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

• Conditions: Autoimmune Diseases
• Interventions: Diagnostic Test: for patients and healthy donors

• Registration Number: NCT03793270
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-01
• Study Start: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Last Update Submitted: 2019-01-03
• Study First Posted: 2019-01-04
• Last Update Posted: 2019-01-04
• Primary Completion: 2019-08-20
• Study Completion: 2020-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients 2	for patients and healthy donors	2. Group 2: 30 diseased with late/chronic Rheumatoid Arthritis. drugs described in the clinic.
healthy donors	for patients and healthy donors	3. Group 3: 30 healthy controls. No drugs.
patients	for patients and healthy donors	1. Group 1: 30 diseased with Early Rheumatoid Arthritis from 6months to 1 year). drugs described in the clinic.

Primary Outcome Measures

Name	Time	Method
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.	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.