Comparative Autoantibody and Immunologic Cell Marker Study

Autoimmune Diseases Clinical Trial

Official title:

Comparative Autoantibody and Immunologic Cell Marker Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02422875
• Other study ID #: IRB00058515
• Secondary ID: 5R37AI049660
• Status: Enrolling by invitation
• Start date: August 2012
• Est. completion date: August 2024

Study information

• Verified date: July 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1050
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

1. Subjects with acute exacerbations of their disease, including hospitalized patients

2. 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.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Communicable Diseases
• Infections
• Lupus Erythematosus, Systemic

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of autoreactive B cells within bone marrow	B cells will be analyzed using flow cytometry.	Baseline