Clinical and Molecular Phenotyping in IBD

IBD Clinical Trial

— Phen_IBD  

Official title:

Systematic Profiling of Anti-inflammatory Drugs for the Detection of Drug- Specific Response Signatures in the Treatment of Chronic Inflammatory Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694588
• Other study ID #: Short-Sys-Inflame
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2021

Study information

• Verified date: June 2022
• Source: University Hospital Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inflammatory bowel disease (IBD) and psoriasis (Ps) are common, chronic, immune- mediated barrier diseases with shared inflammatory pathways. Current therapeutic interventions with anti-cytokine antibodies (TNF-α, IL-23/IL-12) reflect the intent to disrupt specific pathways of inflammatory immunopathology. Individual responses to biological treatment can be thereby be exploited in a systems biology approach that employs a targeted mechanism of action (MOA) to decipher molecular signatures of therapeutic responses in the context of a distinct disease entity. Using a translational approach to investigate clinical and molecular phenotypes during therapeutic interference with cytokine signaling and leukocyte trafficking, the investigators aim to trace common and unique signatures of drug- and therapy-specific responses.

Patients will undergo endoscopic evaluation of the mucosal surface and gastrointestinal wall by conventional HD-colonoscopy, endoscopic ultrasound and confocal laser endomicroscopy prior to and during specific therapies with biologicals. In parallel, mucosa samples will be obtained to define molecular phenotypes during the course of therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2021
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• inflammatory bowel disease

• indication for biological therapy

Exclusion Criteria:

• pregnancy, breast feeding

• no written informed consent to participate in the study

Related Conditions & MeSH terms

• IBD

Intervention

Drug:
• Infliximab
HD-endoscopy, CLE, endoscopic ultrasound after application of TNF alpha antibody
• Vedolizumab
HD-endoscopy, CLE, endoscopic ultrasound after application of Anti-Integrin antibody

Locations

Country	Name	City	State
Germany	Medical Department I, University Hospital Schleswig-Holstein	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucosal healing week 2	Scoring of mucosal healing according to endoscopic Mayo score at week 2 after initiation of therapy	week 2