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Clinical and Molecular Phenotyping in IBD (Phen_IBD)

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ClinicalTrials.gov Identifier: NCT02694588
Recruitment Status : Unknown
Verified June 2016 by Mark Ellrichmann, University of Schleswig-Holstein.
Recruitment status was:  Recruiting
First Posted : February 29, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
Mark Ellrichmann, University of 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.


Condition or disease Intervention/treatment Phase
IBD Drug: Infliximab Drug: Vedolizumab Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : June 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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 Name: 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 Name: Endoscopic assessment after Vedolizumab




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • inflammatory bowel disease
  • indication for biological therapy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694588


Contacts
Contact: Mark Ellrichmann, MD 00494315972075 mark.ellrichmann@uksh.de

Locations
Germany
Medical Department I, University Hospital Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Contact: Mark Ellrichmann, MD    00494315972075    mark.ellrichmann@uksh.de   
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Stefan Schreiber, MD, PhD 00494315971272

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Ellrichmann, Head of Interdisciplinary Endoscopy, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT02694588     History of Changes
Other Study ID Numbers: Short-Sys-Inflame
First Posted: February 29, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016

Keywords provided by Mark Ellrichmann, University of Schleswig-Holstein:
Vedolizumab
Infliximab

Additional relevant MeSH terms:
Infliximab
Vedolizumab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents