NCT06601595

Brief Summary

Prevelance of axial spondylosis arthritis in inflammatory bowel disease and its RESPONSE to tumour necrosis factor (TNF) inhibitors TREATMENT

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Status
not yet recruiting

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 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.3 years

First QC Date

September 15, 2024

Last Update Submit

September 15, 2024

Conditions

Inflammatory Bowel Disease (IBD)SpondylarthropathiesTNF-alpha Inhibitors

Outcome Measures

Primary Outcomes (1)

  • prevalence of SPA in IBD patients

    baseline

Study Arms (2)

(TNF) inhibitors

1- Patients taking biologic (infliximab) treatment

Drug: TNF inhibitors

conventional IBD medical Treatment

patients taking conventional IBD medical Treatment

Drug: conventional ibd medical treatment

Interventions

TNF inhibitorsDRUG

tumour necrosis factor inhibitors approved as treatments for ulcerative colitis and/or Crohns disease

(TNF) inhibitors
conventional ibd medical treatmentDRUG

Conventional therapies for ulcerative colitis and Crohns disease (CD) include aminosalicylates, corticosteroids, thiopurines, methotrexate other than anti-tumor necrosis factor agents.

conventional IBD medical Treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

IBD patients (ulcerative colitis , Crohs disease ) in gastroenterology department ,ASSUIT UNIVERSITY hospital and EL RAGHY hospital inpatient and outpatient clinics

You may qualify if:

  • They fulfil criteria of axial SPA Clinical Criteria 12 Low back pain ≥ 3 months, improved by exercise and not relieved by rest Limitation of lumbar spine in sagittal and frontal planes Limitation of chest expansion (relative to normal values corrected for age and sex) Radiological Criteria Bilateral grade 2-4 sacroiliitis, or; Unilateral 3-4 sacroiliitis Assessment of disease activity of SPA 13 Patient fulfill criteria of IBD 14 Assessment of IBD activity (Esr , CRP ,Faecal calprotectin , CBC , albumin ,endoscopy, histopathology) Mayo score for U.C Crohn\'s disease Activity index

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Van Deventer SJ. Tumour necrosis factor and Crohn's disease. Gut. 1997 Apr;40(4):443-8. doi: 10.1136/gut.40.4.443. No abstract available.

    PMID: 9176068RESULT

  • Everhov AH, Khalili H, Askling J, Myrelid P, Ludvigsson JF, Halfvarson J, Nordenvall C, Soderling J, Olen O, Neovius M. Sick Leave and Disability Pension in Prevalent Patients With Crohn's Disease. J Crohns Colitis. 2018 Nov 28;12(12):1418-1428. doi: 10.1093/ecco-jcc/jjy123.

    PMID: 30165593RESULT

  • Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.

    PMID: 19297344RESULT

  • Hedin CRH, Vavricka SR, Stagg AJ, Schoepfer A, Raine T, Puig L, Pleyer U, Navarini A, van der Meulen-de Jong AE, Maul J, Katsanos K, Kagramanova A, Greuter T, Gonzalez-Lama Y, van Gaalen F, Ellul P, Burisch J, Bettenworth D, Becker MD, Bamias G, Rieder F. The Pathogenesis of Extraintestinal Manifestations: Implications for IBD Research, Diagnosis, and Therapy. J Crohns Colitis. 2019 Apr 26;13(5):541-554. doi: 10.1093/ecco-jcc/jjy191.

    PMID: 30445584RESULT

  • Thjodleifsson B, Geirsson AJ, Bjornsson S, Bjarnason I. A common genetic background for inflammatory bowel disease and ankylosing spondylitis: a genealogic study in Iceland. Arthritis Rheum. 2007 Aug;56(8):2633-9. doi: 10.1002/art.22812.

    PMID: 17665420RESULT

  • Lowenberg M. Anti-TNF Agents in Elderly IBD Patients: Cause for Concern? J Crohns Colitis. 2020 Jul 30;14(7):881-882. doi: 10.1093/ecco-jcc/jjaa025. No abstract available.

    PMID: 32577750RESULT

  • Beaugerie L, Rahier JF, Kirchgesner J. Predicting, Preventing, and Managing Treatment-Related Complications in Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2020 May;18(6):1324-1335.e2. doi: 10.1016/j.cgh.2020.02.009. Epub 2020 Feb 12.

    PMID: 32059920RESULT

  • Singh S, Fumery M, Sandborn WJ, Murad MH. Systematic review and network meta-analysis: first- and second-line biologic therapies for moderate-severe Crohn's disease. Aliment Pharmacol Ther. 2018 Aug;48(4):394-409. doi: 10.1111/apt.14852. Epub 2018 Jun 19.

    PMID: 29920733RESULT

  • Loftus CG, Loftus EV Jr, Harmsen WS, Zinsmeister AR, Tremaine WJ, Melton LJ 3rd, Sandborn WJ. Update on the incidence and prevalence of Crohn's disease and ulcerative colitis in Olmsted County, Minnesota, 1940-2000. Inflamm Bowel Dis. 2007 Mar;13(3):254-61. doi: 10.1002/ibd.20029.

    PMID: 17206702RESULT

  • Salvarani C, Vlachonikolis IG, van der Heijde DM, Fornaciari G, Macchioni P, Beltrami M, Olivieri I, Di Gennaro F, Politi P, Stockbrugger RW, Russel MG; European Collaborative IBD Study Group. Musculoskeletal manifestations in a population-based cohort of inflammatory bowel disease patients. Scand J Gastroenterol. 2001 Dec;36(12):1307-13. doi: 10.1080/003655201317097173.

    PMID: 11761022RESULT

MeSH Terms

Conditions

Inflammatory Bowel DiseasesSpondylarthropathies

Interventions

Tumor Necrosis Factor Inhibitors

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Intervention Hierarchy (Ancestors)

Anti-Inflammatory AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Salwa salaheldin elgendi, professor doctor

    Assiut University

    STUDY DIRECTOR

  • hossam Mahmoud AbdulWahab, assistant professor

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Nasr Mohamed, resident doctor

CONTACT

+20 115 608 3878mohammednasr886@gmail.com

Salwa salaheldin ELgendi, professor doctor

CONTACT

+201005766155salwaelgendi@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Mohamednasr

Study Record Dates

First Submitted

September 15, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

January 1, 2026

Study Completion

March 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09