Examining the Immunological Process of Autoimmune Patients

Sjögren's syndrome (SjS) is an autoimmune disease characterized primarily by exocrine gland dysfunction, specifically of the salivary and lacrimal glands, resulting in dry mouth and dry eyes symptoms. It can be systemic by affecting other organs including the gastrointestinal tract, skin, lungs, vasculature, kidneys, bladder and vagina. Involvement of the musculature can lead to fibromyalgia-like symptoms and chronic fatigue, while approximately 20% of patients develop various neuropathies, including sensory, peripheral, cranial and myelopathic neuropathies exhibited by cognitive impairments such as dementia, lack of concentration, memory loss and various psychiatric disorders. Like most autoimmune connective tissue diseases, SjS shows a sexual dimorphism with women affected 10-times more frequently than men, suggesting a role for sex hormones in disease susceptibility or progression. One common feature of SjS is it infiltration of mononuclear cells into the salivary and lacrimal glands, aggregating into clusters referred to as lymphocytic foci (LF). Critical to the studies proposed is the fact that a predominant cell population of LF is the pathogenic TH17 cell that produces IL-17 cytokine and autoreactive B cells reactive to M3R, Ro, and La autoantigens. The goal of this study is characterize the change in receptor gene repertoires of autoreactive B and T cells at different time points during the disease process and examine the correlation with various disease parameters.

Study Overview

• Status: Withdrawn
• Conditions: Autoimmune Diseases; Sjogren's Syndrome; Dry Mouth; Dry Eyes

Detailed Description

Blood from patient and healthy controls will be collected once every 3-6 months. White blood cells from blood samples will be separated. Tests will be done to see which substances these cells make. Using sequencing techniques, the investigators will determine the genetic code of the receptors expressed on these cells. The investigators plan to test how these cells change over the period of at least 3 years at different visits. In addition, the investigators will check how these changes relate to patients' general medical history relevant to autoimmune disease, lab results and physical examinations and exams pertinent to the diagnosis of autoimmune disease, and psychosocial data.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

150 Sjogren's syndrome patients and 50 healthy controls.

Description

Inclusion Criteria for Sjogren's syndrome patients:

• Primary Sjogren's syndrome patients: primary Sjogren's syndrome patients who meet the revised criteria for SjS diagnosis by the American-European Consensus Group.
• Secondary Sjogren's syndrome patients: secondary Sjogren's syndrome patients who meet the criteria for primary Sjogren's syndrome in association with other autoimmune diseases such as systemic lupus erythematosus , dermatomyositis, scleroderma, idiopathic arthritis, mixed connective tissue disease, etc.

Inclusion Criteria for healthy controls:

-Subjects who does not have history of autoimmune diseases.

Exclusion Criteria:

• Pregnant women.
• Patients with history of lymphoma or malignancy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sjogren's syndrome; Patients who are diagnosed with Sjogren's syndrome. Blood will be collected once every 3-6 months for up to 3 years.
Healthy Control; Patients who are diagnosed with healthy control. Blood will be collected once every 6 months for up to 3 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receptor gene rearrangement.	Gene arrangement of the receptors in patients will be assessed every 3 months for 3 years.	Every 3 months for 3 years
Receptor gene rearrangement	Gene arrangement of the receptors in healthy controls will be assessed every 6 months for 3 years.	Every 6 months for 3 years.

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Cuong Nguyen, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 25, 2014

Study Record Updates

• Last Update Posted (Actual): August 8, 2017
• Last Update Submitted That Met QC Criteria: August 7, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Eye Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Autoimmune Diseases; Sjogren's Syndrome
• Other Study ID Numbers: IRB201400079