Clinical and Molecular Phenotyping in IBD (Phen_IBD)

U

University Hospital Schleswig-Holstein (UKSH)

Status

Completed

Conditions

IBD

Treatments

Drug: Infliximab
Drug: Vedolizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT02694588
Short-Sys-Inflame

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • inflammatory bowel disease
  • indication for biological therapy

Exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups

Infliximab
Active Comparator group
Description:
5 mg/kg body weight, week 0/2/6, then every 8 weeks
Treatment:
Drug: Infliximab
Vedolizumab
Active Comparator group
Description:
300 mg, week 0/2/6, then every 8 weeks
Treatment:
Drug: Vedolizumab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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