Long-term Outcome of TNF Alpha Therapy in IBD

Completed

• Conditions: IBD
• Interventions: Other: TNF Alpha therapy

• Registration Number: NCT04575701
• Lead Sponsor: Medical University of Graz

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

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01
• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-05
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 538

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBD unclassified	TNF Alpha therapy	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.
Crohn's disease (CD)	TNF Alpha therapy	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.
Ulcerative Colitis (UC)	TNF Alpha therapy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Number of side effects	20 years	Side effects of the primarily used TNF-alpha antibodies leading to discontinuation of the drug
Rate of further biologicals after first TNF Alpha therapy	20 years	Follow-up drug therapy after termination of TNF Alpha therapy
Predictive factors	20 years	Predictive factors for long-term response (BMI, CRP, Alb etc.)

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria