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


CONCLUSIONS
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.


BACKGROUND
UKCRN Portfolio ID: 9809 ISRCTN65360827.
Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK. medsbro@leeds.ac.uk.
Sarah
S
Brown
Nuria
N
Navarro Coy
Costantino
C
Pitzalis
Paul
P
Emery
Sue
S
Pavitt
Janine
J
Gray
Claire
C
Hulme
Frances
F
Hall
Robert
R
Busch
Pete
P
Smith
Luke
L
Dawson
Michele
M
Bombardieri
Ng
N
Wan-Fai
Colin
C
Pease
Elizabeth
E
Price
Nurhan
N
Sutcliffe
Clodagh
C
Woods
Sharon
S
Ruddock
Colin
C
Everett
Catherine
C
Reynolds
Emma
E
Skinner
Ana
A
Poveda-Gallego
John
J
Rout
Iain
I
Macleod
Saaeha
S
Rauz
Simon
S
Bowman
D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage* / Q000009:adverse effects; D001402:B-Lymphocytes / Q000187:drug effects* / Q000276:immunology; D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D018450:Disease Progression; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects; D007262:Infusions, Intravenous; D008297:Male; D011788:Quality of Life; D012107:Research Design; D000069283:Rituximab; D012472:Salivation / Q000187:drug effects; D012859:Sjogren's Syndrome / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D013666:Tears / Q000378:metabolism; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
D058846:Antibodies, Monoclonal, Murine-Derived; D015415:Biomarkers; D007155:Immunologic Factors; D000069283:Rituximab