Skip to main content
OpenTrials
Completed

NCT Number: NCT04575701

Long-term Outcome of TNF Alpha Therapy in IBD

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

IBD

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TNF Alpha therapy

Other

Retrospective analysis of outcome of first TNF Alpha therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of further biologicals after first TNF Alpha therapy

    Time frame: 20 years

    Follow-up drug therapy after termination of TNF Alpha therapy

  2. Rate of surgical interventions after first TNF Alpha

    Time frame: 20 years

    Resections after the termination of first TNF Alpha therapy

  3. Reasons for discontinuing therapy

    Time frame: 20 years

    Loss of response, side effects etc.

  4. Predictive factors

    Time frame: 20 years

    Predictive factors for long-term response (BMI, CRP, Alb etc.)

  5. Number of side effects

    Time frame: 20 years

    Side effects of the primarily used TNF-alpha antibodies leading to discontinuation of the drug

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2020
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.