Long-term Outcome of TNF Alpha Therapy in IBD

NCT ID: NCT04575701

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

538 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-07-01

Brief Summary

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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

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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

Conditions

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IBD

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

TNF Alpha therapy

Intervention Type OTHER

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.

TNF Alpha therapy

Intervention Type OTHER

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.

TNF Alpha therapy

Intervention Type OTHER

Retrospective analysis of outcome of first TNF Alpha therapy

Interventions

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TNF Alpha therapy

Retrospective analysis of outcome of first TNF Alpha therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

* Lack of clinical data, no follow up available
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolfgang Petritsch, Prof

Role: PRINCIPAL_INVESTIGATOR

Meduni Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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1465/2018

Identifier Type: -

Identifier Source: org_study_id

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