Entyvio PASS Study

Automatically Closed · 2016 until 2022

Clinical Studies
Multicentric, KSSG as participating partner
Automatically Closed
Start Date
End Date
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
Brief description/objective

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.