NCT02694588

Clinical and Molecular Phenotyping in IBD

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• IBD

Interventions

Type	Name	Description
DRUG	Infliximab	HD-endoscopy, CLE, endoscopic ultrasound after application of TNF alpha antibody
DRUG	Vedolizumab	HD-endoscopy, CLE, endoscopic ultrasound after application of Anti-Integrin antibody

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-10-01
• Completion: 2021-12-01
• First posted: 2016-02-29
• Last updated: 2022-07-01

Locations

1 site across 1 country: Germany