An observational study in Inflammatory Bowel Diseases, Ulcerative Colitis and Crohn Disease, sponsored by University of Southern Denmark. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by University of Southern Denmark · Observational
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.
Inflammatory bowel diseases [IBD] (of which Crohn's disease (CD) and ulcerative colitis (UC) are the two most prevailed entities) is a disease of the immune system that are managed with biological agents targeting the pro-inflammatory cytokine tumour necrosis factor-α (TNF), i.e. TNF inhibitors.
Design: In this prospective cohort study disease activity prior to and after (14-16 weeks) initiation of biologic treatment will be assessed. The endpoint is the treatment outcome defined as A: Responder according to the specific criteria described below (incl. drug-continuation) or B: Non-responder (incl. drug-discontinuation due to unacceptable side effects). Whether a patient will discontinue therapy is assumed to be based on a certain degree of shared decision making between the patient and physician supported by principles from national guidelines for each patient as recommended in the respective national guidelines and laboratory data.
Setting: All patients assigned for initiation of biologic treatment at the Department of Medical Gastroenterology, Odense University Hospital from 1st of February 2022 and until 31th of December 2022 or until a minimum of 20 patients with IBD is achieved.
Clinical data consist of personal data, data on health and disease and disease activity scores. Information registered by clinicians and technicians will be transferred from paper format to electronic format using either double entry of data or automated forms processing.
Sample size considerations: We will include a limited set of patient biopsies from 20 UC patients and analyze the changes in responders versus non-responders for identifying potential predictive pathways and biomarkers. Such a strategy has recently been proven valuable for identification of biomarkers predictive of treatment response in CD with a similar number of samples as in our study All data analysis will be done in R, transparently reporting the source code used to analyze the data.
Project organization: The project is organized with a Clinical Research Group and an Analytical Research Group. The clinical group includes specialists from the medical, gastroenterological, departments that are sampling the cohort. The analytical group will perform the analyses on the biological material.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 2 is below the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →University of Southern Denmark is the lead sponsor of 327 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
targeted therapy and able to read and understand Danish.
Exclusion Criteria:
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
Also known as: Transcriptome signature
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
1. Clinical response to therapy depending on condition
The predefined primary endpoint will be the proportion of patients with clinical response to therapy at first clinical follow-up. * Crohn's disease: Harvey Bradshaw Index (HBI) 4 or less (clinical remission) to \<16 (non-remission) * Ulcerative colitis: Mayo Clinic Score of 2 or less (with no individual subscore of \>1) (remission) to \<12 (non-remission)
Time frame: week 14-16
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Southern Denmark