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

Biogen

Status: Completed

Conditions: Healthy; Sicca Syndrome; Sjögren's Syndrome

Treatments: Procedure: Biopsy

Study type: Observational

Funder types: Industry

Identifiers

NCT02422407

999SJ001

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 4 patient groups

Subgroup 1

Description:

Healthy Volunteers - subset of which 10 will receive salivary gland biopsy.

Treatment:

Procedure: Biopsy

Subgroup 2

Description:

Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with positive biopsy result.

Treatment:

Procedure: Biopsy

Subgroup 3

Description:

Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with negative biopsy result.

Treatment:

Procedure: Biopsy

Subgroup 4

Description:

Presenting with sicca but not satisfying the criteria of the AECCSS for diagnosis of pSS.

Treatment:

Procedure: Biopsy