drugset / Trial / NCT01160666

Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome

NCT01160666

NaSingle-groupOpen-labelTreatment

Summary

Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis of SS in both systemic and glandular features, and B cell downregulation may lead to a decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic lupus erythematosus, where Belimumab has been proven to be effective.

Timeline

Start
2010-03
Primary completion
2011-12
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Belimumab Monoclonal antibody 10 mg/kg

Indications