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 identification

• EU PAS number:
  EUPAS32246
• Study ID:
  32247
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Germany

  Italy

  Spain
• Study description:
  This observational post-market clinical follow-up (PMCF) device study is designed to 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), specifically of the certolizumab pegol (CZP) ava device (ava) and other auto-injectors.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual:26/03/2019

Study start date

Actual:15/11/2019

Date of final study report

Actual:19/05/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

UCB Biopharma S.R.L.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable