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

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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Key information

Conditions

Healthy Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sicca Syndrome Sjogren's Syndrome Sjögren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Hartford, Connecticut, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biopsy

Procedure

Salivary Gland

Primary outcomes

Gene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteers

Time frame: 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

Time frame: Up to 12 months
Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteers

Time frame: Up to 12 months
Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteers

Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Apr 21, 2015
Registry last updated: Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed