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Open Access 01-12-2014 | Study protocol

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

Authors: 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

Published in: BMC Musculoskeletal Disorders | Issue 1/2014

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.

Available only for authorised users

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/15/21/prepub

Title: The TRACTISS Protocol: a randomised double blind placebo controlled clinical TRial of Anti-B-Cell Therapy In patients with primary Sjögren’s Syndrome
Authors: 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
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: BMC Musculoskeletal Disorders / Issue 1/2014
Electronic ISSN: 1471-2474
DOI: https://doi.org/10.1186/1471-2474-15-21

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Background

Methods/design

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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