NCT06034808

Brief Summary

  1. 1.to determine the overall frequency of Inflammatory sacroiliitis among patients with Inflammatory bowel disease using magnetic resonance imaging
  2. 2.identify the association of sacroliitis in IBD patients clinical and laboratory markers

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 2, 2023

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary (main)

    Incidence of sacroliitis in inflammatory bowel disease patients using MRI with Inflammatory bowel disease using magnetic resonance imaging.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Secondary

    through study completion, an average of 1 year

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients were selected from outpatient clinic of IBD of Elraghi hospital.

You may qualify if:

  • subjects between 18 and 65 years.
  • subjects met clinical, pathological or radiological criteria of IBD.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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: 9051003BACKGROUND
  • 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: 24593050BACKGROUND
  • 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: 8835896BACKGROUND
  • 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: 19433414BACKGROUND
  • 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: 10493676BACKGROUND
  • 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: 23807884BACKGROUND
  • 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: 21885516BACKGROUND
  • 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: 17114530BACKGROUND
  • 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: 23999786BACKGROUND
  • 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: 20496416BACKGROUND
  • 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: 17329306BACKGROUND
  • 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: 18438853BACKGROUND

MeSH Terms

Conditions

Sacroiliitis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal Diseases

Central Study Contacts

Magy Wageeh, Doctor

CONTACT

Mohammad Alyamany Kobeisy, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 13, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

September 21, 2023

Record last verified: 2023-09