Autoimmune DiseasesNCT02422875
Comparative Autoantibody and Immunologic Cell Marker Study
An observational study of Autoimmune Diseases and Lupus Erythematosus, Systemic, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Diseases, Lupus Erythematosus, Systemic, Communicable Diseases
- Type of treatment
- Vaccines
- How many people
- 2,500 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2012to May 2028
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Emory University Hospital
Atlanta, Georgia, 30322
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
Grady Health System
Atlanta, Georgia, 30322
About this study
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.
Read the detailed description
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.
- 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
- Medical subject headings
- Autoimmune Diseases, Lupus Erythematosus, Systemic, Communicable Diseases, Sjogren's Syndrome, Scleroderma, Diffuse, Myositis, Arthritis, Juvenile, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of autoreactive B cells within bone marrow
B cells will be analyzed using flow cytometry.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startAug 2012
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Sanz, Emory University
- Investigators
- Ignatio Sanz, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422875
- Sponsor's protocol ID
- IRB00058515
- Other IDs
- 5R37AI049660, 2025P010638
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2015
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Autoantibody and Immunologic Cell Marker Study
- ClinicalTrials.gov ID
- NCT02422875
- Acronym / sponsor ID
- IRB00058515
- Keywords
- Sjögren's Syndrome, Scleroderma, Myositis, Juvenile Idiopathic Arthritis, Rheumatoid Arthritis, Inflammatory Arthritis, Undifferentiated Connective Tissue Disease, Idiopathic thrombocytopenic purpura
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Aug 2012
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (10 listed)
- 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 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distribution of autoreactive B cells within bone marrow
Time frame: Baseline
B cells will be analyzed using flow cytometry.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ignatio Sanz, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases and Lupus Erythematosus, Systemic, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of autoreactive B cells within bone marrow (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.