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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-26

Study Completion Date

2017-08-22

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Sicca Syndrome Sjögren's Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subgroup 1

Healthy Volunteers - subset of which 10 will receive salivary gland biopsy.

Biopsy

Intervention Type PROCEDURE

Salivary Gland

Subgroup 2

Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with positive biopsy result.

Biopsy

Intervention Type PROCEDURE

Salivary Gland

Subgroup 3

Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with negative biopsy result.

Biopsy

Intervention Type PROCEDURE

Salivary Gland

Subgroup 4

Presenting with sicca but not satisfying the criteria of the AECCSS for diagnosis of pSS.

Biopsy

Intervention Type PROCEDURE

Salivary Gland

Interventions

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Biopsy

Salivary Gland

Intervention Type PROCEDURE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes