Efficacy of Tocilizumab in Primary Sjögren's Syndrome. (ETAP)
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.
Primary Sjögren's Syndrome (pSS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy of Tocilizumab for the Treatment of Primary Sjögren's Syndrome.|
- Proportion of patient with an enhancement superior or equal to 30% of the ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Tocilizumab arm
Tocilizumab arm will receive tocilizumab.
Placebo Comparator: Placebo arm
Placebo arm will receive placebo.
|Contact: Jacques-Eric GOTTENBERG||3 88 12 81 89 ext email@example.com|
|Hôpitaux Universitaires de Strasbourg||Not yet recruiting|
|Strasbourg, France, 67098|
|Contact: Jacques-Eric Gottenberg 3 88 12 81 89 ext 0033 firstname.lastname@example.org|
|Principal Investigator: Jacques-Eric Gottenberg|
|Principal Investigator:||Jacques-Eric Gottenberg||Hôpitaux Universitaires de Strasbourg|