Efficacy of Tocilizumab in Primary Sjögren's Syndrome. (ETAP)

NCT01782235 PHASE2, PHASE3 COMPLETED

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.

Details

Lead sponsor	University Hospital, Strasbourg, France
Phase	PHASE2, PHASE3
Status	COMPLETED
Enrolment	110
Start date	Wed Jul 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Jul 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Primary Sjögren's Syndrome (pSS)

Interventions

• Tocilizumab
• Placebo

Countries

France