Efficacy of Tocilizumab in Primary Sjögren's Syndrome.
- Sponsor
- University Hospital, Strasbourg, France
- Study ID
- NCT01782235
- Phase
- PHASE2/PHASE3
- Status
- Completed
Conditions
- Primary Sjögren's Syndrome (pSS)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tocilizumab — DRUG
- Placebo — DRUG
Study Details
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.
Key Dates
- Start date
- Jul 24, 2013
- Status verified
- Jan 2026
- Primary completion
- Jul 16, 2018
- Completion
- Jul 16, 2018
Study Design
- Enrollment
- 110 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Tocilizumab armTocilizumab arm will receive tocilizumab.
- Placebo Comparator: Placebo armPlacebo arm will receive placebo.
Primary Outcome Measure
Improvement of the ESSDAI score equal to or greater than 3 points compared to enrollment. [ Time Frame: 24 weeks ]