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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/3358
• EU PAS number:
  EUPAS3357
• Study ID:
  3358
• Official title and acronym:
  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
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This is a multicentre, non-interventional, retrospective, cohort study to describe clinical patterns of use, clinical outcomes and kinetics of response of certolizumab pegol (CZP or Cimzia®) and other subcutaneous anti-tumour necrosis factor- alpha therapy (anti-TNFα) (etanercept and adalimumab) followed up for at least one year in anti-TNFα naive rheumatoid arthritis (RA) patients in daily hospital clinical practice in the UK. The data will be useful to understand the clinical patterns of use and identify factors that influence clinical outcomes for CZP and other anti-TNFαs in routine clinical practice. The results will also be helpful for the design of prospective/pragmatic studies and help to assess the opportunities for future formal comparative analyses of CZP with other individual subcutaneous anti-TNFαs. Retrospective data contained in patient´s hospital clinical records will be collected in an anonymous manner. The retrospective observational nature of the study does not interfere with the therapeutic decision of the treating physician. The primary objective is to assess the proportion of clinical response at 52 weeks in RA patients commenced on CZP therapy.The secondary objectives are to assess the proportion and kinetics of clinical response by time up to 52 weeks for CZP and individual subcutaneous non-CZP anti-TNFα drugs, etanercept and adalimumab, combined and separately, in RA patients. Other secondary objectives are to determine if an early clinical response, and the accompanying treatment decision, at 12 weeks to CZP therapy is a predictor of long term clinical response at 52 weeks compared with a lack of clinical response at 12 weeks and compared with a 24 week clinical response for CZP. Discontinuation and switching from CZP, etanercept and adalimumab will also be evaluated.
• Study status:
  Planned

Research institution and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London Barts and the London School of Medicine and Dentistry, London Guy's and St Thomas' NHS Foundation Trust, Cannock Cannock Chase Hospital, Christchurch Christchurch Hospital, Eastbourne Eastbourne District General Hospital

Study timelines

Date when funding contract was signed

Planned: 19/10/2012

Study start date

Planned: 30/01/2013

Data analysis start date

Planned: 01/05/2013

Date of final study report

Planned: 30/09/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

UCB Pharma Limited

Regulatory

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