Eligibility for clinical trials in primary sjögren's syndrome: Lessons from the UK primary sjögren's syndrome registry

on behalf of the UK Primary Sjögren’s Syndrome Registry

doi:10.1093/rheumatology/kev373

Eligibility for clinical trials in primary sjögren's syndrome: Lessons from the UK primary sjögren's syndrome registry

on behalf of the UK Primary Sjögren’s Syndrome Registry

University Hospitals Birmingham NHS Foundation Trust
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle University
Great Western Hospitals NHS Foundation Trust
University of Leeds
Leeds Teaching Hospitals NHS Trust
Nottingham University Hospitals NHS Trust
Barts Health NHS Trust
NHS Greater Glasgow and Clyde
NHS Fife
Hampshire Hospitals NHS Foundation Trust
University Hospitals of Derby and Burton NHS Foundation Trust
University College London Hospitals NHS Foundation Trust
Gateshead Health NHS Foundation Trust
South Tyneside and Sunderland NHS Foundation Trust
Mid and South Essex NHS Foundation Trust
Royal United Hospitals Bath NHS Foundation Trust
Portsmouth Hospitals University NHS Trust
Liverpool University Hospitals NHS Foundation Trust
Sheffield Teaching Hospitals NHS Foundation Trust
University of Birmingham
Birmingham Community Healthcare NHS Foundation Trust
Barking, Havering and Redbridge University Hospitals NHS Trust
Dudley Group NHS Foundation Trust
Frimley Health NHS Foundation Trust
Harrogate and District NHS Foundation Trust
East Suffolk and North Essex NHS Foundation Trust
East Cheshire NHS Trust
Torbay and South Devon NHS Foundation Trust

Research output: Contribution to journal › Article › peer-review

Abstract

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%. Conclusion: The UKPSSR identified a number of options for trial design, including selection on ESSDAI≥5, ESSPRI≥5 and serological and other parameters.

Original language	English
Pages (from-to)	544-552
Number of pages	9
Journal	Rheumatology
Volume	55
Issue number	3
DOIs	https://doi.org/10.1093/rheumatology/kev373
Publication status	Published - 1 Mar 2016
Externally published	Yes

Keywords

Clinical trial
Eligibility
Registry
Sjögren's

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10.1093/rheumatology/kev373

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@article{e54259e45e06478b968566ae7e1efa15,

title = "Eligibility for clinical trials in primary sj{\"o}gren's syndrome: Lessons from the UK primary sj{\"o}gren's syndrome registry",

abstract = "Objective: To identify numbers of participants in the UK Primary Sj{\"o}gren'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 Sj{\"o}gren's Syndrome study (Belimumab), 41.4\% fulfilled eligibility for the Trial of Remicade in primary Sj{\"o}gren's syndrome study (Infliximab), 35.4\% for the Efficacy of Tocilizumab in Primary Sj{\"o}gren's Syndrome study (Tocilizumab), 31.6\% for the Tolerance and Efficacy of Rituximab in Sj{\"o}gren'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 Sj{\"o}gren's Syndrome study (Abatacept). If recent measures of outcome, such as the EULAR Sj{\"o}gren's Syndrome Patient Reported Index (ESSPRI) score55 (measure of patient symptoms) and the EULAR Sj{\"o}gren'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\%. Conclusion: The UKPSSR identified a number of options for trial design, including selection on ESSDAI≥5, ESSPRI≥5 and serological and other parameters.",

keywords = "Clinical trial, Eligibility, Registry, Sj{\"o}gren's",

author = "\{on behalf of the UK Primary Sj{\"o}gren{\textquoteright}s Syndrome Registry\} and Clare Oni and Sheryl Mitchell and Katherine James and Ng, \{Wan Fai\} and Bridget Griffiths and Victoria Hindmarsh and Elizabeth Price and Pease, \{Colin T.\} and Paul Emery and Peter Lanyon and Adrian Jones and Michele Bombardieri and Nurhan Sutcliffe and Costantino Pitzalis and John Hunter and Monica Gupta and John McLaren and Annie Cooper and Marian Regan and Ian Giles and David Isenberg and Vadivelu Saravanan and David Coady and Bhaskar Dasgupta and Neil McHugh and Steven Young-Min and Robert Moots and Nagui Gendi and Francesca Barone and Ben Fisher and Saaeha Rauz and Andrea Richards and Bowman, \{Simon J.\} and Bacabac, \{Elalaine C.\} and Kuntal Chadravarty and Shamin Lamabadusuriya and Rashidat Adeniba and John Hamburger and Jon Higham and Ana Poveda-Galego and Joanne Logan and Diarmuid Mulherin and Jacqueline Andrews and Alison McManus and Alison Booth and Theodoros Dimitroulas and Lucy Kadiki and Daljit Kaur and George Kitas and Mark Lloyd",

note = "Publisher Copyright: {\textcopyright} The Author 2015.",

year = "2016",

month = mar,

day = "1",

doi = "10.1093/rheumatology/kev373",

language = "English",

volume = "55",

pages = "544--552",

journal = "Rheumatology",

issn = "1462-0324",

publisher = "Oxford University Press",

number = "3",

}

TY - JOUR

T1 - Eligibility for clinical trials in primary sjögren's syndrome

T2 - Lessons from the UK primary sjögren's syndrome registry

AU - on behalf of the UK Primary Sjögren’s Syndrome Registry

AU - Oni, Clare

AU - Mitchell, Sheryl

AU - James, Katherine

AU - Ng, Wan Fai

AU - Griffiths, Bridget

AU - Hindmarsh, Victoria

AU - Price, Elizabeth

AU - Pease, Colin T.

AU - Emery, Paul

AU - Lanyon, Peter

AU - Jones, Adrian

AU - Bombardieri, Michele

AU - Sutcliffe, Nurhan

AU - Pitzalis, Costantino

AU - Hunter, John

AU - Gupta, Monica

AU - McLaren, John

AU - Cooper, Annie

AU - Regan, Marian

AU - Giles, Ian

AU - Isenberg, David

AU - Saravanan, Vadivelu

AU - Coady, David

AU - Dasgupta, Bhaskar

AU - McHugh, Neil

AU - Young-Min, Steven

AU - Moots, Robert

AU - Gendi, Nagui

AU - Barone, Francesca

AU - Fisher, Ben

AU - Rauz, Saaeha

AU - Richards, Andrea

AU - Bowman, Simon J.

AU - Bacabac, Elalaine C.

AU - Chadravarty, Kuntal

AU - Lamabadusuriya, Shamin

AU - Adeniba, Rashidat

AU - Hamburger, John

AU - Higham, Jon

AU - Poveda-Galego, Ana

AU - Logan, Joanne

AU - Mulherin, Diarmuid

AU - Andrews, Jacqueline

AU - McManus, Alison

AU - Booth, Alison

AU - Dimitroulas, Theodoros

AU - Kadiki, Lucy

AU - Kaur, Daljit

AU - Kitas, George

AU - Lloyd, Mark

PY - 2016/3/1

Y1 - 2016/3/1

N2 - 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%. Conclusion: The UKPSSR identified a number of options for trial design, including selection on ESSDAI≥5, ESSPRI≥5 and serological and other parameters.

AB - 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%. Conclusion: The UKPSSR identified a number of options for trial design, including selection on ESSDAI≥5, ESSPRI≥5 and serological and other parameters.

KW - Clinical trial

KW - Eligibility

KW - Registry

KW - Sjögren's

UR - https://www.scopus.com/pages/publications/84965064785

U2 - 10.1093/rheumatology/kev373

DO - 10.1093/rheumatology/kev373

M3 - Article

C2 - 26510429

AN - SCOPUS:84965064785

SN - 1462-0324

VL - 55

SP - 544

EP - 552

JO - Rheumatology

JF - Rheumatology

IS - 3

ER -

Eligibility for clinical trials in primary sjögren's syndrome: Lessons from the UK primary sjögren's syndrome registry

Abstract

Keywords

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