PIBD-SETQuality: the Inception Cohort and Safety Registry

Recruiting

• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

• Registration Number: NCT03571373
• Lead Sponsor: PIBD-Net

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.

Study Timeline

• Study Start: 2017-01-03
• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictors for outcome and treatment response or non-response	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 Outcome Measures

Name	Time	Method
New biomarkers as classifiers of response or non-response to therapy	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.
Identification of patients with rare and serious complications	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.

Trial Locations

Locations (2)

Erasmus MC - Sophia Children's Hospital; 🇳🇱 Rotterdam, Netherlands

Royal Hospital London; 🇬🇧 London, United Kingdom