Inflammatory Bowel Disease(IBD), Treatment Response

Summary

Inflammatory bowel diseases (IBD) is treated with biologics targeting the pro-inflammatory molecule tumour necrosis factor-α (TNF), i.e. TNF inhibitors. Up to one third of the patients do, however, not respond to biologics and little is known of the biological mechanism as a prognostic factor (possibly enabling personalised medicine). The aim of this project is to identify biomarkers that support individualized forecasting of optimized treatment outcome on these costly drugs.

This prospective cohort study will enroll IBD patients assigned for biologic treatment. At baseline (Pre-treatment), biopsies and blood is taken from each patient. Follow-up will be conducted at week 14-16 after treatment initiation (according to the current Danish standards). Evaluation of a successful treatment outcome response will - for each disease - be based on most frequently used primary endpoints; the major outcome of the analyses will be to detect differences in treatment outcome between patients with the cell expression.

The overarching goal of this project is to improve the lives of patients suffering from IBD, by providing evidence to potential biomarkers that would be likely to improve the clinical outcome.

The study is approved by the local Ethics Committee (S-20160124) and the local Data Agency (2008-58-035). The study findings will be disseminated in peer-reviewed journals, via patient associations, and presented at national and international conferences.

Conditions

• Inflammatory Bowel Diseases
• Ulcerative Colitis
• Crohn Disease

Interventions

OTHER

Primary exposure variable

1. Specific activated CD8+ T-cell transcriptome signature in biopsies is associated with better treatment outcome 2. Specific activated CD8+ T-cell transcriptome signature in blood is associated with better treatment outcome

OTHER

Other (exploratory) exposure variables

Specific transcriptomic signatures in intestinal biopsies and peripheral blood mononuclear cells (PBMCs) of IBD patients can work as a predictive biomarker for the tumor necrosis factor inhibitors (TNFi) treatment response

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Hospital of Southern Jutland

  collaborator OTHER

• University of Kiel

  collaborator OTHER

• Colitis-Crohn Foreningen

  collaborator OTHER

• University of Southern Denmark

  lead OTHER

Principal Investigators

• Vibeke Andersen, Prof · University of Southern Denmark

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-08

Primary Completion

2023-06-30

Completion

2024-06-30

Countries

• Denmark

Study Locations