Analysis of B Cells From Autoimmune Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Frequency of CD19 and IgM low B cells in cord blood of babies born from autoimmune mothers
Study Overview
Brief Summary
This observational study aims at finding out if individual with autoimmunity exhibit increased numbers of B cells that express two types (instead of one type) of antibodies, and if B cells of individuals genetically susceptible to autoimmunity display defects in the biological process of tolerance, which removes B cells that participate in autoimmunity.
Detailed Description
Peripheral blood B cells of SLE patients are analyzed by flow cytometry to determine the frequency of B cells co-expressing immunoglobulin kappa an lambda light chains. This frequency is correlated to the disease activity.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult Males and Females diagnosed with Lupus;
- •Adult Females who are pregnant and diagnosed with:
- •lupus erythematosus
- •rheumatoid arthritis, or
- •type 1 diabetes.
Exclusion Criteria
- •Adult males or adult females treated with B-cell depletion therapies.
Outcomes
Primary Outcomes
Frequency of CD19 and IgM low B cells in cord blood of babies born from autoimmune mothers
Time Frame: 1 day
For cord blood samples, the main outcome measurement is the frequency of B cells that express both low levels of CD19 and IgM within the total (CD19+ or CD20+) B cell population. The collected data will be aggregated as the average frequency of CD19low/IgMlow B cells in subjects that were born from autoimmune mothers relative to those born from healthy mothers. Moreover, data will also be stratified in respect to the presence or absence of the PTPN22-R620W allele, which is a risk allele for autoimmunity.
Frequency of kappa to lambda ratios of B cells in blood of autoimmune adults
Time Frame: 1 day
For peripheral adult blood, the main outcome measure is the frequency of κ/λ (kappa to lambda ratios) dual immunoglobulin B cells within the overall B (CD19+ or CD20+) cell population. The collected data will be aggregated as the average frequency of κ/λ B cells in subjects with autoimmunity relative to healthy controls.
Secondary Outcomes
No secondary outcomes reported