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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subgroup 1 | Healthy Volunteers - subset of which 10 will receive salivary gland biopsy. |
| |
| Subgroup 2 | Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with positive biopsy result. |
| |
| Subgroup 3 | Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with negative biopsy result. |
| |
| Subgroup 4 | Presenting with sicca but not satisfying the criteria of the AECCSS for diagnosis of pSS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Salivary Gland |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
For Healthy Volunteers:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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Participants with sicca and healthy volunteers will be recruited from multiple sites
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hartford | Connecticut | 06105 | United States | ||
| Research Site |
| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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A lip biopsy is taken to determine Sjogrens diagnosis.
| Boston |
| Massachusetts |
| 02111 |
| United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |