MedPath

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

Completed
Conditions
Sjögren's Syndrome
Healthy
Sicca Syndrome
Registration Number
NCT02422407
Lead Sponsor
Biogen
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Gene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteersUp to 12 months
Gene expression levels in immune cells (innate and adaptive) in blood samples from participants with and without pSS including healthy volunteersUp to 12 months
Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteersUp to 12 months
Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteersUp to 12 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Research Site

🇺🇸

Dallas, Texas, United States

Research Site
🇺🇸Dallas, Texas, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.