An observational post-authorization safety study to describe the safety of ustekinumab and other treatments of ulcerative colitis in a cohort of patients with ulcerative colitis using the French Nationwide claims database (SNDS) France

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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

• Medicinal product name:
  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-
• 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