Characterization of the Phenotypic Markers of B Cell Lymphocytes in Rheumatoid Arthritis
1 other identifier
observational
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2019
CompletedStudy Start
First participant enrolled
January 3, 2019
CompletedFirst Posted
Study publicly available on registry
January 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2020
CompletedJanuary 4, 2019
January 1, 2019
8 months
January 1, 2019
January 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
patients
1\. Group 1: 30 diseased with Early Rheumatoid Arthritis from 6months to 1 year). drugs described in the clinic.
patients 2
2\. Group 2: 30 diseased with late/chronic Rheumatoid Arthritis. drugs described in the clinic.
healthy donors
3\. Group 3: 30 healthy controls. No drugs.
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- Patient diagnosed as Rheumatoid arthritis that fulfilled ACR/EULAR Criteria (American College of Rheumatology/European League Against Rheumatism).
- (8) Age \>18 Years.
You may not qualify if:
- Diagnosed patients with other autoimmune disease or other infections.
- Pregnant patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 15180890BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
January 1, 2019
First Posted
January 4, 2019
Study Start
January 3, 2019
Primary Completion
August 20, 2019
Study Completion
August 20, 2020
Last Updated
January 4, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share