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) score ⩾5 (measure of patient symptoms) and the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ⩾5 (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%.


CONCLUSIONS
The UKPSSR identified a number of options for trial design, including selection on ESSDAI ⩾5, ESSPRI ⩾5 and serological and other parameters.
Rheumatology Department, University Hospitals Birmingham NHS Foundation Trust, Birmingham, simon.bowman@uhb.nhs.uk.
Clare
C
Oni
Rheumatology Department, Newcastle upon Tyne Hospitals NHS Foundation Trust.
Sheryl
S
Mitchell
Interdisciplinary Computing and Complex BioSystems Research Group, School of Computing Science, Newcastle University, Newcastle.
Katherine
K
James
Rheumatology Department, Newcastle upon Tyne Hospitals NHS Foundation Trust, Musculoskeletal Research Group, Institute of Cellular Medicine & Newcastle NIHR Biomedical Research Centre for Ageing and Chronic Diseases, Newcastle University, Newcastle upon Tyne.
Wan-Fai
WF
Ng
Rheumatology Department, Newcastle upon Tyne Hospitals NHS Foundation Trust.
Bridget
B
Griffiths
Rheumatology Department, Newcastle upon Tyne Hospitals NHS Foundation Trust.
Victoria
V
Hindmarsh
Rheumatology Department, Great Western Hospitals NHS Foundation Trust, Swindon.
Elizabeth
E
Price
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds.
Colin T
CT
Pease
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds.
Paul
P
Emery
Rheumatology Department, Nottingham University Hospital, Nottingham.
Peter
P
Lanyon
Rheumatology Department, Nottingham University Hospital, Nottingham.
Adrian
A
Jones
Department of Experimental Medicine and Rheumatology, Barts and the London NHS Trust and Barts and the London School of Medicine and Dentistry, London.
Michele
M
Bombardieri
Department of Experimental Medicine and Rheumatology, Barts and the London NHS Trust and Barts and the London School of Medicine and Dentistry, London.
Nurhan
N
Sutcliffe
Department of Experimental Medicine and Rheumatology, Barts and the London NHS Trust and Barts and the London School of Medicine and Dentistry, London.
Costantino
C
Pitzalis
Rheumatology Department, Gartnavel General Hospital, Glasgow.
John
J
Hunter
Rheumatology Department, Gartnavel General Hospital, Glasgow.
Monica
M
Gupta
Rheumatology Department, NHS Fife, Whyteman's Brae Hospital, Kirkcaldy.
John
J
McLaren
Rheumatology Department, Royal Hampshire County Hospital, Winchester.
Annie
A
Cooper
Rheumatology Department, Royal Derby Hospital, Derby.
Marian
M
Regan
Rheumatology Department, University College London Hospitals NHS Foundation Trust, London.
Ian
I
Giles
Rheumatology Department, University College London Hospitals NHS Foundation Trust, London.
David
D
Isenberg
Rheumatology Department, Queen Elizabeth Hospital, Gateshead.
Vadivelu
V
Saravanan
Rheumatology Department, Sunderland Royal Hospital, Sunderland.
David
D
Coady
Rheumatology Department, Southend University Hospital, Southend.
Bhaskar
B
Dasgupta
Rheumatology Department, Royal National Hospital for Rheumatic Diseases, Bath.
Neil
N
McHugh
Rheumatology Department, Portsmouth Hospitals NHS Trust, Portsmouth.
Steven
S
Young-Min
Rheumatology Department, Aintree University Hospitals, Liverpool.
Robert
R
Moots
Rheumatology Department, Basildon Hospital, Basildon.
Nagui
N
Gendi
Rheumatology Department, Royal Hallamshire Hospital, Sheffield.
Mohammed
M
Akil
Centre for Translational Inflammation Research, University of Birmingham, Birmingham and.
Francesca
F
Barone
Centre for Translational Inflammation Research, University of Birmingham, Birmingham and.
Ben
B
Fisher
Centre for Translational Inflammation Research, University of Birmingham, Birmingham and.
Saaeha
S
Rauz
Department of Oral Medicine, Birmingham Dental Hospital, Birmingham, UK.
Andrea
A
Richards
Rheumatology Department, University Hospitals Birmingham NHS Foundation Trust, Birmingham.
Simon J
SJ
Bowman
D000328:Adult; D001688:Biological Products / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D012042:Registries; D012189:Retrospective Studies; D012859:Sjogren's Syndrome / Q000175:diagnosis* / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D006113:United Kingdom
D001688:Biological Products
Sjögren’s; clinical trial; eligibility; registry