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Phen_IBD: Clinical and Molecular Phenotyping in IBD

Sponsor
University Hospital Schleswig-Holstein (Other)
Overall Status
Completed
CT.gov ID
NCT02694588
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
90
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Diagnostic
Official Title:
Systematic Profiling of Anti-inflammatory Drugs for the Detection of Drug- Specific Response Signatures in the Treatment of Chronic Inflammatory Disorders
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Infliximab

5 mg/kg body weight, week 0/2/6, then every 8 weeks

Drug: Infliximab
HD-endoscopy, CLE, endoscopic ultrasound after application of TNF alpha antibody
Other Names:
  • Endoscopic assessment after Infliximab

    		•
    Active Comparator: Vedolizumab

    300 mg, week 0/2/6, then every 8 weeks

    Drug: Vedolizumab
    HD-endoscopy, CLE, endoscopic ultrasound after application of Anti-Integrin antibody
    Other Names:
  • Endoscopic assessment after Vedolizumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mucosal healing week 2 [week 2]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • inflammatory bowel disease

    • indication for biological therapy

    Exclusion Criteria:

    • pregnancy, breast feeding

    • no written informed consent to participate in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Department I, University Hospital Schleswig-Holstein Kiel Germany 24105

    Sponsors and Collaborators

    • University Hospital Schleswig-Holstein

    Investigators

    • Principal Investigator: Stefan Schreiber, MD, PhD, 00494315971272

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mark Ellrichmann, Head of Interdisciplinary Endoscopy, University Hospital Schleswig-Holstein
    ClinicalTrials.gov Identifier:
    NCT02694588
    Other Study ID Numbers:
    • Short-Sys-Inflame
    First Posted:
    Feb 29, 2016
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 1, 2022
    Keywords provided by Mark Ellrichmann, Head of Interdisciplinary Endoscopy, University Hospital Schleswig-Holstein
    Vedolizumab
    Infliximab
    Additional relevant MeSH terms:
    Infliximab
    Vedolizumab

    Study Results

    No Results Posted as of Jul 1, 2022