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临床试验/NCT03711214
NCT03711214进行中(未招募)不适用

Analysis of the Immune Profile of Saliva and Serum of Patients With Primary Sjögren´s Syndrome

University of Sao Paulo General Hospital5 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
5
主要终点
Change from baseline Xerostomia Inventory Score at 3 months

研究概览

简要总结

Primary Sjögren's syndrome (pSS) is a chronic systemic inflammatory disease, which mainly affects the lacrimal and salivary glands, leading to sicca syndrome. pSS has a probable autoimmune etiology, with the production of several autoantibodies such as antinuclear antibodies (ANA), anti-Ro/SS-A, anti-La/SS-B, rheumatoid factor (RF) and cryoglobulins. Recently, our group described a high frequency of antibodies directed to DNase I in the serum of pSS patients and these antibodies were associated with the presence of the anti-Epstein-Barr (EBV) early antigen diffuse (anti-EA-D). This finding becomes interesting considering the recent description of reduction of DNase I activity in the tear of patients with xerophthalmia of different causes, which would result in an accumulation of extracellular DNA and neutrophilic inflammatory infiltrate on the ocular surface. This hypothesis is reinforced by the observation that treatment with DNase I as eye drops results in clinical improvement of dry eye. In addition, it has been shown that periodontal disease is an aggravating factor of xerostomia in pSS, as it leads to a chronic inflammatory process and, consequently, to the destruction of minor salivary glands. Therefore, the objective of the present study will be to evaluate the presence of antibodies directed to DNase I in the saliva and serum of pSS patients and its possible capacity of inhibition of the enzyme before and after treatment of periodontal disease. Such findings will be correlated with the presence of periodontal disease, with the glandular and extraglandular manifestations of SSp and also with the presence of EBV DNA in the serum and oral lavage of these patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Open Label

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary Sjögren's syndrome according to 2016 EULAR/ACR Classification Criteria, and healthy people without any rheumatic disease/symptoms of sicca syndrome
  • Patients regularly followed at the Sjögren's Syndrome outpatient clinic of Rheumatology Division

排除标准

  • Use of drugs that cause oral dryness (mainly antidepressants and antihistamines).
  • Patients with history of head and neck radiation therapy.
  • Current smoking.
  • Pregnancy and/or lactation.
  • History of periodontal treatment for at least 6 months prior to enrollment.

研究组 & 干预措施

pSS patients

Active Comparator

We will evaluate 40 patients with pSS (EULAR/ACR Classification Criteria, 2016) of both sexes before and after periodontal disease treatment.

干预措施: Periodontal scaling (Procedure)

Healthy individuals

Active Comparator

We will evaluate 40 healthy controls before and after periodontal disease treatment.

干预措施: Periodontal scaling (Procedure)

结局指标

主要结局

Change from baseline Xerostomia Inventory Score at 3 months

时间窗: Change from baseline Xerostomia Inventory Score at 3 months

Change from baseline Xerostomia Inventory Score at 3 months. An international validated questionnaire of dry mouth symptoms ranging from 11 to 55 points.

Change from baseline activity of DNAse I enzyme in saliva at 3 months

时间窗: Change from baseline activity of DNAse I enzyme in saliva at 3 months

Change from baseline activity of DNAse I enzyme in saliva at 3 months measured by Enzyme-Linked Immunosorbent Assay (ELISA).

次要结局

  • Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months(Change from baseline interleukin-1b (IL-1b) concentration in saliva at 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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