of Crohn's patients.
It is crucial to differentiate inflammatory back pain due to axial SpA from other causes of chronic low back pain as they have different treatments and prognosis.
The diagnosis is based upon the presence of characteristic inflammatory type back pain with evidence of SI on imaging . Both clinical examination and plain radiographs have their own limitations of only detecting advanced disease.
Importantly, sacroiliitis, which is the hallmark of the spondyloarthropathies, may be clinically silent with an ambiguous or equivocal physical examination tests so imaginghas important role in its diagnosis Imaging findings in sacroiliitis are divided into acute and structural changes.The acute findings of sacroiliitis can be observed on magnetic resonance imaging (MRI) and include periarticular sacroiliac joint (SIJ) bone marrow edema(BME), soft tissue edema, and contrast enhancement. Structural changes including SIJ erosions, subchondral sclerosis and bony bridges appear relatively late in the disease .Indeed, findings compatible with acute inflammation may be seen on MRI years before late structural findings are evident.
MRI is a promising technology with a higher sensitivity and specificity for the diagnosis of SI. As MRI is being utilized more frequently in patients with Crohn's disease, more and more patients are found to have a positive MRI evidence of SI without clinical signs or symptoms so MRI is necessary for diagnosing and evaluating patients with early disease.
Incorporation of magnetic resonance imaging (MRI) to assess axial SpA allows early recognition of axial SpA in CD, especially when patients do not present with classic IBP symptoms.
The introduction of biological drugs from the tumor necrosis factor-alpha (TNF-a) receptor blocker group, has further emphasized the need for early diagnosis of sacroiliitis in patients with IBD, many of which, can be asymptomatic, nonradiographic, or both. These drugs, when administered early in the disease, are capable of changing the course, alleviating the symptoms and even producing withdrawal of early imaging findings, including BME and contrast enhancement.
- Conditions
- Sacroiliitis
- Medical subject headings
- Sacroiliitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary (main)
Incidence of sacroliitis in inflammatory bowel disease patients using MRI
with Inflammatory bowel disease using magnetic resonance imaging.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Secondary
association of sacroliitis in IBD patients assessed by clinical and laboratory markers .
- clinical examination including sacroiliac joint examination
- Laboratory investigations
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SacroiliitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magy Wageeh Abdelmalak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034808
- Sponsor's protocol ID
- Sacroliitis in IBD using MRI
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wills JS, Lobis IF, Denstman FJ. Crohn disease: state of the art. Radiology. 1997 Mar;202(3):597-610. doi: 10.1148/radiology.202.3.9051003. No abstract available.
PubMed 9051003Leclerc-Jacob S, Lux G, Rat AC, Laurent V, Blum A, Chary-Valckenaere I, Peyrin-Biroulet L, Loeuille D. The prevalence of inflammatory sacroiliitis assessed on magnetic resonance imaging of inflammatory bowel disease: a retrospective study performed on 186 patients. Aliment Pharmacol Ther. 2014 May;39(9):957-62. doi: 10.1111/apt.12680. Epub 2014 Mar 4.
PubMed 24593050Veloso FT, Carvalho J, Magro F. Immune-related systemic manifestations of inflammatory bowel disease. A prospective study of 792 patients. J Clin Gastroenterol. 1996 Jul;23(1):29-34. doi: 10.1097/00004836-199607000-00009.
PubMed 8835896Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, Dougados M, Hermann KG, Landewe R, Maksymowych W, van der Heijde D. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009 Jun;68 Suppl 2:ii1-44. doi: 10.1136/ard.2008.104018.
PubMed 19433414Oostveen J, Prevo R, den Boer J, van de Laar M. Early detection of sacroiliitis on magnetic resonance imaging and subsequent development of sacroiliitis on plain radiography. A prospective, longitudinal study. J Rheumatol. 1999 Sep;26(9):1953-8.
PubMed 10493676Sudol-Szopinska I, Urbanik A. Diagnostic imaging of sacroiliac joints and the spine in the course of spondyloarthropathies. Pol J Radiol. 2013 Apr;78(2):43-9. doi: 10.12659/PJR.889039.
PubMed 23807884Baraliakos X, van der Heijde D, Braun J, Landewe RB. OMERACT magnetic resonance imaging initiative on structural and inflammatory lesions in ankylosing spondylitis--report of a special interest group at OMERACT 10 on sacroiliac joint and spine lesions. J Rheumatol. 2011 Sep;38(9):2051-4. doi: 10.3899/jrheum.110423.
PubMed 21885516Bredella MA, Steinbach LS, Morgan S, Ward M, Davis JC. MRI of the sacroiliac joints in patients with moderate to severe ankylosing spondylitis. AJR Am J Roentgenol. 2006 Dec;187(6):1420-6. doi: 10.2214/AJR.05.1423.
PubMed 17114530Hermann KG, Bollow M. Magnetic resonance imaging of sacroiliitis in patients with spondyloarthritis: correlation with anatomy and histology. Rofo. 2014 Mar;186(3):230-7. doi: 10.1055/s-0033-1350411. Epub 2013 Sep 2.
PubMed 23999786Weber U, Lambert RG, Ostergaard M, Hodler J, Pedersen SJ, Maksymowych WP. The diagnostic utility of magnetic resonance imaging in spondylarthritis: an international multicenter evaluation of one hundred eighty-seven subjects. Arthritis Rheum. 2010 Oct;62(10):3048-58. doi: 10.1002/art.27571.
PubMed 20496416Baraliakos X, Listing J, Rudwaleit M, Haibel H, Brandt J, Sieper J, Braun J. Progression of radiographic damage in patients with ankylosing spondylitis: defining the central role of syndesmophytes. Ann Rheum Dis. 2007 Jul;66(7):910-5. doi: 10.1136/ard.2006.066415. Epub 2007 Feb 28.
PubMed 17329306van der Heijde D, Landewe R, Einstein S, Ory P, Vosse D, Ni L, Lin SL, Tsuji W, Davis JC Jr. Radiographic progression of ankylosing spondylitis after up to two years of treatment with etanercept. Arthritis Rheum. 2008 May;58(5):1324-31. doi: 10.1002/art.23471.
PubMed 18438853
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Sacroiliitis in Inflammatory Bowel Disease Patients Using MRI
- ClinicalTrials.gov ID
- NCT06034808
- Acronym / sponsor ID
- Sacroliitis in IBD using MRI
- Conditions
- Sacroiliitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Sep 2023 (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.
- to determine the overall frequency of Inflammatory sacroiliitis among patients with Inflammatory bowel disease using magnetic resonance imaging
- identify the association of sacroliitis in IBD patients clinical and laboratory markers
Detailed description
INFLAMMATORY BOWEL DISEASE (IBD) is a disorder in which an inappropriate response to an unknown antigen, combined with genetic and environmental factors, result in inflammation of the small bowel and colon . The two main forms of IBD are Crohn's disease (CD) and ulcerative colitis (UC) which are both associated with spondyloarthropathy (SpA), an inflammatory arthritis characterized by sacroiliitis and inflammatory back pain .
Articular manifestations of inflammatory bowel disease(IBD), comprising Crohn's disease (CD) and ulcerative colitis (UC), were first described in 1930 and have been considered as spondylarthropathies since 1978. They include peripheral arthritis and inflammatory axial involvement.
Extra-intestinal musculoskeletal manifestations associated with Inflammatory bowel disease, can be divided into axial and peripheral arthropathy, which can be a cause of significant morbidity that can adversely affect the quality of life in these patients. Peripheral arthropathy represent the most frequent (40%) extra-intestinal manifestation in IBD. These manifestations occur more frequently in patients with Crohn's disease.
Sacroiliitis (SI) is considered one of the common axial arthropathies with an estimated prevalence of around 10% of Crohn's patients.
It is crucial to differentiate inflammatory back pain due to axial SpA from other causes of chronic low back pain as they have different treatments and prognosis.
The diagnosis is based upon the presence of characteristic inflammatory type back pain with evidence of SI on imaging . Both clinical examination and plain radiographs have their own limitations of only detecting advanced disease.
Importantly, sacroiliitis, which is the hallmark of the spondyloarthropathies, may be clinically silent with an ambiguous or equivocal physical examination tests so imaginghas important role in its diagnosis Imaging findings in sacroiliitis are divided into acute and structural changes.The acute findings of sacroiliitis can be observed on magnetic resonance imaging (MRI) and include periarticular sacroiliac joint (SIJ) bone marrow edema(BME), soft tissue edema, and contrast enhancement. Structural changes including SIJ erosions, subchondral sclerosis and bony bridges appear relatively late in the disease .Indeed, findings compatible with acute inflammation may be seen on MRI years before late structural findings are evident.
MRI is a promising technology with a higher sensitivity and specificity for the diagnosis of SI. As MRI is being utilized more frequently in patients with Crohn's disease, more and more patients are found to have a positive MRI evidence of SI without clinical signs or symptoms so MRI is necessary for diagnosing and evaluating patients with early disease.
Incorporation of magnetic resonance imaging (MRI) to assess axial SpA allows early recognition of axial SpA in CD, especially when patients do not present with classic IBP symptoms.
The introduction of biological drugs from the tumor necrosis factor-alpha (TNF-a) receptor blocker group, has further emphasized the need for early diagnosis of sacroiliitis in patients with IBD, many of which, can be asymptomatic, nonradiographic, or both. These drugs, when administered early in the disease, are capable of changing the course, alleviating the symptoms and even producing withdrawal of early imaging findings, including BME and contrast enhancement.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were selected from outpatient clinic of IBD of Elraghi hospital.
Key inclusion criteria (2 listed)
- subjects between 18 and 65 years.
- subjects met clinical, pathological or radiological criteria of IBD.
Key exclusion criteria (6 listed)
- Patients who refuse enter the study
- Patients who not diagnosed as IBD
- other inflammatory arthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic or reactive arthritis)
- co-existent autoimmune diseases (e.g. celiac disease, Behcets disease)
- malignancy less than 5 years in remission .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary (main)
Time frame: through study completion, an average of 1 year
Incidence of sacroliitis in inflammatory bowel disease patients using MRI with Inflammatory bowel disease using magnetic resonance imaging.
1 secondary outcome
Secondary
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 9051003Wills JS, Lobis IF, Denstman FJ. Crohn disease: state of the art. Radiology. 1997 Mar;202(3):597-610. doi: 10.1148/radiology.202.3.9051003. No abstract available.
- Background: PubMed 24593050Leclerc-Jacob S, Lux G, Rat AC, Laurent V, Blum A, Chary-Valckenaere I, Peyrin-Biroulet L, Loeuille D. The prevalence of inflammatory sacroiliitis assessed on magnetic resonance imaging of inflammatory bowel disease: a retrospective study performed on 186 patients. Aliment Pharmacol Ther. 2014 May;39(9):957-62. doi: 10.1111/apt.12680. Epub 2014 Mar 4.
- Background: PubMed 8835896Veloso FT, Carvalho J, Magro F. Immune-related systemic manifestations of inflammatory bowel disease. A prospective study of 792 patients. J Clin Gastroenterol. 1996 Jul;23(1):29-34. doi: 10.1097/00004836-199607000-00009.
- Background: PubMed 19433414Sieper J, Rudwaleit M, Baraliakos X, Brandt J, Braun J, Burgos-Vargas R, Dougados M, Hermann KG, Landewe R, Maksymowych W, van der Heijde D. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009 Jun;68 Suppl 2:ii1-44. doi: 10.1136/ard.2008.104018.
- Background: PubMed 10493676Oostveen J, Prevo R, den Boer J, van de Laar M. Early detection of sacroiliitis on magnetic resonance imaging and subsequent development of sacroiliitis on plain radiography. A prospective, longitudinal study. J Rheumatol. 1999 Sep;26(9):1953-8.
- Background: PubMed 23807884Sudol-Szopinska I, Urbanik A. Diagnostic imaging of sacroiliac joints and the spine in the course of spondyloarthropathies. Pol J Radiol. 2013 Apr;78(2):43-9. doi: 10.12659/PJR.889039.
- Background: PubMed 21885516Baraliakos X, van der Heijde D, Braun J, Landewe RB. OMERACT magnetic resonance imaging initiative on structural and inflammatory lesions in ankylosing spondylitis--report of a special interest group at OMERACT 10 on sacroiliac joint and spine lesions. J Rheumatol. 2011 Sep;38(9):2051-4. doi: 10.3899/jrheum.110423.
- Background: PubMed 17114530Bredella MA, Steinbach LS, Morgan S, Ward M, Davis JC. MRI of the sacroiliac joints in patients with moderate to severe ankylosing spondylitis. AJR Am J Roentgenol. 2006 Dec;187(6):1420-6. doi: 10.2214/AJR.05.1423.
- Background: PubMed 23999786Hermann KG, Bollow M. Magnetic resonance imaging of sacroiliitis in patients with spondyloarthritis: correlation with anatomy and histology. Rofo. 2014 Mar;186(3):230-7. doi: 10.1055/s-0033-1350411. Epub 2013 Sep 2.
- Background: PubMed 20496416Weber U, Lambert RG, Ostergaard M, Hodler J, Pedersen SJ, Maksymowych WP. The diagnostic utility of magnetic resonance imaging in spondylarthritis: an international multicenter evaluation of one hundred eighty-seven subjects. Arthritis Rheum. 2010 Oct;62(10):3048-58. doi: 10.1002/art.27571.
- Background: PubMed 17329306Baraliakos X, Listing J, Rudwaleit M, Haibel H, Brandt J, Sieper J, Braun J. Progression of radiographic damage in patients with ankylosing spondylitis: defining the central role of syndesmophytes. Ann Rheum Dis. 2007 Jul;66(7):910-5. doi: 10.1136/ard.2006.066415. Epub 2007 Feb 28.
- Background: PubMed 18438853van der Heijde D, Landewe R, Einstein S, Ory P, Vosse D, Ni L, Lin SL, Tsuji W, Davis JC Jr. Radiographic progression of ankylosing spondylitis after up to two years of treatment with etanercept. Arthritis Rheum. 2008 May;58(5):1324-31. doi: 10.1002/art.23471.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliitis, run by Assiut University.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magy Wageeh, Doctor (01273846971, magywageeh9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (main) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06034808, which also lists 12 linked publications.
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 21 Sep 2023.