Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

ALOFISEL

Study drug International non-proprietary name (INN) or common name

DARVADSTROCEL

Anatomical Therapeutic Chemical (ATC) code

(L04AX08) darvadstrocel
darvadstrocel

Medical condition to be studied

Crohn's disease
Anal fistula
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

5850
Study design details

Main study objective

Primary objective of the study is to estimate the incidence rate and cumulative incidence of malignancies among crohn's disease (CD) patients with perianal fistula who received treatment with darvadstrocel or an alternative standard of care.

Outcomes

The primary outcomes will assess the occurrence and cumulative occurrence of malignancies in CD patients with complex perianal fistula (CPF). The secondary outcomes will assess all-cause mortality and cancer-specific mortality rate in CD participants with CPF, number of participants with anal fistula surgery, colorectal surgery, number of CD participants with CPF characterized by pharmacological therapies, and number of participants with comorbidities.

Data analysis plan

Descriptive statistics will be generated within each data source to describe baseline characteristics. Categorical variables will be summarized by frequencies and proportions, and continuous variables will be summarized by the number of valid observations, means and standard deviations, medians, and interquartile ranges, the minimum and the maximum.