A Longitudinal, Observational Biomarker Study in Participants With Primary Sjogren's Syndrome

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02422407

Enrollment

100

Registered

2015-04-21

Start date

2015-03-26

Completion date

2017-08-22

Last updated

2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Sicca Syndrome, Sjögren's Syndrome

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.

Interventions

PROCEDUREBiopsy

Salivary Gland

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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/

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026