xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06034808</url>
    </required_header>
    <id_info>
      <org_study_id>Sacroliitis in IBD using MRI</org_study_id>
      <nct_id>NCT06034808</nct_id>
    </id_info>
    <brief_title>Frequency of Sacroiliitis in Inflammatory Bowel Disease Patients Using MRI</brief_title>
    <official_title>Frequency of Sacroiliitis in Inflammatory Bowel Disease Patients Using MRI</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        1. to determine the overall frequency of Inflammatory sacroiliitis among patients with&#xD;
             Inflammatory bowel disease using magnetic resonance imaging&#xD;
  &#xD;
          2. identify the association of sacroliitis in IBD patients clinical and laboratory markers&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        INFLAMMATORY BOWEL DISEASE (IBD) is a disorder in which an inappropriate response to an&#xD;
        unknown antigen, combined with genetic and environmental factors, result in inflammation of&#xD;
        the small bowel and colon . The two main forms of IBD are Crohn's disease (CD) and ulcerative&#xD;
        colitis (UC) which are both associated with spondyloarthropathy (SpA), an inflammatory&#xD;
        arthritis characterized by sacroiliitis and inflammatory back pain .&#xD;
  &#xD;
        Articular manifestations of inflammatory bowel disease(IBD), comprising Crohn's disease (CD)&#xD;
        and ulcerative colitis (UC), were first described in 1930 and have been considered as&#xD;
        spondylarthropathies since 1978. They include peripheral arthritis and inflammatory axial&#xD;
        involvement.&#xD;
  &#xD;
        Extra-intestinal musculoskeletal manifestations associated with Inflammatory bowel disease,&#xD;
        can be divided into axial and peripheral arthropathy, which can be a cause of significant&#xD;
        morbidity that can adversely affect the quality of life in these patients. Peripheral&#xD;
        arthropathy represent the most frequent (40%) extra-intestinal manifestation in IBD. These&#xD;
        manifestations occur more frequently in patients with Crohn's disease.&#xD;
  &#xD;
        Sacroiliitis (SI) is considered one of the common axial arthropathies with an estimated&#xD;
        prevalence of around 10% of Crohn's patients.&#xD;
  &#xD;
        It is crucial to differentiate inflammatory back pain due to axial SpA from other causes of&#xD;
        chronic low back pain as they have different treatments and prognosis.&#xD;
  &#xD;
        The diagnosis is based upon the presence of characteristic inflammatory type back pain with&#xD;
        evidence of SI on imaging . Both clinical examination and plain radiographs have their own&#xD;
        limitations of only detecting advanced disease.&#xD;
  &#xD;
        Importantly, sacroiliitis, which is the hallmark of the spondyloarthropathies, may be&#xD;
        clinically silent with an ambiguous or equivocal physical examination tests so imaginghas&#xD;
        important role in its diagnosis Imaging findings in sacroiliitis are divided into acute and&#xD;
        structural changes.The acute findings of sacroiliitis can be observed on magnetic resonance&#xD;
        imaging (MRI) and include periarticular sacroiliac joint (SIJ) bone marrow edema(BME), soft&#xD;
        tissue edema, and contrast enhancement. Structural changes including SIJ erosions,&#xD;
        subchondral sclerosis and bony bridges appear relatively late in the disease .Indeed,&#xD;
        findings compatible with acute inflammation may be seen on MRI years before late structural&#xD;
        findings are evident.&#xD;
  &#xD;
        MRI is a promising technology with a higher sensitivity and specificity for the diagnosis of&#xD;
        SI. As MRI is being utilized more frequently in patients with Crohn's disease, more and more&#xD;
        patients are found to have a positive MRI evidence of SI without clinical signs or symptoms&#xD;
        so MRI is necessary for diagnosing and evaluating patients with early disease.&#xD;
  &#xD;
        Incorporation of magnetic resonance imaging (MRI) to assess axial SpA allows early&#xD;
        recognition of axial SpA in CD, especially when patients do not present with classic IBP&#xD;
        symptoms.&#xD;
  &#xD;
        The introduction of biological drugs from the tumor necrosis factor-alpha (TNF-a) receptor&#xD;
        blocker group, has further emphasized the need for early diagnosis of sacroiliitis in&#xD;
        patients with IBD, many of which, can be asymptomatic, nonradiographic, or both. These drugs,&#xD;
        when administered early in the disease, are capable of changing the course, alleviating the&#xD;
        symptoms and even producing withdrawal of early imaging findings, including BME and contrast&#xD;
        enhancement.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Primary (main)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Incidence of sacroliitis in inflammatory bowel disease patients using MRI&#xD;
  with Inflammatory bowel disease using magnetic resonance imaging.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Secondary</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>association of sacroliitis in IBD patients assessed by clinical and laboratory markers</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Sacroiliitis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All patients were selected from outpatient clinic of IBD of Elraghi hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  subjects between 18 and 65 years.&#xD;
  &#xD;
            -  subjects met clinical, pathological or radiological criteria of IBD.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who refuse enter the study&#xD;
  &#xD;
            2. Patients who not diagnosed as IBD&#xD;
  &#xD;
            3. other inflammatory arthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus,&#xD;
               psoriatic or reactive arthritis)&#xD;
  &#xD;
            4. co-existent autoimmune diseases (e.g. celiac disease, Behcets disease)&#xD;
  &#xD;
            5. malignancy less than 5 years in remission .&#xD;
  &#xD;
            6. having a contraindication to MRI.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Magy Wageeh, Doctor</last_name>
      <phone>01273846971</phone>
      <email>magywageeh9@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mohammad Alyamany Kobeisy, Prof</last_name>
      <phone>01002228914</phone>
      <email>yamany1@yahoo.com</email>
    </overall_contact_backup>
    <reference>
      <citation>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.</citation>
      <PMID>9051003</PMID>
    </reference>
    <reference>
      <citation>Leclerc-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.</citation>
      <PMID>24593050</PMID>
    </reference>
    <reference>
      <citation>Veloso 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.</citation>
      <PMID>8835896</PMID>
    </reference>
    <reference>
      <citation>Sieper 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.</citation>
      <PMID>19433414</PMID>
    </reference>
    <reference>
      <citation>Oostveen 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.</citation>
      <PMID>10493676</PMID>
    </reference>
    <reference>
      <citation>Sudol-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.</citation>
      <PMID>23807884</PMID>
    </reference>
    <reference>
      <citation>Baraliakos 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.</citation>
      <PMID>21885516</PMID>
    </reference>
    <reference>
      <citation>Bredella 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.</citation>
      <PMID>17114530</PMID>
    </reference>
    <reference>
      <citation>Hermann 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.</citation>
      <PMID>23999786</PMID>
    </reference>
    <reference>
      <citation>Weber 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.</citation>
      <PMID>20496416</PMID>
    </reference>
    <reference>
      <citation>Baraliakos 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.</citation>
      <PMID>17329306</PMID>
    </reference>
    <reference>
      <citation>van 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.</citation>
      <PMID>18438853</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Magy Wageeh Abdelmalak</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sacroiliitis</mesh_term>
      <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06034808
  org study id: Sacroliitis in IBD using MRI
  nct id: NCT06034808
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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
  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.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Primary (main)
  time frame: through study completion, an average of 1 year
  description: Incidence of sacroliitis in inflammatory bowel disease patients using MRI
  with Inflammatory bowel disease using magnetic resonance imaging.
  measure: Secondary
  time frame: through study completion, an average of 1 year
  description: association of sacroliitis in IBD patients assessed by clinical and laboratory markers
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Magy Wageeh, Doctor
  phone: 01273846971
  email: magywageeh9@gmail.com
  last name: Mohammad Alyamany Kobeisy, Prof
  phone: 01002228914
  email: yamany1@yahoo.com
  citation: 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.
  PMID: 9051003
  citation: Leclerc-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.
  PMID: 24593050
  citation: Veloso 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.
  PMID: 8835896
  citation: Sieper 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.
  PMID: 19433414
  citation: Oostveen 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.
  PMID: 10493676
  citation: Sudol-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.
  PMID: 23807884
  citation: Baraliakos 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.
  PMID: 21885516
  citation: Bredella 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.
  PMID: 17114530
  citation: Hermann 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.
  PMID: 23999786
  citation: Weber 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.
  PMID: 20496416
  citation: Baraliakos 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.
  PMID: 17329306
  citation: van 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.
  PMID: 18438853
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Magy Wageeh Abdelmalak
  investigator title: Director
  mesh term: Sacroiliitis
  mesh term: Inflammatory Bowel Diseases