Multinational, multicentre, non-interventional study, in patients with rheumatoid arthritis (RA) treated with tocilizumab (ACT-UP)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Actemra
• Study drug International non-proprietary name (INN) or common name:
  TOCILIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC07) tocilizumab

  tocilizumab
• Medical condition to be studied:
  Rheumatoid arthritis

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:
  169

Study design details

• Main study objective:
  To observe, in routine clinical practice, patterns of use of tocilizumab in patients with RA, for continuity of treatment and adherence to the recommendations adopted in the instructions or data sheet.
• Outcomes:
  To observe, in routine clinical practice, patterns of use of tocilizumab in patients with RA, for continuity of treatment and adherence to the recommendations adopted in the instructions or data sheet. Observe the behavior of hemoglobin at weeks 0 and 24• Observe the rates and reasons for the changes in the doses oftocilizumab•To observe the demographics and characteristics of RA when starting treatment with tocilizumab•To observe the efficacy and safety of treatment in clinical practice
• Data analysis plan:
  The analysis in this study primarily used descriptive statistical methods. In addition, it will use modeling and exploratory statistical analyses to highlight interesting aspects of the data.Unless otherwise specified, all tests will be bilateral and practiced using an alpha error rate of 5% without correction for multiplicity.The main moments of interest are baseline (initiation of treatment with tocilizumab), week 12 and 24. Given that this is a non-interventional study, and the evaluation times are not scheduled in advance, appropriate windows around such moments will be defined.The main variable of interest, the proportion of patients treated with tocilizumab at 6 months, will be analyzed descriptively. Confidence intervals (CI) for this and similar variables, such as the IS rate will be calculated using the Clopper-Pearson method.