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An observatIoNal poSt-marketing registry on the effectiveness and safety of darvadstrocel in PatIents with CRohn’s disease and complex pErianal fistulas

IDENTIFIERS
Trial Protocol: Alofisel-5003
EUPAS: EUPAS24267
PURPOSE

This is an observational, non-interventional, multinational, open-enrollment registry. The primary objective is to evaluate the real-world clinical effectiveness and safety of darvadstrocel in patients with Crohn’s disease (CD) with complex perianal fistulas for a duration of 36 months (primary evaluation at six months). The secondary objectives are to: characterize real-world patients in terms of demographics and medical and treatment histories; assess real-world darvadstrocel safety; assess impact on patient reported outcomes (PROs) of drainage, pain, and health-related quality of life (HRQoL); assess impact on, work productivity; assess impact on healthcare resource utilization; and assess the real-world clinical effectiveness, safety and impact on PROs and HRQoL of re-treatment. 

Recruiting
AT
BE
BA
28+
BG
CA
HR
CZ
DK
EE
FI
FR
DE
GR
HU
IE
IL
IT
LV
LT
NL
NO
PL
PT
RO
RS
SK
SI
ES
SE
CH
GB

Trial at a glance

What medical condition is being studied?   Crohn's 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