Vedolizumab-4020: A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With Ulcerative Colitis and Crohn’s Disease

Study type

• Study topic:
  Human medicinal product
• Study type:
  Clinical trial
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  VEDOLIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA33) 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)
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  The main objective of the study is to assess the safety and effectiveness of vedolizumab intravenously (IV) in participants with UC or CD in India.
• Outcomes:
  To assess the safety of vedolizumab IV in participants with UC or CD in India the primary endpoint includes: Incidence of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESIs), adverse drug reactions (ADRs), and unexpected ADRs. To assess the efficacy of vedolizumab IV in participants with UC or CD in India the secondary endpoints include: Proportion of participants with clinical response, clinical remission, vedolizumab discontinuation and mucosal healing/endoscopic response, Change in the patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire) from Baseline.
• Data analysis plan:
  For assessment of primary outcome measure, exposure-adjusted incidence rates and 95 percent (%) confidence intervals (Cis) will be calculated based on total numbers of incident events and person-time at risk. Two separate incidence calculations will be used: incidence rates for events that occur while on vedolizumab therapy, and incidence rate for events that occur after discontinuation of vedolizumab. Descriptive summaries will be provided for effectiveness outcomes too.