Study type

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Long term safety profile of ustekinumab for UC, as measured by incidence of malignancies, infections (serious infections, opportunistic infections, and tuberculosis) and VTE.
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

STELARA

Medical condition to be studied

Colitis ulcerative
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

6667
Study design details

Main study objective

The primary study objective is to describe the long-term safety of ustekinumab for UC, as measured by incidence of malignancies, infections (serious infections, serious opportunistic infections and tuberculosis), VTE, MACE and all-cause mortality The secondary study objective is to compare the long-term safety in patients treated with ustekinumab for UC and patients treated with other therapies

Outcomes

Malignancies, infections and VTEs at 3-year and 5-year of follow-up:Incidence rate expressed per 1 000 patient-year in each cohort, Estimation of the cumulative incidence of each outcome in each cohort Comparison of incidence of each study outcome defined above between: ustekinumab and primary comparator, ustekinumab and secondary comparator

Data analysis plan

Analyses will be conducted for each outcome and will include descriptive analyses, comparative analyses, and any relevant sensitivity analyses for each study cohort. Population description, comparative and sensitivity analyses will be performed at 3-year and 5-year follow-up