An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  REMSIMA
• Medical condition to be studied:
  Disseminated tuberculosis

  Cardiac failure congestive

  Opportunistic infection

  Serum sickness

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:
  450

Study design details

• Main study objective:
  The primary objective of this study is to assess the long-term safety and efficacy of RemsimaTM in Rheumatoid Arthritis (RA) patients.
• Outcomes:
  to assess the long term safety of Remsima in RA patients, to evaluate efficacy in patients with RA
• 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.