The TRACTISS protocol: a randomised double blind placebo controlled clinical trial of anti-B-cell therapy in patients with primary Sjögren's Syndrome

Research output: Contribution to journalArticlepeer-review

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

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.

Details

Original languageEnglish
Article number21
JournalBMC Musculoskeletal Disorders
Volume15
Publication statusPublished - 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