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2 Studies to recruit to BILAG Biologics Register (BILAG BR) Short title: BILAG Biologics Prospective Cohort Full title of the research: BILAG Biologics Prospective Cohort: The Use of Novel Biological Therapies in the Treatment of Systemic Lupus Erythematosus (SLE) REC Reference Number: 09/H1014/64 CSP reference: 24407 UK CRN ID: 8251 The BILAG Biologics Prospective Cohort is a prospective observational cohort study of patients with SLE who are starting treatment with a biologic drug or a conventional, nonbiologic therapy. The study aims to recruit 220 patients into the biologic treatment group and a further 220 patients into the conventional, non-biologic therapy cohort. The aim of the BILAG BR is to ascertain whether using biologics in the routine treatment of SLE is associated with an increased risk of hospitalisation for infection, compared to SLE patients with similar disease activity receiving conventional therapies. The secondary purpose of the BILAG Biologics Prospective Cohort is to determine the longterm efficacy of biological therapies in the treatment of SLE. This prospective cohort study will recruit an exposed cohort of patients with SLE treated with biological therapies and an unexposed cohort of patients with similar disease characteristics but exposed only to conventional non-biological therapies. Comprehensive data will be collected at baseline, from the clinic team and the patient, including data on disease diagnosis and activity, risk factors for infection and routine laboratory results. Follow-up data will be collected at 3, 6, 12, 24 and 36 months to include any changes in medications, adverse events, hospitalisations for infections, disease activity and quality of life along with biological samples for biomarker analysis. Contact If you would like any additional information regarding the study, please contact Emily Sutton, BILAG BR Study Coordinator. Email: Emily.sutton@manchester.ac.uk Tel: 0161 3061916 Fax: 0161 2751640 BILAG BR Arthritis Research UK Epidemiology Unit The University of Manchester Rutherford House (Unit 4) Manchester Science Park 40 Pencroft Way MANCHESTER M15 6SZ
3 Studies to recruit to MYOSITIS GENETICS STUDY Polymyositis (PM), dermatomyositis (DM) and Inclusion Body Myositis (IBM) belong to a group of inflammatory muscle disorders, of unknown cause, that are characterised by skeletal muscle inflammation and progressive muscular weakness, which can be debilitating and chronic in nature. The current treatment options for these conditions are steroids and various other immunosuppressive drugs. However, these are usually only partially effective at reducing symptoms, and their toxic side effects also limit their usefulness. In order to develop more specific treatments for myositis in the future (and therefore more effective), it is important to understand the exact mechanisms that cause the disease in the first instance. In other similar inflammatory diseases such as rheumatoid arthritis and lupus, it is known that changes to the Human Leukocyte Antigen (HLA), as well as certain inflammatory cytokines, are involved in both the development and expression of the disease. As many of the inflammatory mechanisms that cause damage in PM, DM and IBM are similar to those in RA and SLE, it seems likely that similar genetic factors will also be involved in the development and expression of PM, DM and IBM. In order to understand the genetic aspects / causes of myositis, and ultimately develop more effective treatment therapies in the future, patients with PM, DM or IBM, are being asked to give 20 mls of blood. These blood samples, along with the patient’s clinical details, will then be sent to the Centre for Integrated Genomic Medical Research (CIGMR), at The University of Manchester, where all of the genetic analyses will take place. By understanding the genetic cause of the disease, it should be possible to design specific drugs for treating the condition in the future. For further information about recruiting to this study (portfolio ID 7996) please contact Paul New at Salford Royal NHS Foundation Trust at:- Email: Paul.new@srft.nhs.uk Telephone: 0161 206 4295
Page 1: 1 Issue 4 May 2011 Welcome to the 4
Page 5 and 6: 5 Studies to recruit to
Page 7 and 8: 7 Recruitment figures 2009-2010 and
Page 9 and 10: 9 Commercial study accrual update 2
Page 11 and 12: 11 Introducing the new research nur
Page 13 and 14: 13 Workshop survey feedback 1. To w

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