Clinical and Molecular Phenotyping in IBD

NCT ID: NCT02694588

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2021-12-31

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.

Conditions

IBD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Infliximab

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

Group Type: ACTIVE_COMPARATOR

Infliximab

Intervention Type: DRUG

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

Vedolizumab

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

Group Type: ACTIVE_COMPARATOR

Vedolizumab

Intervention Type: DRUG

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

Interventions

Infliximab

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

Intervention Type: DRUG

Vedolizumab

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

Intervention Type: DRUG

Other Intervention Names

Endoscopic assessment after Infliximab; Endoscopic assessment after Vedolizumab

Eligibility Criteria

Inclusion Criteria

• inflammatory bowel disease
• indication for biological therapy

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Mark Ellrichmann

Head of Interdisciplinary Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Schreiber, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

00494315971272

Locations

Medical Department I, University Hospital Schleswig-Holstein

Kiel, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 29730603 (View on PubMed)

Other Identifiers

Short-Sys-Inflame

Identifier Type: -

Identifier Source: org_study_id