Inflammatory Bowel Disease(IBD), Treatment Response

NCT05350644 | Terminated

• 1 other identifier: BELIEVE-IBD-SCT
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Biomarkers; Treatment outcome; Transcriptomics

Outcome Measures

Primary Outcomes (1)

• 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)

  week 14-16

Interventions

Primary exposure variable OTHER

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

Other (exploratory) exposure variables OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

targeted therapy and able to read and understand Danish.

You may qualify if:

• diagnosed with inflammatory bowel disease
• initiation of targeted therapy
• able to read and understand Danish

You may not qualify if:

• Patients with cancer
• Not mentally able to reply the questionnaire

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator
• Hospital of Southern Jutland: collaborator
• University of Kiel: collaborator
• Colitis-Crohn Foreningen: collaborator

Study Sites (1)

Odense University Hospital

Odense, Denmark, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Intestinal biopsies

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Vibeke Andersen, Prof

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: April 28, 2022
• Study Start: February 8, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: December 10, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)