Eligibility for clinical trials in primary Sjögren's syndrome: lessons from the UK Primary Sjögren's Syndrome Registry.

Objective: To identify numbers of participants in the UK Primary Sjögren’s Syndrome Registry (UKPSSR) who would fulfil eligibility criteria for previous/current or potential clinical trials in primary SS (pSS) in order to optimize recruitment. Methods: We did a retrospective analysis of UKPSSR cohort data of 688 participants who had pSS with evaluable data. Results: In relation to previous/current trials, 75.2% fulfilled eligibility for the Belimumab in Subjects with Primary Sjögren’s Syndrome study (Belimumab), 41.4% fulfilled eligibility for the Trial of Remicade in primary Sjögren’s syndrome study (Infliximab), 35.4% for the Efficacy of Tocilizumab in Primary Sjögren’s Syndrome study (Tocilizumab), 31.6% for the Tolerance and Efficacy of Rituximab in Sjögren’s Disease study (Rituximab), 26.9% for the Trial of anti-B-cell therapy in pSS study (Rituximab) and 26.6% for the Efficacy and Safety of Abatacept in Patients With Primary Sjögren’s Syndrome study (Abatacept). If recent measures of outcome, such as the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) score55 (measure of patient symptoms) and the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) score55 (measure of systemic disease activity) are incorporated into a study design, with requirements for an unstimulated salivary flow>0 and anti-Ro positivity, then the pool of eligible participants is reduced to 14.3%. Rheumatology Department, University Hospitals Birmingham NHS Foundation Trust, Birmingham, Rheumatology Department, Newcastle upon Tyne Hospitals NHS Foundation Trust, Interdisciplinary Computing and Complex BioSystems Research Group, School of Computing Science, Newcastle University, Newcastle, Musculoskeletal Research Group, Institute of Cellular Medicine & Newcastle NIHR Biomedical Research Centre for Ageing and Chronic Diseases, Newcastle University, Newcastle upon Tyne, Rheumatology Department, Great Western Hospitals NHS Foundation Trust, Swindon, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, Rheumatology Department, Nottingham University Hospital, Nottingham, Department of Experimental Medicine and Rheumatology, Barts and the London NHS Trust and Barts and the London School of Medicine and Dentistry, London, Rheumatology Department, Gartnavel General Hospital, Glasgow, Rheumatology Department, NHS Fife, Whyteman’s Brae Hospital, Kirkcaldy, Rheumatology Department, Royal Hampshire County Hospital, Winchester, Rheumatology Department, Royal Derby Hospital, Derby, Rheumatology Department, University College London Hospitals NHS Foundation Trust, London, Rheumatology Department, Queen Elizabeth Hospital, Gateshead, Rheumatology Department, Sunderland Royal Hospital, Sunderland, Rheumatology Department, Southend University Hospital, Southend, Rheumatology Department, Royal National Hospital for Rheumatic Diseases, Bath, Rheumatology Department, Portsmouth Hospitals NHS Trust, Portsmouth, Rheumatology Department, Aintree University Hospitals, Liverpool, Rheumatology Department, Basildon Hospital, Basildon, Rheumatology Department, Royal Hallamshire Hospital, Sheffield, Centre for Translational Inflammation Research, University of Birmingham, Birmingham and Department of Oral Medicine, Birmingham Dental Hospital, Birmingham, UK Correspondence to: Simon J. Bowman, Rheumatology Department, Queen Elizabeth Hospital, Edgbaston, Birmingham B15 2TH, UK. E-mail: simon.bowman@uhb.nhs.uk *For other collaborators in the UK Primary Sjögren’s Syndrome Registry, see Acknowledgements section. Submitted 18 May 2015; revised version accepted 10 September 2015 ! The Author 2015 Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com 1 RHEUMATOLOGY 294

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