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

NCT ID: NCT03793270

Last Updated: 2019-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-03

Study Completion Date

2020-08-20

Brief Summary

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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

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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).

Conditions

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Autoimmune Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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patients

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

drugs described in the clinic.

for patients and healthy donors

Intervention Type DIAGNOSTIC_TEST

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.

for patients and healthy donors

Intervention Type DIAGNOSTIC_TEST

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.

for patients and healthy donors

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient diagnosed as Rheumatoid arthritis that fulfilled ACR/EULAR Criteria (American College of Rheumatology/European League Against Rheumatism).
* (8) Age \>18 Years.

Exclusion Criteria

* Diagnosed patients with other autoimmune disease or other infections.
* Pregnant patients.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Rayan Mohammed

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Khaled M Hasanein, Prof

Role: CONTACT

01118508060 ext. 002

Mohamed S Badaery Ali, Prof

Role: CONTACT

01000103328 ext. 002

References

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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.

Reference Type BACKGROUND
PMID: 15180890 (View on PubMed)

Other Identifiers

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17200278

Identifier Type: -

Identifier Source: org_study_id

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