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 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; TRACTISS trial team

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 Bombardieri, 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, TRACTISS trial team

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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.

TRIAL REGISTRATION: UKCRN Portfolio ID: 9809 ISRCTN65360827.

Original language	English
Article number	21
Journal	BMC Musculoskeletal Disorders
Volume	15
DOIs	https://doi.org/10.1186/1471-2474-15-21
Publication status	Published - 17 Jan 2014

Keywords

Antibodies, Monoclonal, Murine-Derived
B-Lymphocytes
Biological Markers
Clinical Protocols
Disease Progression
Double-Blind Method
Drug Administration Schedule
Female
Great Britain
Humans
Immunologic Factors
Infusions, Intravenous
Male
Quality of Life
Research Design
Salivation
Sjogren's Syndrome
Tears
Time Factors
Treatment Outcome

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10.1186/1471-2474-15-21

Brown_et_al_TRACTISS_Protocol_BMC_Musculoskeletal_Disorders_2014
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Checked October 2015
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Cite this

Brown, S., Navarro Coy, N., Pitzalis, C., Emery, P., Pavitt, S., Gray, J., Hulme, C., Hall, F., Busch, R., Smith, P., Dawson, L., Bombardieri, M., Wan-Fai, N., Pease, C., Price, E., Sutcliffe, N., Woods, C., Ruddock, S., Everett, C., ... TRACTISS trial team (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

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title = "The TRACTISS protocol: a randomised double blind placebo controlled clinical trial of anti-B-cell therapy in patients with primary Sj{\"o}gren'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.TRIAL REGISTRATION: UKCRN Portfolio ID: 9809 ISRCTN65360827.",

keywords = "Antibodies, Monoclonal, Murine-Derived, B-Lymphocytes, Biological Markers, Clinical Protocols, Disease Progression, Double-Blind Method, Drug Administration Schedule, Female, Great Britain, Humans, Immunologic Factors, Infusions, Intravenous, Male, Quality of Life, Research Design, Salivation, Sjogren's Syndrome, Tears, Time Factors, Treatment Outcome",

author = "Sarah Brown and {Navarro Coy}, Nuria 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 Bombardieri 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 and {TRACTISS trial team}",

year = "2014",

month = jan,

day = "17",

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

language = "English",

volume = "15",

journal = "BMC Musculoskeletal Disorders",

issn = "1471-2474",

publisher = "Springer",

}

Brown, S, Navarro Coy, N, Pitzalis, C, Emery, P, Pavitt, S, Gray, J, Hulme, C, Hall, F, Busch, R, Smith, P, Dawson, L, Bombardieri, 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 & TRACTISS trial team 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 - Navarro Coy, Nuria

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 - Bombardieri, 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

AU - TRACTISS trial team

PY - 2014/1/17

Y1 - 2014/1/17

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.TRIAL REGISTRATION: UKCRN Portfolio ID: 9809 ISRCTN65360827.

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.TRIAL REGISTRATION: UKCRN Portfolio ID: 9809 ISRCTN65360827.

KW - Antibodies, Monoclonal, Murine-Derived

KW - B-Lymphocytes

KW - Biological Markers

KW - Clinical Protocols

KW - Disease Progression

KW - Double-Blind Method

KW - Drug Administration Schedule

KW - Female

KW - Great Britain

KW - Humans

KW - Immunologic Factors

KW - Infusions, Intravenous

KW - Male

KW - Quality of Life

KW - Research Design

KW - Salivation

KW - Sjogren's Syndrome

KW - Tears

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1186/1471-2474-15-21

DO - 10.1186/1471-2474-15-21

M3 - Article

C2 - 24438039

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

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Keywords

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