NCT04575701

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
538

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

September 29, 2020

Last Update Submit

February 23, 2021

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Rate of further biologicals after first TNF Alpha therapy

    20 years

  • Rate of surgical interventions after first TNF Alpha

    20 years

  • Reasons for discontinuing therapy

    20 years

  • Predictive factors

    20 years

  • Number of side effects

    20 years

Study Arms (3)

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.

Other: 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.

Other: 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.

Other: TNF Alpha therapy

Interventions

TNF Alpha therapyOTHER

Retrospective analysis of outcome of first TNF Alpha therapy

Crohn's disease (CD)IBD unclassifiedUlcerative Colitis (UC)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study Population includes all patients with a confirmed IBD diagnosis who have been treated with an TNF Alpha antibody in the last 20 years at our outpatient clinic in Graz, Austria

You may qualify if:

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

You may not qualify if:

  • Lack of clinical data, no follow up available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Austria

Location

Study Officials

  • Wolfgang Petritsch, Prof

    Meduni Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 5, 2020

Study Start

May 1, 2019

Primary Completion

June 1, 2020

Study Completion

July 1, 2020

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)