Trial document




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  DRKS00013251

Trial Description

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Title

Vedolizumab Study with Inflammatory Bowel Disease Patients in Germany

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Trial Acronym

VEDOibd I Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

It is a study for safety on biologics in the treatment (with Vedolizumab) of inflammatory bowel disease patients in Germany. In the context of standard ward round information will be gathered to the case history, the location of the disease, medication and pathology. If it is necessary to take blood, stool or urine, the patients get to spend the residual material for research, after determination standard parameter.
Patients with Crohns disease or ulcerative colitis in the age 18 - 80 years will be included.
The primary endpoint will be safety data in the treatment with Vedolizumab.
As part of an amendment dated 01.03.2019, the recruitment target was reduced from 2500 to 1500 patients.

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Brief Summary in Scientific Language

The study on biologics (Vedolizumab/anti-TNF) in the treatment of inflammatory bowel disease patients (IBD) in Germany has got the intention to prospectively document the efficacy in induction and maintenance therapy of Vedolizumab/anti-TNF. The secondary effect will be the in standard ward round obtained references of the efficacy of the substance, if applicable with attention 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.
As part of an amendment dated 01.03.2019, the recruitment target was reduced from 2500 to 1500 patients.

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Organizational Data

  •   DRKS00013251
  •   2017/11/08
  •   [---]*
  •   no
  •   Approved
  •   D 461/17, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K50 -  Crohn disease [regional enteritis]
  •   K51 -  Ulcerative colitis
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Interventions/Observational Groups

  •   IBD-patients (age at enrollment 18-80 years) receiving a new treatment with vedolizumab (900 patients). A former treatment with biologics will be allowed. More than 30% of patients with Vedolizumab therapy will be biologics-naiv.
  •   IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti TNF-alpha therapy other than Vedolizumab (n=375) in biologics-naiv patients.
  •   IBD-patients (age at enrollment: 18-80 years) with an early disease (n=225), who were first diagnosed <2 yaers befor 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.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/10/09
  •   1500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- IBD-patients (UC/CD) aged 18-80 years at enrollment
- Written informed consent is given

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Exclusion Criteria

Lack of adequate documentation possibilities
- Malignant disease in history
- Planned surgical intervention

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Addresses

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    • CED Service GmbH
    • Mr.  Klaus  Fitzke 
    • Hopfenstraße 60
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Mr.  Prof. Dr. med.  Stefan  Schreiber 
    • Arnold-Heller-Str. 3, Haus 6
    • 24105  Kiel
    • Germany
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    • InterMedCon
    • Ms.  Maria  Stumpe 
    • Harkortstraße 1
    • 48163  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Takeda Vertrieb GmbH&Co.KG
    • Mr.  Hans-Dieter  Orzechowski 
    • Jägerstraße 27
    • 10117  Berlin
    • Germany
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.