Clinical trial NCT03793270: Characterization of the Phenotypic Markers of B Cell Lymphocytes in Rheumatoid Arthritis
Official title: Characterization of the Phenotypic Markers of B Cell Lymphocytes in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autoimmune Diseases
Keywords: Rheumatoid arthritis RA - B cells (B Lymphocyte).
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: after 6 monthes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Silverman GJ, Carson DA. Roles of B cells in rheumatoid arthritis. Arthritis Res Ther. 2003;5 Suppl 4(Suppl 4):S1-6. doi: 10.1186/ar1010. Epub 2003 Dec 2.