Development of an Inflammatory Bowel Disease (IBD) patient population dashboard to monitor and improve care through machine learning

Lead Investigator: Hanne Vanluchene, AZ Delta
Title of Proposal Research: Development of an Inflammatory Bowel Disease (IBD) patient population dashboard to monitor and improve care through machine learning
Vivli Data Request: 10028
Funding Source: The project is funded by Takeda Belgium NV under a ‘Value-Based Partnership Healthcare Collaboration Agreement’.
Potential Conflicts of Interest: The research is funded by data contributor Takeda, this conflict of interest will be declared in any subsequent publication.

Summary of the Proposed Research:
It is estimated that around 0.5% of the population is affected by Inflammatory Bowel Disease (IBD) and the number of patients has been increasing worldwide. IBD includes two main types: Ulcerative Colitis (UC) and Crohn’s Disease (CD). People with IBD have symptoms like diarrhea, abdominal pain and weight loss due to recurring inflammations in their gastrointestinal tract. Different therapeutic options have been developed in the last decades, where biologic treatment plays an important role. These biologics are a medication type where substances are used that are derived from living organisms. Unfortunately, these treatments do not always work and some patients do not respond to the medication.

As more people get IBD and the treatments do not always help, it is making things harder for hospitals and its patients and it increases health costs. Therefore, it is really important to optimize the care delivered to the patient. This can be done using a clinical pathway, which is a standardized way of delivering care by consistently using a fixed healthcare path for each patient. This allows to collect clinical results (data) in a systematic way. The data can be clearly visualised in an overview on a computer screen, called a clinical dashboard. Within this dashboard, prediction tools can be added to further support the physicians. These prediction tools are pieces of software that help physicians to decide which treatment might work best for each patient and therefore will also improve care delivery. Combining the dashboard with these prediction tools results into a so-called Clinical Decision Support Tool (CDST).

The main goal of this project is to make these CDSTs to predict the outcome of biologic treatment. The technology that will be used for these prediction tools are Machine Learning (ML) models. ML models are more reliable if numerous data is used and therefore data from clinical trials are requested. The collected data of the different clinical trials will be merged in one big dataset, based on common datapoints. This large dataset will then be used for developing different ML models that will predict whether a patient will respond or not to a specific biologic treatment. As a final step, the ML models will be validated on historical data from our local hospital to make sure they are accurate within clinical practise.

Requested Studies:
A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT00036439
Sponsor ID: CR004777

A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT00096655
Sponsor ID: CR004783

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT00488631
Sponsor ID: CR014179

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT00487539
Sponsor ID: CR014176

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT00488774
Sponsor ID: CR014188

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: AbbVie
Study ID: NCT00408629
Sponsor ID: M06-827

A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: AbbVie
Study ID: NCT00385736
Sponsor ID: M06-826

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Data Contributor: Johnson & Johnson
Study ID: NCT02407236
Sponsor ID: CR106920

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Previously Treated With TNF Antagonist Therapy
Data Contributor: Johnson & Johnson
Study ID: NCT00771667
Sponsor ID: CR015238

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn’s Disease (UNITI-2)
Data Contributor: Johnson & Johnson
Study ID: NCT01369342
Sponsor ID: CR018418

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease
Data Contributor: Johnson & Johnson
Study ID: NCT01369355
Sponsor ID: CR018421

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)
Data Contributor: Johnson & Johnson
Study ID: NCT01369329
Sponsor ID: CR018415

A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderate to Severe Crohn’s Disease
Data Contributor: AbbVie
Study ID: NCT00409617
Sponsor ID: M06-829

Crohn’s Therapy, Resource, Evaluation, and Assessment Tool Registry
Data Contributor: Johnson & Johnson
Study ID: NCT00553176
Sponsor ID: CR014140