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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Biogen
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Gene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteers
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Gene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteers
Time Frame: 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
Time Frame: Up to 12 months
Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteers
Time Frame: Up to 12 months
Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteers
Time Frame: Up to 12 months