NCT02422407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

March 26, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2017

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

March 19, 2015

Last Update Submit

January 18, 2018

Conditions

HealthySicca SyndromeSjögren's Syndrome

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteers

    Up to 12 months

  • Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteers

    Up to 12 months

Study Arms (4)

Subgroup 1

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

Procedure: Biopsy

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

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

Subgroup 4

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

Procedure: Biopsy

Interventions

BiopsyPROCEDURE

Salivary Gland

Subgroup 1Subgroup 2Subgroup 3Subgroup 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Hartford, Connecticut, 06105, United States

Location

Research Site

Boston, Massachusetts, 02111, United States

Location

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Research Site

Dallas, Texas, 75231, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A lip biopsy is taken to determine Sjogrens diagnosis.

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2015

First Posted

April 21, 2015

Study Start

March 26, 2015

Primary Completion

August 22, 2017

Study Completion

August 22, 2017

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

US(4)