A MULTICENTER, OBSERVATIONAL POST-MARKET CLINICAL FOLLOW-UP STUDY IN PATIENTS WITH RA, PsA, OR axSpA ASSESSING THE PATIENT EXPERIENCE WITH THE CIMZIA AVA DEVICE OR OTHER TNF-BLOCKER AUTO-INJECTOR DEVICES

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Assess utility and use of auto-injection devices available on the market for administration of tumor necrosis factor (TNF)-blocking agents in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-approval study on Device utilisation

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CERTOLIZUMAB PEGOL
• Medical condition to be studied:
  Rheumatoid arthritis

  Psoriatic arthropathy

  Axial spondyloarthritis

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:
  200

Study design details

• Main study objective:
  Assess the patients’ satisfaction with self-injection by either ava or other auto-injector devices for administration of a tumor necrosis factor (TNF)-blocking agent at observational point 1 (OP1, about 3 months after device prescription), using 6 questions of the post-self-injection assessment questionnaire (SIAQ) V2.1 satisfaction domain
• Outcomes:
  The summary score describing patient’s satisfaction with self-injection as calculated from 6 questions (Q15, and Q17 to Q21) of the post-self-injection assessment questionnaire (SIAQ) V2.1 satisfaction domain documented about 3 months (OP1) after device prescription, The time in days from initial prescription to discontinuation of device use at about 12 months (360 days) after device prescription (persistence of use)
• Data analysis plan:
  This is an exploratory study design without any formal statistical hypothesis testing. The study will estimate the true population proportion or mean of self-injection related endpoints for each device group separately (ava and all other devices). Data will be appropriately summarized and analyzed using tabulation and graphs with respect to demographic/baseline characteristics, disposition, utility/safety observations and other measurements. Summary statistics for continuous variables will include: number of available observations, mean with 95% confidence interval (CI), standard deviation (SD), minimum, median, and maximum. For categorical variables, the number and proportion of patients will be presented. Time-to-event variables will be summarized by Kaplan- Meier analyses.