Healthy Clinical Trial
Official title:
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
Verified date | January 2018 |
Source | Biogen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 22, 2017 |
Est. primary completion date | August 22, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Boston | Massachusetts |
United States | Research Site | Dallas | Texas |
United States | Research Site | Hartford | Connecticut |
United States | Research Site | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Biogen |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Primary | 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 | ||
Primary | Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteers | Up to 12 months | ||
Primary | Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteers | Up to 12 months |
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