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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422407
• Other study ID #: 999SJ001
• Status: Completed
• Phase: N/A
• First received: March 19, 2015
• Last updated: January 18, 2018
• Start date: March 26, 2015
• Est. completion date: August 22, 2017

Study information

• Verified date: January 2018
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 22, 2017
• Est. primary completion date: August 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Sicca Syndrome
• Sjogren's Syndrome
• Sjögren's Syndrome
• Syndrome

Intervention

Procedure:
• Biopsy
Salivary Gland

Locations

Country	Name	City	State
United States	Research Site	Boston	Massachusetts
United States	Research Site	Dallas	Texas
United States	Research Site	Hartford	Connecticut
United States	Research Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteers		Up to 12 months
Primary	Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteers		Up to 12 months