Art

Reichweite

Bereiche

Status

Start

Ende

Finanzierungsart

Kurzbeschreibung/Zielsetzung

This is a non-interventional prospective observational study in patients receiving Vedolizumab
therapy for IBD. Sites will enroll patients with moderately to severely active IBD (UC or CD),
initiating or ongoing IV induction treatment with vedolizumab in accordance with the current
SmPC at baseline OR IBD patients receiving ongoing/maintenance IV vedolizumab treatment,
with the option to switch to SC vedolizumab. [Note: All sites must have the Vedolizumab SC
preparation available to prescribe].
The planned observational period is for at least 12 months, during which time data will be
collected via an electronic case report form (eCRF).
Baseline demographics and disease characteristics will be captured at study entry, as will prior
and concomitant medications, and medical history, and use of any patient support program. Prior
use of biologics for IBD, will be specifically noted, as will other IBD medication. Patientreported
outcomes (PROs) - relating to Quality of Life (QoL), Work Productivity and fatigue will
be recorded, as will satisfaction with treatment. Where routine blood and stool samples have been
collected (namely for CRP and fecal calprotectin respectively) results will be documented, as will
results of any routine investigations such as endoscopy +/- biopsy, histology as well as any IBD
related imaging.
Drug related safety and tolerability will be followed up throughout the study period, as per
normal clinical practice, and reasons for any discontinuation of vedolizumab therapy
documented. Where possible, following discontinuation of vedolizumab, data capturing future
management (i.e., next therapy) will be noted, as will outcome if available. Healthcare resource
utilization will also be documented.
This study is part of an umbrella protocol which is adapted to local needs but maintains a core
structure which will enable solid data pooling with study results from other countries. Swiss data
may also be analyzed and published separately.