IBDNCT04575701
Long-term Outcome of TNF Alpha Therapy in IBD
An observational study of IBD, run by Medical University of Graz at 1 site in Austria.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- IBD
- What is being tested?
- TNF Alpha therapy
- How many people
- 538 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2019to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Patients with a confirmed IBD diagnosis
- TNF Alpha antibody therapy in the last 20 years at our outpatient clinic
Who cannot join
- Not Meeting the inclusion criteria
- Lack of clinical data, no follow up available
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- IBD
- Being tested
- TNF Alpha therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF Alpha therapyOther
Retrospective analysis of outcome of first TNF Alpha therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: TNF Alpha therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 years
Secondary outcomes (5)
Rate of further biologicals after first TNF Alpha therapy
Follow-up drug therapy after termination of TNF Alpha therapy
Measured: 20 years
Rate of surgical interventions after first TNF Alpha
Resections after the termination of first TNF Alpha therapy
Measured: 20 years
Reasons for discontinuing therapy
Loss of response, side effects etc.
Measured: 20 years
Predictive factors
Predictive factors for long-term response (BMI, CRP, Alb etc.)
Measured: 20 years
Number of side effects
Side effects of the primarily used TNF-alpha antibodies leading to discontinuation of the drug
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 May 2019
- Primary completion1 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolfgang Petritsch, Prof, Principal investigator, Meduni Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575701
- Sponsor's protocol ID
- 1465/2018
- Status last verified
- Feb 2021
- First submitted
- 29 Sep 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of TNF Alpha Therapy in IBD
- ClinicalTrials.gov ID
- NCT04575701
- Acronym / sponsor ID
- 1465/2018
- Conditions
- IBD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis (UC) | – | Other: TNF Alpha therapyThis 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. |
| Crohn's disease (CD) | – | Other: TNF Alpha therapyThis 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. |
| IBD unclassified | – | Other: TNF Alpha therapyThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients with a confirmed IBD diagnosis
- TNF Alpha antibody therapy in the last 20 years at our outpatient clinic
Key exclusion criteria (2 listed)
- Not Meeting the inclusion criteria
- Lack of clinical data, no follow up available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNF Alpha therapyRetrospective analysis of outcome of first TNF Alpha therapy | Other | Crohn's disease (CD), IBD unclassified, Ulcerative Colitis (UC) |
Primary outcome
Length of first TNF Alpha Therapy in IBD patients
Time frame: 20 years
The main endpoint of this retrospective Analysis is the length of Treatment with the first TNF Alpha therapy in IBD
5 secondary outcomes
Rate of further biologicals after first TNF Alpha therapy
Time frame: 20 years
Rate of surgical interventions after first TNF Alpha
Time frame: 20 years
Reasons for discontinuing therapy
Time frame: 20 years
Predictive factors
Time frame: 20 years
Number of side effects
Time frame: 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Petritsch, Prof principal investigator
Meduni Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of first TNF Alpha Therapy in IBD patients (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.