Inflammatory Bowel DiseasesVEDOibdINCT03375424
Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany
An observational study of Inflammatory Bowel Diseases and Treatment, run by Ced Service GmbH at 1 site in Germany.
Trial summary
This study on biologics (Vedolizumab/anti-TNF) in the treatment of inflammatory bowel disease (IBD) patients in Germany extends the prospective documentation of efficacy in induction and maintenance therapy of anti-TNF to the use of Vedolizumab with a particular interest in the construction of a multifactorial model… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Treatment
- What is being tested?
- vedolizumab
- How many people
- 2,500 participants
- Where
- 1 siteGermany
- Study dates
- 2 Oct 2017to 30 Apr 2024
- How long will I take part?
- 60 Months
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There are three subpopulations: 1. IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv. 2. IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients. 3. IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed <2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future.
Who may be able to join
- IBD-patients (UC/CD) aged 18-80 years at enrollment
- Written informed consent is given
Who cannot join
- Lack of adequate documentation possibilities
- Malignant disease in history
- Planned surgical intervention
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Gastroenterologische Gemeinschaftspraxis Minden
Minden, Lower Saxony, 32423
Bernd Bokemeyer, PD Dr. med., +49 571/22567, mailto:bernd.bokemeyer@t-online.de
About this study
Official title: Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany Documentation of Vedolizumab Induction and Maintenance Therapy in Conjunction With Long-term Outcome and Predictors of Response
This study on biologics (Vedolizumab/anti-TNF) in the treatment of inflammatory bowel disease (IBD) patients in Germany extends the prospective documentation of efficacy in induction and maintenance therapy of anti-TNF to the use of Vedolizumab with a particular interest in the construction of a multifactorial model to predict long-term responses and favorable disease outcome or to predict severe side effects caused by therapy with biologics. Little data are available on the efficacy and safety of biologics in Germany in a real world situation. While the increasing use of anti-TNF-alpha antibodies in IBD-patients the new therapy with Vedolizumab opens up new opportunities in IBD-therapy, it may also pose new options and problems in terms of efficacy and predictors of response and potential side effects.
Read the detailed description
The IBD-patients will be prospectively documented in the BIOibd-Registry. The diagnosis is made in accordance with current DGVS/ECCO UC/CD guidelines. There are the following inclusion and exclusion criteria:
Inclusion Criteria:
- IBD-patients (UC/CD) aged 18-80 years at enrollment
- Written informed consent is given Exclusion Criteria:Lack of adequate documentation possibilities
- Malignant disease in history
- Planned surgical intervention
There are three subpopulations:
- IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv.
- IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients.
- IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed < 2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future.
Patients with IBD on Vedolizumab/anti-TNF will be documented in a prospective online documentation form at the participating study sites. In parallel, these sites will also document consecutively early disease IBD patients who were diagnosed less than 2 years previously. These patients will be used as a control group.The data will be documented in an online documentation form. After initial documentation at enrollment and during induction (0, 2, 6 and 14 weeks), follow-up documentation using an abbreviated online follow-up form will be requested every 6 months during the longitudinal investigation. Any drug side effects are also captured online on a side effects form.
- Conditions
- Inflammatory Bowel Diseases, Treatment
- Being tested
- vedolizumab
- Keywords
- Vedolizumab, Crohns disease, Ulcerative colitis, safety
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vedolizumabBiological
duration of disease and kind of therapy
| Study group | Role | What they receive |
|---|---|---|
| 1st subpopulation | IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv. Receives: Biological: vedolizumab | |
| 2nd subpopulation | IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients. | |
| 3rd subpopulation | IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed <2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future. |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety index (Chronic steroid-use ≥ 20 mg for ≥ 6 months, New secreting fistula, Op caused by stenosis, Mortality (all), Hospitalization > 14 days, Long-term-illness (with > 30 days off work), Early retirement)
Success - no; Failure - yes
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
Comparison of the disease course in IBD-patients on Vedolizumab/anti-TNF therapy with IBD-patients with an early-stage disease
percent responders/remitters at week 2, 6 and 14, time to response, time to remission etc.
Measured: during the first 14 weeks after individual participation
Development of a multifactorial model to predict a favorable course of disease
Controlling the systematic analysis (e.g. Chronic steroid-use ≥ 20 mg for ≥ 6 months, new secreting fistula etc.) to forecast the good treatment of the participants (to avoid the primary outcome and to reach the secondary outcome/remission).
Measured: through study completion, an average of 1 year
Online documentation of effectiveness in induction and maintenance therapy including the occurrence of serious side effects
Online documentation of effectiveness in induction and maintenance therapy including the occurrence of serious side effects (e.g. death, tumor, tuberculosis, serious infection or other side effects requiring hospitalization.
Measured: through study completion, an average of 1 year
Efficacy (remission and response) of induction therapy (week 14)
Efficacy (remission and response) of induction therapy (week 14)
Measured: through study completion, an average of 1 year
Generation of health economic data in IBD-patients on biologicals
Generation of health economic data in IBD-patients on biologicals (number of hospitalizations, kind of disabilties, cost of treatment, quality of life e.g. WPAI-CD or EQ-5D) through CRF.
Measured: through study completion, an average of 1 year
Generation of follow-up data on IBD-patients with early disease
Generation of follow-up data on IBD-patients with early disease (initiation of documentation < 2 years after first diagnosis) through CRF (e.g. actual diagnostic findings or laboratory reports) and IBD-patients on biologics e.g. actual diagnostic findings or laboratory reports) with reference to treatment modalities and psychosocial impairment among patients.
Measured: through study completion, an average of 1 year
Formation of a large-scaled patient-collective of IBD-patients with an early course of disease
Formation of a large-scaled patient-collective of IBD-patients (350 patients) with an early course of disease (disease course < 2 years) by combining different registries running on the BIOibd platform (6000 patients) of the IBD Competence Net in Germany for the comparison of special subgroups, e.g. IBD-patients on biologics.
Measured: through study completion, an average of 1 year
Efficacy (remission and response) of maintenance therapy (month 6 and 12)
maintenance therapy (month 6 and 12)
Measured: through study completion, an average of 1 year
Efficacy (remission and response) of effectiveness in different subpopulations
effectiveness in different subpopulations, e.g. based on prior biological therapy (remission: HBI ≤ 4 in CD and partial Mayo Score ≤ 1 plus a bleeding subscore of 0 in UC)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start2 Oct 2017
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Ced Service GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernd Bokemeyer, PD Dr. med., Principal investigator, Gastroenterologische Gemeinschaftspraxis Minden, Uferstr. 3, 32423 Minden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375424
- Sponsor's protocol ID
- Version 1.4
- Acronym
- VEDOibdI
- Status last verified
- Dec 2017
- First submitted
- 6 Nov 2017
- Last updated
- 18 Dec 2017
- 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 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany Documentation of Vedolizumab Induction and Maintenance Therapy in Conjunction With Long-term Outcome and Predictors of Response
- ClinicalTrials.gov ID
- NCT03375424
- Acronym / sponsor ID
- VEDOibdI / Version 1.4
- Conditions
- Inflammatory Bowel Diseases, Treatment
- Keywords
- Vedolizumab, Crohns disease, Ulcerative colitis, safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Ced Service GmbHUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 18 Dec 2017 (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.
This study on biologics (Vedolizumab/anti-TNF) in the treatment of inflammatory bowel disease (IBD) patients in Germany extends the prospective documentation of efficacy in induction and maintenance therapy of anti-TNF to the use of Vedolizumab with a particular interest in the construction of a multifactorial model to predict long-term responses and favorable disease outcome or to predict severe side effects caused by therapy with biologics. Little data are available on the efficacy and safety of biologics in Germany in a real world situation. While the increasing use of anti-TNF-alpha antibodies in IBD-patients the new therapy with Vedolizumab opens up new opportunities in IBD-therapy, it may also pose new options and problems in terms of efficacy and predictors of response and potential side effects.
Detailed description
The IBD-patients will be prospectively documented in the BIOibd-Registry. The diagnosis is made in accordance with current DGVS/ECCO UC/CD guidelines. There are the following inclusion and exclusion criteria:
Inclusion Criteria:
- IBD-patients (UC/CD) aged 18-80 years at enrollment
- Written informed consent is given Exclusion Criteria:Lack of adequate documentation possibilities
- Malignant disease in history
- Planned surgical intervention
There are three subpopulations:
- IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv.
- IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients.
- IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed < 2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future.
Patients with IBD on Vedolizumab/anti-TNF will be documented in a prospective online documentation form at the participating study sites. In parallel, these sites will also document consecutively early disease IBD patients who were diagnosed less than 2 years previously. These patients will be used as a control group.The data will be documented in an online documentation form. After initial documentation at enrollment and during induction (0, 2, 6 and 14 weeks), follow-up documentation using an abbreviated online follow-up form will be requested every 6 months during the longitudinal investigation. Any drug side effects are also captured online on a side effects form.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1st subpopulation | – | Biological: vedolizumabIBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv. |
| 2nd subpopulation | – | –IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients. |
| 3rd subpopulation | – | –IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed <2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are three subpopulations: 1. IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv. 2. IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients. 3. IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed <2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future.
Key inclusion criteria (2 listed)
- IBD-patients (UC/CD) aged 18-80 years at enrollment
- Written informed consent is given
Key exclusion criteria (3 listed)
- Lack of adequate documentation possibilities
- Malignant disease in history
- Planned surgical intervention
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 |
|---|---|---|
| vedolizumabduration of disease and kind of therapy | Biological | 1st subpopulation |
Primary outcome
safety index (Chronic steroid-use ≥ 20 mg for ≥ 6 months, New secreting fistula, Op caused by stenosis, Mortality (all), Hospitalization > 14 days, Long-term-illness (with > 30 days off work), Early retirement)
Time frame: through study completion, an average of 1 year
Success - no; Failure - yes
9 secondary outcomes
Comparison of the disease course in IBD-patients on Vedolizumab/anti-TNF therapy with IBD-patients with an early-stage disease
Time frame: during the first 14 weeks after individual participation
Development of a multifactorial model to predict a favorable course of disease
Time frame: through study completion, an average of 1 year
Online documentation of effectiveness in induction and maintenance therapy including the occurrence of serious side effects
Time frame: through study completion, an average of 1 year
Efficacy (remission and response) of induction therapy (week 14)
Time frame: through study completion, an average of 1 year
Generation of health economic data in IBD-patients on biologicals
Time frame: through study completion, an average of 1 year
Generation of follow-up data on IBD-patients with early disease
Time frame: through study completion, an average of 1 year
Formation of a large-scaled patient-collective of IBD-patients with an early course of disease
Time frame: through study completion, an average of 1 year
Efficacy (remission and response) of maintenance therapy (month 6 and 12)
Time frame: through study completion, an average of 1 year
Efficacy (remission and response) of effectiveness in different subpopulations
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- 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.
Bernd Bokemeyer, PD Dr. med. principal investigator
Gastroenterologische Gemeinschaftspraxis Minden, Uferstr. 3, 32423 Minden
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 Inflammatory Bowel Diseases and Treatment, run by Ced Service GmbH at 1 site in Germany.
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 3 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: status not confirmed, as of the sponsor's last update on 18 Dec 2017. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Koch (+49 431/592 957 5600, a.koch@kompetenznetz-ced.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety index (Chronic steroid-use ≥ 20 mg for ≥ 6 months, New secreting fistula, Op caused by stenosis, Mortality (all), Hospitalization > 14 days, Long-term-illness (with > 30 days off work), Early retirement) (time frame: through study completion, an average of 1 year). 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 18 Dec 2017.