Vedolizumab-4018: Observational Study of the Effectiveness of Vedolizumab on Treatment Outcomes and HRQoL in biologic naïve Patients with Inflammatory Bowel Diseases in Greece (TROVE)

Study type

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

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and 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
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AG05) vedolizumab

  vedolizumab
• Medical condition to be studied:
  Inflammatory bowel disease

  Colitis ulcerative

  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:
  200

Study design details

• Main study objective:
  The primary objective is to assess long term clinical benefit for the biologic naïve patients with inflammatory bowel disease (IBD) on treatment with vedolizumab.
• Outcomes:
  The primary outcome is the drug discontinuation rate in patients with UC or CD under treatment with vedolizumab until 2 years follow-up period. Changes in partial Mayo score(PMS)(UC),Harvey-Bradshaw index(HBI)(CD),short IBD,EQ-5D and treatment satisfaction questionnaire,rate of dose intensification,UC/CD patients on steroids,impact of treat-to-target treatment by PMS(UC)and HBI(CD),endoscopic disease activity,effects of biological parameters,collection of Nr of serious adverse events(AEs),non-serious related AEs,special situation reports.
• Data analysis plan:
  The analysis will be descriptive. All variables will be listed and illustrated by frequency or parameter tables. Continuous variables will be expressed as median, as percent where appropriate, as means (standard deviation SD), and prevalence rates as crude and standardized gender-adjusted, and age-adjusted values. The epidemiological methods will be employed for data analysis and therefore no inferential statistics will be considered with respect to primary and secondary endpoints. Summary statistics for continuous variables will include mean, SD, median and range. For categorical variables the number and percentage of patients in each category will be presented. An interim analysis will be performed when 50 percent (%) of the UC and 50% of the CD enrolled patients will have completed approximately 1 year of follow-up from first patient in (FPI) date, depending in the recruitment rate per group.