Efficacy of Tocilizumab in Primary Sjögren's Syndrome. (ETAP)
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|ClinicalTrials.gov Identifier: NCT01782235|
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : August 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Sjögren's Syndrome (pSS)||Drug: Tocilizumab Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy of Tocilizumab for the Treatment of Primary Sjögren's Syndrome.|
|Actual Study Start Date :||July 24, 2013|
|Actual Primary Completion Date :||July 16, 2018|
|Actual Study Completion Date :||July 16, 2018|
Experimental: Tocilizumab arm
Tocilizumab arm will receive tocilizumab.
Placebo Comparator: Placebo arm
Placebo arm will receive placebo.
- Improvement of the ESSDAI score equal to or greater than 3 points compared to enrollment. [ Time Frame: 24 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782235
|Hôpitaux Universitaires de Strasbourg|
|Strasbourg, France, 67098|
|Principal Investigator:||Jacques-Eric Gottenberg||Hôpitaux Universitaires de Strasbourg|