Clinical and Molecular Phenotyping in IBD

Not Applicable

Completed

• Conditions: IBD
• Interventions: Drug: Infliximab; Drug: Vedolizumab

• Registration Number: NCT02694588
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-29
• Primary Completion: 2018-10
• Study Completion: 2021-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• inflammatory bowel disease
• indication for biological therapy

Exclusion Criteria

• pregnancy, breast feeding
• no written informed consent to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infliximab	Infliximab	5 mg/kg body weight, week 0/2/6, then every 8 weeks
Vedolizumab	Vedolizumab	300 mg, week 0/2/6, then every 8 weeks

Primary Outcome Measures

Name	Time	Method
Mucosal healing week 2	week 2	Scoring of mucosal healing according to endoscopic Mayo score at week 2 after initiation of therapy

Trial Locations

Locations (1)

Medical Department I, University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Germany