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Retrospective Observational Study on the Effect of Vedolizumab Treatment on Patients With Inflammatory Bowel Disease and Extraintestinal Manifestations

IDENTIFIERS
Trial Protocol: Vedolizumab-5041
EUPAS: EUPAS25761
PURPOSE

This is retrospective multi-national, multi-centre medical chart review study of patients with inflammatory bowel disease (IBD) and extraintestinal manifestations (EIMs) who have initiated treatment with vedolizumab between 01 January 2015 and 31 December 2016. The study will review the medical charts of patients who have initiated the medical treatment with vedolizumab during the defined eligibility period under standard clinical practice to provide the real-world evidence of treatment effectiveness and safety in the adult patients with ulcerative colitis (UC) or Crohn's disease (CD) and EIMs. Patients who will be taking vedolizumab as per the standard clinical practice will be observed in this study. The data for participants will be collected in two main periods: Pre-index event period (from the data of diagnosis of UC or CD until one day prior to the date when vedolizumab treatment was initiated during the eligibility period), and Post-index event period (from the date when vedolizumab treatment was initiated during the eligibility period until the death of participants, lost-to-follow up, or date of chart abstraction initiation). The overall duration of the study will be 14 months.

Recruiting
BE
DK
IL
2+
NL
CH

Trial at a glance

What medical condition is being studied?   Inflammatory Bowel Disease
When is the trial being conducted?   

Key requirements

Sex   
All
Age   
From 18 Years
Accepts Healthy Volunteers?   
No

Trial Details / Participation Requirements

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Trial Type:   Observational