A prospective, non-interventional, multi-country cohort study of the effectiveness and safety of filgotinib in adult patients with moderately to severely active ulcerative colitis (GALOCEAN)

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:
  FILGOTINIB MALEATE
• Medical condition to be studied:
  Colitis ulcerative

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:
  600

Study design details

• Main study objective:
  To describe the real-world clinical treatment persistence in adult patients with moderately or severely active UC treated with filgotinib for approximately 52 weeks in routine clinical practice.
• Outcomes:
  Treatment persistence rate at week 52, Treatment persistence rate at weeks 10 and 24, Clinical response rate, Clinical remission rate, change from baseline in Health-Related Quality of Life (HRQoL) as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), Urgency Numeric Rating Scale (NRS), and Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F), rate of AE and SAE during 52 weeks
• Data analysis plan:
  In general, data analysis will be descriptive and use summary statistics. Continuous variables will include the number of patients (N), mean, standard deviation (SD), median, interquartile range (IQR), minimum, and maximum, together with the number of missing values. Categorical variables will include numbers and percentages, with missing values as separate category. Descriptive summary statistics will be conducted for all effectiveness measurements, as well as baseline characteristics, demographics, medical and treatment histories, HRU, AEs, and HRQoL. More advanced analysis (e.g. time-to-event, change from baseline) may also be conducted.