PIBD-SETQuality: the Inception Cohort and Safety Registry

Официальное название

Paediatric Inflammatory Bowel Diseases Network for Safety, Efficacy, Treatment and Quality Improvement of Care: The PIBD-NET Inception Cohort and Safety Registry

Обзор

The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.

Подробное описание

In this prospective observational study children with newly diagnosed inflammatory bowel disease (IBD) will be included in the inception cohort. The primary aim of the inception cohort is to analyse the effectiveness and safety signals of current treatment strategies and to correlate them to individual risk factors. In order to capture information on rare and severe complications in PIBD as well, the safety registry was designed to estimate incidence and prevalence rates of these complications and get more insight in disease and treatment characteristics of these patients.

Вмешательства

• Другое No intervention
  No intervention due to the observational set-up of this study.

Первичные конечные точки

• Predictors for outcome and treatment response or non-response [Срок оценки: Over a period of three years after inclusion of the last patient.]

Вторичные конечные точки (2)

• New biomarkers as classifiers of response or non-response to therapy [Срок оценки: Over a period of three years after inclusion of the last patient.]
• Identification of patients with rare and serious complications [Срок оценки: Until the end of patients recruitment, for a period of 2 years.]

Критерии участия

Inclusion Criteria Inception cohort:

Newly diagnosed patient, <18 years of age, with a likely diagnosis of IBD or a confirmed diagnosis of IBD can be included in the study. In order to be eligible to continue in the study the subject must meet all of the following criteria:

• Diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features according to the revised Porto criteria (1)
• Diagnosis has been made or is confirmed within 2 months of inclusion
• Data on all diagnostic procedures are available for inclusion in the database
• Informed consent of patient (if indicated) and parents has been obtained
• Concerning the patients of whom biological specimens will be included: patients have not started IBD treatment yet

Inclusion Criteria Safety Registry:

Any child with IBD <19 years old with complications as detailed in the agreed safety monitoring list (or future updates of the list of conditions) can be reported. For the initial reporting of incident cases no patient identifiable details will be required.

Exclusion Criteria Inception cohort:

• Inability to read and understand the patient and family information sheets (for example insufficient knowledge of national language, where no health advocate or family member is available to translate and ensure full understanding of the study)
• Informed consent of patient or parents has not been obtained when required
• Patients on similar treatments as for IBD but for other conditions, or known with conditions directly affecting the IBD (e.g. immunodeficiency or major gastrointestinal resections)

Exclusion Criteria Safety registry: none.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 1 центр

• Erasmus MC - Sophia Children's Hospital — Rotterdam

Великобритания · 1 центр

• Royal Hospital London — London

Публикации

• Timmer A, Behrens R, Buderus S, Findeisen A, Hauer A, Keller KM, Kliemann G, Lang T, Lohr W, Rzehak P, Koletzko S; CEDATA-GPGE Study Group. Childhood onset inflammatory bowel disease: predictors of delayed diagnosis from the CEDATA German-language pediatric inflammatory bowel disease registry. J Pediatr. 2011 Mar;158(3):467-473.e2. doi: 10.1016/j.jpeds.2010.09.014. Epub 2010 Nov 4. PMID 21051046
• De Greef E, Hoffman I, Smets F, Van Biervliet S, Bontems P, Hauser B, Paquot I, Alliet P, Arts W, Dewit O, De Vos M, Baert F, Bossuyt P, Rahier JF, Franchimont D, Vermeire S, Fontaine F, Louis E, Coche JC, Veereman G; IBD working group of BESPGHAN, BIRD. Paediatric Crohn Disease: Disease Activity and Growth in the BELCRO Cohort After 3 Years Follow-up. J Pediatr Gastroenterol Nutr. 2016 Aug;63(2): PMID 26835906
• Vuijk SA, Klomberg RCW, Katgert E, Wessels MMS, Miele E, Cameron FL, Milovanovich ID, Muhammed R, Devadason D, Hart J, Rizopoulos D, Croft NM, de Ridder L; PIBD-SETQuality Consortium; PIBD-SETQuality Consortium. Comparative effectiveness of adalimumab versus infliximab in children with Crohn's disease: real-world data from the prospective PIBD-SETQuality inception cohort study. Crohns Colitis 360. PMID 42549261
• Klomberg RCW, Griffiths AM, Aloi M, Kiparissi F, Lawrence S, Otley AR, Critch J, van der Feen C, Rodrigues A, Mack DR, Huynh HQ, Church PC, Rizopoulos D, Croft NM, de Ridder L, Walters TD; European Paediatric IBD Network for Safety, Efficicacy of Treatment and Quality Improvement of Care (PIBD-SETQuality); Canadian Children IBD Network (CIDsCaNN). A comparative analysis of corticosteroids and excl PMID 42154069
• Vuijk SA, Klomberg RCW, Schwerd T, Griffiths AM, Hussey S, Carroll MW, Malmborg P, Deb P, Wessels M, Mouratidou N, van Biervliet S, Friedt M, Minson S, Vrieling-Prince FHM, Croft NM, de Ridder L; PIBD-SETQuality Safety Registry Collaborative Group. Significant kidney impairment in pediatric inflammatory bowel disease and practice points for pediatric gastroenterologists. J Pediatr Gastroenterol Nu PMID 41807295
• Nugteren S, Simons-Oosterhuis Y, Menckeberg CL, Hulleman-van Haaften DH, Lindenbergh-Kortleve DJ, Samsom JN. Endogenous secretory leukocyte protease inhibitor inhibits microbial-induced monocyte activation. Eur J Immunol. 2023 Feb;53(2):e2249964. doi: 10.1002/eji.202249964. Epub 2022 Dec 22. PMID 36480463
• Aardoom MA, Kemos P, Tindemans I, Aloi M, Koletzko S, Levine A, Turner D, Veereman G, Neyt M, Russell RK, Walters TD, Ruemmele FM, Samsom JN, Croft NM, de Ridder L; PIBD-SETQuality consortium and PIBD-NET. International prospective observational study investigating the disease course and heterogeneity of paediatric-onset inflammatory bowel disease: the protocol of the PIBD-SETQuality inception coh PMID 32611739

Идентификаторы

NCT: NCT03571373 · PIBD-Net 2016-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗