An observational, prospective cohort study to evaluate the safety and efficacy of Remsima in patients with Crohn's disease (CD) and Ulcerative Colitis (UC)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  REMSIMA
• Medical condition to be studied:
  Crohn's disease

  Colitis ulcerative

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  500

Study design details

• Main study objective:
  to assess the safety of Remsima™ by evaluation of Events of Special Interest (ESI) in IBD patients, who have active Crohn’s disease (CD), fistulizing Crohn’s disease (CD), or Ulcerative Colitis (UC) for up to 5 years for each patient.
• Outcomes:
  to assess long term safey of Remsima in IBD patients, to evaluate efficacy in patients with IBD
• Data analysis plan:
  the statistical analysis will be performed using SAS software version.9.1.3 or later. Interim report of study results will be generated every May from 2016 and the final report will be generated in 2026.