Clinical and Molecular Phenotyping in IBD

Study Overview
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Brief Summary
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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.

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

Conditions
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IBD

Intervention / Treatment
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* Drug: Infliximab
* Drug: Vedolizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: inflammatory bowel disease indication for biological therapy Exclusion Criteria: pregnancy, breast feeding no written informed consent to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infliximab<br>5 mg/kg body weight, week 0/2/6, then every 8 weeks | Drug: Infliximab<br>* HD-endoscopy, CLE, endoscopic ultrasound after application of TNF alpha antibody<br>* Other names: Endoscopic assessment after Infliximab;|
| Active Comparator: Vedolizumab<br>300 mg, week 0/2/6, then every 8 weeks | Drug: Vedolizumab<br>* HD-endoscopy, CLE, endoscopic ultrasound after application of Anti-Integrin antibody<br>* Other names: Endoscopic assessment after Vedolizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal healing week 2 | Scoring of mucosal healing according to endoscopic Mayo score at week 2 after initiation of therapy | week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vedolizumab, Infliximab