A Biomarker Study to Determine the Gene Expression Signatures of Salivary Gland and Blood in Subjects With Incident Primary Sjögren's Syndrome, Subjects With Sicca, and Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteers
研究概览
简要总结
The main objective of the study is to characterize the gene expression in immune and epithelial cells in salivary gland biopsy samples and blood of pSS (primary Sjögren's syndrome) and non-pSS participants including healthy volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Healthy Volunteers:
- •In good overall health as determined by the Investigator For Participants With Sicca
- •Subjects should present with sicca (i.e., dry eyes and dry mouth) at Baseline
- •Must be willing to undergo a minor salivary gland (labial) biopsy
排除标准
- •A history of any clinically significant medical condition, as determined by the Investigator, that may impact study analyses
- •A chronic or persistent infection human immunodeficiency virus (HIV), hepatitis B, hepatitis C, and/or tuberculosis
- •Pre-existing connective tissue disease or autoimmune disease, such as systemic lupus erythematosus (SLE), rheumatoid arthritis, systemic sclerosis, or sarcoidosis
- •Any known contraindications of sialoscintigraphy
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
结局指标
主要结局
Gene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteers
时间窗: Up to 12 months
Gene expression levels in immune cells (innate and adaptive) in blood samples from participants with and without pSS including healthy volunteers
时间窗: Up to 12 months
Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteers
时间窗: Up to 12 months
Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteers
时间窗: Up to 12 months
次要结局
未报告次要终点