Clinical and Molecular Phenotyping in IBD (Phen_IBD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02694588
Recruitment Status : Recruiting
First Posted : February 29, 2016
Last Update Posted : June 20, 2016
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
U.S. FDA Resources

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, Senior)
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

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 identifier (NCT number): NCT02694588

Contact: Mark Ellrichmann, MD 00494315972075

Medical Department I, University Hospital Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Contact: Mark Ellrichmann, MD    00494315972075   
Sponsors and Collaborators
University of Schleswig-Holstein
Principal Investigator: Stefan Schreiber, MD, PhD 00494315971272

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mark Ellrichmann, Head of Interdisciplinary Endoscopy, University of Schleswig-Holstein 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:

Additional relevant MeSH terms:
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents