Open Access Study protocol

The TRACTISS Protocol: a randomised double blind placebo controlled clinical TRial of Anti-B-Cell Therapy In patients with primary Sjögren’s Syndrome

Sarah Brown1*, Nuria Navarro Coy26, Costantino Pitzalis3, Paul Emery26, Sue Pavitt8, Janine Gray1, Claire Hulme7, Frances Hall4, Robert Busch174, Pete Smith5, Luke Dawson5, Michele Bombardieri3, Ng Wan-fai9, Colin Pease10, Elizabeth Price11, Nurhan Sutcliffe12, Clodagh Woods13, Sharon Ruddock1, Colin Everett1, Catherine Reynolds1, Emma Skinner18, Ana Poveda-Gallego14, John Rout14, Iain Macleod15, Saaeha Rauz16, Simon Bowman19 and TRACTISS trial team

Author Affiliations

1 Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK

2 Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK

3 Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, Barts & The London, Queen Mary University of London, 2nd Floor John Vane Science Centre, Charterhouse Square, London EC1M 6BQ, UK

4 Department of Clinical Medicine, University of Cambridge, Addenbrookes Hospital, Hills Road, Cambridge CB2 2QQ, UK

5 School of Dental Sciences, University of Liverpool, Liverpool L69 3GN, UK

6 NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK

7 Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK

8 Centre for Health Sciences Research, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK

9 Musculoskeletal Research Group, University of Newcastle, 4th Floor Catherine Cookson Building, Framlington Place, Newcastle-upon-Tyne NE2 4HH, UK

10 Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK

11 Great Western Hospital, Marlborough Road, Swindon SN3 6BB, UK

12 Royal London Hospital (Mile End), Bancroft Road, London E1 4DG, UK

13 TRACTISS PPI representative, c/o Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK

14 Birmingham Dental Hospital, St Chad’s Queensway, Birmingham B4 6NN, UK

15 Newcastle Dental Hospital & School, Richardson road, Newcastle upon Tyne NE2 4AZ, UK

16 Academic Unit of Ophthalmology, Centre for Translational Inflammation Research, University of Birmingham, Birmingham B15 2TT, UK

17 Department of Life Sciences, University of Roehampton, Whitelands College, Holybourne Ave, London SW15 4JD, UK

18 Arthritis Research UK Primary Care Centre, Primary Care Services, University of Keele, Staffordshire ST5 5BG, UK

19 New Queen Elizabeth Hospital, Mindelsohn Way, Edgbaston, Birmingham B15 2WB, UK

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BMC Musculoskeletal Disorders 2014, 15:21  doi:10.1186/1471-2474-15-21

Published: 17 January 2014

Abstract

Background

Primary Sjögren’s Syndrome (PSS) mainly affects women (9:1 female:male ratio) and is one of the commonest autoimmune diseases with a prevalence of 0.1 – 0.6% of adult women. For patients with PSS there is currently no effective therapy that can alter the progression of the disease. The aim of the TRACTISS study is to establish whether in patients with PSS, treatment with rituximab improves clinical outcomes.

Methods/design

TRACTISS is a UK multi-centre, double-blind, randomised, controlled, parallel group trial of 110 patients with PSS. Patients will be randomised on a 1:1 basis to receive two courses of either rituximab or placebo infusion in addition to standard therapy, and will be followed up for up to 48 weeks. The primary objective is to assess the extent to which rituximab improves symptoms of fatigue and oral dryness. Secondary outcomes include ocular dryness, salivary flow rates, lacrimal flow, patient quality of life, measures of disease damage and disease activity, serological and peripheral blood biomarkers, and glandular histology and composition.

Discussion

The TRACTISS trial will provide direct evidence as to whether rituximab in patients with PSS leads to an improvement in patient symptoms and a reduction in disease damage and activity.

Trial registration

UKCRN Portfolio ID: 9809 ISRCTN65360827.

Keywords:
Sjögren’s syndrome; Rituximab; Anti-B-cell; Double-blind; Placebo; Trial