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

BMC Musculoskeletal Disorders

Simon Bowman^1,14  Saaeha Rauz⁴  Iain Macleod⁹  John Rout^1,12  Ana Poveda-Gallego^1,12  Emma Skinner^1,10  Catherine Reynolds³  Colin Everett³  Sharon Ruddock³  Clodagh Woods⁷  Nurhan Sutcliffe^1,13  Elizabeth Price⁵  Colin Pease^1,15  Ng Wan-fai¹  Michele Bombardieri⁸  Luke Dawson^1,11  Pete Smith^1,11  Robert Busch⁶  Frances Hall⁶  Claire Hulme^1,17  Janine Gray³  Sue Pavitt^1,16  Paul Emery²  Costantino Pitzalis⁸  Nuria Navarro Coy²  Sarah Brown³ 

[1] Musculoskeletal Research Group, University of Newcastle, 4th Floor Catherine Cookson Building, Framlington Place, Newcastle-upon-Tyne NE2 4HH, UK;NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK;Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK;Academic Unit of Ophthalmology, Centre for Translational Inflammation Research, University of Birmingham, Birmingham B15 2TT, UK;Great Western Hospital, Marlborough Road, Swindon SN3 6BB, UK;Department of Clinical Medicine, University of Cambridge, Addenbrookes Hospital, Hills Road, Cambridge CB2 2QQ, UK;TRACTISS PPI representative, c/o Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK;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;Newcastle Dental Hospital & School, Richardson road, Newcastle upon Tyne NE2 4AZ, UK;Arthritis Research UK Primary Care Centre, Primary Care Services, University of Keele, Staffordshire ST5 5BG, UK;School of Dental Sciences, University of Liverpool, Liverpool L69 3GN, UK;Birmingham Dental Hospital, St Chad’s Queensway, Birmingham B4 6NN, UK;Royal London Hospital (Mile End), Bancroft Road, London E1 4DG, UK;New Queen Elizabeth Hospital, Mindelsohn Way, Edgbaston, Birmingham B15 2WB, UK;Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK;Centre for Health Sciences Research, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK;Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9LJ, UK

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

Others  :  1128878
DOI  :  10.1186/1471-2474-15-21

 received in 2013-12-20, accepted in 2014-01-09,  发布年份 2014

【 摘 要 】

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.

【 授权许可】

   
2014 Brown et al.; licensee BioMed Central Ltd.

【 图 表 】

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