drugset
drugset / Trial / NCT01782235

Efficacy of Tocilizumab in Primary Sjögren's Syndrome.

NCT01782235 ↗

Phase 2/3 Completed 110 enrolled University Hospital, Strasbourg, France
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2013-07-24
Primary completion
2018-07-16
Completion
2018-07-16

Outcome

Missed primary endpoint

paper At 24 weeks, the proportion of patients meeting the primary endpoint was 52.7% (29/55) in the tocilizumab group and 63.6% (35/55) in the placebo group PMID 33208345 ↗

paper the use of tocilizumab did not improve systemic involvement and symptoms over 24 weeks of treatment compared with placebo. PMID 33208345 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody — —

Indications

Sjogren syndrome