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Lookup NU author(s): Sheryl Mitchell, Dr Katherine JamesORCiD, Professor Fai NgORCiD, Dr Bridget Griffiths, Vicki Hindmarsh, Dr Vadivelu Saravanan, Dr David Coady, Dr Steven Young-Min
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Objective: To identify numbers of participants in the UK Primary Sjogren'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 Sjogren's Syndrome study (Belimumab), 41.4% fulfilled eligibility for the Trial of Remicade in primary Sjogren's syndrome study (Infliximab), 35.4% for the Efficacy of Tocilizumab in Primary Sjogren's Syndrome study (Tocilizumab), 31.6% for the Tolerance and Efficacy of Rituximab in Sjogren'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 Sjogren's Syndrome study (Abatacept). If recent measures of outcome, such as the EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) score >= 5 (measure of patient symptoms) and the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score >= 5 (measure of systemic disease activity) are incorporated intostudy design, with requirements for an unstimulated salivary flow >0 and an a ti-Ro positivity, then the pool of eligible participants is reduced to 14.3%.Conclusion: The UKPSSR identified a number of options for trial design, including selection on ESSDAI >= 5, ESSPRI >= 5 and serological and other parameters.
Author(s): Oni C, Mitchell S, James K, Ng WF, Griffiths B, Hindmarsh V, Prices E, Pease CT, Emery P, Lanyon P, Jones A, Bombardieri M, Sutcliffe N, Pitzalis C, Hunter J, Gupta M, McLaren J, Cooper A, Regan M, Giles I, Isenberg D, Saravanan V, Coady D, Dasgupta B, McHugh N, Young-Min S, Moots R, Gendi N, Akil M, Barone F, Fisher B, Rauz S, Richards A, Bowman SJ, UK Primary Sjogren's Syndrome
Publication type: Article
Publication status: Published
Journal: Rheumatology
Year: 2016
Volume: 55
Issue: 3
Pages: 544-552
Print publication date: 01/03/2016
Acceptance date: 10/09/2015
ISSN (print): 1462-0324
ISSN (electronic): 1462-0332
Publisher: Oxford University Press
URL: http://dx.doi.org/10.1093/rheumatology/kev373
DOI: 10.1093/rheumatology/kev373
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