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

January 18, 2018 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with sicca and healthy volunteers will be recruited from multiple sites

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteers
Time Frame: Up to 12 months
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
Time Frame: Up to 12 months
Up to 12 months
Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteers
Time Frame: Up to 12 months
Up to 12 months
Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteers
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2015

Primary Completion (Actual)

August 22, 2017

Study Completion (Actual)

August 22, 2017

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

April 16, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Actual)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999SJ001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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