Long-term Outcome of TNF Alpha Therapy in IBD

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04575701

Enrollment

538

Registered

2020-10-05

Start date

2019-05-01

Completion date

2020-07-01

Last updated

2021-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD

Brief summary

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

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

Interventions

OTHERTNF Alpha therapy

Retrospective analysis of outcome of first TNF Alpha therapy

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026