Vedolizumab-5055: Long Term Outcomes of Drug Program for Biological Treatment in Adult Patients With Ulcerative Colitis in Poland (MAZUREK Study)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  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
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA33) vedolizumab

  vedolizumab
• Medical condition to be studied:
  Colitis ulcerative

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:
  70

Study design details

• Main study objective:
  The primary objective of the study is to assess relapse rate in patients who completed DP with response or remission for UC within Week 26 after biological treatment cessation with infliximab or vedolizumab.
• Outcomes:
  The primary outcome will assess relapse rate after 26 weeks of treatment cessation understood as: any colectomy due to UC, any hospitalization, new course of biological treatment, new course of steroids, necessity to increase a dose of steroids, and new course of an immunomodulator (IMM) (such as azathioprine, 6-mercaptopurine, methotrexate, ciclosporin or tofacitinib) due to exacerbation of UC. Relapse rate in patients who completed DP with response/remission for UC with response within Weeks 52, 78, 104 after treatment cessation with infliximab/vedolizumab, necessity for steroid and biological treatment within Weeks 26, 52, 78, and 104, effectiveness in induction and maintenance therapy, use of steroids/IMM and real life safety biological treatment in patients with UC in DP.
• 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. Relapse rates and response rates will be presented with 95 percent (%) confidence intervals. For exploratory analyses of factors influencing response and remission durability groups of patients with relapse reported on each follow-up visit will be compared. In addition, mixed effects models will be performed taking these factors into consideration. The safety endpoints will be presented as incidence rate calculated using person-time analyses.