Healthy Volunteers Clinical Trial
— BregOfficial title:
Characterization of B Regulatory (Breg) Cells in Healthy Subjects and in Rheumatoid Arthritis (RA)
NCT number | NCT02615951 |
Other study ID # | 9461 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2, 2015 |
Est. completion date | September 10, 2018 |
Verified date | December 2021 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 10, 2018 |
Est. primary completion date | September 10, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - RA responding to ACR/EULAR 2010 criteria Exclusion Criteria: - steroid> 10 mg/d - previous use of biological disease-modifying antirheumatic drug (DMARD) - age<18 years |
Country | Name | City | State |
---|---|---|---|
France | Regional University Hospital | Montpellier | Hérault |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | Centre Hospitalier Universitaire de Nimes, Institut de Génétique Moléculaire de Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 | ||
Secondary | : 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 | ||
Secondary | 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 |
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