Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-20 @ 7:10 AM
Study NCT ID:
NCT06601595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevelance of Axial Spondylosis Arthritis in Inflammatory Bowel Disease and Its RESPONSE to Tumour Necrosis Factor (TNF) Inhibitors Treatment in Assiut University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079424', 'term': 'Tumor Necrosis Factor Inhibitors'}], 'ancestors': [{'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-15', 'studyFirstSubmitDate': '2024-09-15', 'studyFirstSubmitQcDate': '2024-09-15', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of SPA in IBD patients', 'timeFrame': 'baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease (IBD)', 'Spondylarthropathies', 'TNF-alpha Inhibitors']}, 'referencesModule': {'references': [{'pmid': '9176068', 'type': 'RESULT', 'citation': "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': '30165593', 'type': 'RESULT', 'citation': "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': '19297344', 'type': 'RESULT', 'citation': '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': '30445584', 'type': 'RESULT', 'citation': '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': '17665420', 'type': 'RESULT', 'citation': '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': '32577750', 'type': 'RESULT', 'citation': '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': '32059920', 'type': 'RESULT', 'citation': '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': '29920733', 'type': 'RESULT', 'citation': "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': '17206702', 'type': 'RESULT', 'citation': "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': '11761022', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Prevelance of axial spondylosis arthritis in inflammatory bowel disease and its RESPONSE to tumour necrosis factor (TNF) inhibitors TREATMENT', 'detailedDescription': "Inflammatory bowel disease \\[IBD\\], encompassing Crohn's disease and ulcerative colitis, represents a chronic inflammatory disease entity that mainly affects the gastrointestinal tract.1 Extraintestinal manifestations, however, frequently occur and may involve different organ systems.2 Among the most common extraintestinal manifestations are spondyloarthritis \\[SpA\\], here defined as ankylosing spondylitis, psoriatic arthritis, enteropathic arthritis, reactive arthritis, and undifferentiated spondyloarthritis diagnosis.3 This group of rheumatic diseases share a similar clinical presentation with involvement of the spine, sacroiliac joints, peripheral arthritis, and frequently also enthesitis.4 Both IBD and SpA are also highly heritable diseases, and genome-wide and family-based association studies have demonstrated evidence of a shared genetic basis between IBD and SpA.5-6 Comorbidity with SpA has been associated with disability and decreased quality of life in IBD patients.7 In some IBD patients, these complications of SpA can lead to greater morbidity than the typical gastrointestinal symptoms for IBD.8 Even though lower back pain is commonly reported by IBD patients with SpA, early symptoms related to SpA may be mild and not always recognisable. However, an early diagnosis of SpA is important since a delayed diagnosis may potentially lead to a more severe disease course and poor treatment responses in patients with SpA.9 Infliximab is a genetically constructed immunoglobulin (Ig)G1 murine-human chimeric monoclonal antibody that binds the soluble subunit and the membrane-bound precursor of tumor necrosis factor-α (TNF-α). Consequently, it helps to decrease the biological activity of TNF-α (10). Neutralization of TNF-α has been suggested as a therapeutic strategy for patients with inflammatory bowel disease (IBD), rheumatoid arthritis (RA), spondyloarthropathy (SpA) and various other chronic inflammatory conditions (11)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'IBD patients (ulcerative colitis , Crohs disease ) in gastroenterology department ,ASSUIT UNIVERSITY hospital and EL RAGHY hospital inpatient and outpatient clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:IBD patients (ulcerative colitis , Crohn\\'s disease )on TNF inhibitors Data collected included SPA and IBD variables, demographics, concurrent medications, co-morbidities and autoimmune serology.\n\nThey 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\n\nExclusion Criteria: Other autoimmune disease , DM, LCF ,CRF ,Malignancy , Mechanical low back pain, Fracture , Spondylolisthesis , Spine tumores , Kidney stones .\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06601595', 'briefTitle': 'Prevelance of Axial Spondylosis Arthritis in Inflammatory Bowel Disease and Its RESPONSE to Tumour Necrosis Factor (TNF) Inhibitors Treatment in Assiut University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Spondyloarthropathy in Inflammatory Bowel Disease Patients and Evaluation of Its Response to TNF Inhibitors in Assiut University Hospital', 'orgStudyIdInfo': {'id': 'SPA in IBD and response TNFI'}}, 'armsInterventionsModule': {'armGroups': [{'label': '(TNF) inhibitors', 'description': '1- Patients taking biologic (infliximab) treatment', 'interventionNames': ['Drug: TNF inhibitors']}, {'label': 'conventional IBD medical Treatment', 'description': 'patients taking conventional IBD medical Treatment', 'interventionNames': ['Drug: conventional ibd medical treatment']}], 'interventions': [{'name': 'TNF inhibitors', 'type': 'DRUG', 'description': 'tumour necrosis factor inhibitors approved as treatments for ulcerative colitis and/or Crohns disease', 'armGroupLabels': ['(TNF) inhibitors']}, {'name': 'conventional ibd medical treatment', 'type': 'DRUG', 'description': 'Conventional therapies for ulcerative colitis and Crohns disease (CD) include aminosalicylates, corticosteroids, thiopurines, methotrexate other than anti-tumor necrosis factor agents.', 'armGroupLabels': ['conventional IBD medical Treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Nasr Mohamed, resident doctor', 'role': 'CONTACT', 'email': 'mohammednasr886@gmail.com', 'phone': '+20 115 608 3878'}, {'name': 'Salwa salaheldin ELgendi, professor doctor', 'role': 'CONTACT', 'email': 'salwaelgendi@aun.edu.eg', 'phone': '+201005766155', 'phoneExt': '+201005766155'}], 'overallOfficials': [{'name': 'Salwa salaheldin elgendi, professor doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'hossam Mahmoud AbdulWahab, assistant professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Nasr', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Mohamednasr', 'investigatorFullName': 'Mohamed Nasr', 'investigatorAffiliation': 'Assiut University'}}}}