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Compare efficacy of different biologicals in induction of remission including clinical, laboratory and histopathological remission.
IBD are multifactorial disorders characterized by chronic relapsing intestinal inflammation (Fousekis et al .,2021). Main subtypes of pediatric IBD are Crohn's disease (CD), ulcerative colitis (UC), and IBD unclassified (Corica \& Romano .., 2017) Mechanism of IBD involves uncontrolled immune mediated inflammatory response in genetically predisposed individuals to an unknown environmental trigger that interacts with gut microbiome and primarily affects gastrointestinal tract ( Iyer \& Corr ..,2021) Pediatric onset IBD is more aggressive and rapidly progressive disease compared to adult onset IBD. Nearly a quarter of all patients with IBD develop this disease during childhood (Moon .., 2019), mean age at diagnosis ranged from 4.5 to 16 years in pediatric cases (Mosli et al ..,2021) Rates of pediatric onset IBD continue to rise around the world (Kuenzig et al ..,2022 ). In2018, the highest annual incidences of pediatric IBD were 23/100000 person in Europe, 15.2/100000 in North America, and 11.4/100000 in Asia/ Middle East and Oceania (Sýkora et al .., 2018) Pediatric IBD management and therapeutic approach can be chall enging, especially in younger patients (Romeo et al .., 2020 )). Biologic agents have revolutionized the treatment paradigm of pediatric IBD (Kapoor \& Crowley ..,2021) Biological drugs are monoclonal antibodies target specific cytokines involved in inflammatory cascade, such as tumour necrosis factor alpha (TNFα), integrins or interleukin 12/23, and have been approved for both pediatric CD and UC (Romeo et al 2020)
Age
0 - 16 years
Sex
ALL
Healthy Volunteers
No
Start Date
January 15, 2025
Primary Completion Date
April 13, 2026
Completion Date
December 13, 2026
Last Updated
December 19, 2024
40
ESTIMATED participants
Group 1 of patients will receive Adalimumab while Group 1 will receive ustekinumab
BIOLOGICAL
Lead Sponsor
Ain Shams University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06432309