PIBD-SETQuality: the Inception Cohort and Safety Registry (PIBD-SETQ)

August 7, 2026 updated by: Lissy de Ridder, Erasmus Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Other: No intervention

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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Lissy de Ridder, Professor, MD
Phone Number: +31715262824
Email: l.deridder@erasmusmc.nl

Study Contact Backup

Name: Nick M. Croft, Professor, MD
Phone Number: +44 20 7882 2642
Email: n.m.croft@qmul.ac.uk

Study Locations

Netherlands
- - Rotterdam, Netherlands, 3015GD
    - Recruiting
    - Erasmus MC - Sophia Children's Hospital
    - Contact:
      
      Lissy De Ridder, MD, PhD
      
      Email: l.deridder@erasmusmc.nl
United Kingdom
- - London, United Kingdom
    - Recruiting
    - Royal Hospital London
    - Contact:
      
      Nicholas Croft, MD, PhD
      
      Email: n.m.croft@qmul.ac.uk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with paediatric-onset IBD (either Crohn's disease, ulcerative colitis or IBD-unclassified).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors for outcome and treatment response or non-response Time Frame: Over a period of three years after inclusion of the last patient.	Factors predictive for outcome and treatment response or non-response This includes factors at baseline and 12 weeks after disease-onset that predict adverse outcomes (e.g. fibrostricturing disease, penetrating disease, active perianal fistula or abcess and need of surgery).	Over a period of three years after inclusion of the last patient.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New biomarkers as classifiers of response or non-response to therapy Time Frame: Over a period of three years after inclusion of the last patient.	Part of the children in the inception cohort will deliver biological specimens to develop new biomarkers as classifiers of disease risk of complicated disease or side effects in PIBD patients, as well as predictors of (non-)response to a specific immunomodulator or biological agent.	Over a period of three years after inclusion of the last patient.
Identification of patients with rare and serious complications Time Frame: Until the end of patients recruitment, for a period of 2 years.	Secondary outcome is to identify patients with rare and serious complications of PIBD or its treatment.	Until the end of patients recruitment, for a period of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Queen Mary University of London

European Commission

Hôpital Necker-Enfants Malades, Paris

Investigators

Principal Investigator: Lissy de Ridder, Professor, MD, Erasmus Medical Center
Principal Investigator: Nicholas Croft, Professor, MD, Barts and the London School of Medicine, Queen Mary University of London
Principal Investigator: Frank Ruemmele, Professor, MD, Hopital Necker-Enfants Malades, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2017

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

June 14, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 7, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

PIBD-Net 2016-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.