Long-term Outcome of TNF Alpha Therapy in IBD

IBD Clinical Trial

Official title:

Long-term Outcome of TNF Alpha Therapy in IBD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04575701
• Other study ID #: 1465/2018
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: February 2021
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• IBD

Intervention

Other:
• TNF Alpha therapy
Retrospective analysis of outcome of first TNF Alpha therapy

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of first TNF Alpha Therapy in IBD patients	The main endpoint of this retrospective Analysis is the length of Treatment with the first TNF Alpha therapy in IBD	20 years
Secondary	Rate of further biologicals after first TNF Alpha therapy	Follow-up drug therapy after termination of TNF Alpha therapy	20 years
Secondary	Rate of surgical interventions after first TNF Alpha	Resections after the termination of first TNF Alpha therapy	20 years
Secondary	Reasons for discontinuing therapy	Loss of response, side effects etc.	20 years
Secondary	Predictive factors	Predictive factors for long-term response (BMI, CRP, Alb etc.)	20 years
Secondary	Number of side effects	Side effects of the primarily used TNF-alpha antibodies leading to discontinuation of the drug	20 years