Safety and Effectiveness of Vedolizumab IV in Real World Clinical Practice in Taiwan: A Registry-Based Study

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  VEDOLIZUMAB
• Medical condition to be studied:
  Inflammatory bowel disease

  Crohn's disease

  Colitis ulcerative

Population studied

• Short description of the study population:
  The study population is all UC and CD patients in the Registry who receive at least 1 dose of vedolizumab IV during a 2.75-year period (ie, from August 2017 through 17 May 2020).; ; Inclusion and Exclusion Criteria; The following inclusion criteria will be used to identify patients treated with vedolizumab IV in the Registry:;  Patient initiated vedolizumab IV treatment from August 2017 through 17 May 2020.;  Patient was enrolled in the Registry.;  Patient was at least 18 years of age at time of initiating vedolizumab IV.;  IBD clinic and local institutional review board (IRB) (where required) agrees to use of their data from the Registry in this analysis.; The following exclusion criteria will be applied:;  Patient was enrolled in an IBD clinical trial at time of using vedolizumab IV.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Ulcerative colitis (UC) and Crohn’s disease (CD) patients
• Estimated number of subjects:
  90

Study design details

• Main study objective:
  The primary objective of the study is to assess the safety and effectiveness of vedolizumab IV in patients with UC and CD in Taiwan.
• Outcomes:
  The primary outcomes include treatment persistence for effectiveness assessment and incidence rates of adverse events for safety assessment.
• Data analysis plan:
  The analytical dataset will be comprised of all patients in the Registry who receive at least 1 dose of vedolizumab IV from August 2017 through 17 May 2020. Longitudinal data on each patient will be abstracted from the registry and form the analytical dataset. Continuous variables will be summarized using: number of patients (N), mean, standard deviation (SD), median, interquartile range (IQR), minimum, and maximum, where appropriate. Categorical variables will be summarized using the number of patients (N) and percentage of patients for each category where appropriate. There will not be imputation of missing data.