K50 K51
Conditions
Interventions
Group 1: IBD-patients (age at enrollment 18-80 years) receiving a new treatment with vedolizumab. A former treatment with biologics will be allowed. More than 30% of patients with Vedolizumab therapy
Sponsors
CED Service GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - IBD-patients (UC/CD) aged 18-80 years at enrollment - Written informed consent is given
Exclusion criteria
Exclusion criteria: Lack of adequate documentation possibilities - Malignant disease in history - Planned surgical intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite endpoint of seven different measurements (Chronic steroid-use, New secreting fistula, Op caused by stenosis,Mortality (all), Hospitalization > 14 days,Long-term-illness (with > 30 days off work),Early retirement) as binary criteria (“success” or “failure”) with defined limits. The Outcome measures of the primary endpoint have been designed according to robustness and sensitivity to change. They are of high clinical impact and reflect the effect desired by clinicians. Treatment failure is defined as a study event (“failure”) if in one of the seven outcome measurements. A “failure” is defined if any of the components of the outcome measures are met and the definitions are shown in the following table. We consider the primary endpoint is highly significant for a problematic long-term outcome of IBD. Therefore the analysis concert is to describe a “best practice use” of Vedolizumab that avoids reaching this endpoint. Through our modeling approach we want to individualize this approach. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of the disease course in IBD-patients on Vedolizumab/anti-TNF therapy with IBD-patients with an early-stage disease (initiation of documentation < 2 years after first diagnosis). Data will be compared to late introduction with a life-table-analysis (Kaplan Mayer Statistics), which if positively differentiating will be followed by descriptive subanalyses (e.g. percent responders/remitters at week 6 and 14, time to response, time to remission etc.). 2.Development of a multifactorial model to predict a favorable course of disease (i.e. avoiding the primary endpoint and achieving the secondary endpoint remission) to forecast induction and maintenance remission/response in IBD-patients. 3.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 4.Efficacy (remission and response) of induction therapy (week 14) and maintenance therapy (month 6 and 12) and 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) 5.Generation of health economic data in IBD-patients on biologicals (hospitalizations, disability, cost of treatment, quality of life). 6.Generation of follow-up data on IBD-patients with early disease (initiation of documentation < 2 years after first diagnosis) and IBD-patients on biologics (Vedolizumab/anti-TNF-alpha-therapy), with reference to treatment modalities and psychosocial impairment among patients. 7.Formation of a large-scaled patient-collective of IBD-patients with an early course of disease (disease course < 2 years) by combining different registries running on the BIOibd platform of the IBD Competence Net in Germany for the comparison of special subgroups, e.g. IBD-patients on biologics. | — |
Countries
Germany
Contacts
Public ContactSina Franzenburg
CED Service GmbH
Outcome results
None listed