Vedolizumab-5060: Association Between Disease Activity and QoL, Fatigue, Mood and Sleep Disorders in Patients with Moderate to Severe Ulcerative Colitis or Crohn’s Disease Treated with Vedolizumab - A Prospective, Observational Study Based on Patient Reported Outcomes (KUJAWIAK)

Study type

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

  Safety study (incl. comparative)

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:
  Colitis ulcerative

  Crohn's disease

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The primary objective of the study is to determine effect of vedolizumab on quality of life (QoL) measured at Week 14 (end of induction therapy in the DP).
• Outcomes:
  Primary endpoint will include change from baseline to end of induction therapy in the DP (Week 14) in inflammatory bowel disease questionnaire (IBDQ) total score, domain score (for bowel symptoms, systemic symptoms, emotional function, and social function), and proportion of patients with response (defined as an increase in IBDQ total score of >=16 points at the end of induction therapy in DP). The secondary endpoint will include proportion of patients with clinical response to vedolizumab treatment at end of induction therapy in DP, change from baseline to end of induction therapy in DP (Week 14) in frequency/severity of fatigue, impact of fatigue on individuals’ lives, depression and sleep disturbance expressed as value of T-score calculated from PROMIS Sleep disturbance questionnaire.
• Data analysis plan:
  Standard descriptive statistic methods will be used which comprise the number of patients, arithmetic mean, standard deviation, upper and lower quartiles, minimum, median and maximum. For categorical variables frequencies and percentages (absolute and relative frequencies) will be presented. The safety endpoints will be presented as incidence rate calculated using person-time analyses.