Vedolizumab-5056: Clinical Effectiveness of Vedolizumab Used in Frames of Drug Program for Crohn’s Disease Treatment in Poland – Prospective, Observational Study Considering Fatigue and Other Patient-reported-outcomes (PROs) (POLONEZ II)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ENTYVIO
• Study drug International non-proprietary name (INN) or common name:
  VEDOLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA) Selective immunosuppressants

  Selective immunosuppressants
• 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:
  100

Study design details

• Main study objective:
  The primary objective of the study is to assess the effectiveness of vedolizumab in CD patients treated in frames of the DP in Poland defined as response and remission rates assessed using CD Activity Index (CDAI).
• Outcomes:
  The primary outcome will include the percentage of patients achieving response or remission on Week 102. The secondary outcome will include the characteristic of CD patients eligible for DP, Abdominal Pain Score (APS), Number of Liquid or Very Soft Stools (NLVSS), patient reported outcomes (PROs), inflammatory bowel disease-fatique (IBD-F), IBD questionnaire, measurement of quality of life, rate of emergency room visits, hospitalization rate, surgery rate due to CD, and real-world safety of Entyvio.
• Data analysis plan:
  Standard descriptive statistic methods will be used which comprise the number of patients, arithmetic mean, standard deviation, minimum, median and maximum. For categorical variables tables of frequencies (absolute and relative frequencies) will be presented. For exploratory analyses of factors influencing response and remission rates a univariate and multivariate logistic regression will be performed. The safety endpoints will be presented as incidence rate calculated using person-time analyses. Appropriate 95 percent (%) confidence interval will be provided.

Documents

Study report

Vedolizumab-5056-clinical-study-report-redact.pdf