A Longitudinal, Observational Biomarker Study in Participants With Primary Sjogren's Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Rheumatology |
| Therapuetic Areas: | Rheumatology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/21/2018 |
| Start Date: | March 26, 2015 |
| End Date: | August 22, 2017 |
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
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.
epithelial cells in salivary gland biopsy samples and blood of pSS (primary Sjögren's
syndrome) and non-pSS participants including healthy volunteers.
Key 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
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