• Sarah Brown, Nuria Navarro Coy, Costantino Pitzalis, Paul Emery, Sue Pavitt, Janine Gray, Claire Hulme, Frances Hall, Robert Busch, Pete Smith, Luke Dawson, Michele Bombardieri, Ng Wan-Fai, Colin Pease, Elizabeth Price, Nurhan Sutcliffe, Clodagh Woods, Sharon Ruddock, Colin Everett, Catherine Reynolds, Emma Skinner, Ana Poveda-Gallego, John Rout, Iain Macleod, Saaeha Rauz, Simon Bowman, and TRACTISS trial team.
• Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK. medsbro@leeds.ac.uk.
• Bmc Musculoskel Dis. 2014 Jan 1;15:21.

BackgroundPrimary 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/DesignTRACTISS 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.DiscussionThe 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 RegistrationUKCRN Portfolio ID: 9809 ISRCTN65360827.

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