NCT02694588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

4.3 years

First QC Date

December 4, 2015

Last Update Submit

June 30, 2022

Conditions

IBD

Keywords

VedolizumabInfliximab

Outcome Measures

Primary Outcomes (1)

  • Mucosal healing week 2

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

    week 2

Study Arms (2)

Infliximab

ACTIVE COMPARATOR

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

Drug: Infliximab

Vedolizumab

ACTIVE COMPARATOR

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

Drug: Vedolizumab

Interventions

InfliximabDRUG

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

Also known as: Endoscopic assessment after Infliximab
Infliximab
VedolizumabDRUG

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

Also known as: Endoscopic assessment after Vedolizumab
Vedolizumab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • inflammatory bowel disease
  • indication for biological therapy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Department I, University Hospital Schleswig-Holstein

Kiel, 24105, Germany

Location

Related Publications (1)

  • Zeissig S, Rosati E, Dowds CM, Aden K, Bethge J, Schulte B, Pan WH, Mishra N, Zuhayra M, Marx M, Paulsen M, Strigli A, Conrad C, Schuldt D, Sinha A, Ebsen H, Kornell SC, Nikolaus S, Arlt A, Kabelitz D, Ellrichmann M, Lutzen U, Rosenstiel PC, Franke A, Schreiber S. Vedolizumab is associated with changes in innate rather than adaptive immunity in patients with inflammatory bowel disease. Gut. 2019 Jan;68(1):25-39. doi: 10.1136/gutjnl-2018-316023. Epub 2018 May 5.

    PMID: 29730603DERIVED

MeSH Terms

Interventions

Infliximabvedolizumab

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Stefan Schreiber, MD, PhD

    00494315971272

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Interdisciplinary Endoscopy

Study Record Dates

First Submitted

December 4, 2015

First Posted

February 29, 2016

Study Start

June 1, 2014

Primary Completion

October 1, 2018

Study Completion

December 1, 2021

Last Updated

July 1, 2022

Record last verified: 2022-06

Locations

DE(1)