Retrospective non-interventional chart review study of the dosing and short-term clinical outcomes of patients with Crohn’s Disease treated with ustekinumab in Finland (FINUSTE2)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, non-interventional, retrospective patient chart review study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  USTEKINUMAB
• Medical condition to be studied:
  Crohn's disease

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:
  150

Study design details

• Main study objective:
  The primary objective of the study is to investigate the real-life dosing patterns and the positioning of ustekinumab in the treatment of CD patients in Finland
• Outcomes:
  The primary outcome of the study is the ustekinumab treatment and dose adjustments (mean and median ustekinumab dose and dosing interval), Secondary outcomes include disease activity measured by Harvey-Bradshaw index, and disease activity, measured by SES-CD. Both are measured at 0 and 16 weeks, 1 year, 1.5 years, 2 years, and at the end of study period.
• Data analysis plan:
  To present the observed variables, frequencies and statistical testing for each sensible comparison. To perform statistical tests on univariate comparisons, the χ2 test (for categorical data) and parametric tests, such as the analysis of variance (ANOVA, for continuous data) are considered if the sample size is sufficient. E.g. with less than 30 observations in a group with continuous variable being compared, non-parametric tests are considered. Where feasible, point estimates with interval estimates (confidence intervals or standard errors) are presented. P-value lower than 0.050 is considered statistically significant.