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

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.