Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Inflammatory Bowel Diseases, Treatment

Intervention / Treatment
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* Biological: vedolizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1st subpopulation<br>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. | Biological: vedolizumab<br>* duration of disease and kind of therapy<br>|
| 2nd subpopulation<br>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<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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) | 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. | 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. | 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. | 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) | 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) | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vedolizumab, Crohns disease, Ulcerative colitis, safety