[ISRCTN reference: ISRCTN 65360827]
Status: Closed to recruitment
A multi-centre, randomised double-blind placebo controlled phase III clinical trial of anti-B-cell therapy in patients with primary Sjögren's syndrome with fatigue, oral dryness. The aim of the study is to assess the extent to which rituximab improves symptoms of fatigue and oral dryness in patients with primary Sjögren’s syndrome with a 30% reduction at 48 weeks from baseline in either oral dryness or fatigue measured using Visual Analogue Scales (VAS – Range 0-100mm) will be the primary endpoint. Patients were randomised on a 1:1 basis to receive either rituximab or placebo infusion. Each patient recruited to the study will have an approximate 48 weeks of intervention/follow-up examination. Males and females were recruited between 18 and 80 years of age with an AECG diagnosis of Primary Sjögren’s Syndrome. Results of this study can be found here and here.
Biological samples (tissue & fluids) were collected at five timepoints over a 48-week follow-up period and are linked to clinical outcome measures. 136 patients were recruited to this study, with 27 baseline and 17 follow-up salivary gland biopsies collected. Blood samples have been collected for 680 time-points and include tissue (salivary gland), saliva, serum, peripheral blood mononuclear cells (PBMCs), RNA, and DNA.