Examining the Immunological Process of Autoimmune Patients

NCT02123147 | Withdrawn

• 1 other identifier: IRB201400079
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sjogren's Syndrome; Autoimmune Diseases; Dry Eyes; Dry Mouth

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 9 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

150 Sjogren's syndrome patients and 50 healthy controls.

You may qualify if:

• 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.
• Subjects who does not have history of autoimmune diseases.

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Autoimmune Diseases; Dry Eye Syndromes; Xerostomia

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Officials

• Cuong Nguyen, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 25, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

US (1)