PIBD-SETQuality: the Inception Cohort and Safety Registry

NCT ID: NCT03571373

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-03
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

No intervention

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

• 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)

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

PIBD-Net

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lissy de Ridder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus MC-Sophia Children's Hospital

Nicholas Croft, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Barts and the London School of Medicine, Queen Mary University of London

Locations

Erasmus MC - Sophia Children's Hospital

Rotterdam, , Netherlands

Site Status: RECRUITING

Royal Hospital London

London, , United Kingdom

Site Status: RECRUITING

Countries

Netherlands; United Kingdom

Central Contacts

Frank Ruemmele, MD, PhD

Role: CONTACT

frank.ruemmele@nck.aphp.fr

Lissy de Ridder, MD, PhD

Role: CONTACT

l.deridder@erasmusmc.nl

Facility Contacts

Lissy De Ridder, MD, PhD

Role: primary

l.deridder@erasmusmc.nl

Nicholas Croft, MD, PhD

Role: primary

n.m.croft@qmul.ac.uk

References

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.

Reference Type: BACKGROUND

PMID: 21051046 (View on PubMed)

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):253-8. doi: 10.1097/MPG.0000000000001132.

Reference Type: BACKGROUND

PMID: 26835906 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36480463 (View on PubMed)

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 cohort study. BMJ Open. 2020 Jul 1;10(7):e035538. doi: 10.1136/bmjopen-2019-035538.

Reference Type: DERIVED

PMID: 32611739 (View on PubMed)

Other Identifiers

PIBD-Net 2016-02

Identifier Type: -

Identifier Source: org_study_id