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OpenTrials
Completed

NCT Number: NCT02747277

Analysis of B Cells From Autoimmune Individuals

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.

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Key information

Conditions

Lupus Erythematosus Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Type 1 Diabetes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2016
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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