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

Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03793270
• Other study ID #: 17200278
• Status: Not yet recruiting
• Start date: January 3, 2019
• Est. completion date: August 20, 2020

Study information

• Verified date: January 2019
• Source: Assiut University
• Contact: Khaled M Hasanein, Prof
• Phone: 01118508060
• Email: khaledhassanein70[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 20, 2020
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Diseases

Intervention

Diagnostic Test:
• for patients and healthy donors
Detection of (CD19, CD24, CD38 & CD27) markers in peripheral blood samples by Flow Cytometry Determine the serum level of IL 10 using ELISA plate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Silverman GJ, Carson DA. Roles of B cells in rheumatoid arthritis. Arthritis Res Ther. 2003;5 Suppl 4:S1-6. Epub 2003 Dec 2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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