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

Lookup NU author(s): Sheryl Mitchell, Dr Katherine James, Professor Fai Ng, Dr Bridget Griffiths, Vicki Hindmarsh, Dr Vadivelu Saravanan, Dr David Coady, Dr Steven Young-Min

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Abstract

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.


Publication metadata

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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