Kantonsspital St.Gallen
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Entyvio PASS Study

Claudia Krieger Grübel & Stephan Brand

abstract

Entyvio (vedolizumab) long-term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn’s Disease.

This is a prospective, observational, multi-center, cohort study designed primarily to assess the long-term safety of vedolizumab versus other biologic agents in patients with UC or CD. The study has two cohorts: a vedolizumab cohort and an other biologic agents cohort.
The study is non-interventional. All decisions on clinical management are made by the investigator as part of routine standard of care, and independent of participation in the study. The study design allows the investigator to modify or change patients’ treatment at any time during the study period without having to withdraw the patients from the study.
   
type of project clinical studies
status scheduled
start of project 2016
end of project 2022
study design A non-interventional observational study*

‘Observe, measure & record’

No randomisation of treatment

Takeda does not provide study drug

Physician manages patients according to standard or care

No protocol defined procedures

Physician may modify treatment at any time

Cease vedolizumab (vedolizumab cohort)

Introduce vedolizumab (other biologic agents cohort)

Cease all treatment and go to surgery
responsible person Prof. Stephan Brand