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

Sarah Brown; Nuria Navarro Coy; Costantino Pitzalis; Paul Emery; Sue Pavitt; Janine Gray; Claire Hulme; Frances Hall; Robert Busch; Pete Smith; Luke Dawson; Michele Bombarieri; 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

doi:10.1186/1471-2474-15-21

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

Sarah Brown, Nuria Navarro Coy, Costantino Pitzalis, Paul Emery, Sue Pavitt, Janine Gray, Claire Hulme, Frances Hall, Robert Busch, Pete Smith, Luke Dawson, Michele Bombarieri, Ng Wan-fai, Colin Pease, Elizabeth Price, Nurhan Sutcliffe, Clodagh Woods, Sharon Ruddock, Colin Everett, Catherine ReynoldsEmma Skinner, Ana Poveda-Gallego, John Rout, Iain Macleod, Saaeha Rauz, Simon Bowman

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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.

Original language	English
Article number	21
Number of pages	10
Journal	BMC MUSCULOSKELETAL DISORDERS
Volume	15
DOIs	https://doi.org/10.1186/1471-2474-15-21
Publication status	Published - 2014

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10.1186/1471-2474-15-21

Brown 2014 TRACTISS protocol report BMC MSKD1471-2474-15-21Final published version, 800 KBLicence: Unspecified

http://dx.doi.org/10.1186/1471-2474-15-21

Robert Busch
- robert.buschroehampton.acuk
- School of Life and Health Sciences - Senior Lecturer
- Centre for Integrated Research in Life and Health Sciences
Person: Academic

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Brown, S., Coy, N. N., Pitzalis, C., Emery, P., Pavitt, S., Gray, J., Hulme, C., Hall, F., Busch, R., Smith, P., Dawson, L., Bombarieri, M., Wan-fai, N., Pease, C., Price, E., Sutcliffe, N., Woods, C., Ruddock, S., Everett, C., ... Bowman, S. (2014). 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, 15, Article 21. https://doi.org/10.1186/1471-2474-15-21

@article{e5337b918c384362ab80b3cc800530b1,

title = "The TRACTISS Protocol:: a randomised double blind placebo controlled clinical TRial of Anti-B-Cell Therapy In patients with primary Sj{\"o}gren{\textquoteright}s Syndrome",

abstract = "Background: Primary Sj{\"o}gren'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.",

author = "Sarah Brown and Coy, \{Nuria Navarro\} and Costantino Pitzalis and Paul Emery and Sue Pavitt and Janine Gray and Claire Hulme and Frances Hall and Robert Busch and Pete Smith and Luke Dawson and Michele Bombarieri and Ng Wan-fai and Colin Pease and Elizabeth Price and Nurhan Sutcliffe and Clodagh Woods and Sharon Ruddock and Colin Everett and Catherine Reynolds and Emma Skinner and Ana Poveda-Gallego and John Rout and Iain Macleod and Saaeha Rauz and Simon Bowman",

year = "2014",

doi = "10.1186/1471-2474-15-21",

language = "English",

volume = "15",

journal = "BMC MUSCULOSKELETAL DISORDERS",

issn = "1471-2474",

publisher = "Springer",

}

Brown, S, Coy, NN, Pitzalis, C, Emery, P, Pavitt, S, Gray, J, Hulme, C, Hall, F, Busch, R, Smith, P, Dawson, L, Bombarieri, M, Wan-fai, N, Pease, C, Price, E, Sutcliffe, N, Woods, C, Ruddock, S, Everett, C, Reynolds, C, Skinner, E, Poveda-Gallego, A, Rout, J, Macleod, I, Rauz, S & Bowman, S 2014, '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, vol. 15, 21. https://doi.org/10.1186/1471-2474-15-21

TY - JOUR

T1 - The TRACTISS Protocol:

T2 - a randomised double blind placebo controlled clinical TRial of Anti-B-Cell Therapy In patients with primary Sjögren’s Syndrome

AU - Brown, Sarah

AU - Coy, Nuria Navarro

AU - Pitzalis, Costantino

AU - Emery, Paul

AU - Pavitt, Sue

AU - Gray, Janine

AU - Hulme, Claire

AU - Hall, Frances

AU - Busch, Robert

AU - Smith, Pete

AU - Dawson, Luke

AU - Bombarieri, Michele

AU - Wan-fai, Ng

AU - Pease, Colin

AU - Price, Elizabeth

AU - Sutcliffe, Nurhan

AU - Woods, Clodagh

AU - Ruddock, Sharon

AU - Everett, Colin

AU - Reynolds, Catherine

AU - Skinner, Emma

AU - Poveda-Gallego, Ana

AU - Rout, John

AU - Macleod, Iain

AU - Rauz, Saaeha

AU - Bowman, Simon

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

U2 - 10.1186/1471-2474-15-21

DO - 10.1186/1471-2474-15-21

M3 - Article

SN - 1471-2474

VL - 15

JO - BMC MUSCULOSKELETAL DISORDERS

JF - BMC MUSCULOSKELETAL DISORDERS

M1 - 21

ER -

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

Abstract

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Robert Busch

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