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NCT Number: NCT03571373

PIBD-SETQuality: the 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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Ulcerative Colitis

Age range

0 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus MC - Sophia Children's Hospital, Rotterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Frank Ruemmele, MD, PhD

CONTACT

[email protected]

Lissy de Ridder, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

PIBD-Net

Other

Collaborators

  • European Commission

Registry information

Official study title

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

Acronym: PIBD-SETQ

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2018
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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