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

Completed

• Conditions: Sjögren's Syndrome; Healthy; Sicca Syndrome
• Interventions: Procedure: Biopsy

• 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

Study Timeline

• Study First Submitted: 2015-03-19
• Study Start: 2015-03-26
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-21
• Primary Completion: 2017-08-22
• Study Completion: 2017-08-22
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-19

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

Arm && Interventions

Group	Intervention	Description
Subgroup 4	Biopsy	Presenting with sicca but not satisfying the criteria of the AECCSS for diagnosis of pSS.
Subgroup 1	Biopsy	Healthy Volunteers - subset of which 10 will receive salivary gland biopsy.
Subgroup 2	Biopsy	Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with positive biopsy result.
Subgroup 3	Biopsy	Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with negative biopsy result.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Dallas, Texas, United States