NCT02422875Enrolling by invitation
Comparative Autoantibody and Immunologic Cell Marker Study
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 2500 (estimated)
- First submitted
- 17 Apr 2015
- Start date
- 1 Aug 2012
- Primary completion date
- 31 May 2028
- Lead sponsor
- Emory University
- NCT number
- NCT02422875
What you commit to
- Study type: Observational
- Planned participants: 2500
- From 1 Aug 2012 to the primary completion date, 31 May 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Normal controls must be free of acute or chronic diseases or medications that may affect the assay (as determined by the investigator).
Other
- Poor venous access
- Subjects who have had side effects to local anesthetics such as lidocaine and who are on blood thinners such as warfarin
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grady Health System Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory University/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.