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Observational Study of the Effectiveness of Vedolizumab on Treatment Outcomes and HRQoL in biologic naïve Patients with Inflammatory Bowel Diseases in Greece

IDENTIFIERS
Trial Protocol: Vedolizumab-4018
EUPAS: EUPAS23580
PURPOSE

This is a prospective, observational, multi-center and a cohort study of biologic naïve patients with moderate to severe ulcerative colitis (UC) or Crohn’s disease (CD) who have had an inadequate response with, lost response to, or were intolerant to conventional therapy. This study will assess long-term clinical benefits in patients who are initiating treatment with vedolizumab. Patients that are initiated on treatment with vedolizumab will be recruited into cohorts of UC or CD. This study will enroll approximately 200 patients (100 patients with UC and 100 with CD) into 2 cohorts who have initiated a treatment with vedolizumab in a clinical practice. The study will be conducted at 23 sites in Greece. The data will be collected for up to 2 years or until discontinuation of vedolizumab treatment, whichever occurs earlier after enrolment in the study.

Recruiting
GR

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