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.
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
1,500
No intervention due to the observational set-up of this study.
Erasmus MC - Sophia Children's Hospital
Rotterdam, Netherlands
RECRUITINGRoyal Hospital London
London, United Kingdom
RECRUITINGPredictors 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).
Time frame: Over a period of three years after inclusion of the last patient.
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.
Time frame: Over a period of three years after inclusion of the last patient.
Identification of patients with rare and serious complications
Secondary outcome is to identify patients with rare and serious complications of PIBD or its treatment.
Time frame: Until the end of patients recruitment, for a period of 2 years.
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