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

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ClinicalTrials.gov Identifier: NCT02422407
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Healthy Sicca Syndrome Sjögren's Syndrome Procedure: Biopsy

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 : March 26, 2015
Actual Primary Completion Date : August 22, 2017
Actual Study Completion Date : August 22, 2017

Resource links provided by the National Library of Medicine


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




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

Biospecimen Retention:   Samples With DNA
A lip biopsy is taken to determine Sjogrens diagnosis.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants with sicca and healthy volunteers will be recruited from multiple sites
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422407


Locations
United States, Connecticut
Research Site
Hartford, Connecticut, United States, 06105
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02111
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Research Site
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02422407     History of Changes
Other Study ID Numbers: 999SJ001
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases