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Lupus ErythematosusNCT02747277

Analysis of B Cells From Autoimmune Individuals

An observational study of Lupus Erythematosus and Rheumatoid Arthritis, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
How many people
46 participants
Where
1 siteUnited States
Study dates
May 2016to Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult males and females with a diagnoses of lupus erythematosus, rheumatoid arthritis, or type 1 diabetes

Who may be able to join

  • Adult Males and Females diagnosed with Lupus;
  • Adult Females who are pregnant and diagnosed with:
  • lupus erythematosus
  • rheumatoid arthritis, or
  • type 1 diabetes.

Who cannot join

  • Adult males or adult females treated with B-cell depletion therapies.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the 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.

Medical subject headings
Arthritis, Rheumatoid, Diabetes Mellitus, Type 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 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.

    Measured: 1 day

  2. 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.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionJan 2022
  4. Study completionJan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02747277
Sponsor's protocol ID
16-0541
Other IDs
UL1TR001082
Status last verified
Nov 2023
First submitted
14 Apr 2016
Last updated
4 Dec 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: De-identified individual participant data will be presented at conferences and eventually published in peer-reviewed publication.

Publications

  • 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. Front Immunol. 2022 Feb 4;13:795209. doi: 10.3389/fimmu.2022.795209. eCollection 2022.

    PubMed 35185888

  • 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 Sci U S A. 2021 Apr 20;118(16):e2021570118. doi: 10.1073/pnas.2021570118.

    PubMed 33850015

Questions about this trial

What is this clinical trial studying?

An observational study of Lupus Erythematosus and Rheumatoid Arthritis, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of kappa to lambda ratios of B cells in blood of autoimmune adults (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02747277, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.

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