NCT02615951

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

October 2, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2018

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

2.9 years

First QC Date

May 28, 2015

Last Update Submit

December 28, 2021

Conditions

Keywords

Regulatory B cells (Breg)GenesCell surface proteinsNutrient transportersChemokine receptors

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

OTHER

Blood sampling from 10 patients vith RA and 10 control patient for biological analysis and measure of nutrient transporters expression

Other: blood sampling

Chemokine receptors study

OTHER

Blood sampling from 10 patients vith RA and 10 control patient for biological analysis and measure of chemokine receptors expression

Other: blood sampling

Genes study

OTHER

Blood sampling from 10 patients vith RA and 10 control patient for biological analysis and measure of genes expression

Other: blood sampling

Protein surface study

OTHER

Blood sampling from 10 patients vith RA and 10 control patient for biological analysis and measure of protein surface expression

Other: blood sampling

Protein surface & genes data validation

OTHER

Blood 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.

Other: blood sampling

Interventions

Blood sample retrieval for biological and genetic analysis and comparison

Chemokine receptors studyGenes studyNutrient transporters studyProtein surface & genes data validationProtein surface study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Claire I Daien, MD PhD

    Montpellier teaching hospital

    PRINCIPAL INVESTIGATOR

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

Locations