Overview

This trial is active, not recruiting.

Conditions healthy, sjögren's syndrome
Treatment biopsy
Sponsor Biogen
Start date March 2015
End date August 2017
Trial size 100 participants
Trial identifier NCT02422407, 999SJ001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Healthy Volunteers - subset of which 10 will receive salivary gland biopsy.
biopsy
Salivary Gland
Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with positive biopsy result.
biopsy
Salivary Gland
Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with negative biopsy result.
biopsy
Salivary Gland
Presenting with sicca but not satisfying the criteria of the AECCSS for diagnosis of pSS.
biopsy
Salivary Gland

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Biogen.