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Paediatric Inflammatory Bowel Diseases Network for Safety, Efficacy, Treatment and Quality improvement of care

Project description

Predicting treatment outcome for paediatric inflammatory bowel disease

Inflammatory bowel disease (IBD) refers to a group of chronic conditions like Crohn's disease and ulcerative colitis that are associated with inflammation in the gastrointestinal tract. IBD emergence during childhood is increasing; treatment may have long-lasting implications during adulthood. The EU-funded PIBD-SETQuality project aims to develop a treatment algorithm for paediatric IBD that considers high- or low-risk predictors for complicated or relapsing disease. The objectives include creating a risk-stratified treatment algorithm, establishing a long-term cohort to analyse effectiveness and safety, and conducting a large-scale clinical trial based on risk groups. The goal is to optimise therapy outcome and minimise treatment-related risks, leading to a personalised approach for treating paediatric IBD.

Objective

"The incidence of paediatric onset Inflammatory Bowel Diseases (PIBD) has risen dramatically in recent decades. Compared to adult forms, PIBD reflects a more severe disease, more often requiring aggressive treatment with immunomodulators, and thereby exposing children to a life-long risk of serious disease and treatment-related adverse events, such as infections and malignancies. Therefore, there is an urgent need to develop strategies which balance, on an individual basis, therapeutic effectiveness with risks of treatment.
The overall goal of this proposal is to develop and validate a treatment algorithm for PIBD based on high or low risk predictors for early complicated or relapsing disease. This will improve effectiveness, while reducing treatment related risks and life-long complications due to uncontrolled disease progression.

To attain this goal 3 specific aims are proposed under the umbrella of an international network, the ""PIBD-net"":
1) Development of an accessible and feasible risk-stratified treatment algorithm for new onset paediatric IBD on an existing inception cohort and validation in an independent cohort
2) Generation of a prospective large longterm real world inception cohort in a registry designed to analyze effectiveness and safety signals and correlate them to individual risk factors
3) Design and performance of a risk algorithm-based prospective large-scale multicenter randomized clinical trial (RCT) (stratification into high or low risk groups based on specific aim#1) in order to provide optimal personalized therapy : low risk azathioprine vx. methotrexate, high risk : methotrexate vx. adalimumab
This project will translate into the first risk-stratified PIBD treatment algorithms allowing optimization of medical therapy while minimizing treatment-related risk (personalized medicine).

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RIA - Research and Innovation action

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Call for proposal

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(opens in new window) H2020-PHC-2014-2015

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Coordinator

UNIVERSITE PARIS CITE
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 580 000,00
Address
85 BD SAINT GERMAIN
75006 Paris
France

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Region
Ile-de-France Ile-de-France Paris
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 580 000,00

Participants (13)

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