[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655947":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":36,"studyPopulation":37,"armGroups":38,"interventions":32,"overallOfficials":45,"centralContacts":50,"locations":32,"responsibleParty":56,"collaborators":32,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":32,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":32,"maxAge":68,"enrollmentInfo":69,"targetDuration":72,"studyType":73,"phases":32,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":88,"whyStopped":32,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":32},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical remission rate","Proportion of patients achieving clinical remission at week 8-12, 6 months, and 12 months, defined as PCDAI ≤ 10 for Crohn's disease or PUCAI \\\u003C 10 for ulcerative colitis.","At week 8-12, 6 months, and 12 months",[14,17,21,25,29],{"measure":15,"description":16,"timeFrame":12},"Clinical response rate","Proportion of patients achieving clinical response, defined as a decrease from baseline of ≥12.5 points in PCDAI (Crohn's disease) or ≥20 points in PUCAI (ulcerative colitis).",{"measure":18,"description":19,"timeFrame":20},"Steroid-free remission rate","Proportion of patients in clinical remission without systemic corticosteroid use.","At 12 months",{"measure":22,"description":23,"timeFrame":24},"Incidence of adverse events","Proportion of patients experiencing adverse events (infusion\u002Finjection reactions, infections, hematologic abnormalities, hepatotoxicity), graded according to CTCAE-adapted criteria","Through 12 months",{"measure":26,"description":27,"timeFrame":28},"Change in growth parameters","Change in height z-score, weight z-score, and BMI z-score from baseline.","From baseline to 12 months",{"measure":30,"description":31,"timeFrame":24},"Treatment escalation or switch rate","Proportion of patients requiring treatment escalation or switching between conventional and biologic agents.",null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":35,"maskingInfo":32},"COHORT","PROSPECTIVE","Pediatric-onset inflammatory bowel disease differs from adult-onset disease in phenotype, disease extent, and long-term prognosis. Conventional therapy (5-aminosalicylates, corticosteroids, and immunomodulators) and biologic therapy (mainly anti-TNFα agents) are used for induction and maintenance of remission.\n\nThis observational cohort study will include pediatric patients with confirmed Crohn's disease, ulcerative colitis, or IBD-unclassified. Patients will be classified into conventional therapy and biologic therapy groups. Clinical remission, response rates, steroid-free remission, adverse events, and growth parameters will be assessed over a 12-month period.","Children and adolescents up to 18 years of age with confirmed inflammatory bowel disease receiving conventional and\u002For biologic therapy at Assiut University Children Hospital and the Health Insurance IBD Committee, Assiut Branch.",[39,42],{"label":40,"type":32,"description":41,"interventionNames":32},"Conventional Therapy","Patients managed with 5-aminosalicylates, corticosteroids, and\u002For immunomodulators without biologic exposure during the observation period.",{"label":43,"type":32,"description":44,"interventionNames":32},"Biologic Therapy","Patients who received biologic therapy (with or without concomitant conventional agents) during the observation period.",[46],{"name":47,"affiliation":48,"role":49},"Nafisa H Abdel-Aziz, prof","Pediatrics Department, Assiut University Hospitals","STUDY_CHAIR",[51],{"name":52,"role":53,"phone":54,"phoneExt":32,"email":55},"Elizabeth M lshak, Resident","CONTACT","01221541345","elithabeth.17289856@med.aun.edu.eg",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Elizabeth Makar Ishak","Resident Physician","100655947","conventional-vs-biologic-therapy-in-pediatric-ibd-100655947",false,"NCT07818473","Conventional vs Biologic Therapy in Pediatric IBD","Effectiveness, Safety, and Adverse Events of Conventional and Biologic Therapy in Pediatric Inflammatory Bowel Disease","Inclusion Criteria:\n\n* \\- Confirmed diagnosis of Crohn's disease, ulcerative colitis, or IBD-unclassified according to revised Porto criteria\n* Age at diagnosis less than 18 years\n* Receipt of conventional therapy and\u002For biologic therapy for a minimum evaluable treatment duration\n* Availability of adequate medical records\n* Written informed consent (for prospective component)\n\nExclusion Criteria:\n\n* \\- Incomplete medical records precluding assessment of primary endpoints\n* Age more than 18 years\n* Discontinuation of follow-up before a minimum evaluable treatment period","ALL","18 Years",{"count":70,"type":71},100,"ESTIMATED","12 Months","OBSERVATIONAL","This combined retrospective-prospective cohort study aims to evaluate the effectiveness, safety, and adverse events of conventional versus biologic therapy in children and adolescents with inflammatory bowel disease at Assiut University Children Hospital.",[76,77,78],"Inflammatory Bowel Diseases","Crohn Disease","Ulcerative Colitis",[80,81,82,83,84,85,86,87],"Pediatric IBD","Biologic therapy","Conventional therapy","Infliximab","Adalimumab","PCDAI","PUCAI","Assiut","NOT_YET_RECRUITING","2026-09-08",{"date":91,"type":92},"2026-09-14","ACTUAL",{"date":94,"type":71},"2026-09-10",{"date":96,"type":71},"2028-01-10",{"name":5,"class":6}]