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

Clare Oni; Sheryl Mitchell; Katherine James; Wan-Fai Ng; Bridget Griffiths; Victoria Hindmarsh; Elizabeth Price; Colin T Pease; Paul Emery; Peter Lanyon; Adrian Jones; Michele Bombardieri; Nurhan Sutcliffe; Costantino Pitzalis; John Hunter; Monica Gupta; John McLaren; Annie Cooper; Marian Regan; Ian Giles; David Isenberg; Vadivelu Saravanan; David Coady; Bhaskar Dasgupta; Neil McHugh; Steven Young-Min; Robert Moots; Nagui Gendi; Mohammed Akil; Francesca Barone; Ben Fisher; Saaeha Rauz; Andrea Richards; Simon J Bowman

doi:10.1093/rheumatology/kex331

. 2017 Aug 18;56(12):2255. doi: 10.1093/rheumatology/kex331

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

Clare Oni ¹, Sheryl Mitchell ², Katherine James ³, Wan-Fai Ng ^2,⁴, Bridget Griffiths ², Victoria Hindmarsh ², Elizabeth Price ⁵, Colin T Pease ^6,⁷, Paul Emery ^6,⁷, Peter Lanyon ⁸, Adrian Jones ⁸, Michele Bombardieri ⁹, Nurhan Sutcliffe ⁹, Costantino Pitzalis ⁹, John Hunter ¹⁰, Monica Gupta ¹⁰, John McLaren ¹¹, Annie Cooper ¹², Marian Regan ¹³, Ian Giles ¹⁴, David Isenberg ¹⁴, Vadivelu Saravanan ¹⁵, David Coady ¹⁶, Bhaskar Dasgupta ¹⁷, Neil McHugh ¹⁸, Steven Young-Min ¹⁹, Robert Moots ²⁰, Nagui Gendi ²¹, Mohammed Akil ²², Francesca Barone ²³, Ben Fisher ²³, Saaeha Rauz ²³, Andrea Richards ²⁴, Simon J Bowman ^1,^*

¹Rheumatology Department, University Hospitals Birmingham NHS Foundation Trust, Birmingham

²Rheumatology Department, Newcastle upon Tyne Hospitals NHS Foundation Trust

³Interdisciplinary Computing and Complex BioSystems Research Group, School of Computing Science, Newcastle University, Newcastle

⁴Musculoskeletal Research Group, Institute of Cellular Medicine & Newcastle NIHR Biomedical Research Centre for Ageing and Chronic Diseases, Newcastle University, Newcastle upon Tyne

⁵Rheumatology Department, Great Western Hospitals NHS Foundation Trust, Swindon

⁶Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital

⁷NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds

⁸Rheumatology Department, Nottingham University Hospital, Nottingham

⁹Department of Experimental Medicine and Rheumatology, Barts and the London NHS Trust and Barts and the London School of Medicine and Dentistry, London

¹⁰Rheumatology Department, Gartnavel General Hospital, Glasgow

¹¹Rheumatology Department, NHS Fife, Whyteman’s Brae Hospital, Kirkcaldy

¹²Rheumatology Department, Royal Hampshire County Hospital, Winchester

¹³Rheumatology Department, Royal Derby Hospital, Derby

¹⁴Rheumatology Department, University College London Hospitals NHS Foundation Trust, London

¹⁵Rheumatology Department, Queen Elizabeth Hospital, Gateshead

¹⁶Rheumatology Department, Sunderland Royal Hospital, Sunderland

¹⁷Rheumatology Department, Southend University Hospital, Southend

¹⁸Rheumatology Department, Royal National Hospital for Rheumatic Diseases, Bath

¹⁹Rheumatology Department, Portsmouth Hospitals NHS Trust, Portsmouth

²⁰Rheumatology Department, Aintree University Hospitals, Liverpool

²¹Rheumatology Department, Basildon Hospital, Basildon

²²Rheumatology Department, Royal Hallamshire Hospital, Sheffield

²³Centre for Translational Inflammation Research, University of Birmingham, Birmingham

²⁴Department of Oral Medicine, Birmingham Dental Hospital, Birmingham, UK

^*

on Behalf of the UK Primary Sjögren’s Syndrome Registry*

^*

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.

PMCID: PMC6790499 PMID: 28968900

Rheumatology 2016;55:544–552. doi:10.1093/rheumatology/kev373

Further to publication of this paper the Authors have identified that although all 688 participants had a clinical diagnosis of primary Sjögren’s Syndrome and 668 (97.1%) fulfilled the American-European Consensus Group (AECG) classification criteria, 20 patients (2.9%) did not have sufficient features to do so. This error arose from an incorrect assumption derived from the database during analysis, for which the Authors apologize. There is no impact on the outcome or conclusions of the paper, but the methods have been amended accordingly online. The Authors also identified a small number of minor errors as follows: In the abstract the number eligible for the TEARS study is 46.3% not 31.6% (see Table 2). In Table 1: DMARD %=9.6; Pilocarpine or DMARD %=16.6; Unstimulated flow rate > 1.5mls/15 mins %=15.0; Low C3%=2.0; Low C4%=17.2; Lymphoma %=4.8 (see supplementary table).

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

Clare Oni

Sheryl Mitchell

Katherine James

Wan-Fai Ng

Bridget Griffiths

Victoria Hindmarsh

Elizabeth Price

Colin T Pease

Paul Emery

Peter Lanyon

Adrian Jones

Michele Bombardieri

Nurhan Sutcliffe

Costantino Pitzalis

John Hunter

Monica Gupta

John McLaren

Annie Cooper

Marian Regan

Ian Giles

David Isenberg

Vadivelu Saravanan

David Coady

Bhaskar Dasgupta

Neil McHugh

Steven Young-Min

Robert Moots

Nagui Gendi

Mohammed Akil

Francesca Barone

Ben Fisher

Saaeha Rauz

Andrea Richards

Simon J Bowman

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