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.|
- Improvement of the ESSDAI score equal to or greater than 3 points compared to enrollment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Improvement of the ESSDAI score equal to or greater than 3 points compared to enrollment, with no new domain with high activity of the ESSDAI compared to enrollment, and no clinical worsening according to the clinician (no worsening compared to enrollment greater than 1 point of the Systemic Activity 0-10 VAS according to the physician.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||January 2017 (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 firstname.lastname@example.org|
|Hôpitaux Universitaires de Strasbourg||Recruiting|
|Strasbourg, France, 67098|
|Contact: Jacques-Eric Gottenberg 3 88 12 81 89 ext 0033 email@example.com|
|Principal Investigator: Jacques-Eric Gottenberg|
|Principal Investigator:||Jacques-Eric Gottenberg||Hôpitaux Universitaires de Strasbourg|