A Longitudinal, Observational Biomarker Study in Participants With Primary Sjogren's Syndrome
Completed
- Conditions
- Sjögren's SyndromeHealthySicca Syndrome
- Registration Number
- NCT02422407
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Key
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteers 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 Up to 12 months Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteers Up to 12 months Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteers Up to 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇺🇸Dallas, Texas, United States
Research Site🇺🇸Dallas, Texas, United States