Analysis of B Cells From Autoimmune Individuals

Completed

• Conditions: Lupus Erythematosus; Type 1 Diabetes; Rheumatoid Arthritis

• Registration Number: NCT02747277
• Lead Sponsor: University of Colorado, Denver

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 Timeline

• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-21
• Study Start: 2016-05
• Primary Completion: 2022-01
• Study Completion: 2022-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of CD19 and IgM low B cells in cord blood of babies born from autoimmune mothers	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	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.

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States