Characterization of Breg Cells
Breg
Characterization of B Regulatory (Breg) Cells in Healthy Subjects and in Rheumatoid Arthritis (RA)
1 other identifier
interventional
100
1 country
1
Brief Summary
Recently, it has been shown that B cells could also have regulatory functions through the secretion of interleukin 10 (IL-10). They are called the B regulatory cells (Breg). In the mouse model the most commonly used of rheumatoid arthritis, collagen-induced arthritis (CIA), the transfer Breg helps prevent the development of CIA and cure established arthritis. The investigators have recently shown that Breg were decreased in patients with RA compared to controls and that the rate of Breg was inversely correlated with disease activity and autoantibody. These results thus suggest that the lack of IL-10 secretion by B cells plays an important role in the pathophysiology of RA. Nevertheless, in humans, the Breg remain poorly understood. The main objective of this project is to better characterize the B capable of producing IL-10 both in subjects with RA and controls. Understanding which induces the secretion of IL-10 by B could allow to consider new therapeutic approaches in autoimmune diseases, including in RA. The investigators therefore aim to identify nutrient transporters, chemokine receptors, genes and surface proteins differentially expressed between Breg and other B cells in patients with RA and in controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy-volunteers
Started Oct 2015
Longer than P75 for not_applicable healthy-volunteers
1 active site
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
May 28, 2015
CompletedStudy Start
First participant enrolled
October 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2018
CompletedDecember 29, 2021
December 1, 2021
2.9 years
May 28, 2015
December 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identification of nutrient transporters' and of chemokine receptors' differentially expressed between Breg and other B cells in patients with RA
Comparison between Breg (B IL-10+) and IL-10 non secreting B lymphocytes (B IL-10 -) in RA patient of : * Medium fluorescence intensity of B lymphocytes for ASCT2, Glut1, PiT1, PiT2, RFT1\&3 * Percentage of B lymphocytes expressing chemokine receptors CCR4, CCR7, CCR9, CXCR3, CXCR4 and CXCR5
after analysis of the blood sample from the subject selected for the primary outcome mesure. Estimated at half a year after subject recruitement started
Secondary Outcomes (4)
Identification of genes and surface receptors expressed differentially between Breg and others B cells in patients with RA
Estimated at 6 month after end of subject recruitement
Identification of nutrient transporters and chemokine receptors expressed differentially between Breg and others B cells in control patients
Estimated at 6 month after end of subject recruitement
: Identification of genes and surface receptors expressed differentially between Breg and others B cells in control patients
Estimated at 6 month after end of subject recruitement
Comparison of nutrient transporters, chemokine receptors, gene and protein surface expression expressed between Breg in patients with RA and Breg in control patients
Estimated at 6 month after end of subject recruitement
Study Arms (5)
Nutrient transporters study
OTHERBlood sampling from 10 patients vith RA and 10 control patient for biological analysis and measure of nutrient transporters expression
Chemokine receptors study
OTHERBlood sampling from 10 patients vith RA and 10 control patient for biological analysis and measure of chemokine receptors expression
Genes study
OTHERBlood sampling from 10 patients vith RA and 10 control patient for biological analysis and measure of genes expression
Protein surface study
OTHERBlood sampling from 10 patients vith RA and 10 control patient for biological analysis and measure of protein surface expression
Protein surface & genes data validation
OTHERBlood sampling from 10 patients vith RA and 10 control patient for biological analysis and measure for validation of the data from "protein surface study" and "genes study" arms analysis.
Interventions
Blood sample retrieval for biological and genetic analysis and comparison
Eligibility Criteria
You may qualify if:
- RA responding to ACR/EULAR 2010 criteria
You may not qualify if:
- steroid\> 10 mg/d
- previous use of biological disease-modifying antirheumatic drug (DMARD)
- age\<18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Regional University Hospital
Montpellier, Hérault, 34295, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire I Daien, MD PhD
Montpellier teaching hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2015
First Posted
November 26, 2015
Study Start
October 2, 2015
Primary Completion
September 10, 2018
Study Completion
September 10, 2018
Last Updated
December 29, 2021
Record last verified: 2021-12