PIBD-SETQuality: the Inception Cohort and Safety Registry

Ulcerative Colitis Clinical Trial

— PIBD-SETQ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03571373
• Other study ID #: PIBD-Net 2016-02
• Status: Recruiting
• Start date: January 3, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: PIBD-Net
• Contact: Frank Ruemmele, MD, PhD
• Email: frank.ruemmele[@]nck.aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Netherlands	Erasmus MC - Sophia Children's Hospital	Rotterdam
United Kingdom	Royal Hospital London	London

Sponsors (2)

Lead Sponsor	Collaborator
PIBD-Net	European Commission

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictors for outcome and treatment response or non-response	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	New biomarkers as classifiers of response or non-response to therapy	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.
Secondary	Identification of patients with rare and serious complications	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.