BSRBR-RAUK CRN ID: 7302

August 2013 update

Recruitment Certolizumab

Must have diagnosis of

RA

Must be registered within 6 months of first dose of certolizumab

Can be re-registered if already on the

study

TocilizumabMust have

diagnosis of RA

Must be registered within 6 months of first

dose of tocilizumab

Can be re-registered if already on the

study

Anti-TNF Comparison CohortMust have

diagnosis of RA

Must be registered within 6 months of first dose of etanercept, adalimumab or infliximab

Numbers recruited up to 25/07/2013

605As of 25/07/2013

561As of 25/07//2013

492As of 25/07//2013

Recruitment

July 2011 July 2013

Certolizumab recruitment by month

Tocilizumab recruitment by month

Anti-TNF cohort recruitment by month

Dec2011 July 20130

60

30

July 2011 July 20130

40

20

0

40

20

Recruitment 01/01/2013 – 19/07/2013

BSR Region Number recruited since 1st January 2013

North West 90East Midlands 89

Yorkshire and the Humber 85West Midlands 64

South West 61Mersey 49

London (South) 22South Central 21

North East 18South East 18

East of England 17London Central and North East 17

Scotland 14London (North West) 13

Wales 8Northern Ireland 3

BSR Region Awards January - July 2013

North West East

Midlands Yorkshire and the Humber

90 89 85

Help is available with the BSRBR-RAIf you do not have enough staff support currently, then in England the National Institute for Health Research Comprehensive

Clinical Research Network (CCRN) may be able to provide assistance

What is the CCRN?The CCRN is made up of 25 Comprehensive Local Research Networks (CLRNs) which cover the whole of England. Each local Network facilitates research within their region, with the aim of widening participation in research. A study is eligible for CLRN assistance if it has been adopted on to the Network portfolio of studies; the BSRBR-RA was adopted on to this portfolio in 2008 (ID: 7302).

How can my CLRN help me?The CLRN may be able to help by assisting in R&D set up or by providing funding for the people/facilities you require in order to carry out research in which you are involved in. For example, you may be allocated research nurse time or a data clerk to assist with the recruitment and follow up of participants on the BSRBR-RA.

How can I apply for CLRN help?You should contact the team within your regional network (details found via the link below) to discuss your requirements. You will then have to complete an application form, with which we can help.

www.crncc.nihr.ac.uk/about_us/ccrn/ccrn_about_us/clrns_list.htm

The BSRBR-RA Study reference number within the Network is 7302 – please remember to quote this when asking for help with the study. If you need any help with completing the paperwork, please contact katy.mowbray@manchester.ac.uk

Is there help outside of England?Regional Support

Northern Ireland

info.NICRN@belfasttrust.hscni.net

The Northern Ireland Clinical Research Network (NICRN) may be able to provide assistance in Northern Ireland in the same way as the NIHR CCRN in England, please contact the team to discuss requirements:

Wales

The National Institute for Social Care and Health Research Clinical Research Centre (NISCHR CRC) may be able to provide assistance in Wales in the same way as the NIHR CCRN in England , please contact the team to discuss requirements:

nischr-crc@wales.nhs.uk

Scotland

NHS Scotland may be able to provide assistance in Scotland in the same way as the NIHR CCRN in England, please contact the team to discuss if support is possible for you:

http://nrs.mtcserver8.com/297_ClinicalResearchNetworks.html

Recent BSRBR-RA publications– Risk of cancer in patients receiving non-biologic disease-modifying therapy for

rheumatoid arthritis compared with the UK general population.Mercer, L., Davies, R., Galloway, J., Low, A., Lunt, M., Dixon, W., Watson, K., Symmons, D., Hyrich, K. & BSRBR_Control_Centre Consortium, B (2013). Rheumatology (Oxford), 52(1), 91-98.

– Anti-TNF therapy in women with rheumatoid arthritis with a history of carcinoma in situ of the cervix. Mercer, L., Low, A., Galloway, J., Watson, K., Lunt, M., Symmons, D., Hyrich, K. & BSRBR_Control_Centre_Consortium, B (2013). Ann Rheum Dis, 72(1), 143-144.

– The risk of gastrointestinal perforations in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the BSRBR-RA. Závada, J., Lunt, M., Davies, R., Low, A., Mercer, L., Galloway, J., Watson, K., Symmons, D., Hyrich, K. & , B (2013). Ann Rheum Dis, [Epub ahead of print]

Accessing BSRBR-RA data

http://www.rheumatology.org.uk/resources/bsr_biologics_registers/requesting_data_from_bsrbr.aspx

Recent/ongoing research projects via the BSRBR-RA data access scheme

Non-inflammatory pain mechanisms as confounders in the clinical assessment of synovitis in RA

Study of fatigue in inflammatory arthritis

Effectiveness of TNF response define by season of initiation of therapy, with particular focus on vitamin D

To explore the influence of gender and gender-related variables on severity of prognosis for RA

Obesity and clinical response to anti-TNF medication

2) ACR conference 2013 – San Diego

1. Non-differential Reporting of Myocardial Infarction to a National Observational Drug Safety Study Using Linked Data: Linkage of the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis and the Myocardial Ischaemia National Audit Project.

2. Comparison of the Occurrence and Severity of Myocardial Infarction in Subjects with Rheumatoid Arthritis Receiving Tumour Necrosis Factor Inhibitors or Standard Non-biologic Disease Modifying Anti-rheumatic Drugs: Results from a Linkage between the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis and the Myocardial Ischaemia National Audit Project.

3. The risk of serious infections in patients receiving rituximab for rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register-Rheumatoid Arthritis.

BSRBR-RA abstracts submitted:

What to look out for soon1) Web portal development

The Robertson Centre at the University of Glasgow are developing a new web portal for online data capture.

The portal will include the facility to register new patients as well as enter follow-up data for patients already on the study

Acknowledgements

• UK Consultant Rheumatologists and Specialist Nurses

• Comprehensive Local Research Networks

• BSRBR Control Centre Consortium

• British Society for Rheumatology

• Arthritis Research UK Epidemiology Unit, Manchester