Comparative Autoantibody and Immunologic Cell Marker Study

NCT02422875 | Enrolling By Invitation

• 2 other identifiers: IRB000585155R37AI049660
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to compare immune phenotype, function, and specificity of B lymphocytes from different developmental stages in autoimmune patients to B cells from infectious disease patients and healthy controls.

Conditions

Autoimmune Diseases; Lupus Erythematosus, Systemic; Communicable Diseases

Keywords

Sjögren's Syndrome; Scleroderma; Myositis; Juvenile Idiopathic Arthritis; Rheumatoid Arthritis; Inflammatory Arthritis; Undifferentiated Connective Tissue Disease; Idiopathic thrombocytopenic purpura; Graft vs Host Disease; Autoimmune Lymphoproliferative Syndrome; Immunoglobulin G4 (IgG4)-related disease; Hepatitis C; Epstein Barr Virus (infectious mononucleosis - EBV); Sepsis; Guillain-Barre syndrome; Mycoplasma pneumoniae; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Distribution of autoreactive B cells within bone marrow

  B cells will be analyzed using flow cytometry.

  Baseline

Study Arms (5)

Healthy Controls

Subjects are healthy persons without any autoimmune conditions or infectious diseases

Autoimmune Disease

Subjects diagnosed with autoimmune disease including but not limited to: Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome (SS), Scleroderma, Myositis, Juvenile Idiopathic Arthritis (JIA), Rheumatoid Arthritis (RA), inflammatory arthritis, undifferentiated connective tissue disease, idiopathic thrombocytopenic purpura (ITP), Graft vs Host Disease (GVHD), Autoimmune Lymphoproliferative Syndrome (ALPS) and IgG4-related disease

Infectious Disease

Subjects diagnosed with an infectious disease including but not limited to: Hepatitis C, Epstein Barr Virus (infectious mononucleosis - EBV), Sepsis, Guillain-Barre syndrome (GBS), Mycoplasma pneumoniae or Human Immunodeficiency Virus (HIV)

Autoimmune - Family

Subjects have a brother, sister, mother, father, or child with an autoimmune disease

Vaccination

Subjects have received or will receive a vaccination as part of regular standard of care from their healthcare provider or other outside source

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Subjects with certain autoimmune conditions or if subjects have brothers, sisters, mother, father, or children with an autoimmune condition * Subjects with certain infectious diseases * Subjects who are without an autoimmune condition or infectious disease * Subjects who have received or will receive a vaccination as part of their regular standard of care from one of their healthcare providers

You may qualify if:

• Signed written informed consent by the subject or, if the subject is unable to provide informed consent, the subject's legal representative may provide consent.
• Subjects can be of either gender
• Subjects with autoimmune diseases, and Systemic Lupus Erythematosus (SLE) patients will fulfill the American College of Rheumatology Classification criteria for SLE to be determined by their treating physician but may have incomplete criteria (\<4 items). SLE patients are not restricted by treatment or by disease activity as determined by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) or Systemic Lupus Activity Measure (SLAM) score
• Subjects with acute exacerbations of their disease, including hospitalized patients
• First-degree relatives of subjects with active disease
• Subjects who have received or will receive a vaccination may be enrolled for bone marrow aspirates before and/or after vaccination. Vaccination will have been done by the subject's healthcare provider or through another outside source.
• Subjects may have a screening blood draw performed in cases where a certain subset of cells or antibody titer is desired. This may be followed by additional blood draws and/or bone marrow aspiration after the ideal candidates have been identified.
• Subjects who have been diagnosed with HIV or another infectious disease
• Subjects taking biologic and/or immune modulatory agents in diseases such as cancer, allergy, and pulmonary diseases will be enrolled.
• Healthy controls must be free of acute or chronic disease at the time of bone marrow donation. Healthy controls that are first-degree relatives of subjects with active disease will be enrolled as well.

You may not qualify if:

• Poor venous access
• Subjects who have had side effects to local anesthetics such as lidocaine and who are on blood thinners such as warfarin
• Normal controls must be free of acute or chronic diseases or medications that may affect the assay (as determined by the investigator).
• For subjects donating bone marrow, insufficient access to the iliac crest such that the periosteum and bone is hindered based on normal aspiration procedures.
• Pregnant or lactating women may not donate bone marrow.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Grady Health System

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Acquisition and storage of blood and bone marrow samples

MeSH Terms

Conditions

Autoimmune Diseases; Lupus Erythematosus, Systemic; Communicable Diseases; Sjogren's Syndrome; Scleroderma, Diffuse; Myositis; Arthritis, Juvenile; Arthritis, Rheumatoid; Arthritis; Undifferentiated Connective Tissue Diseases; Purpura, Thrombocytopenic, Idiopathic; Graft vs Host Disease; Autoimmune Lymphoproliferative Syndrome; Immunoglobulin G4-Related Disease; Hepatitis C; Epstein-Barr Virus Infections; Sepsis; Guillain-Barre Syndrome; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Immune System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Scleroderma, Systemic; Skin Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Hemorrhage; Skin Manifestations; Signs and Symptoms; Lymphoproliferative Disorders; Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunoproliferative Disorders; Blood-Borne Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Herpesviridae Infections; DNA Virus Infections; Tumor Virus Infections; Systemic Inflammatory Response Syndrome; Inflammation; Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Post-Infectious Disorders; Chronic Disease; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes

Study Officials

• Ignatio Sanz, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 21, 2015
• Study Start: August 1, 2012
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

US (3)