Retrospective Cohort Study of Certolizumab Pegol (Cimzia®) and Other Subcutaneous Anti-Tumour Necrosis Factor-Alpha Drugs in Rheumatoid Arthritis to Explore Usage Patterns and Clinical Outcomes in daily clinical practice in the United Kingdom

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CERTOLIZUMAB PEGOL

  ETANERCEPT

  ADALIMUMAB
• 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:
  532

Study design details

• Main study objective:
  The primary purpose of the study is to assess the proportion of patients with DAS response, defined as a reduction from Baseline in a DAS28(ESR) score of ≥ 1.2 points, which is considered the minimum clinically important difference (MCID), at 52 (+/- 6) weeks in RA patients commenced on CZP therapy.
• Outcomes:
  The primary efficacy variable is the proportion of patients with a DAS response at 52 (+/- 6) weeks. • Proportion of patients achieving a DAS response at 12 weeks and 24 weeks.• Proportion of patients achieving low disease activity.• Proportion of patients achieving remission. • Proportion of patients discontinuing the index therapy.• Proportion of patients switching from the index therapy to another biological agent (anti-TNFα, rituximab and other DMARDS).
• Data analysis plan:
  The primary efficacy endpoint will be analysed using frequency, proportion and corresponding 95% confidence intervals.The primary endpoint will be subject to subgroup analyses investigating the effect of several baseline factors using logistic regression. Secondary efficacy endpoints will be analysed using frequency, proportion, and logistic regression, controlling by centre effect (if applicable). Sensitivity analyses will be conducted that differ in how missing data at the 52 week time point are treated.Discontinuation rates will be calculated and hazard rates will be computed by Kaplan–Meier.