An Observational, Prospective Cohort Study to Evaluate Safety of Remsima® Subcutaneous in Patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis (CT-P13 4.8)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

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

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB02) infliximab

  infliximab
• Medical condition to be studied:
  Rheumatoid arthritis

  Ankylosing spondylitis

  Psoriatic arthropathy

  Psoriasis

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:
  864

Study design details

• Main study objective:
  The main objective of this study is to evaluate safety of Remsima® subcutaneous in patients with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis.
• Outcomes:
  Primary objective of this study is to assess the safety of Remsima® Subcutaneous (SC) in Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA) and Psoriasis (Ps) patients by evaluation of adverse events of special interest (AESI). Secondary objective of this study is to evaluate additional safety of Remsima® SC in RA, AS, PsA and Ps patients.
• Data analysis plan:
  Results will be summarized using descriptive statistics (n, mean, median, standard deviation SD, minimum, and maximum) for quantitative variables and frequencies for qualitative variables. Demographics (age, gender, weight, height, and race) will be summarized in tables in the safety population. Previous medical history will be presented by means of summary tables. In addition, for RA patients, the safety results will be systematically compared against the historical cohorts of patients from published peer-reviewed clinical studies and post-marketing studies conducted with infliximab (IV and SC formulation), including but not limited to Studies CT-P13 3.5, 1.6 and risk management plan. For AS, PsA, and Ps patients, the results of Remsima® SC will be compared against the patients in Remsima® IV group who receive at least 1 (full or partial) dose of Remsima® IV.