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

Study Protocol

Claire Hulme¹  Saaeha Rauz²  Emma Skinner³  Ana Poveda-Gallego⁴  John Rout⁴  Michele Bombardieri⁵  Costantino Pitzalis⁵  Sue Pavitt⁶  Colin Pease⁷  Janine Gray⁸  Catherine Reynolds⁸  Colin Everett⁸  Sarah Brown⁸  Sharon Ruddock⁸  Frances Hall⁹  Robert Busch^1,10  Elizabeth Price^1,11  Paul Emery^1,12  Nuria Navarro Coy^1,12  Ng Wan-fai^1,13  Simon Bowman^1,14  Iain Macleod^1,15  Nurhan Sutcliffe^1,16  Pete Smith^1,17  Luke Dawson^1,17  Clodagh Woods^1,18 

[1] Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, LS2 9LJ, Leeds, UK;Academic Unit of Ophthalmology, Centre for Translational Inflammation Research, University of Birmingham, B15 2TT, Birmingham, UK;Arthritis Research UK Primary Care Centre, Primary Care Services, University of Keele, ST5 5BG, Staffordshire, UK;Birmingham Dental Hospital, St Chad’s Queensway, B4 6NN, Birmingham, 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, EC1M 6BQ, London, UK;Centre for Health Sciences Research, Leeds Institute of Health Sciences, University of Leeds, LS2 9LJ, Leeds, UK;Chapel Allerton Hospital, Chapeltown Road, LS7 4SA, Leeds, UK;Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, LS2 9JT, Leeds, UK;Department of Clinical Medicine, University of Cambridge, Addenbrookes Hospital, Hills Road, CB2 2QQ, Cambridge, UK;Department of Clinical Medicine, University of Cambridge, Addenbrookes Hospital, Hills Road, CB2 2QQ, Cambridge, UK;Department of Life Sciences, University of Roehampton, Whitelands College, Holybourne Ave, SW15 4JD, London, UK;Great Western Hospital, Marlborough Road, SN3 6BB, Swindon, UK;Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Chapeltown Road, LS7 4SA, Leeds, UK;NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK;Musculoskeletal Research Group, University of Newcastle, 4th Floor Catherine Cookson Building, Framlington Place, NE2 4HH, Newcastle-upon-Tyne, UK;New Queen Elizabeth Hospital, Mindelsohn Way, Edgbaston, B15 2WB, Birmingham, UK;Newcastle Dental Hospital & School, Richardson road, NE2 4AZ, Newcastle upon Tyne, UK;Royal London Hospital (Mile End), Bancroft Road, E1 4DG, London, UK;School of Dental Sciences, University of Liverpool, L69 3GN, Liverpool, UK;TRACTISS PPI representative, c/o Chapel Allerton Hospital, Chapeltown Road, LS7 4SA, Leeds, UK;

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

DOI  :  10.1186/1471-2474-15-21

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

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© Brown et al.; licensee BioMed Central Ltd. 2014