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

• Sponsor: Biogen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02422407
• Collaborator: (none)
• Enrollment: 100
• Locations: 4
• Actual Duration (Months): 28.9
• Patients Per Site: 25
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Sicca Syndrome; Sjögren's Syndrome	Procedure: Biopsy

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Mar 26, 2015
• Actual Primary Completion Date: Aug 22, 2017
• Actual Study Completion Date: Aug 22, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteers [Up to 12 months]

4. Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteers [Up to 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Hartford	Connecticut	United States	06105
2	Research Site	Boston	Massachusetts	United States	02111
3	Research Site	Philadelphia	Pennsylvania	United States	19104
4	Research Site	Dallas	Texas	United States	75231

Sponsors and Collaborators

• Biogen

Investigators

• Study Director: Medical Director, Biogen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT02422407
• Other Study ID Numbers: 999SJ001
• First Posted: Apr 21, 2015
• Last Update Posted: Jan 19, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Sjogren's Syndrome; Syndrome

Study Results

No Results Posted as of Jan 19, 2018