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Analysis of B Cells From Autoimmune Individuals

Analysis of B Cells From Autoimmune Individuals

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02747277
Enrollment
46
Registered
2016-04-21
Start date
2016-05-31
Completion date
2022-01-31
Last updated
2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Erythematosus, Rheumatoid Arthritis, Type 1 Diabetes

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.

Interventions

None listed

Sponsors

National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of kappa to lambda ratios of B cells in blood of autoimmune adults1 dayFor 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.
Frequency of CD19 and IgM low B cells in cord blood of babies born from autoimmune mothers1 dayFor 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026