Efficacy of Tocilizumab in Primary Sjögren's Syndrome.
Status:
Completed
Trial end date:
2018-07-16
Target enrollment:
Participant gender:
Summary
Primary Sjögren's syndrome (pSS) is a systemic autoimmune disease characterized by
lymphocytic infiltration leading to destruction of acinar and ductal cells and loss of
glandular parenchyma. The main symptoms of pSS are dry eyes and dry mouth, diffuse pain, and
fatigue. One third of patients develop systemic features, the most severe being lymphomas.
Serum IL-6 is increased in serum, saliva, and tears of patients with pSS. IL-6 plays a
pivotal role in B-cell activation, a hallmark of the pathogenesis of pSS, and in T-cell
differentiation. Tocilizumab, a recombinant humanised monoclonal antibody acts as an IL-6R
antagonist. The aim of this randomised double blind placebo controlled trial iss to evaluate
the efficacy of tocilizumab for the treatment of pSS.