Analysis of B Cells From Autoimmune Individuals

Rheumatoid Arthritis Clinical Trial

Official title:

Analysis of B Cells From Autoimmune Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747277
• Other study ID #: 16-0541
• Secondary ID: UL1TR001082
• Status: Completed
• Start date: May 2016
• Est. completion date: January 2022

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Diabetes Mellitus, Type 1
• Lupus Erythematosus
• Rheumatoid Arthritis
• Type 1 Diabetes

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Alves da Costa T, Peterson JN, Lang J, Shulman J, Liang X, Freed BM, Boackle SA, Lauzurica P, Torres RM, Pelanda R. Central human B cell tolerance manifests with a distinctive cell phenotype and is enforced via CXCR4 signaling in hu-mice. Proc Natl Acad S — View Citation

Peterson JN, Boackle SA, Taitano SH, Sang A, Lang J, Kelly M, Rahkola JT, Miranda AM, Sheridan RM, Thurman JM, Rao VK, Torres RM, Pelanda R. Elevated Detection of Dual Antibody B Cells Identifies Lupus Patients With B Cell-Reactive VH4-34 Autoantibodies. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of kappa to lambda ratios of B cells in blood of autoimmune adults	For peripheral adult blood, the main outcome measure is the frequency of ?/? (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 ?/? B cells in subjects with autoimmunity relative to healthy controls.	1 day
Primary	Frequency of CD19 and IgM low B cells in cord blood of babies born from autoimmune mothers	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.	1 day