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

Brief Title

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

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

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.
    



Study Type

Observational


Primary Outcome

Gene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteers


Condition

Healthy

Intervention

Biopsy

Study Arms / Comparison Groups

 Subgroup 1
Description:  Healthy Volunteers - subset of which 10 will receive salivary gland biopsy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

100

Start Date

March 26, 2015

Completion Date

August 22, 2017

Primary Completion Date

August 22, 2017

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02422407

Organization ID

999SJ001


Responsible Party

Sponsor

Study Sponsor

Biogen


Study Sponsor

Medical Director, Study Director, Biogen


Verification Date

January 2018