Characterization of the Phenotypic Markers of B Cell Lymphocytes in Rheumatoid Arthritis

January 3, 2019 updated by: Asmaa Rayan Mohammed, Assiut University

Rheumatoid Arthritis (RA):

RA is a chronic inflammatory autoimmune disease that primarily affects the small joints, eventually leading to bone erosion and an inability to move (1). Several immune cells participate in the pathogenesis of RA. One of those cells is B cell.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

B cell population:

B lymphocytes play several critical roles in the pathogenesis of rheumatoid arthritis. They are the source of the rheumatoid factors (RF) and anti-cyclic-citrullinated peptide (anti-CCP), which contribute to immune complex formation and complement activation in the joints (2).

There is different B cell subpopulation according to the stage of maturation and activity. Distinction of this subpopulation can be done by detection of different CD molecules expressed on cell surface (3). From all sub-population this research will focus on these immunophenotypes; immature, mature, memory and B-reg cells by using CD 19, CD24, CD38 & CD27 respectively.

Joa˜ o E. Fonseca and his team found the reduction in B cell subpopulation especially (Pre- switched memory B cells) both in RA and Arthritis in the early stage. This observation not related to using methotrexate or corticosteroid in the treatment. They used the classification of B cells with CD 19 mainly and then IgD and CD27 to identify B cells (4).

Gabriella Sármay team found that the number of B-reg CD19+ CD27+ IL-10+ cells in peripheral blood is fewer in RA patients compared with healthy controls (5).

Interleukin 10:

Interleukin (IL)-10 functions as an anti-inflammatory cytokine in rheumatoid arthritis. IL-10 mRNA levels were significantly elevated in synovial fluid mononuclear cells (SFMCs) from patients with RA compared with PBMCs peripheral blood mononuclear cells (PBMCs) from RA patients or healthy volunteers according to Isomäki P (6).

IL 10 is primarily produced by monocytes mainly and, then by lymphocytes; type 2 T helper cells (TH2), mast cells, CD4+CD25+Foxp3+ regulatory T cells, and in a certain subset of activated T cells and B cells (7).

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Total sample size will be 90 samples will be divided into groups:

  1. Group 1: 30 diseased with Early Rheumatoid Arthritis from 6months to 1 year).
  2. Group 2: 30 diseased with late/chronic Rheumatoid Arthritis.
  3. Group 3: 30 healthy controls.

Description

Inclusion criteria:

  • Patient diagnosed as Rheumatoid arthritis that fulfilled ACR/EULAR Criteria (American College of Rheumatology/European League Against Rheumatism).

  • (8) Age >18 Years.

    b. Exclusion criteria:

  • Diagnosed patients with other autoimmune disease or other infections.
  • Pregnant patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients

1. Group 1: 30 diseased with Early Rheumatoid Arthritis from 6months to 1 year).

drugs described in the clinic.
Diagnostic test: for patients and healthy donors
  1. Detection of (CD19, CD24, CD38 & CD27) markers in peripheral blood samples by Flow Cytometry
  2. Determine the serum level of IL 10 using ELISA plate
patients 2
2. Group 2: 30 diseased with late/chronic Rheumatoid Arthritis. drugs described in the clinic.
Diagnostic test: for patients and healthy donors
  1. Detection of (CD19, CD24, CD38 & CD27) markers in peripheral blood samples by Flow Cytometry
  2. Determine the serum level of IL 10 using ELISA plate
healthy donors
3. Group 3: 30 healthy controls. No drugs.
Diagnostic test: for patients and healthy donors
  1. Detection of (CD19, CD24, CD38 & CD27) markers in peripheral blood samples by Flow Cytometry
  2. Determine the serum level of IL 10 using ELISA plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of the percentage (%) B cell subpopulation in early-detected Rheumatic arthritis before taking long course medication and in late Rheumatic arthritis. Detection of the level of IL 10 in the serum for all patients.
Time Frame: after 6 monthes
WBCs will be isolated from whole blood sample, then different monoclonal antibodies labeled with different markers will mixed with sample to be used for measuring the percent of each in the B cell population. Serum Samples will be collected and preserved in -80 degree then all samples will be measured with Elisa according to the manufacture procedures.
after 6 monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 3, 2019

Primary Completion (ANTICIPATED)

August 20, 2019

Study Completion (ANTICIPATED)

August 20, 2020

Study Registration Dates

First Submitted

January 1, 2019

First Submitted That Met QC Criteria

January 3, 2019

First Posted (ACTUAL)

January 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17200278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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