Post-Marketing Surveillance of REMSIMA 100mg (Infliximab) (monoclonal antibody, gene recombination) to Evaluate Its Safety and Efficacy in Korea (REMSIMA_PMS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

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

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational study

Study drug and medical condition

• Name of medicine:
  REMSIMA
• Medical condition to be studied:
  Rheumatoid arthritis

  Crohn's disease

  Psoriasis

  Ankylosing spondylitis

  Colitis ulcerative

  Psoriatic arthropathy

Population studied

• Short description of the study population:
  All intended patients from the first patient to receive REMSIMATM for any indication approved to the agreed number of cases were consecutively enrolled as patients in the post-marketing surveillance (PMS)
• Age groups:
  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:
  1600

Study design details

• Main study objective:
  The objectives of this post-marketing surveillance (PMS) are to evaluate the safety and efficacy of REMSIMA in Korea under routine care and identify the issues regarding SAEs, ADRs, unexpected AEs and ADRs, already known ADRs, non-serious AEs and other information about safety and efficacy.
• Data analysis plan:
  <Method of safety analysis>Overall incidence rate of adverse events and its 95% confidence interval are made available, all serious or unexpected AEs and ADRs are analysed in terms of incidence and causality, incidence rate analysis based on background factors, concomitant medications and drug administration history and other relevant data, a logistic regression analysis, and, identification of causes for drug withdrawal. <Method of efficacy analysis>Efficacy of Remsima is analysed in terms of short-term effectiveness (or ineffectiveness) based on the criteria for evaluation of primary efficacy and according to background factors, concomitant medications and drug administration histories of subjects, logistic regression analysis to estimate factors that may affect analysed effective rates, and, McNemar test or Bowker test is performed on differences between long-term and short-term outcomes of Remsima in subjects for long-term surveillance.