Status: Planned First registered on: 11/01/2013
Last updated on: 11/01/2013
1. Study identification
EU PAS Register NumberEUPAS3357
Official titleRetrospective 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 title acronym
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOXON
Department/Research group
Organisation/affiliationOxon Epidemiology Ltd.
Website/Homepagewww.oxonepi.com
Details of (Primary) lead investigator
Title Professor
Last name Pitzalis
First name Costantino
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5
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
Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/10/2012
Start date of data collection30/01/2013
Start date of data analysis01/05/2013
Date of interim report, if expected
Date of final study report30/09/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesUCB Pharma Limited100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Nawab
First name Qizilbash
Address line 1200 Northcote Road
Address line 2 
Address line 3 
CityLondon 
PostcodeE177DH 
CountryUnited Kingdom
Phone number (incl. country code)447749739566 
Alternative phone number442035744617 
Fax number (incl. country code) 
Email address n.qizilbash@oxonepi.com
Public Enquiries
Title Dr 
Last name Nawab 
First name Qizilbash 
Address line 1200 Northcote Road 
Address line 2 
Address line 3 
CityLondon 
PostcodeE177DH 
CountryUnited Kingdom 
Phone number (incl. country code)447749739566 
Alternative phone number442035744617 
Fax number (incl. country code) 
Email address n.qizilbash@oxonepi.com 
Top