Post-Marketing Observational Cohort Study of Patients with Inflammatory Bowel Disease (IBD) Treated with CT-P13 in Usual Clinical Practice (CONNECT-IBD)

Study type

• Study topic:
  Disease /health condition

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

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  INFLIXIMAB
• Medical condition to be studied:
  Crohn's disease

  Colitis ulcerative

Population studied

• Short description of the study population:
  Patients with Crohn's disease (CD) or Ulcerative Colitis (UC), who are being treated with, or initiating treatment with, CT-P13 (or Remicade for the SOC cohort) at the time of study enrolment.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Crohn’s Disease (CD), Ulcerative Colitis (UC)
• Estimated number of subjects:
  2500

Study design details

• Main study objective:
  1) To characterise the population and drug utilisation patterns of patients treated with CT-P13 for Crohn's disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade2) To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
• Outcomes:
  •Patients’ demo characteristics •Clin and diagnostic characteristics: Relevant med history of CD or UC including prior treatments •CT-P13 treatment: 1)CT-P13 & Remicade switches and reasons for switch, 2) Dose and freq, augmentation/reduction & reasons of changes•Co-therapies related to management of CD or UC•All AEs, SAEs, AESIs and special situation events (e.g. pregnancy) during study, •Clinical assessment of disease activity, data relating to: Harvey Bradshaw Index (HBI) for patients with CD, Partial Mayo Scoring System for Assessment of UC Activity, Montreal classification index for CD, Montreal classification index for UC, and fistula drainage assessment index for CD• Laboratory and imaging results related to the treatment or assessment of CD or UC
• Data analysis plan:
  The statistical analysis for this observational study will be descriptive in nature. Given the expected heterogeneity of patients commonly seen in observational studies, patients will be stratified (eg, UC vs. CD, by subgroup, by country) based on final data available for analysis. Data permitting, post hoc inferential analysis may be used to examine the impact of risk factors or predictors on outcomes of interest, as appropriate.