Entyvio PASS Study

Projekt

Entyvio PASS Study

Automatisch geschlossen · 2016 bis 2022

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

Art

Klinische Forschung

Reichweite

Multizentrisch, KSSG als teilnehmendes Zentrum

Bereiche

Gastroenterologie | Hepatologie , Muskelzentrum | ALS Clinic

Status

Automatisch geschlossen

Start

2016

Ende

2022

Finanzierungsart

Industrie

Studiendesign

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

Kurzbeschreibung/Zielsetzung

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.