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OpenTrials
Completed

NCT Number: NCT02694588

Clinical and Molecular Phenotyping in IBD

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.

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Key information

Conditions

IBD

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Department I, University Hospital Schleswig-Holstein

Kiel, 24105, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • inflammatory bowel disease
  • indication for biological therapy

Exclusion criteria

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

Treatment and study plan

Infliximab

Drug

HD-endoscopy, CLE, endoscopic ultrasound after application of TNF alpha antibody

Other names: Endoscopic assessment after Infliximab

Vedolizumab

Drug

HD-endoscopy, CLE, endoscopic ultrasound after application of Anti-Integrin antibody

Other names: Endoscopic assessment after Vedolizumab

Primary outcomes

  1. Mucosal healing week 2

    Time frame: week 2

    Scoring of mucosal healing according to endoscopic Mayo score at week 2 after initiation of therapy

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

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

Acronym: Phen_IBD

Important dates

Study start
2014
Primary completion
2018
Study completion
2021
First posted
Feb 29, 2016
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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