Long-term Outcome of TNF Alpha Therapy in IBD

February 23, 2021 updated by: Medical University of Graz
The aim of this retrospective study is to assess the outcome of patients with inflammatory bowel disease (IBD) under TNF-alpha antibody therapy over a period of 20 years

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Long-term results published so far show that over the years a large part of patients have to stop TNF Alpha antibody therapy in IBD. Reasons are mostly loss of effectiveness or intolerance or side effects. Reasons for the termination are usually poorly characterized with regard to the exact reason and time. As a consequence, the aim of this retrospective study is to assess the outcome of patients with inflammatory bowel disease under TNF-alpha antibody therapy over a period of 20 years

Study Type

Observational

Enrollment (Actual)

538

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study Population includes all patients with a confirmed IBD diagnosis who have been treated with an TNF Alpha antibody in the last 20 years at our outpatient clinic in Graz, Austria

Description

Inclusion Criteria:

  • Patients with a confirmed IBD diagnosis
  • TNF Alpha antibody therapy in the last 20 years at our outpatient clinic

Exclusion Criteria:

  • Not Meeting the inclusion criteria
  • Lack of clinical data, no follow up available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ulcerative Colitis (UC)
This Group includes all patients suffering from UC who have been treated with a TNF Alpha antibody within the last 20 years at the IBD outpatient clinic at our Hospital.
Other: TNF Alpha therapy
Retrospective analysis of outcome of first TNF Alpha therapy
Crohn's disease (CD)
This Group includes all patients suffering from CD who have been treated with a TNF Alpha antibody within the last 20 years at the IBD outpatient clinic at our Hospital.
Other: TNF Alpha therapy
Retrospective analysis of outcome of first TNF Alpha therapy
IBD unclassified
This Group includes all patients suffering from IBD unclassified who have been treated with a TNF Alpha antibody within the last 20 years at the IBD outpatient clinic at our Hospital.
Other: TNF Alpha therapy
Retrospective analysis of outcome of first TNF Alpha therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of first TNF Alpha Therapy in IBD patients
Time Frame: 20 years
The main endpoint of this retrospective Analysis is the length of Treatment with the first TNF Alpha therapy in IBD
20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of further biologicals after first TNF Alpha therapy
Time Frame: 20 years
Follow-up drug therapy after termination of TNF Alpha therapy
20 years
Rate of surgical interventions after first TNF Alpha
Time Frame: 20 years
Resections after the termination of first TNF Alpha therapy
20 years
Reasons for discontinuing therapy
Time Frame: 20 years
Loss of response, side effects etc.
20 years
Predictive factors
Time Frame: 20 years
Predictive factors for long-term response (BMI, CRP, Alb etc.)
20 years
Number of side effects
Time Frame: 20 years
Side effects of the primarily used TNF-alpha antibodies leading to discontinuation of the drug
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Wolfgang Petritsch, Prof, Meduni Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

September 29, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 1465/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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