Entyvio PASS Study

Project

Entyvio PASS Study

Automatically Closed · 2016 until 2022

Dora Barbara, Knellwolf Christina, Sulz Michael, Krieger-Grübel Claudia, Brand Stephan

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Units

Gastroenterology/Hepatology, Muskelzentrum | ALS Clinic

Status

Automatically Closed

Start Date

2016

End Date

2022

Financing

Industry

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.