Comparative Autoantibody and Immunologi… | Clinical Trial

Key information

Conditions

Autoimmune Diseases Acquired Immunodeficiency Syndrome Arthritis Arthritis, Juvenile Arthritis, Rheumatoid Autoimmune Diseases of the Nervous System Autoimmune Lymphoproliferative Syndrome Blood Coagulation Disorders Blood Platelet Disorders Blood-Borne Infections Chronic Disease Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cytopenia DNA Virus Infections Demyelinating Diseases Digestive System Diseases Disease Attributes Dry Eye Syndromes Epstein-Barr Virus Infections Eye Diseases Flaviviridae Infections Genetic Diseases, Inborn Genital Diseases Graft vs Host Disease Guillain-Barre Syndrome HIV Infections Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hepatitis Hepatitis C Hepatitis, Viral, Human Herpesviridae Infections Immune System Diseases Immunoglobulin G4-Related Disease Immunologic Deficiency Syndromes Immunoproliferative Disorders Infections Inflammation Joint Diseases Lacrimal Apparatus Diseases Lentivirus Infections Liver Diseases Lupus Erythematosus, Systemic Lymphatic Diseases Lymphoproliferative Disorders Mouth Diseases Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic RNA Virus Infections Retroviridae Infections Rheumatic Diseases Salivary Gland Diseases Scleroderma, Diffuse Scleroderma, Systemic Sepsis Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Sjogren's Syndrome Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Slow Virus Diseases Stomatognathic Diseases Systemic Inflammatory Response Syndrome Thrombocytopenia Thrombotic Microangiopathies Tumor Virus Infections Undifferentiated Connective Tissue Diseases Urogenital Diseases Virus Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University Hospital, Atlanta, Georgia, United States

About this study

Systemic lupus erythematosus (SLE) is an autoimmune disease (in autoimmune illness, the immune system in the body attacks it's own cells, leading to illness). It is not completely understood how this disease develops in the body. In a normal person, there is a tolerance of antigens (substances that make antibodies, which protect the body from disease-causing agents). Research in mice suggests that defects in certain types of cells can make the body lose this tolerance, therefore recognizing antigens made in the body as foreign, and mounting an immune response to the "self", thus causing autoimmune disease. In this study, the researchers will look at these potentially defective cells in people with SLE and other autoimmune diseases and compare them to cells in healthy participants, as well as looking at the blood of first-degree relatives of people with autoimmune disease.

The study involves blood draws and bone marrow aspirates. Participants may be asked to donate 2/3 to about 9 tablespoons of blood. The volume of blood needed will depend on the experiment being done as different numbers of cells are necessary to run different experiments. Study participants may return for additional blood draws will not donate blood more than twice a week, and will not have more than 16 tablespoons of blood drawn in a one-month period. Participants donating bone marrow will have about 3 ½ tablespoons of bone marrow obtained, which will be drawn with a large needle from the bone located in the back of the hip. Bone marrow participants may be asked to donate up to 7 tablespoons of blood as well, in order to correlate the blood with the bone marrow sample and the populations of cells residing in each. Participants donating bone marrow may donate more than once, but must wait a minimum of 8 weeks between donations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Distribution of autoreactive B cells within bone marrow

Time frame: Baseline

B cells will be analyzed using flow cytometry.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Important dates

Study start: 2012
Primary completion: 2028
Study completion: 2028
First posted: Apr 21, 2015
Registry last updated: Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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